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CDC: Vaccinated people can mostly drop masks outdoors
After hinting that new guidelines on outdoor mask-wearing were coming, the Centers for Disease Control and Prevention on April 27 officially gave a green light to fully vaccinated people gathering outside in uncrowded activities without the masks that have become so common during the COVID-19 pandemic.
It is a minor – but still significant – step toward the end of pandemic restrictions.
“Over the past year, we have spent a lot of time telling Americans what they cannot do, what they should not do,” CDC director Rochelle Walensky, MD, MPH, said at a White House press briefing. “Today, I’m going to tell you some of the things you can do if you are fully vaccinated.”
President Joe Biden affirmed the new guidelines at a press conference soon after the CDC briefing ended.
,” he said, adding “the bottom line is clear: If you’re vaccinated, you can do more things, more safely, both outdoors as well as indoors.”
President Biden emphasized the role science played in the decision, saying “The CDC is able to make this announcement because our scientists are convinced by the data that the odds of getting or giving the virus to others is very, very low if you’ve both been fully vaccinated and are out in the open air.”
President Biden also said these new guidelines should be an incentive for more people to get vaccinated. “This is another great reason to go get vaccinated now. Now,” he said.
The CDC has long advised that outdoor activities are safer than indoor activities.
“Most of transmission is happening indoors rather than outdoors. Less than 10% of documented transmissions in many studies have occurred outdoors,” said Dr. Walensky. “We also know there’s almost a 20-fold increased risk of transmission in the indoor setting, than the outdoor setting.”
Dr. Walensky said the lower risks outdoors, combined with growing vaccination coverage and falling COVID cases around the country, motivated the change.
The new guidelines come as the share of people in the United States who are vaccinated is growing. About 37% of all eligible Americans are fully vaccinated, according to the CDC. Nearly 54% have had at least one dose.
The new guidelines say unvaccinated people should continue to wear masks outdoors when gathering with others or dining at an outdoor restaurant.
And vaccinated people should continue to wear masks outdoors in crowded settings where social distancing might not always be possible, like a concert or sporting event. People are considered fully vaccinated when they are 2 weeks past their last shot
The CDC guidelines say people who live in the same house don’t need to wear masks if they’re exercising or hanging out together outdoors.
You also don’t need a mask if you’re attending a small, outdoor gathering with fully vaccinated family and friends, whether you’re vaccinated or not.
The new guidelines also say it’s OK for fully vaccinated people to take their masks off outdoors when gathering in a small group of vaccinated and unvaccinated people, but suggest that unvaccinated people should still wear a mask.
Reporter Marcia Frellick contributed to this report.
A version of this article originally appeared on WebMD.com.
After hinting that new guidelines on outdoor mask-wearing were coming, the Centers for Disease Control and Prevention on April 27 officially gave a green light to fully vaccinated people gathering outside in uncrowded activities without the masks that have become so common during the COVID-19 pandemic.
It is a minor – but still significant – step toward the end of pandemic restrictions.
“Over the past year, we have spent a lot of time telling Americans what they cannot do, what they should not do,” CDC director Rochelle Walensky, MD, MPH, said at a White House press briefing. “Today, I’m going to tell you some of the things you can do if you are fully vaccinated.”
President Joe Biden affirmed the new guidelines at a press conference soon after the CDC briefing ended.
,” he said, adding “the bottom line is clear: If you’re vaccinated, you can do more things, more safely, both outdoors as well as indoors.”
President Biden emphasized the role science played in the decision, saying “The CDC is able to make this announcement because our scientists are convinced by the data that the odds of getting or giving the virus to others is very, very low if you’ve both been fully vaccinated and are out in the open air.”
President Biden also said these new guidelines should be an incentive for more people to get vaccinated. “This is another great reason to go get vaccinated now. Now,” he said.
The CDC has long advised that outdoor activities are safer than indoor activities.
“Most of transmission is happening indoors rather than outdoors. Less than 10% of documented transmissions in many studies have occurred outdoors,” said Dr. Walensky. “We also know there’s almost a 20-fold increased risk of transmission in the indoor setting, than the outdoor setting.”
Dr. Walensky said the lower risks outdoors, combined with growing vaccination coverage and falling COVID cases around the country, motivated the change.
The new guidelines come as the share of people in the United States who are vaccinated is growing. About 37% of all eligible Americans are fully vaccinated, according to the CDC. Nearly 54% have had at least one dose.
The new guidelines say unvaccinated people should continue to wear masks outdoors when gathering with others or dining at an outdoor restaurant.
And vaccinated people should continue to wear masks outdoors in crowded settings where social distancing might not always be possible, like a concert or sporting event. People are considered fully vaccinated when they are 2 weeks past their last shot
The CDC guidelines say people who live in the same house don’t need to wear masks if they’re exercising or hanging out together outdoors.
You also don’t need a mask if you’re attending a small, outdoor gathering with fully vaccinated family and friends, whether you’re vaccinated or not.
The new guidelines also say it’s OK for fully vaccinated people to take their masks off outdoors when gathering in a small group of vaccinated and unvaccinated people, but suggest that unvaccinated people should still wear a mask.
Reporter Marcia Frellick contributed to this report.
A version of this article originally appeared on WebMD.com.
After hinting that new guidelines on outdoor mask-wearing were coming, the Centers for Disease Control and Prevention on April 27 officially gave a green light to fully vaccinated people gathering outside in uncrowded activities without the masks that have become so common during the COVID-19 pandemic.
It is a minor – but still significant – step toward the end of pandemic restrictions.
“Over the past year, we have spent a lot of time telling Americans what they cannot do, what they should not do,” CDC director Rochelle Walensky, MD, MPH, said at a White House press briefing. “Today, I’m going to tell you some of the things you can do if you are fully vaccinated.”
President Joe Biden affirmed the new guidelines at a press conference soon after the CDC briefing ended.
,” he said, adding “the bottom line is clear: If you’re vaccinated, you can do more things, more safely, both outdoors as well as indoors.”
President Biden emphasized the role science played in the decision, saying “The CDC is able to make this announcement because our scientists are convinced by the data that the odds of getting or giving the virus to others is very, very low if you’ve both been fully vaccinated and are out in the open air.”
President Biden also said these new guidelines should be an incentive for more people to get vaccinated. “This is another great reason to go get vaccinated now. Now,” he said.
The CDC has long advised that outdoor activities are safer than indoor activities.
“Most of transmission is happening indoors rather than outdoors. Less than 10% of documented transmissions in many studies have occurred outdoors,” said Dr. Walensky. “We also know there’s almost a 20-fold increased risk of transmission in the indoor setting, than the outdoor setting.”
Dr. Walensky said the lower risks outdoors, combined with growing vaccination coverage and falling COVID cases around the country, motivated the change.
The new guidelines come as the share of people in the United States who are vaccinated is growing. About 37% of all eligible Americans are fully vaccinated, according to the CDC. Nearly 54% have had at least one dose.
The new guidelines say unvaccinated people should continue to wear masks outdoors when gathering with others or dining at an outdoor restaurant.
And vaccinated people should continue to wear masks outdoors in crowded settings where social distancing might not always be possible, like a concert or sporting event. People are considered fully vaccinated when they are 2 weeks past their last shot
The CDC guidelines say people who live in the same house don’t need to wear masks if they’re exercising or hanging out together outdoors.
You also don’t need a mask if you’re attending a small, outdoor gathering with fully vaccinated family and friends, whether you’re vaccinated or not.
The new guidelines also say it’s OK for fully vaccinated people to take their masks off outdoors when gathering in a small group of vaccinated and unvaccinated people, but suggest that unvaccinated people should still wear a mask.
Reporter Marcia Frellick contributed to this report.
A version of this article originally appeared on WebMD.com.
Pfizer and Moderna vaccines appear safe, effective during pregnancy
The Pfizer and Moderna COVID-19 vaccines appear to be safe in pregnant patients, according to preliminary findings published in the New England Journal of Medicine.
The Centers for Disease Control and Prevention have said pregnant people have an increased risk of being severely ill from COVID-19; however, this group was excluded from major clinical trials that led up to the current vaccine approvals.
But based on the new findings, Rochelle Walensky, MD, director of the CDC, announced during a White House COVID-19 briefing that the CDC recommends that pregnant people receive the COVID-19 vaccine.
The new study, which analyzed data between Dec. 14, 2020, and Feb. 28, 2021, from three federal databases, adds to a pool of limited data about the safety and efficacy of the vaccine in pregnant persons. Researchers did not include people who received the Johnson & Johnson vaccine because it received emergency use authorization on Feb. 27, just 1 day before they study’s cutoff.
“Our hope is that these initial data will be reassuring to pregnant people and their health care providers as well as the public, and contribute to increasing vaccination rates,” study author Christine Olson, MD, said in an interview. “While the data are preliminary and will continue to be analyzed as more reports become available, our findings are reassuring.”
For the study, Dr. Olson and colleagues analyzed v-safe survey data, data from those enrolled in the v-safe pregnancy registry, and Vaccine Adverse Event Reporting System (VAERS) reports.
Researchers found that 86% of pregnancies resulted in a live birth, 12.6 % resulted in spontaneous abortions, and 0.1% resulted in stillbirth. They also found that, among the live births, 9.4% were preterm, 3.2% of babies were small for their gestational age, and 2.2% had congenital anomalies.
Researchers also found that injection-site pain, fatigue, and headaches were reported more frequently in pregnant patients than among those who were not pregnant. Among VAERS reports, they found that 70% of adverse events were nonpregnancy specific. Nearly 30% involved pregnancy- or neonatal-specific adverse events. The most frequently reported pregnancy-related events were spontaneous abortions, followed by stillbirths, premature rupture of membranes and vaginal bleeding.
“I think the results are actually quite reassuring as the proportion of the pregnancy outcomes, such as pregnancy loss and health effects to the newborns, are really quite consistent with what we’d expect in the background rate of the population,” Dr. Walensky said in a podcast accompanying the study. “So this study adds to growing evidence confirming that pregnant people develop a robust immune response to COVID-19 vaccination without so far seeing any adverse events to the mom or the fetus.”
Researchers said limitations of the study include the accuracy of self-reported data, and there being limited information on other potential risk factors for adverse pregnancies and neonatal outcomes. They acknowledged that continuous monitoring is needed to look at maternal safety and pregnancy outcomes in earlier stages of pregnancy and during the preconception period.
David Jaspan, DO, chair of the department of obstetrics and gynecology at Einstein Medical Center, Philadelphia, who was not involved with the study, said in an interview that, despite the limitations, the study provides much-needed insight on the vaccine’s safety and efficacy in pregnant patients.
“In December we had no data for any pregnant patient,” Dr. Jaspan said. “And now just 4 short months later, this paper [has data from] at least had 35,000 people. We can’t answer every question, but we have more answers today than we had just 4 months ago.”
Dr. Olson hopes the present data is enough to help inform decision-making of pregnant patients and their health care providers when it comes to deciding to get the COVID-19 vaccination.
The study author and experts interviewed disclosed no relevant financial relationships.
The Pfizer and Moderna COVID-19 vaccines appear to be safe in pregnant patients, according to preliminary findings published in the New England Journal of Medicine.
The Centers for Disease Control and Prevention have said pregnant people have an increased risk of being severely ill from COVID-19; however, this group was excluded from major clinical trials that led up to the current vaccine approvals.
But based on the new findings, Rochelle Walensky, MD, director of the CDC, announced during a White House COVID-19 briefing that the CDC recommends that pregnant people receive the COVID-19 vaccine.
The new study, which analyzed data between Dec. 14, 2020, and Feb. 28, 2021, from three federal databases, adds to a pool of limited data about the safety and efficacy of the vaccine in pregnant persons. Researchers did not include people who received the Johnson & Johnson vaccine because it received emergency use authorization on Feb. 27, just 1 day before they study’s cutoff.
“Our hope is that these initial data will be reassuring to pregnant people and their health care providers as well as the public, and contribute to increasing vaccination rates,” study author Christine Olson, MD, said in an interview. “While the data are preliminary and will continue to be analyzed as more reports become available, our findings are reassuring.”
For the study, Dr. Olson and colleagues analyzed v-safe survey data, data from those enrolled in the v-safe pregnancy registry, and Vaccine Adverse Event Reporting System (VAERS) reports.
Researchers found that 86% of pregnancies resulted in a live birth, 12.6 % resulted in spontaneous abortions, and 0.1% resulted in stillbirth. They also found that, among the live births, 9.4% were preterm, 3.2% of babies were small for their gestational age, and 2.2% had congenital anomalies.
Researchers also found that injection-site pain, fatigue, and headaches were reported more frequently in pregnant patients than among those who were not pregnant. Among VAERS reports, they found that 70% of adverse events were nonpregnancy specific. Nearly 30% involved pregnancy- or neonatal-specific adverse events. The most frequently reported pregnancy-related events were spontaneous abortions, followed by stillbirths, premature rupture of membranes and vaginal bleeding.
“I think the results are actually quite reassuring as the proportion of the pregnancy outcomes, such as pregnancy loss and health effects to the newborns, are really quite consistent with what we’d expect in the background rate of the population,” Dr. Walensky said in a podcast accompanying the study. “So this study adds to growing evidence confirming that pregnant people develop a robust immune response to COVID-19 vaccination without so far seeing any adverse events to the mom or the fetus.”
Researchers said limitations of the study include the accuracy of self-reported data, and there being limited information on other potential risk factors for adverse pregnancies and neonatal outcomes. They acknowledged that continuous monitoring is needed to look at maternal safety and pregnancy outcomes in earlier stages of pregnancy and during the preconception period.
David Jaspan, DO, chair of the department of obstetrics and gynecology at Einstein Medical Center, Philadelphia, who was not involved with the study, said in an interview that, despite the limitations, the study provides much-needed insight on the vaccine’s safety and efficacy in pregnant patients.
“In December we had no data for any pregnant patient,” Dr. Jaspan said. “And now just 4 short months later, this paper [has data from] at least had 35,000 people. We can’t answer every question, but we have more answers today than we had just 4 months ago.”
Dr. Olson hopes the present data is enough to help inform decision-making of pregnant patients and their health care providers when it comes to deciding to get the COVID-19 vaccination.
The study author and experts interviewed disclosed no relevant financial relationships.
The Pfizer and Moderna COVID-19 vaccines appear to be safe in pregnant patients, according to preliminary findings published in the New England Journal of Medicine.
The Centers for Disease Control and Prevention have said pregnant people have an increased risk of being severely ill from COVID-19; however, this group was excluded from major clinical trials that led up to the current vaccine approvals.
But based on the new findings, Rochelle Walensky, MD, director of the CDC, announced during a White House COVID-19 briefing that the CDC recommends that pregnant people receive the COVID-19 vaccine.
The new study, which analyzed data between Dec. 14, 2020, and Feb. 28, 2021, from three federal databases, adds to a pool of limited data about the safety and efficacy of the vaccine in pregnant persons. Researchers did not include people who received the Johnson & Johnson vaccine because it received emergency use authorization on Feb. 27, just 1 day before they study’s cutoff.
“Our hope is that these initial data will be reassuring to pregnant people and their health care providers as well as the public, and contribute to increasing vaccination rates,” study author Christine Olson, MD, said in an interview. “While the data are preliminary and will continue to be analyzed as more reports become available, our findings are reassuring.”
For the study, Dr. Olson and colleagues analyzed v-safe survey data, data from those enrolled in the v-safe pregnancy registry, and Vaccine Adverse Event Reporting System (VAERS) reports.
Researchers found that 86% of pregnancies resulted in a live birth, 12.6 % resulted in spontaneous abortions, and 0.1% resulted in stillbirth. They also found that, among the live births, 9.4% were preterm, 3.2% of babies were small for their gestational age, and 2.2% had congenital anomalies.
Researchers also found that injection-site pain, fatigue, and headaches were reported more frequently in pregnant patients than among those who were not pregnant. Among VAERS reports, they found that 70% of adverse events were nonpregnancy specific. Nearly 30% involved pregnancy- or neonatal-specific adverse events. The most frequently reported pregnancy-related events were spontaneous abortions, followed by stillbirths, premature rupture of membranes and vaginal bleeding.
“I think the results are actually quite reassuring as the proportion of the pregnancy outcomes, such as pregnancy loss and health effects to the newborns, are really quite consistent with what we’d expect in the background rate of the population,” Dr. Walensky said in a podcast accompanying the study. “So this study adds to growing evidence confirming that pregnant people develop a robust immune response to COVID-19 vaccination without so far seeing any adverse events to the mom or the fetus.”
Researchers said limitations of the study include the accuracy of self-reported data, and there being limited information on other potential risk factors for adverse pregnancies and neonatal outcomes. They acknowledged that continuous monitoring is needed to look at maternal safety and pregnancy outcomes in earlier stages of pregnancy and during the preconception period.
David Jaspan, DO, chair of the department of obstetrics and gynecology at Einstein Medical Center, Philadelphia, who was not involved with the study, said in an interview that, despite the limitations, the study provides much-needed insight on the vaccine’s safety and efficacy in pregnant patients.
“In December we had no data for any pregnant patient,” Dr. Jaspan said. “And now just 4 short months later, this paper [has data from] at least had 35,000 people. We can’t answer every question, but we have more answers today than we had just 4 months ago.”
Dr. Olson hopes the present data is enough to help inform decision-making of pregnant patients and their health care providers when it comes to deciding to get the COVID-19 vaccination.
The study author and experts interviewed disclosed no relevant financial relationships.
FROM THE NEW ENGLAND JOURNAL OF MEDICINE
More reassurance for certain antiseizure drugs in pregnancy
Further evidence supporting the safety of two antiseizure medications in pregnancy has come from a new study. Most of the women with epilepsy in the study took either lamotrigine or levetiracetam, or a combination of the two, during their pregnancy.
However, a secondary analysis suggested a possible signal of exposure-dependent effects on child outcomes – worse outcomes with higher exposure levels – with levetiracetam.
The results were presented at the American Academy of Neurology’s 2021 annual meeting.
Additional reassurance
“Our new study adds confidence to the use of lamotrigine and levetiracetam during pregnancy, adding larger numbers with a new cohort. In addition, it provides some preliminary data on some of the other new antiseizure medications, and it is the first study to address the effects of clearance in pregnancy to better assess exposure,” said lead investigator, Kimford J. Meador, MD. “Overall, I am reassured by this data, but there is still a lot that is unknown,” he added.
“Our main results show no difference in verbal index or general conceptual ability scores in children born to women with epilepsy compared to children born to healthy women. This is a big positive message,” Dr. Meador said.
In terms of secondary analysis focusing on exposure levels (dose and blood levels of antiseizure medications), there was no overall signal of harm when looking at the whole group, but when the researchers analyzed the data on individual drugs, they found a “slight signal” toward reduced verbal index scores with increasing exposure levels with levetiracetam. No differences were seen on general conceptual ability.
“In the secondary analysis, there was a marginal signal for exposure levels with levetiracetam, with increased blood levels of the drug associated with reduced verbal index scores,” reported Dr. Meador, professor of neurology and neurological sciences at Stanford (Calif.) University. “We saw some signal in the children when they were 2 years old, and this was still there but not as striking at 3 years old.”
He said these secondary results should be interpreted with extreme caution. “We don’t want to overemphasize these secondary findings, as the primary outcome showed no difference, and there was no effect on exposure levels when looking at all the drugs together. I don’t want to oversimplify this, as I am still not sure whether this is a real association or not,” Dr. Meador commented.
He explained that conducting neurobehavioral tests on 2- and 3-year-olds was very difficult. “It is more of an art form than science, and as the children get older these signals often dissipate. We will know more by the time they are 6, when these tests become easier to conduct,” he said. He also noted that the results would need to be replicated in a different cohort.
“I don’t think these results would change how we manage women during pregnancy in terms of using levetiracetam. It is still a safe drug during pregnancy,” Dr. Meador said.
He pointed out that data on safety in pregnancy is only available for very few antiseizure drugs. “There are over 30 antiseizure medications, but we have adequate data in pregnancy on only a handful. We have data suggesting lamotrigine, levetiracetam, and carbamazepine appear to be relatively safe, and evidence showing phenobarbital and valproate are not safe.”
Antiseizure medications as a class are among the most commonly prescribed teratogenic drugs given to women of childbearing age, Dr. Meador noted. They are used not only for epilepsy but also for many other psychiatric and pain indications, so these results are applicable to quite a broad population, he added.
He pointed out that previous studies did not assess exposure using blood levels, which is important, as clearance of drug increases during pregnancy but varies across antiseizure medications and across individuals on the same drug. “Thus, it is unclear if these changes could obscure exposure-dependent effects. Our present studies assessed blood levels to better measure fetal exposure.”
Advice for pregnant patients with epilepsy
Dr. Meador explained that risk for adverse effects with antiseizure medication always needs to be balanced with risk for seizures if the medication was not used.
“In women planning a pregnancy, we recommend that they plan ahead with their physician to try and use the safest antiseizure medication and gain good control beforehand and then maintain the same blood levels of whichever drug is being used during pregnancy,” Dr. Meador said. “At present, lamotrigine and levetiracetam are the two safest drugs to use in pregnancy. They both look generally very safe compared with some other epilepsy drugs – such as valproate, which poses a serious risk to cognitive and behavioral development.”
He also advised that women should be taking folic acid regularly, as this has been shown to be related to improved cognitive and behavioral outcomes. “Since half of pregnancies are not planned, it is important to take these actions before pregnancy,” he added.
The current study involved 289 women with epilepsy and 89 women without epilepsy, all of whom enrolled in the study during pregnancy. Use of antiseizure medications was recorded. Of the women with epilepsy, 74% were on monotherapy, with 43% on lamotrigine and 37% on levetiracetam. There were 4% who took no drug and 22% took more than one drug. Of those who took more than one drug, close to half took a combination of lamotrigine and levetiracetam. Levels of medications in the blood of the women with epilepsy were measured in the third trimester.
Assessment of neurobehavioral development
For the current analysis, the children were evaluated at age 3 with a series of cognitive and developmental tests that measured vocabulary, listening comprehension, number recall, and pattern recognition, and results were adjusted for mother’s IQ, education level, age at enrollment, postbirth average BAI (Beck Anxiety Inventory score), and child’s ethnicity, sex, and breastfeeding status.
The primary outcome showed that verbal Index scores at age 3 did not differ for children of women with epilepsy versus those for children of women without epilepsy (LS mean 102.7 vs. 102.1).
Antiseizure medication exposure as evident by the maximum third trimester blood levels was not related to verbal index scores (n = 265; adjusted parameter estimate, -1.9; 95% confidence interval, -6.8 to 3.1).
General conceptual ability scores also did not differ between the two groups: 105.1 for children of women with epilepsy versus 103.5 for children of healthy women.
In terms of exposure levels, the third trimester maximum observed ratio of antiseizure medication blood levels was not significantly associated with adjusted general conceptual ability scores for children of women with epilepsy; neither were monotherapies or polytherapies evaluated separately, Dr. Meador reported.
However, when the verbal index scores for the main antiepileptic drug groups were analyzed separately, exposure level to levetiracetam was the only one that was significant, with a P value of .028. But Dr. Meador again stressed that this finding should be interpreted with caution given that it is a secondary exploratory analysis without control for multiple comparisons.
The researchers plan to assess these children at older ages where evaluations are more sensitive to ultimate outcomes.
“Information on use in pregnancy for most antiseizure medications is still unknown, so further studies to assess risks for the newer antiseizure medications are needed,” Dr. Meador added. “Further, additional research is needed on the underlying mechanisms including genetic predispositions, since teratogens act on a susceptible genotype.”
The study was supported by the National Institutes of Health, the National Institute of Neurological Disorders and Stroke, and the Eunice Kennedy Shriver National Institute of Child Health and Human Development.
A version of this article first appeared on Medscape.com.
Further evidence supporting the safety of two antiseizure medications in pregnancy has come from a new study. Most of the women with epilepsy in the study took either lamotrigine or levetiracetam, or a combination of the two, during their pregnancy.
However, a secondary analysis suggested a possible signal of exposure-dependent effects on child outcomes – worse outcomes with higher exposure levels – with levetiracetam.
The results were presented at the American Academy of Neurology’s 2021 annual meeting.
Additional reassurance
“Our new study adds confidence to the use of lamotrigine and levetiracetam during pregnancy, adding larger numbers with a new cohort. In addition, it provides some preliminary data on some of the other new antiseizure medications, and it is the first study to address the effects of clearance in pregnancy to better assess exposure,” said lead investigator, Kimford J. Meador, MD. “Overall, I am reassured by this data, but there is still a lot that is unknown,” he added.
“Our main results show no difference in verbal index or general conceptual ability scores in children born to women with epilepsy compared to children born to healthy women. This is a big positive message,” Dr. Meador said.
In terms of secondary analysis focusing on exposure levels (dose and blood levels of antiseizure medications), there was no overall signal of harm when looking at the whole group, but when the researchers analyzed the data on individual drugs, they found a “slight signal” toward reduced verbal index scores with increasing exposure levels with levetiracetam. No differences were seen on general conceptual ability.
“In the secondary analysis, there was a marginal signal for exposure levels with levetiracetam, with increased blood levels of the drug associated with reduced verbal index scores,” reported Dr. Meador, professor of neurology and neurological sciences at Stanford (Calif.) University. “We saw some signal in the children when they were 2 years old, and this was still there but not as striking at 3 years old.”
He said these secondary results should be interpreted with extreme caution. “We don’t want to overemphasize these secondary findings, as the primary outcome showed no difference, and there was no effect on exposure levels when looking at all the drugs together. I don’t want to oversimplify this, as I am still not sure whether this is a real association or not,” Dr. Meador commented.
He explained that conducting neurobehavioral tests on 2- and 3-year-olds was very difficult. “It is more of an art form than science, and as the children get older these signals often dissipate. We will know more by the time they are 6, when these tests become easier to conduct,” he said. He also noted that the results would need to be replicated in a different cohort.
“I don’t think these results would change how we manage women during pregnancy in terms of using levetiracetam. It is still a safe drug during pregnancy,” Dr. Meador said.
He pointed out that data on safety in pregnancy is only available for very few antiseizure drugs. “There are over 30 antiseizure medications, but we have adequate data in pregnancy on only a handful. We have data suggesting lamotrigine, levetiracetam, and carbamazepine appear to be relatively safe, and evidence showing phenobarbital and valproate are not safe.”
Antiseizure medications as a class are among the most commonly prescribed teratogenic drugs given to women of childbearing age, Dr. Meador noted. They are used not only for epilepsy but also for many other psychiatric and pain indications, so these results are applicable to quite a broad population, he added.
He pointed out that previous studies did not assess exposure using blood levels, which is important, as clearance of drug increases during pregnancy but varies across antiseizure medications and across individuals on the same drug. “Thus, it is unclear if these changes could obscure exposure-dependent effects. Our present studies assessed blood levels to better measure fetal exposure.”
Advice for pregnant patients with epilepsy
Dr. Meador explained that risk for adverse effects with antiseizure medication always needs to be balanced with risk for seizures if the medication was not used.
“In women planning a pregnancy, we recommend that they plan ahead with their physician to try and use the safest antiseizure medication and gain good control beforehand and then maintain the same blood levels of whichever drug is being used during pregnancy,” Dr. Meador said. “At present, lamotrigine and levetiracetam are the two safest drugs to use in pregnancy. They both look generally very safe compared with some other epilepsy drugs – such as valproate, which poses a serious risk to cognitive and behavioral development.”
He also advised that women should be taking folic acid regularly, as this has been shown to be related to improved cognitive and behavioral outcomes. “Since half of pregnancies are not planned, it is important to take these actions before pregnancy,” he added.
The current study involved 289 women with epilepsy and 89 women without epilepsy, all of whom enrolled in the study during pregnancy. Use of antiseizure medications was recorded. Of the women with epilepsy, 74% were on monotherapy, with 43% on lamotrigine and 37% on levetiracetam. There were 4% who took no drug and 22% took more than one drug. Of those who took more than one drug, close to half took a combination of lamotrigine and levetiracetam. Levels of medications in the blood of the women with epilepsy were measured in the third trimester.
Assessment of neurobehavioral development
For the current analysis, the children were evaluated at age 3 with a series of cognitive and developmental tests that measured vocabulary, listening comprehension, number recall, and pattern recognition, and results were adjusted for mother’s IQ, education level, age at enrollment, postbirth average BAI (Beck Anxiety Inventory score), and child’s ethnicity, sex, and breastfeeding status.
The primary outcome showed that verbal Index scores at age 3 did not differ for children of women with epilepsy versus those for children of women without epilepsy (LS mean 102.7 vs. 102.1).
Antiseizure medication exposure as evident by the maximum third trimester blood levels was not related to verbal index scores (n = 265; adjusted parameter estimate, -1.9; 95% confidence interval, -6.8 to 3.1).
General conceptual ability scores also did not differ between the two groups: 105.1 for children of women with epilepsy versus 103.5 for children of healthy women.
In terms of exposure levels, the third trimester maximum observed ratio of antiseizure medication blood levels was not significantly associated with adjusted general conceptual ability scores for children of women with epilepsy; neither were monotherapies or polytherapies evaluated separately, Dr. Meador reported.
However, when the verbal index scores for the main antiepileptic drug groups were analyzed separately, exposure level to levetiracetam was the only one that was significant, with a P value of .028. But Dr. Meador again stressed that this finding should be interpreted with caution given that it is a secondary exploratory analysis without control for multiple comparisons.
The researchers plan to assess these children at older ages where evaluations are more sensitive to ultimate outcomes.
“Information on use in pregnancy for most antiseizure medications is still unknown, so further studies to assess risks for the newer antiseizure medications are needed,” Dr. Meador added. “Further, additional research is needed on the underlying mechanisms including genetic predispositions, since teratogens act on a susceptible genotype.”
The study was supported by the National Institutes of Health, the National Institute of Neurological Disorders and Stroke, and the Eunice Kennedy Shriver National Institute of Child Health and Human Development.
A version of this article first appeared on Medscape.com.
Further evidence supporting the safety of two antiseizure medications in pregnancy has come from a new study. Most of the women with epilepsy in the study took either lamotrigine or levetiracetam, or a combination of the two, during their pregnancy.
However, a secondary analysis suggested a possible signal of exposure-dependent effects on child outcomes – worse outcomes with higher exposure levels – with levetiracetam.
The results were presented at the American Academy of Neurology’s 2021 annual meeting.
Additional reassurance
“Our new study adds confidence to the use of lamotrigine and levetiracetam during pregnancy, adding larger numbers with a new cohort. In addition, it provides some preliminary data on some of the other new antiseizure medications, and it is the first study to address the effects of clearance in pregnancy to better assess exposure,” said lead investigator, Kimford J. Meador, MD. “Overall, I am reassured by this data, but there is still a lot that is unknown,” he added.
“Our main results show no difference in verbal index or general conceptual ability scores in children born to women with epilepsy compared to children born to healthy women. This is a big positive message,” Dr. Meador said.
In terms of secondary analysis focusing on exposure levels (dose and blood levels of antiseizure medications), there was no overall signal of harm when looking at the whole group, but when the researchers analyzed the data on individual drugs, they found a “slight signal” toward reduced verbal index scores with increasing exposure levels with levetiracetam. No differences were seen on general conceptual ability.
“In the secondary analysis, there was a marginal signal for exposure levels with levetiracetam, with increased blood levels of the drug associated with reduced verbal index scores,” reported Dr. Meador, professor of neurology and neurological sciences at Stanford (Calif.) University. “We saw some signal in the children when they were 2 years old, and this was still there but not as striking at 3 years old.”
He said these secondary results should be interpreted with extreme caution. “We don’t want to overemphasize these secondary findings, as the primary outcome showed no difference, and there was no effect on exposure levels when looking at all the drugs together. I don’t want to oversimplify this, as I am still not sure whether this is a real association or not,” Dr. Meador commented.
He explained that conducting neurobehavioral tests on 2- and 3-year-olds was very difficult. “It is more of an art form than science, and as the children get older these signals often dissipate. We will know more by the time they are 6, when these tests become easier to conduct,” he said. He also noted that the results would need to be replicated in a different cohort.
“I don’t think these results would change how we manage women during pregnancy in terms of using levetiracetam. It is still a safe drug during pregnancy,” Dr. Meador said.
He pointed out that data on safety in pregnancy is only available for very few antiseizure drugs. “There are over 30 antiseizure medications, but we have adequate data in pregnancy on only a handful. We have data suggesting lamotrigine, levetiracetam, and carbamazepine appear to be relatively safe, and evidence showing phenobarbital and valproate are not safe.”
Antiseizure medications as a class are among the most commonly prescribed teratogenic drugs given to women of childbearing age, Dr. Meador noted. They are used not only for epilepsy but also for many other psychiatric and pain indications, so these results are applicable to quite a broad population, he added.
He pointed out that previous studies did not assess exposure using blood levels, which is important, as clearance of drug increases during pregnancy but varies across antiseizure medications and across individuals on the same drug. “Thus, it is unclear if these changes could obscure exposure-dependent effects. Our present studies assessed blood levels to better measure fetal exposure.”
Advice for pregnant patients with epilepsy
Dr. Meador explained that risk for adverse effects with antiseizure medication always needs to be balanced with risk for seizures if the medication was not used.
“In women planning a pregnancy, we recommend that they plan ahead with their physician to try and use the safest antiseizure medication and gain good control beforehand and then maintain the same blood levels of whichever drug is being used during pregnancy,” Dr. Meador said. “At present, lamotrigine and levetiracetam are the two safest drugs to use in pregnancy. They both look generally very safe compared with some other epilepsy drugs – such as valproate, which poses a serious risk to cognitive and behavioral development.”
He also advised that women should be taking folic acid regularly, as this has been shown to be related to improved cognitive and behavioral outcomes. “Since half of pregnancies are not planned, it is important to take these actions before pregnancy,” he added.
The current study involved 289 women with epilepsy and 89 women without epilepsy, all of whom enrolled in the study during pregnancy. Use of antiseizure medications was recorded. Of the women with epilepsy, 74% were on monotherapy, with 43% on lamotrigine and 37% on levetiracetam. There were 4% who took no drug and 22% took more than one drug. Of those who took more than one drug, close to half took a combination of lamotrigine and levetiracetam. Levels of medications in the blood of the women with epilepsy were measured in the third trimester.
Assessment of neurobehavioral development
For the current analysis, the children were evaluated at age 3 with a series of cognitive and developmental tests that measured vocabulary, listening comprehension, number recall, and pattern recognition, and results were adjusted for mother’s IQ, education level, age at enrollment, postbirth average BAI (Beck Anxiety Inventory score), and child’s ethnicity, sex, and breastfeeding status.
The primary outcome showed that verbal Index scores at age 3 did not differ for children of women with epilepsy versus those for children of women without epilepsy (LS mean 102.7 vs. 102.1).
Antiseizure medication exposure as evident by the maximum third trimester blood levels was not related to verbal index scores (n = 265; adjusted parameter estimate, -1.9; 95% confidence interval, -6.8 to 3.1).
General conceptual ability scores also did not differ between the two groups: 105.1 for children of women with epilepsy versus 103.5 for children of healthy women.
In terms of exposure levels, the third trimester maximum observed ratio of antiseizure medication blood levels was not significantly associated with adjusted general conceptual ability scores for children of women with epilepsy; neither were monotherapies or polytherapies evaluated separately, Dr. Meador reported.
However, when the verbal index scores for the main antiepileptic drug groups were analyzed separately, exposure level to levetiracetam was the only one that was significant, with a P value of .028. But Dr. Meador again stressed that this finding should be interpreted with caution given that it is a secondary exploratory analysis without control for multiple comparisons.
The researchers plan to assess these children at older ages where evaluations are more sensitive to ultimate outcomes.
“Information on use in pregnancy for most antiseizure medications is still unknown, so further studies to assess risks for the newer antiseizure medications are needed,” Dr. Meador added. “Further, additional research is needed on the underlying mechanisms including genetic predispositions, since teratogens act on a susceptible genotype.”
The study was supported by the National Institutes of Health, the National Institute of Neurological Disorders and Stroke, and the Eunice Kennedy Shriver National Institute of Child Health and Human Development.
A version of this article first appeared on Medscape.com.
From AAN 2021
Clinical Edge Journal Scan Commentary: Contraception April 2021
Patients receive the full range of contraception options when providers are educated on the proper use and spectrum of contraceptive options. When an educational intervention was introduced in three countries (Democratic Republic of Congo, Somalia, and Pakistan), aimed at training providers on counseling and provision of immediate postpartum LARC, a significant number of women opted for LARC. This was in comparison to countries that did not implement this educational intervention (Rwanda, Syria, Yemen). The rate of LARC adoption was 10.01% versus 0.77%, respectively in countries providing the educational intervention versus those that did not.
The copper IUD has long been utilized for emergency contraception, providing nearly 100% efficacy in pregnancy prevention, as well as long-acting, reversible contraception. Recently, the levonorgestrel (LNG) IUD was considered for similar use as emergency contraception. Turok et al studied the pregnancy rate of the LNG IUD compared the copper IUD and found that the LNG IUD was noninferior to the copper IUD when used for emergency contraception, with pregnancy rates of 1 in 317 (LNG) compared to 0 in 321 (copper). LNG IUDs are often more readily available in OBGYN offices and could improve access to higher efficacy emergency contraception compared to traditional emergency contraceptive pills.
When placing IUDs, providers have a range of devices to measure the length of the uterus for correct IUD placement, including endometrial biopsy pipelles, uterine sounds, both plastic and metal, as well as the device inserters. In a biomechanical ex vivo analysis, Duncan et al examined the maximum force generated for IUD placement with the levonorgestrel placement instrument, the copper IUD placement instrument, and a metal sound. Using their model, the investigators found that the metal sound caused uterine perforation, but the plastic IUD placement device did not. Although the study authors utilized the device inserters themselves, we recommend the use of plastic uterine sounds or biopsy pipelles over the device inserters in accordance with IUD packaging instructions. IUD packaging should not be opened until both the ability to access the uterine cavity and appropriate uterine size are determined to avoid needing to discard the IUD.
Patients receive the full range of contraception options when providers are educated on the proper use and spectrum of contraceptive options. When an educational intervention was introduced in three countries (Democratic Republic of Congo, Somalia, and Pakistan), aimed at training providers on counseling and provision of immediate postpartum LARC, a significant number of women opted for LARC. This was in comparison to countries that did not implement this educational intervention (Rwanda, Syria, Yemen). The rate of LARC adoption was 10.01% versus 0.77%, respectively in countries providing the educational intervention versus those that did not.
The copper IUD has long been utilized for emergency contraception, providing nearly 100% efficacy in pregnancy prevention, as well as long-acting, reversible contraception. Recently, the levonorgestrel (LNG) IUD was considered for similar use as emergency contraception. Turok et al studied the pregnancy rate of the LNG IUD compared the copper IUD and found that the LNG IUD was noninferior to the copper IUD when used for emergency contraception, with pregnancy rates of 1 in 317 (LNG) compared to 0 in 321 (copper). LNG IUDs are often more readily available in OBGYN offices and could improve access to higher efficacy emergency contraception compared to traditional emergency contraceptive pills.
When placing IUDs, providers have a range of devices to measure the length of the uterus for correct IUD placement, including endometrial biopsy pipelles, uterine sounds, both plastic and metal, as well as the device inserters. In a biomechanical ex vivo analysis, Duncan et al examined the maximum force generated for IUD placement with the levonorgestrel placement instrument, the copper IUD placement instrument, and a metal sound. Using their model, the investigators found that the metal sound caused uterine perforation, but the plastic IUD placement device did not. Although the study authors utilized the device inserters themselves, we recommend the use of plastic uterine sounds or biopsy pipelles over the device inserters in accordance with IUD packaging instructions. IUD packaging should not be opened until both the ability to access the uterine cavity and appropriate uterine size are determined to avoid needing to discard the IUD.
Patients receive the full range of contraception options when providers are educated on the proper use and spectrum of contraceptive options. When an educational intervention was introduced in three countries (Democratic Republic of Congo, Somalia, and Pakistan), aimed at training providers on counseling and provision of immediate postpartum LARC, a significant number of women opted for LARC. This was in comparison to countries that did not implement this educational intervention (Rwanda, Syria, Yemen). The rate of LARC adoption was 10.01% versus 0.77%, respectively in countries providing the educational intervention versus those that did not.
The copper IUD has long been utilized for emergency contraception, providing nearly 100% efficacy in pregnancy prevention, as well as long-acting, reversible contraception. Recently, the levonorgestrel (LNG) IUD was considered for similar use as emergency contraception. Turok et al studied the pregnancy rate of the LNG IUD compared the copper IUD and found that the LNG IUD was noninferior to the copper IUD when used for emergency contraception, with pregnancy rates of 1 in 317 (LNG) compared to 0 in 321 (copper). LNG IUDs are often more readily available in OBGYN offices and could improve access to higher efficacy emergency contraception compared to traditional emergency contraceptive pills.
When placing IUDs, providers have a range of devices to measure the length of the uterus for correct IUD placement, including endometrial biopsy pipelles, uterine sounds, both plastic and metal, as well as the device inserters. In a biomechanical ex vivo analysis, Duncan et al examined the maximum force generated for IUD placement with the levonorgestrel placement instrument, the copper IUD placement instrument, and a metal sound. Using their model, the investigators found that the metal sound caused uterine perforation, but the plastic IUD placement device did not. Although the study authors utilized the device inserters themselves, we recommend the use of plastic uterine sounds or biopsy pipelles over the device inserters in accordance with IUD packaging instructions. IUD packaging should not be opened until both the ability to access the uterine cavity and appropriate uterine size are determined to avoid needing to discard the IUD.
Feds lift pause of J&J COVID vaccine, add new warning
Use of the Johnson & Johnson COVID-19 vaccine should resume in the United States for all adults, the Food and Drug Administration and Centers for Disease Contol and Prevention said April 23, although health care providers should warn patients of the risk of developing the rare and serious blood clots that caused the agencies to pause the vaccine’s distribution earlier this month.
“What we are seeing is the overall rate of events was 1.9 cases per million people. In women 18 to 29 years there was an approximate 7 cases per million. The risk is even lower in women over the age of 50 at .9 cases per million,” CDC Director Rochelle Walensky, MD, said in a news briefing the same day.
In the end, the potential benefits of the vaccine far outweighed its risks.
“In terms of benefits, we found that for every 1 million doses of this vaccine, the J&J vaccine could prevent over 650 hospitalizations and 12 deaths among women ages 18-49,” Dr. Walensky said. The potential benefits to women over 50 were even greater: It could prevent 4,700 hospitalizations and 650 deaths.
“In the end, this vaccine was shown to be safe and effective for the vast majority of people,” Dr. Walensky said.
The recommendation to continue the vaccine’s rollout came barely 2 hours after a CDC Advisory Committee on Immunization Practices voted to recommend the pause be lifted. The vote was 10-4 with one abstention.
The decision also includes instructions for the warning directed at women under 50 who have an increased risk of a rare but serious blood clot disorder called thrombosis with thrombocytopenia syndrome (TTS).
As of April 21, 15 cases of TTS, all in women and 13 of them in women under 50, have been confirmed among 7.98 million doses of the J&J vaccine administered in the United States. Three women have died.
The FDA and CDC recommended the pause on April 13 after reports that 6 women developed a blood clotting disorder 6 to 13 days after they received the J&J vaccine.
William Schaffner, MD, an infectious disease expert at Vanderbilt University in Nashville, and a non-voting ACIP member, said in an interview the panel made the right recommendation.
He applauded both the decision to restart the vaccine and the updated warning information that “will explain [TTS] more fully to people, particularly women, who are coming to be vaccinated.”
As to women in the risk group needing to have a choice of vaccines, Dr. Schaffner said that will be addressed differently across the country.
“Every provider will not have alternative vaccines in their location so there will be many different ways to do this. You may have to get this information and select which site you’re going to depending on which vaccine is available if this matter is important to you,” he noted.
ACIP made the decision after a 6-hour emergency meeting to hear evidence on the Johnson & Johnson vaccine's protective benefits against COVID-19 vs. risk of TTS.
In the CDC-FDA press briefing, Dr. Walensky pointed out that over the past few days, as regulators have reviewed the rare events, newly identified patients had been treated appropriately, without the use of heparin, which is not advised for treating TTS.
As a result, regulators felt as if their messages had gotten out to doctors who now knew how to take special precautions when treating patients with the disorder.
She said the Johnson & Johnson shot remained an important option because it was convenient to give and easier to store than the other vaccines currently authorized in the United States.
Peter Marks, MD, the director of FDA’s Center for Biologics Evaluation and Research, said the agency had already added information describing the risk of the rare clotting disorder to its fact sheets for patients and doctors.
Janet Woodcock, MD, acting commissioner of the FDA, said vaccination centers could resume giving the “one and done” shots as early as April 24.
This article was updated April 24, 2021, and first appeared on WebMD.com.
Use of the Johnson & Johnson COVID-19 vaccine should resume in the United States for all adults, the Food and Drug Administration and Centers for Disease Contol and Prevention said April 23, although health care providers should warn patients of the risk of developing the rare and serious blood clots that caused the agencies to pause the vaccine’s distribution earlier this month.
“What we are seeing is the overall rate of events was 1.9 cases per million people. In women 18 to 29 years there was an approximate 7 cases per million. The risk is even lower in women over the age of 50 at .9 cases per million,” CDC Director Rochelle Walensky, MD, said in a news briefing the same day.
In the end, the potential benefits of the vaccine far outweighed its risks.
“In terms of benefits, we found that for every 1 million doses of this vaccine, the J&J vaccine could prevent over 650 hospitalizations and 12 deaths among women ages 18-49,” Dr. Walensky said. The potential benefits to women over 50 were even greater: It could prevent 4,700 hospitalizations and 650 deaths.
“In the end, this vaccine was shown to be safe and effective for the vast majority of people,” Dr. Walensky said.
The recommendation to continue the vaccine’s rollout came barely 2 hours after a CDC Advisory Committee on Immunization Practices voted to recommend the pause be lifted. The vote was 10-4 with one abstention.
The decision also includes instructions for the warning directed at women under 50 who have an increased risk of a rare but serious blood clot disorder called thrombosis with thrombocytopenia syndrome (TTS).
As of April 21, 15 cases of TTS, all in women and 13 of them in women under 50, have been confirmed among 7.98 million doses of the J&J vaccine administered in the United States. Three women have died.
The FDA and CDC recommended the pause on April 13 after reports that 6 women developed a blood clotting disorder 6 to 13 days after they received the J&J vaccine.
William Schaffner, MD, an infectious disease expert at Vanderbilt University in Nashville, and a non-voting ACIP member, said in an interview the panel made the right recommendation.
He applauded both the decision to restart the vaccine and the updated warning information that “will explain [TTS] more fully to people, particularly women, who are coming to be vaccinated.”
As to women in the risk group needing to have a choice of vaccines, Dr. Schaffner said that will be addressed differently across the country.
“Every provider will not have alternative vaccines in their location so there will be many different ways to do this. You may have to get this information and select which site you’re going to depending on which vaccine is available if this matter is important to you,” he noted.
ACIP made the decision after a 6-hour emergency meeting to hear evidence on the Johnson & Johnson vaccine's protective benefits against COVID-19 vs. risk of TTS.
In the CDC-FDA press briefing, Dr. Walensky pointed out that over the past few days, as regulators have reviewed the rare events, newly identified patients had been treated appropriately, without the use of heparin, which is not advised for treating TTS.
As a result, regulators felt as if their messages had gotten out to doctors who now knew how to take special precautions when treating patients with the disorder.
She said the Johnson & Johnson shot remained an important option because it was convenient to give and easier to store than the other vaccines currently authorized in the United States.
Peter Marks, MD, the director of FDA’s Center for Biologics Evaluation and Research, said the agency had already added information describing the risk of the rare clotting disorder to its fact sheets for patients and doctors.
Janet Woodcock, MD, acting commissioner of the FDA, said vaccination centers could resume giving the “one and done” shots as early as April 24.
This article was updated April 24, 2021, and first appeared on WebMD.com.
Use of the Johnson & Johnson COVID-19 vaccine should resume in the United States for all adults, the Food and Drug Administration and Centers for Disease Contol and Prevention said April 23, although health care providers should warn patients of the risk of developing the rare and serious blood clots that caused the agencies to pause the vaccine’s distribution earlier this month.
“What we are seeing is the overall rate of events was 1.9 cases per million people. In women 18 to 29 years there was an approximate 7 cases per million. The risk is even lower in women over the age of 50 at .9 cases per million,” CDC Director Rochelle Walensky, MD, said in a news briefing the same day.
In the end, the potential benefits of the vaccine far outweighed its risks.
“In terms of benefits, we found that for every 1 million doses of this vaccine, the J&J vaccine could prevent over 650 hospitalizations and 12 deaths among women ages 18-49,” Dr. Walensky said. The potential benefits to women over 50 were even greater: It could prevent 4,700 hospitalizations and 650 deaths.
“In the end, this vaccine was shown to be safe and effective for the vast majority of people,” Dr. Walensky said.
The recommendation to continue the vaccine’s rollout came barely 2 hours after a CDC Advisory Committee on Immunization Practices voted to recommend the pause be lifted. The vote was 10-4 with one abstention.
The decision also includes instructions for the warning directed at women under 50 who have an increased risk of a rare but serious blood clot disorder called thrombosis with thrombocytopenia syndrome (TTS).
As of April 21, 15 cases of TTS, all in women and 13 of them in women under 50, have been confirmed among 7.98 million doses of the J&J vaccine administered in the United States. Three women have died.
The FDA and CDC recommended the pause on April 13 after reports that 6 women developed a blood clotting disorder 6 to 13 days after they received the J&J vaccine.
William Schaffner, MD, an infectious disease expert at Vanderbilt University in Nashville, and a non-voting ACIP member, said in an interview the panel made the right recommendation.
He applauded both the decision to restart the vaccine and the updated warning information that “will explain [TTS] more fully to people, particularly women, who are coming to be vaccinated.”
As to women in the risk group needing to have a choice of vaccines, Dr. Schaffner said that will be addressed differently across the country.
“Every provider will not have alternative vaccines in their location so there will be many different ways to do this. You may have to get this information and select which site you’re going to depending on which vaccine is available if this matter is important to you,” he noted.
ACIP made the decision after a 6-hour emergency meeting to hear evidence on the Johnson & Johnson vaccine's protective benefits against COVID-19 vs. risk of TTS.
In the CDC-FDA press briefing, Dr. Walensky pointed out that over the past few days, as regulators have reviewed the rare events, newly identified patients had been treated appropriately, without the use of heparin, which is not advised for treating TTS.
As a result, regulators felt as if their messages had gotten out to doctors who now knew how to take special precautions when treating patients with the disorder.
She said the Johnson & Johnson shot remained an important option because it was convenient to give and easier to store than the other vaccines currently authorized in the United States.
Peter Marks, MD, the director of FDA’s Center for Biologics Evaluation and Research, said the agency had already added information describing the risk of the rare clotting disorder to its fact sheets for patients and doctors.
Janet Woodcock, MD, acting commissioner of the FDA, said vaccination centers could resume giving the “one and done” shots as early as April 24.
This article was updated April 24, 2021, and first appeared on WebMD.com.
How about contraceptives for men?
With the introduction of new technology to vaccinate the world with the Pfizer and Moderna mRNA vaccines, I considered other health conditions that could benefit from new modalities. Unplanned pregnancies are a public health crisis, yet the burden falls solely on women to solve, burdening them with contraceptive practices to prevent unplanned pregnancy. With the insurrection of Row v. Wade and the new bills being pushed through states that are limiting abortion, perhaps the time has come for males to accept the responsibility for contraception to prevent unplanned pregnancy. The methods that currently exist for males are condoms and vasectomy. Other options are being explored – both nonhormonal and reversible contraception including daily pills, gels, and long-acting injections.
The pill for men has been under preliminary trials with promising results. This contraceptive pill contains dimethandrolone undecanoate, which is an androgen anabolic steroid progesterone once-daily pill that suppresses FSH and LH, causing a decrease in the production of testosterone and consequently sperm production.1 (Long, Lee, & Blithe, 2019). This pill is in long-term trials to determine the efficacy and side effects, including the impact on libido, liver, and kidney disease.
The injectable male contraceptive in trials now includes two different options. The first was a long-acting progestin, testosterone, and androgen combination. The male participants received an intramuscular injection every 8 weeks. Although the results of the study were promising – sperm production was effectively reduced, the side effects were too severe for participants to continue use. Side effects much like those of the female Depo-Provera injections included acne and mood disorders. Men experienced erectile dysfunction while at the same time having an increase in sex drive.2 (Em, 2018).
Recently, researchers in India have studied a nonhormonal injectable with promising outcomes. It prevented pregnancy in more than 97% of participants. This injectable polymer gel is placed into the male’s vas deferens to block sperm from leaving the body. This product inactivates sperm, essentially creating temporary sterilization for men. The benefit of this product, called RISUG (reversible inhibition of sperm under guidance), is a single injection that can be effective for 13 years. It can be reversed earlier if needed by injecting a dissolving gel into the male’s vas deferens.1,2 In the United States, there is an identical product called Vasalgel – a polymer injected into the vas deferens – also being studied for temporary infertility.
Another synthetic implanted androgen product being studied is 7 alpha-methyl-19-nortestosterone (MENT), a synthetic steroid that resembles testosterone but does not convert into testosterone and, consequently, does not stimulate prostate growth. It is administered via two subdermal implants and is effective for 12 months. The first subdermal implant releases the synthetic androgen, which is more potent than testosterone, and the other emits LH-releasing hormone.3 Studies demonstrate that MENT suppresses sperm production.1
Finally, studies are underway using transdermal gel applications to suppress sperm concentrations. The daily gel is absorbed through the skin after application to two different areas of the man’s body: the shoulders and upper arms. The daily application of the progestin product, Nestorone, and testosterone gel has been found to reduce sperm concentrations to < 1 x 106/mL. Studies measured gonadal concentrations after 4 weeks.1 Users were happy with the use of a topical gel, with minimal side effects such as lower libido, weight gain, and changes in cholesterol, yet inconsistent use of the product resulted in lower than anticipated results.4
Male contraceptive options are long overdue to dramatically reduce the rate of unplanned pregnancies and the burden of contraception placed on women. Getting these products to market will be half the battle – getting men to commit to using these options and women to trust male compliance may further impede acceptance. Men have not had to carry the burden and economics of single parenting. Men interested in casual sex may now need to accept more responsibility for unplanned pregnancy and be proactive with prevention, particularly as abortion laws are being challenged.
Ms. Thew is medical director of the department of pediatrics division of adolescent medicine at the Medical College of Wisconsin in Milwaukee. She is a member of the editorial board for Pediatric News and has no relevant disclosures.
References
1. Long J E et al. Clin Chem. 2019;65(1):153-60.
2. Male birth control: Current options and new breakthroughs, SingleCare: Health Education. Aug. 6, 2018.
3. Sundaram K et al. Ann Med. 1993;25(2):199-205.
4. Anawalt BD et al. Andrology. 2019;7(6):878-87.
With the introduction of new technology to vaccinate the world with the Pfizer and Moderna mRNA vaccines, I considered other health conditions that could benefit from new modalities. Unplanned pregnancies are a public health crisis, yet the burden falls solely on women to solve, burdening them with contraceptive practices to prevent unplanned pregnancy. With the insurrection of Row v. Wade and the new bills being pushed through states that are limiting abortion, perhaps the time has come for males to accept the responsibility for contraception to prevent unplanned pregnancy. The methods that currently exist for males are condoms and vasectomy. Other options are being explored – both nonhormonal and reversible contraception including daily pills, gels, and long-acting injections.
The pill for men has been under preliminary trials with promising results. This contraceptive pill contains dimethandrolone undecanoate, which is an androgen anabolic steroid progesterone once-daily pill that suppresses FSH and LH, causing a decrease in the production of testosterone and consequently sperm production.1 (Long, Lee, & Blithe, 2019). This pill is in long-term trials to determine the efficacy and side effects, including the impact on libido, liver, and kidney disease.
The injectable male contraceptive in trials now includes two different options. The first was a long-acting progestin, testosterone, and androgen combination. The male participants received an intramuscular injection every 8 weeks. Although the results of the study were promising – sperm production was effectively reduced, the side effects were too severe for participants to continue use. Side effects much like those of the female Depo-Provera injections included acne and mood disorders. Men experienced erectile dysfunction while at the same time having an increase in sex drive.2 (Em, 2018).
Recently, researchers in India have studied a nonhormonal injectable with promising outcomes. It prevented pregnancy in more than 97% of participants. This injectable polymer gel is placed into the male’s vas deferens to block sperm from leaving the body. This product inactivates sperm, essentially creating temporary sterilization for men. The benefit of this product, called RISUG (reversible inhibition of sperm under guidance), is a single injection that can be effective for 13 years. It can be reversed earlier if needed by injecting a dissolving gel into the male’s vas deferens.1,2 In the United States, there is an identical product called Vasalgel – a polymer injected into the vas deferens – also being studied for temporary infertility.
Another synthetic implanted androgen product being studied is 7 alpha-methyl-19-nortestosterone (MENT), a synthetic steroid that resembles testosterone but does not convert into testosterone and, consequently, does not stimulate prostate growth. It is administered via two subdermal implants and is effective for 12 months. The first subdermal implant releases the synthetic androgen, which is more potent than testosterone, and the other emits LH-releasing hormone.3 Studies demonstrate that MENT suppresses sperm production.1
Finally, studies are underway using transdermal gel applications to suppress sperm concentrations. The daily gel is absorbed through the skin after application to two different areas of the man’s body: the shoulders and upper arms. The daily application of the progestin product, Nestorone, and testosterone gel has been found to reduce sperm concentrations to < 1 x 106/mL. Studies measured gonadal concentrations after 4 weeks.1 Users were happy with the use of a topical gel, with minimal side effects such as lower libido, weight gain, and changes in cholesterol, yet inconsistent use of the product resulted in lower than anticipated results.4
Male contraceptive options are long overdue to dramatically reduce the rate of unplanned pregnancies and the burden of contraception placed on women. Getting these products to market will be half the battle – getting men to commit to using these options and women to trust male compliance may further impede acceptance. Men have not had to carry the burden and economics of single parenting. Men interested in casual sex may now need to accept more responsibility for unplanned pregnancy and be proactive with prevention, particularly as abortion laws are being challenged.
Ms. Thew is medical director of the department of pediatrics division of adolescent medicine at the Medical College of Wisconsin in Milwaukee. She is a member of the editorial board for Pediatric News and has no relevant disclosures.
References
1. Long J E et al. Clin Chem. 2019;65(1):153-60.
2. Male birth control: Current options and new breakthroughs, SingleCare: Health Education. Aug. 6, 2018.
3. Sundaram K et al. Ann Med. 1993;25(2):199-205.
4. Anawalt BD et al. Andrology. 2019;7(6):878-87.
With the introduction of new technology to vaccinate the world with the Pfizer and Moderna mRNA vaccines, I considered other health conditions that could benefit from new modalities. Unplanned pregnancies are a public health crisis, yet the burden falls solely on women to solve, burdening them with contraceptive practices to prevent unplanned pregnancy. With the insurrection of Row v. Wade and the new bills being pushed through states that are limiting abortion, perhaps the time has come for males to accept the responsibility for contraception to prevent unplanned pregnancy. The methods that currently exist for males are condoms and vasectomy. Other options are being explored – both nonhormonal and reversible contraception including daily pills, gels, and long-acting injections.
The pill for men has been under preliminary trials with promising results. This contraceptive pill contains dimethandrolone undecanoate, which is an androgen anabolic steroid progesterone once-daily pill that suppresses FSH and LH, causing a decrease in the production of testosterone and consequently sperm production.1 (Long, Lee, & Blithe, 2019). This pill is in long-term trials to determine the efficacy and side effects, including the impact on libido, liver, and kidney disease.
The injectable male contraceptive in trials now includes two different options. The first was a long-acting progestin, testosterone, and androgen combination. The male participants received an intramuscular injection every 8 weeks. Although the results of the study were promising – sperm production was effectively reduced, the side effects were too severe for participants to continue use. Side effects much like those of the female Depo-Provera injections included acne and mood disorders. Men experienced erectile dysfunction while at the same time having an increase in sex drive.2 (Em, 2018).
Recently, researchers in India have studied a nonhormonal injectable with promising outcomes. It prevented pregnancy in more than 97% of participants. This injectable polymer gel is placed into the male’s vas deferens to block sperm from leaving the body. This product inactivates sperm, essentially creating temporary sterilization for men. The benefit of this product, called RISUG (reversible inhibition of sperm under guidance), is a single injection that can be effective for 13 years. It can be reversed earlier if needed by injecting a dissolving gel into the male’s vas deferens.1,2 In the United States, there is an identical product called Vasalgel – a polymer injected into the vas deferens – also being studied for temporary infertility.
Another synthetic implanted androgen product being studied is 7 alpha-methyl-19-nortestosterone (MENT), a synthetic steroid that resembles testosterone but does not convert into testosterone and, consequently, does not stimulate prostate growth. It is administered via two subdermal implants and is effective for 12 months. The first subdermal implant releases the synthetic androgen, which is more potent than testosterone, and the other emits LH-releasing hormone.3 Studies demonstrate that MENT suppresses sperm production.1
Finally, studies are underway using transdermal gel applications to suppress sperm concentrations. The daily gel is absorbed through the skin after application to two different areas of the man’s body: the shoulders and upper arms. The daily application of the progestin product, Nestorone, and testosterone gel has been found to reduce sperm concentrations to < 1 x 106/mL. Studies measured gonadal concentrations after 4 weeks.1 Users were happy with the use of a topical gel, with minimal side effects such as lower libido, weight gain, and changes in cholesterol, yet inconsistent use of the product resulted in lower than anticipated results.4
Male contraceptive options are long overdue to dramatically reduce the rate of unplanned pregnancies and the burden of contraception placed on women. Getting these products to market will be half the battle – getting men to commit to using these options and women to trust male compliance may further impede acceptance. Men have not had to carry the burden and economics of single parenting. Men interested in casual sex may now need to accept more responsibility for unplanned pregnancy and be proactive with prevention, particularly as abortion laws are being challenged.
Ms. Thew is medical director of the department of pediatrics division of adolescent medicine at the Medical College of Wisconsin in Milwaukee. She is a member of the editorial board for Pediatric News and has no relevant disclosures.
References
1. Long J E et al. Clin Chem. 2019;65(1):153-60.
2. Male birth control: Current options and new breakthroughs, SingleCare: Health Education. Aug. 6, 2018.
3. Sundaram K et al. Ann Med. 1993;25(2):199-205.
4. Anawalt BD et al. Andrology. 2019;7(6):878-87.
Study: COVID-19 can kill months after infection
Long-haul COVID-19 patients face many health threats – including a higher chance of dying – up to 6 months after they catch the virus, according to a massive study published in the journal Nature.
Researchers examined more than 87,000 COVID-19 patients and nearly 5 million control patients in a federal database. They found COVID-19 patients had a 59% higher risk of death up to 6 months after infection, compared with noninfected people.
Those findings translate into about 8 extra deaths per 1,000 patients over 6 months, because many deaths caused by long-term COVID complications are not recorded as COVID-19 deaths, the researchers said. Among patients who were hospitalized and died after more than 30 days, there were 29 excess deaths per 1,000 patients over 6 months.
“As far as total pandemic death toll, these numbers suggest that the deaths we’re counting due to the immediate viral infection are only the tip of the iceberg,” Ziyad Al-Aly, MD, the senior author of the study and a director of the Clinical Epidemiology Center at the Veterans Affairs St. Louis Health Care System, said in a news release from the Washington University, St. Louis.
Johns Hopkins University in Baltimore says more than 3 million people worldwide and about 570,000 people in the United States have died of coronavirus-related reasons.
Long-haul COVID patients also had a much higher chance of getting sick, and not just in the respiratory system, according to the study.
The patients had a high rate of stroke and other nervous system ailments, mental health problems such as depression, the onset of diabetes, heart disease and other coronary problems, diarrhea and digestive disorders, kidney disease, blood clots, joint pain, hair loss, and general fatigue.
Patients often had clusters of these ailments. And the more severe the case of COVID-19, the higher the chance of long-term health problems, the study said.
Researchers based their study on health care databases of the U.S. Department of Veterans Affairs. Besides the 87,000 COVID patients, the database included about 5 million patients who didn’t catch COVID. The veterans in the study were about 88% men, but the large sample size included 8,880 women with confirmed cases, the news release said.
Dr. Al-Aly, an assistant professor at Washington University, said the study shows that long-haul COVID-19 could be “America’s next big health crisis.”
“Our study demonstrates that, up to 6 months after diagnosis, the risk of death following even a mild case of COVID-19 is not trivial and increases with disease severity,” he said. “Given that more than 30 million Americans have been infected with this virus, and given that the burden of long COVID-19 is substantial, the lingering effects of this disease will reverberate for many years and even decades.”
A version of this article first appeared on WebMD.com.
Long-haul COVID-19 patients face many health threats – including a higher chance of dying – up to 6 months after they catch the virus, according to a massive study published in the journal Nature.
Researchers examined more than 87,000 COVID-19 patients and nearly 5 million control patients in a federal database. They found COVID-19 patients had a 59% higher risk of death up to 6 months after infection, compared with noninfected people.
Those findings translate into about 8 extra deaths per 1,000 patients over 6 months, because many deaths caused by long-term COVID complications are not recorded as COVID-19 deaths, the researchers said. Among patients who were hospitalized and died after more than 30 days, there were 29 excess deaths per 1,000 patients over 6 months.
“As far as total pandemic death toll, these numbers suggest that the deaths we’re counting due to the immediate viral infection are only the tip of the iceberg,” Ziyad Al-Aly, MD, the senior author of the study and a director of the Clinical Epidemiology Center at the Veterans Affairs St. Louis Health Care System, said in a news release from the Washington University, St. Louis.
Johns Hopkins University in Baltimore says more than 3 million people worldwide and about 570,000 people in the United States have died of coronavirus-related reasons.
Long-haul COVID patients also had a much higher chance of getting sick, and not just in the respiratory system, according to the study.
The patients had a high rate of stroke and other nervous system ailments, mental health problems such as depression, the onset of diabetes, heart disease and other coronary problems, diarrhea and digestive disorders, kidney disease, blood clots, joint pain, hair loss, and general fatigue.
Patients often had clusters of these ailments. And the more severe the case of COVID-19, the higher the chance of long-term health problems, the study said.
Researchers based their study on health care databases of the U.S. Department of Veterans Affairs. Besides the 87,000 COVID patients, the database included about 5 million patients who didn’t catch COVID. The veterans in the study were about 88% men, but the large sample size included 8,880 women with confirmed cases, the news release said.
Dr. Al-Aly, an assistant professor at Washington University, said the study shows that long-haul COVID-19 could be “America’s next big health crisis.”
“Our study demonstrates that, up to 6 months after diagnosis, the risk of death following even a mild case of COVID-19 is not trivial and increases with disease severity,” he said. “Given that more than 30 million Americans have been infected with this virus, and given that the burden of long COVID-19 is substantial, the lingering effects of this disease will reverberate for many years and even decades.”
A version of this article first appeared on WebMD.com.
Long-haul COVID-19 patients face many health threats – including a higher chance of dying – up to 6 months after they catch the virus, according to a massive study published in the journal Nature.
Researchers examined more than 87,000 COVID-19 patients and nearly 5 million control patients in a federal database. They found COVID-19 patients had a 59% higher risk of death up to 6 months after infection, compared with noninfected people.
Those findings translate into about 8 extra deaths per 1,000 patients over 6 months, because many deaths caused by long-term COVID complications are not recorded as COVID-19 deaths, the researchers said. Among patients who were hospitalized and died after more than 30 days, there were 29 excess deaths per 1,000 patients over 6 months.
“As far as total pandemic death toll, these numbers suggest that the deaths we’re counting due to the immediate viral infection are only the tip of the iceberg,” Ziyad Al-Aly, MD, the senior author of the study and a director of the Clinical Epidemiology Center at the Veterans Affairs St. Louis Health Care System, said in a news release from the Washington University, St. Louis.
Johns Hopkins University in Baltimore says more than 3 million people worldwide and about 570,000 people in the United States have died of coronavirus-related reasons.
Long-haul COVID patients also had a much higher chance of getting sick, and not just in the respiratory system, according to the study.
The patients had a high rate of stroke and other nervous system ailments, mental health problems such as depression, the onset of diabetes, heart disease and other coronary problems, diarrhea and digestive disorders, kidney disease, blood clots, joint pain, hair loss, and general fatigue.
Patients often had clusters of these ailments. And the more severe the case of COVID-19, the higher the chance of long-term health problems, the study said.
Researchers based their study on health care databases of the U.S. Department of Veterans Affairs. Besides the 87,000 COVID patients, the database included about 5 million patients who didn’t catch COVID. The veterans in the study were about 88% men, but the large sample size included 8,880 women with confirmed cases, the news release said.
Dr. Al-Aly, an assistant professor at Washington University, said the study shows that long-haul COVID-19 could be “America’s next big health crisis.”
“Our study demonstrates that, up to 6 months after diagnosis, the risk of death following even a mild case of COVID-19 is not trivial and increases with disease severity,” he said. “Given that more than 30 million Americans have been infected with this virus, and given that the burden of long COVID-19 is substantial, the lingering effects of this disease will reverberate for many years and even decades.”
A version of this article first appeared on WebMD.com.
Female genital cutting: Caring for patients through the lens of health care equity
Female genital cutting (FGC), also known as female circumcision or female genital mutilation, is defined by the World Health Organization (WHO) as “the partial or total removal of the external female genitalia, or other injury to the female genital organs for non-medical reasons.”1 It is a culturally determined practice that is mainly concentrated in certain parts of Africa, the Middle East, and Asia and now is observed worldwide among migrants from those areas.1 Approximately 200 million women and girls alive today have undergone FGC in 31 countries, although encouragingly the practice’s prevalence seems to be declining, especially among younger women.2
Too often, FGC goes unrecognized in women who present for medical care, even in cases where a genitourinary exam is performed and documented.3,4 As a result, patients face delays in diagnosis and management of associated complications and symptoms. Female genital cutting is usually excluded from medical school or residency training curricula,5 and physicians often lack familiarity with the necessary clinical or surgical management of patients who have had the procedure.6 It is crucial, however, that ObGyns feel comfortable recognizing FGC and clinically caring for pregnant and nonpregnant patients who have undergone the procedure. The obstetric-gynecologic setting should be the clinical space in which FGC is correctly diagnosed and from where patients with complications can be referred for appropriate care.
FGC: Through the lens of inequity
Providing culturally competent and sensitive care to women who have undergone FGC is paramount to reducing health care inequities for these patients. Beyond the medical recommendations we review below, we suggest the following considerations when approaching care for these patients.
Acknowledge our biases. It is paramount for us, as providers, to acknowledge our own biases and how these might affect our relationship with the patient and how our care is received. This starts with our language and terminology: The term female genital mutilation can be judgmental or offensive to our patients, many of whom do not consider themselves to have been mutilated. This is why we prefer to use the term female genital cutting, or whichever word the patient uses, so as not to alienate a patient who might already face many other barriers and microaggressions in seeking health care.
Control our responses. Another way we must check our bias is by controlling our reactions during history taking or examining patients who have undergone FGC. Understandably, providers might be shocked to hear patients recount their childhood experiences of FGC or by examining an infibulated scar, but patients report noticing and experiencing hurt, distress, and shame when providers display judgment, horror, or disgust.7 Patients have reported that they are acutely aware that they might be viewed as “backward” and “primitive” in US health care settings.8 These kinds of feelings and experiences can further exacerbate patients’ distrust and avoidance of the health care system altogether. Therefore, providers should acknowledge their own biases regarding the issue as well as those of their staff and work to mitigate them.
Avoid stigmatization. While FGC can have long-term effects (discussed below), it is important to remember that many women who have undergone FGC do not experience symptoms that are bothersome or feel that FGC is central to their lives or lived experiences. While we must be thorough in our history taking to explore possible urinary, gynecologic, and sexual symptoms of concern and bother to the patient, we must avoid stigmatizing our patients by assuming that all who have undergone FGC are “sexually disabled,” which may lead a provider to recommend medically unindicated intervention, such as clitoral reconstruction.9
Continue to: Classifying FGC types...
Classifying FGC types
The WHO has classified FGC into 4 different types1:
- type 1, partial or total removal of the clitoris or prepuce
- type 2, partial or total removal of part of the clitoris and labia minora
- type 3 (also known as infibulation), the narrowing of the vaginal orifice by cutting, removing, and/or repositioning the labia, and
- type 4, all other procedures to the female genitalia for nonmedical reasons.
Long-term complications
Female genital cutting, especially types 2 and 3, can lead to long-term obstetric and gynecologic complications that the ObGyn should be able to diagnose and manage (TABLE).
The most common long-term complications of FGC are dysmenorrhea, dyspareunia, recurrent vaginal and urinary tract infections, and sexual dysfunction/dissatisfaction.10 One recent cross-sectional study that used validated questionnaires on pelvic floor and psychosexual symptoms found that women with FGC had higher distress scores than women who had not undergone FGC, indicating various pelvic floor symptoms responsible for impact on their daily lives.11
Infertility can result from a combination of physical barriers (vaginal stenosis and an infibulated scar) and psychologic barriers secondary to dyspareunia, for example.12 Labor and delivery also presents a challenge to both patients and providers, especially in cases of infibulation. Studies show that patients who have undergone FGC are at increased risk of adverse obstetric outcomes, including postpartum hemorrhage, episiotomy, cesarean delivery, and extended hospital stay.13 Neonatal complications, including infant resuscitation and perinatal death, are more commonly reported in studies outside the United States.13
Clinical management recommendations
It is important to be aware of the WHO FCG classifications and be able to recognize evidence of the procedure on examination. The ObGyn should perform a detailed physical exam of the external genitalia as well as a pelvic floor exam of every patient. If the patient does not disclose a history of FGC but it is suspected based on the examination, the clinician should inquire sensitively if the patient is aware of having undergone any genital procedures.
Especially when a history of FGC has been confirmed, clinicians should ask patients sensitively about their urinary and sexual function and satisfaction. Validated tools, such as the Female Sexual Function Index, the Female Sexual Distress Scale, and the Pelvic Floor Disability Index, may be helpful in gathering an objective and detailed assessment of the patient’s symptoms and level of distress.14 Clinicians also should ask about the patient’s detailed obstetric history, particularly regarding the second stage, delivery, and postpartum complications. The clinician also should specifically inquire about a history of defibulation or additional genital procedures.
Patients with urethral strictures or stenosis may require an exam under anesthesia, cystoscopy, urethral dilation, or urethroplasty.12 Those with chronic urinary tract or vaginal infections may require chronic oral suppressive therapy or defibulation (described below). Defibulation also may be considered for relief of severe dysmenorrhea and menorrhagia that may be resulting from hematocolpos. The ObGyn also should make certain to evaluate for other common causes of these symptoms that may be unrelated to FGC, such as endometriosis.
Many women who have undergone FGC do not report dyspareunia or sexual dissatisfaction; however, infibulation especially has been associated with higher rates of these sequelae.12 In addition to defibulation, pelvic floor physical therapy with an experienced therapist may be helpful for patients with pelvic floor dysfunction, vaginismus, and/or dyspareunia.
The defibulation procedure
Defibulation (or deinfibulation) is a surgical reconstructive procedure that opens the infibulated scar of patients who have undergone type 3 FGC (infibulation), thus exposing the urethra and introitus, and in almost half of cases an intact clitoris.15 Defibulation may be specifically requested by a patient or it may be recommended by the ObGyn either for reducing complications of pregnancy or to address the patient’s gynecologic, sexual, or urogynecologic symptoms by allowing penetrative intercourse, urinary flow, physiologic delivery, and menstruation.16
Defibulation should be performed under regional or general anesthesia and can be performed during pregnancy (or even in labor). An anterior incision is made on the infibulated scar, creating a new labia major, and the edges are sutured separately. Postoperatively, patients should be instructed to perform sitz baths and to expect a change in their urinary voiding stream.12 The few studies that have evaluated defibulation have shown high rates of success in addressing preoperative symptoms; the complication rates of defibulation are low and the satisfaction rates are high.16
The ethical conundrum of reinfibulation
Reinfibulation is defined as the restitching or reapproximation of scar tissue or the labia after delivery or a gynecologic procedure, and it is often performed routinely after every delivery in patients’ countries of origin.17
Postpartum reinfibulation on patient request raises legal and ethical issues for the ObGyn. In the United Kingdom, reinfibulation is illegal, and some international organizations, including the International Federation of Gynecology and Obstetrics and the WHO, have recommended against the practice. In the United States, reinfibulation of an adult is legal, as it falls under the umbrella of elective female genital cosmetic surgery.18,19
The procedure could create or exacerbate long-term complications and should generally be discouraged. However, if despite extensive counseling (preferably in the prenatal period) a patient insists on having the procedure, the ObGyn may need to elevate the principle of patient autonomy and either comply or find a practitioner who is comfortable performing it. One retrospective review in Switzerland suggested that specific care and informative counseling prenatally with the inclusion of a patient’s partner in the discussion can improve the acceptability of defibulation without reinfibulation.20
Conclusion
It is important for ObGyns to be familiar with the practice of FGC and to be trained in its recognition on examination and care for the long-term complications that can result from the practice. At the same time, ObGyns should be especially conscious of their biases in order to provide culturally competent care and reduce health care stigmatization and inequities for these patients.
- World Health Organization. Female genital mutilation. February 3, 2020. https://www.who.int/news-room/fact-sheets/detail/female-genital-mutilation. Accessed February 22, 2021.
- UNICEF. Female genital mutilation (FGM). February 2020. https://data.unicef.org/topic/child-protection/female-genital-mutilation/. Accessed February 22, 2021.
- Stoklosa H, Nour NM. The eye cannot see what the mind does not know: female genital mutilation. Emerg Med J. 2018;35:585-586. doi: 10.1136/emermed-2018-207994.
- Abdulcadir J, Dugerdil A, Boulvain M, et al. Missed opportunities for diagnosis of female genital mutilation. Int J Gynaecol Obstet. 2014;125:256-260. doi: 10.1016/j.ijgo.2013.11.016.
- Jäger F, Schulze S, Hohlfeld P. Female genital mutilation in Switzerland: a survey among gynaecologists. Swiss Med Wkly. 2002;132:259-264.
- Zaidi N, Khalil A, Roberts C, et al. Knowledge of female genital mutilation among healthcare professionals. J Obstet Gynaecol. 2007;27:161-164. doi: 10.1080/01443610601124257.
- Chalmers B, Hashi KO. 432 Somali women’s birth experiences in Canada after earlier female genital mutilation. Birth. 2000;27:227-234. doi: 10.1046/j.1523-536x.2000.00227.x.
- Shahawy S, Amanuel H, Nour NM. Perspectives on female genital cutting among immigrant women and men in Boston. Soc Sci Med. 2019;220:331-339. doi: 10.1016/j.socscimed.2018.11.030.
- Sharif Mohamed F, Wild V, Earp BD, et al. Clitoral reconstruction after female genital mutilation/cutting: a review of surgical techniques and ethical debate. J Sex Med. 2020;17:531-542. doi: 10.1016/j.jsxm.2019.12.004.
- Nour NM. Female genital cutting: a persisting practice. Rev Obstet Gynecol. 2008 Summer;1(3):135-139.
- Binkova A, Uebelhart M, Dällenbach P, et al. A cross-sectional study on pelvic floor symptoms in women living with female genital mutilation/cutting. Reprod Health. 2021;18:39. doi: 10.1186/s12978-021-01097-9.
- Nour NM. Female genital cutting: clinical and cultural guidelines. Obstet Gynecol Surv. 2004;59:272-279. doi: 10.1097/01.ogx.0000118939.19371.af.
- WHO Study Group on Female Genital Mutilation and Obstetric Outcome; Banks E, Meirik O, Farley T, et al. Female genital mutilation and obstetric outcome: WHO collaborative prospective study in six African countries. Lancet. 2006;367:1835-1841. doi: 10.1016/S0140-6736(06)68805-3.
- American College of Obstetricians and Gynecologists. ACOG practice bulletin no. 119: female sexual dysfunction. Obstet Gynecol. 2011;117:996-1007. doi: 10.1097/AOG.0b013e31821921ce.
- Nour NM, Michels KB, Bryant AE. Defibulation to treat female genital cutting: effect on symptoms and sexual function. Obstet Gynecol. 2006;108:55-60. doi: 10.1097/01.AOG.0000224613.72892.77.
- Johnson C, Nour NM. Surgical techniques: defibulation of type III female genital cutting. J Sex Med. 2007;4:1544-1547. doi: 10.1111/j.1743-6109.2007.00616.x.
- Serour GI. The issue of reinfibulation. Int J Gynaecol Obstet. 2010;109:93-96. doi: 10.1016/j.ijgo.2010.01.001.
- Shahawy S, Deshpande NA, Nour NM. Cross-cultural obstetric and gynecologic care of Muslim patients. Obstet Gynecol. 2015;126:969-973. doi: 10.1097/AOG.0000000000001112.
- American College of Obstetricians and Gynecologists. Elective female genital cosmetic surgery: ACOG committee opinion summary, number 795. Obstet Gynecol. 2020;135:249-250. doi: 10.1097/AOG.0000000000003617.
- Abdulcadir J, McLaren S, Boulvain M, et al. Health education and clinical care of immigrant women with female genital mutilation/cutting who request postpartum reinfibulation. Int J Gynaecol Obstet. 2016;135:69-72. doi: 10.1016/j.ijgo.2016.03.027.
Female genital cutting (FGC), also known as female circumcision or female genital mutilation, is defined by the World Health Organization (WHO) as “the partial or total removal of the external female genitalia, or other injury to the female genital organs for non-medical reasons.”1 It is a culturally determined practice that is mainly concentrated in certain parts of Africa, the Middle East, and Asia and now is observed worldwide among migrants from those areas.1 Approximately 200 million women and girls alive today have undergone FGC in 31 countries, although encouragingly the practice’s prevalence seems to be declining, especially among younger women.2
Too often, FGC goes unrecognized in women who present for medical care, even in cases where a genitourinary exam is performed and documented.3,4 As a result, patients face delays in diagnosis and management of associated complications and symptoms. Female genital cutting is usually excluded from medical school or residency training curricula,5 and physicians often lack familiarity with the necessary clinical or surgical management of patients who have had the procedure.6 It is crucial, however, that ObGyns feel comfortable recognizing FGC and clinically caring for pregnant and nonpregnant patients who have undergone the procedure. The obstetric-gynecologic setting should be the clinical space in which FGC is correctly diagnosed and from where patients with complications can be referred for appropriate care.
FGC: Through the lens of inequity
Providing culturally competent and sensitive care to women who have undergone FGC is paramount to reducing health care inequities for these patients. Beyond the medical recommendations we review below, we suggest the following considerations when approaching care for these patients.
Acknowledge our biases. It is paramount for us, as providers, to acknowledge our own biases and how these might affect our relationship with the patient and how our care is received. This starts with our language and terminology: The term female genital mutilation can be judgmental or offensive to our patients, many of whom do not consider themselves to have been mutilated. This is why we prefer to use the term female genital cutting, or whichever word the patient uses, so as not to alienate a patient who might already face many other barriers and microaggressions in seeking health care.
Control our responses. Another way we must check our bias is by controlling our reactions during history taking or examining patients who have undergone FGC. Understandably, providers might be shocked to hear patients recount their childhood experiences of FGC or by examining an infibulated scar, but patients report noticing and experiencing hurt, distress, and shame when providers display judgment, horror, or disgust.7 Patients have reported that they are acutely aware that they might be viewed as “backward” and “primitive” in US health care settings.8 These kinds of feelings and experiences can further exacerbate patients’ distrust and avoidance of the health care system altogether. Therefore, providers should acknowledge their own biases regarding the issue as well as those of their staff and work to mitigate them.
Avoid stigmatization. While FGC can have long-term effects (discussed below), it is important to remember that many women who have undergone FGC do not experience symptoms that are bothersome or feel that FGC is central to their lives or lived experiences. While we must be thorough in our history taking to explore possible urinary, gynecologic, and sexual symptoms of concern and bother to the patient, we must avoid stigmatizing our patients by assuming that all who have undergone FGC are “sexually disabled,” which may lead a provider to recommend medically unindicated intervention, such as clitoral reconstruction.9
Continue to: Classifying FGC types...
Classifying FGC types
The WHO has classified FGC into 4 different types1:
- type 1, partial or total removal of the clitoris or prepuce
- type 2, partial or total removal of part of the clitoris and labia minora
- type 3 (also known as infibulation), the narrowing of the vaginal orifice by cutting, removing, and/or repositioning the labia, and
- type 4, all other procedures to the female genitalia for nonmedical reasons.
Long-term complications
Female genital cutting, especially types 2 and 3, can lead to long-term obstetric and gynecologic complications that the ObGyn should be able to diagnose and manage (TABLE).
The most common long-term complications of FGC are dysmenorrhea, dyspareunia, recurrent vaginal and urinary tract infections, and sexual dysfunction/dissatisfaction.10 One recent cross-sectional study that used validated questionnaires on pelvic floor and psychosexual symptoms found that women with FGC had higher distress scores than women who had not undergone FGC, indicating various pelvic floor symptoms responsible for impact on their daily lives.11
Infertility can result from a combination of physical barriers (vaginal stenosis and an infibulated scar) and psychologic barriers secondary to dyspareunia, for example.12 Labor and delivery also presents a challenge to both patients and providers, especially in cases of infibulation. Studies show that patients who have undergone FGC are at increased risk of adverse obstetric outcomes, including postpartum hemorrhage, episiotomy, cesarean delivery, and extended hospital stay.13 Neonatal complications, including infant resuscitation and perinatal death, are more commonly reported in studies outside the United States.13
Clinical management recommendations
It is important to be aware of the WHO FCG classifications and be able to recognize evidence of the procedure on examination. The ObGyn should perform a detailed physical exam of the external genitalia as well as a pelvic floor exam of every patient. If the patient does not disclose a history of FGC but it is suspected based on the examination, the clinician should inquire sensitively if the patient is aware of having undergone any genital procedures.
Especially when a history of FGC has been confirmed, clinicians should ask patients sensitively about their urinary and sexual function and satisfaction. Validated tools, such as the Female Sexual Function Index, the Female Sexual Distress Scale, and the Pelvic Floor Disability Index, may be helpful in gathering an objective and detailed assessment of the patient’s symptoms and level of distress.14 Clinicians also should ask about the patient’s detailed obstetric history, particularly regarding the second stage, delivery, and postpartum complications. The clinician also should specifically inquire about a history of defibulation or additional genital procedures.
Patients with urethral strictures or stenosis may require an exam under anesthesia, cystoscopy, urethral dilation, or urethroplasty.12 Those with chronic urinary tract or vaginal infections may require chronic oral suppressive therapy or defibulation (described below). Defibulation also may be considered for relief of severe dysmenorrhea and menorrhagia that may be resulting from hematocolpos. The ObGyn also should make certain to evaluate for other common causes of these symptoms that may be unrelated to FGC, such as endometriosis.
Many women who have undergone FGC do not report dyspareunia or sexual dissatisfaction; however, infibulation especially has been associated with higher rates of these sequelae.12 In addition to defibulation, pelvic floor physical therapy with an experienced therapist may be helpful for patients with pelvic floor dysfunction, vaginismus, and/or dyspareunia.
The defibulation procedure
Defibulation (or deinfibulation) is a surgical reconstructive procedure that opens the infibulated scar of patients who have undergone type 3 FGC (infibulation), thus exposing the urethra and introitus, and in almost half of cases an intact clitoris.15 Defibulation may be specifically requested by a patient or it may be recommended by the ObGyn either for reducing complications of pregnancy or to address the patient’s gynecologic, sexual, or urogynecologic symptoms by allowing penetrative intercourse, urinary flow, physiologic delivery, and menstruation.16
Defibulation should be performed under regional or general anesthesia and can be performed during pregnancy (or even in labor). An anterior incision is made on the infibulated scar, creating a new labia major, and the edges are sutured separately. Postoperatively, patients should be instructed to perform sitz baths and to expect a change in their urinary voiding stream.12 The few studies that have evaluated defibulation have shown high rates of success in addressing preoperative symptoms; the complication rates of defibulation are low and the satisfaction rates are high.16
The ethical conundrum of reinfibulation
Reinfibulation is defined as the restitching or reapproximation of scar tissue or the labia after delivery or a gynecologic procedure, and it is often performed routinely after every delivery in patients’ countries of origin.17
Postpartum reinfibulation on patient request raises legal and ethical issues for the ObGyn. In the United Kingdom, reinfibulation is illegal, and some international organizations, including the International Federation of Gynecology and Obstetrics and the WHO, have recommended against the practice. In the United States, reinfibulation of an adult is legal, as it falls under the umbrella of elective female genital cosmetic surgery.18,19
The procedure could create or exacerbate long-term complications and should generally be discouraged. However, if despite extensive counseling (preferably in the prenatal period) a patient insists on having the procedure, the ObGyn may need to elevate the principle of patient autonomy and either comply or find a practitioner who is comfortable performing it. One retrospective review in Switzerland suggested that specific care and informative counseling prenatally with the inclusion of a patient’s partner in the discussion can improve the acceptability of defibulation without reinfibulation.20
Conclusion
It is important for ObGyns to be familiar with the practice of FGC and to be trained in its recognition on examination and care for the long-term complications that can result from the practice. At the same time, ObGyns should be especially conscious of their biases in order to provide culturally competent care and reduce health care stigmatization and inequities for these patients.
Female genital cutting (FGC), also known as female circumcision or female genital mutilation, is defined by the World Health Organization (WHO) as “the partial or total removal of the external female genitalia, or other injury to the female genital organs for non-medical reasons.”1 It is a culturally determined practice that is mainly concentrated in certain parts of Africa, the Middle East, and Asia and now is observed worldwide among migrants from those areas.1 Approximately 200 million women and girls alive today have undergone FGC in 31 countries, although encouragingly the practice’s prevalence seems to be declining, especially among younger women.2
Too often, FGC goes unrecognized in women who present for medical care, even in cases where a genitourinary exam is performed and documented.3,4 As a result, patients face delays in diagnosis and management of associated complications and symptoms. Female genital cutting is usually excluded from medical school or residency training curricula,5 and physicians often lack familiarity with the necessary clinical or surgical management of patients who have had the procedure.6 It is crucial, however, that ObGyns feel comfortable recognizing FGC and clinically caring for pregnant and nonpregnant patients who have undergone the procedure. The obstetric-gynecologic setting should be the clinical space in which FGC is correctly diagnosed and from where patients with complications can be referred for appropriate care.
FGC: Through the lens of inequity
Providing culturally competent and sensitive care to women who have undergone FGC is paramount to reducing health care inequities for these patients. Beyond the medical recommendations we review below, we suggest the following considerations when approaching care for these patients.
Acknowledge our biases. It is paramount for us, as providers, to acknowledge our own biases and how these might affect our relationship with the patient and how our care is received. This starts with our language and terminology: The term female genital mutilation can be judgmental or offensive to our patients, many of whom do not consider themselves to have been mutilated. This is why we prefer to use the term female genital cutting, or whichever word the patient uses, so as not to alienate a patient who might already face many other barriers and microaggressions in seeking health care.
Control our responses. Another way we must check our bias is by controlling our reactions during history taking or examining patients who have undergone FGC. Understandably, providers might be shocked to hear patients recount their childhood experiences of FGC or by examining an infibulated scar, but patients report noticing and experiencing hurt, distress, and shame when providers display judgment, horror, or disgust.7 Patients have reported that they are acutely aware that they might be viewed as “backward” and “primitive” in US health care settings.8 These kinds of feelings and experiences can further exacerbate patients’ distrust and avoidance of the health care system altogether. Therefore, providers should acknowledge their own biases regarding the issue as well as those of their staff and work to mitigate them.
Avoid stigmatization. While FGC can have long-term effects (discussed below), it is important to remember that many women who have undergone FGC do not experience symptoms that are bothersome or feel that FGC is central to their lives or lived experiences. While we must be thorough in our history taking to explore possible urinary, gynecologic, and sexual symptoms of concern and bother to the patient, we must avoid stigmatizing our patients by assuming that all who have undergone FGC are “sexually disabled,” which may lead a provider to recommend medically unindicated intervention, such as clitoral reconstruction.9
Continue to: Classifying FGC types...
Classifying FGC types
The WHO has classified FGC into 4 different types1:
- type 1, partial or total removal of the clitoris or prepuce
- type 2, partial or total removal of part of the clitoris and labia minora
- type 3 (also known as infibulation), the narrowing of the vaginal orifice by cutting, removing, and/or repositioning the labia, and
- type 4, all other procedures to the female genitalia for nonmedical reasons.
Long-term complications
Female genital cutting, especially types 2 and 3, can lead to long-term obstetric and gynecologic complications that the ObGyn should be able to diagnose and manage (TABLE).
The most common long-term complications of FGC are dysmenorrhea, dyspareunia, recurrent vaginal and urinary tract infections, and sexual dysfunction/dissatisfaction.10 One recent cross-sectional study that used validated questionnaires on pelvic floor and psychosexual symptoms found that women with FGC had higher distress scores than women who had not undergone FGC, indicating various pelvic floor symptoms responsible for impact on their daily lives.11
Infertility can result from a combination of physical barriers (vaginal stenosis and an infibulated scar) and psychologic barriers secondary to dyspareunia, for example.12 Labor and delivery also presents a challenge to both patients and providers, especially in cases of infibulation. Studies show that patients who have undergone FGC are at increased risk of adverse obstetric outcomes, including postpartum hemorrhage, episiotomy, cesarean delivery, and extended hospital stay.13 Neonatal complications, including infant resuscitation and perinatal death, are more commonly reported in studies outside the United States.13
Clinical management recommendations
It is important to be aware of the WHO FCG classifications and be able to recognize evidence of the procedure on examination. The ObGyn should perform a detailed physical exam of the external genitalia as well as a pelvic floor exam of every patient. If the patient does not disclose a history of FGC but it is suspected based on the examination, the clinician should inquire sensitively if the patient is aware of having undergone any genital procedures.
Especially when a history of FGC has been confirmed, clinicians should ask patients sensitively about their urinary and sexual function and satisfaction. Validated tools, such as the Female Sexual Function Index, the Female Sexual Distress Scale, and the Pelvic Floor Disability Index, may be helpful in gathering an objective and detailed assessment of the patient’s symptoms and level of distress.14 Clinicians also should ask about the patient’s detailed obstetric history, particularly regarding the second stage, delivery, and postpartum complications. The clinician also should specifically inquire about a history of defibulation or additional genital procedures.
Patients with urethral strictures or stenosis may require an exam under anesthesia, cystoscopy, urethral dilation, or urethroplasty.12 Those with chronic urinary tract or vaginal infections may require chronic oral suppressive therapy or defibulation (described below). Defibulation also may be considered for relief of severe dysmenorrhea and menorrhagia that may be resulting from hematocolpos. The ObGyn also should make certain to evaluate for other common causes of these symptoms that may be unrelated to FGC, such as endometriosis.
Many women who have undergone FGC do not report dyspareunia or sexual dissatisfaction; however, infibulation especially has been associated with higher rates of these sequelae.12 In addition to defibulation, pelvic floor physical therapy with an experienced therapist may be helpful for patients with pelvic floor dysfunction, vaginismus, and/or dyspareunia.
The defibulation procedure
Defibulation (or deinfibulation) is a surgical reconstructive procedure that opens the infibulated scar of patients who have undergone type 3 FGC (infibulation), thus exposing the urethra and introitus, and in almost half of cases an intact clitoris.15 Defibulation may be specifically requested by a patient or it may be recommended by the ObGyn either for reducing complications of pregnancy or to address the patient’s gynecologic, sexual, or urogynecologic symptoms by allowing penetrative intercourse, urinary flow, physiologic delivery, and menstruation.16
Defibulation should be performed under regional or general anesthesia and can be performed during pregnancy (or even in labor). An anterior incision is made on the infibulated scar, creating a new labia major, and the edges are sutured separately. Postoperatively, patients should be instructed to perform sitz baths and to expect a change in their urinary voiding stream.12 The few studies that have evaluated defibulation have shown high rates of success in addressing preoperative symptoms; the complication rates of defibulation are low and the satisfaction rates are high.16
The ethical conundrum of reinfibulation
Reinfibulation is defined as the restitching or reapproximation of scar tissue or the labia after delivery or a gynecologic procedure, and it is often performed routinely after every delivery in patients’ countries of origin.17
Postpartum reinfibulation on patient request raises legal and ethical issues for the ObGyn. In the United Kingdom, reinfibulation is illegal, and some international organizations, including the International Federation of Gynecology and Obstetrics and the WHO, have recommended against the practice. In the United States, reinfibulation of an adult is legal, as it falls under the umbrella of elective female genital cosmetic surgery.18,19
The procedure could create or exacerbate long-term complications and should generally be discouraged. However, if despite extensive counseling (preferably in the prenatal period) a patient insists on having the procedure, the ObGyn may need to elevate the principle of patient autonomy and either comply or find a practitioner who is comfortable performing it. One retrospective review in Switzerland suggested that specific care and informative counseling prenatally with the inclusion of a patient’s partner in the discussion can improve the acceptability of defibulation without reinfibulation.20
Conclusion
It is important for ObGyns to be familiar with the practice of FGC and to be trained in its recognition on examination and care for the long-term complications that can result from the practice. At the same time, ObGyns should be especially conscious of their biases in order to provide culturally competent care and reduce health care stigmatization and inequities for these patients.
- World Health Organization. Female genital mutilation. February 3, 2020. https://www.who.int/news-room/fact-sheets/detail/female-genital-mutilation. Accessed February 22, 2021.
- UNICEF. Female genital mutilation (FGM). February 2020. https://data.unicef.org/topic/child-protection/female-genital-mutilation/. Accessed February 22, 2021.
- Stoklosa H, Nour NM. The eye cannot see what the mind does not know: female genital mutilation. Emerg Med J. 2018;35:585-586. doi: 10.1136/emermed-2018-207994.
- Abdulcadir J, Dugerdil A, Boulvain M, et al. Missed opportunities for diagnosis of female genital mutilation. Int J Gynaecol Obstet. 2014;125:256-260. doi: 10.1016/j.ijgo.2013.11.016.
- Jäger F, Schulze S, Hohlfeld P. Female genital mutilation in Switzerland: a survey among gynaecologists. Swiss Med Wkly. 2002;132:259-264.
- Zaidi N, Khalil A, Roberts C, et al. Knowledge of female genital mutilation among healthcare professionals. J Obstet Gynaecol. 2007;27:161-164. doi: 10.1080/01443610601124257.
- Chalmers B, Hashi KO. 432 Somali women’s birth experiences in Canada after earlier female genital mutilation. Birth. 2000;27:227-234. doi: 10.1046/j.1523-536x.2000.00227.x.
- Shahawy S, Amanuel H, Nour NM. Perspectives on female genital cutting among immigrant women and men in Boston. Soc Sci Med. 2019;220:331-339. doi: 10.1016/j.socscimed.2018.11.030.
- Sharif Mohamed F, Wild V, Earp BD, et al. Clitoral reconstruction after female genital mutilation/cutting: a review of surgical techniques and ethical debate. J Sex Med. 2020;17:531-542. doi: 10.1016/j.jsxm.2019.12.004.
- Nour NM. Female genital cutting: a persisting practice. Rev Obstet Gynecol. 2008 Summer;1(3):135-139.
- Binkova A, Uebelhart M, Dällenbach P, et al. A cross-sectional study on pelvic floor symptoms in women living with female genital mutilation/cutting. Reprod Health. 2021;18:39. doi: 10.1186/s12978-021-01097-9.
- Nour NM. Female genital cutting: clinical and cultural guidelines. Obstet Gynecol Surv. 2004;59:272-279. doi: 10.1097/01.ogx.0000118939.19371.af.
- WHO Study Group on Female Genital Mutilation and Obstetric Outcome; Banks E, Meirik O, Farley T, et al. Female genital mutilation and obstetric outcome: WHO collaborative prospective study in six African countries. Lancet. 2006;367:1835-1841. doi: 10.1016/S0140-6736(06)68805-3.
- American College of Obstetricians and Gynecologists. ACOG practice bulletin no. 119: female sexual dysfunction. Obstet Gynecol. 2011;117:996-1007. doi: 10.1097/AOG.0b013e31821921ce.
- Nour NM, Michels KB, Bryant AE. Defibulation to treat female genital cutting: effect on symptoms and sexual function. Obstet Gynecol. 2006;108:55-60. doi: 10.1097/01.AOG.0000224613.72892.77.
- Johnson C, Nour NM. Surgical techniques: defibulation of type III female genital cutting. J Sex Med. 2007;4:1544-1547. doi: 10.1111/j.1743-6109.2007.00616.x.
- Serour GI. The issue of reinfibulation. Int J Gynaecol Obstet. 2010;109:93-96. doi: 10.1016/j.ijgo.2010.01.001.
- Shahawy S, Deshpande NA, Nour NM. Cross-cultural obstetric and gynecologic care of Muslim patients. Obstet Gynecol. 2015;126:969-973. doi: 10.1097/AOG.0000000000001112.
- American College of Obstetricians and Gynecologists. Elective female genital cosmetic surgery: ACOG committee opinion summary, number 795. Obstet Gynecol. 2020;135:249-250. doi: 10.1097/AOG.0000000000003617.
- Abdulcadir J, McLaren S, Boulvain M, et al. Health education and clinical care of immigrant women with female genital mutilation/cutting who request postpartum reinfibulation. Int J Gynaecol Obstet. 2016;135:69-72. doi: 10.1016/j.ijgo.2016.03.027.
- World Health Organization. Female genital mutilation. February 3, 2020. https://www.who.int/news-room/fact-sheets/detail/female-genital-mutilation. Accessed February 22, 2021.
- UNICEF. Female genital mutilation (FGM). February 2020. https://data.unicef.org/topic/child-protection/female-genital-mutilation/. Accessed February 22, 2021.
- Stoklosa H, Nour NM. The eye cannot see what the mind does not know: female genital mutilation. Emerg Med J. 2018;35:585-586. doi: 10.1136/emermed-2018-207994.
- Abdulcadir J, Dugerdil A, Boulvain M, et al. Missed opportunities for diagnosis of female genital mutilation. Int J Gynaecol Obstet. 2014;125:256-260. doi: 10.1016/j.ijgo.2013.11.016.
- Jäger F, Schulze S, Hohlfeld P. Female genital mutilation in Switzerland: a survey among gynaecologists. Swiss Med Wkly. 2002;132:259-264.
- Zaidi N, Khalil A, Roberts C, et al. Knowledge of female genital mutilation among healthcare professionals. J Obstet Gynaecol. 2007;27:161-164. doi: 10.1080/01443610601124257.
- Chalmers B, Hashi KO. 432 Somali women’s birth experiences in Canada after earlier female genital mutilation. Birth. 2000;27:227-234. doi: 10.1046/j.1523-536x.2000.00227.x.
- Shahawy S, Amanuel H, Nour NM. Perspectives on female genital cutting among immigrant women and men in Boston. Soc Sci Med. 2019;220:331-339. doi: 10.1016/j.socscimed.2018.11.030.
- Sharif Mohamed F, Wild V, Earp BD, et al. Clitoral reconstruction after female genital mutilation/cutting: a review of surgical techniques and ethical debate. J Sex Med. 2020;17:531-542. doi: 10.1016/j.jsxm.2019.12.004.
- Nour NM. Female genital cutting: a persisting practice. Rev Obstet Gynecol. 2008 Summer;1(3):135-139.
- Binkova A, Uebelhart M, Dällenbach P, et al. A cross-sectional study on pelvic floor symptoms in women living with female genital mutilation/cutting. Reprod Health. 2021;18:39. doi: 10.1186/s12978-021-01097-9.
- Nour NM. Female genital cutting: clinical and cultural guidelines. Obstet Gynecol Surv. 2004;59:272-279. doi: 10.1097/01.ogx.0000118939.19371.af.
- WHO Study Group on Female Genital Mutilation and Obstetric Outcome; Banks E, Meirik O, Farley T, et al. Female genital mutilation and obstetric outcome: WHO collaborative prospective study in six African countries. Lancet. 2006;367:1835-1841. doi: 10.1016/S0140-6736(06)68805-3.
- American College of Obstetricians and Gynecologists. ACOG practice bulletin no. 119: female sexual dysfunction. Obstet Gynecol. 2011;117:996-1007. doi: 10.1097/AOG.0b013e31821921ce.
- Nour NM, Michels KB, Bryant AE. Defibulation to treat female genital cutting: effect on symptoms and sexual function. Obstet Gynecol. 2006;108:55-60. doi: 10.1097/01.AOG.0000224613.72892.77.
- Johnson C, Nour NM. Surgical techniques: defibulation of type III female genital cutting. J Sex Med. 2007;4:1544-1547. doi: 10.1111/j.1743-6109.2007.00616.x.
- Serour GI. The issue of reinfibulation. Int J Gynaecol Obstet. 2010;109:93-96. doi: 10.1016/j.ijgo.2010.01.001.
- Shahawy S, Deshpande NA, Nour NM. Cross-cultural obstetric and gynecologic care of Muslim patients. Obstet Gynecol. 2015;126:969-973. doi: 10.1097/AOG.0000000000001112.
- American College of Obstetricians and Gynecologists. Elective female genital cosmetic surgery: ACOG committee opinion summary, number 795. Obstet Gynecol. 2020;135:249-250. doi: 10.1097/AOG.0000000000003617.
- Abdulcadir J, McLaren S, Boulvain M, et al. Health education and clinical care of immigrant women with female genital mutilation/cutting who request postpartum reinfibulation. Int J Gynaecol Obstet. 2016;135:69-72. doi: 10.1016/j.ijgo.2016.03.027.
Can we get to ‘COVID zero’? Experts predict the next 8 months
COVID-19 is likely to follow a seasonal pattern – similar to some other respiratory viruses – with fewer cases come summer 2021 followed by a jump next winter, experts predicted in a Thursday briefing.
If that pattern holds, it could mean a need to reinforce the mask-wearing message as the weather gets colder and people once again congregate indoors.
“Right now, we are projecting the United States all the way to Aug. 1 [will have] 619,000 deaths from COVID-19, with 4.7 million globally,” said Ali H. Mokdad, PhD, professor of health metrics sciences at the Institute for Health Metrics and Evaluation at the University of Washington, Seattle, during today’s media briefing sponsored by the Infectious Diseases Society of America and IHME.
The encouraging news is the vaccines appear to be working, and more Americans are getting them. “If you look at the data for these vaccines, they are extremely safe, they are extremely efficacious, and they make you basically impervious – for the most part – to getting serious disease, hospitalization, or death,” said Amesh Adalja, MD, senior scholar at Johns Hopkins University Center for Health Security in Baltimore.
“These vaccines do what they were meant to do: defang this virus,” said Dr. Adalja, who is an IDSA Fellow and adjunct assistant professor at Johns Hopkins Bloomberg School of Public Health. Emerging data out of Israel and other countries suggest a vaccinated person is less likely to transmit the virus as well, he added.
Still aiming for herd immunity
Furthermore, the U.S. Food and Drug Administration is likely to approve emergency use authorization (EUA) among teenagers 12-15 years old “imminently,” thereby expanding the pool of people potentially protected by vaccines.
Such authorization could help with overall public health efforts. “That’s simply a mathematical formula,” Dr. Adalja said. “The more people that are vaccinated, including children, the quicker we’ll get to herd immunity.”
In addition, with lower case numbers expected this summer, herd immunity might become more achievable, said Dr. Mokdad, who is also chief strategy officer for population health at the University of Washington.
As important as herd immunity is, so-called decoupling is “more important to me,” Dr. Adalja said. Decoupling refers to separating infections from the more severe outcomes, so people who get COVID-19 are less likely to need hospitalization or die from it.
Vaccines get the credit here, he added, including with the variants. “Even if you get a breakthrough infection with a variant, it’s not likely to land you in the hospital or cause serious disease or death,” Dr. Adalja said.
Masks and the uncommon cold
Wearing a mask until we reach herd immunity is important because it’s not possible to tell who is vaccinated and who isn’t, Dr. Mokdad said. “Remember, as many people are waiting to get a vaccine, all of us have access to a mask,” he said.
Dr. Adalja agreed, adding that public health guidance on masks will likely stay in place until we cross that herd immunity threshold and community circulation of the virus goes down.
“People are probably going to want to continue wearing masks, at least some proportion, because they see the benefit for other respiratory viruses,” Dr. Adalja said. “How many of you had a common cold this year?”
Variants: Some good news?
Experts are monitoring the spread of variants of concern in the United States and abroad. On a positive note, the B.1.1.7 variant first identified in the United Kingdom appears to be dominant in the United States at this time, which is potentially good for two reasons. One is that the available COVID-19 vaccines show sufficient efficacy against the strain, Dr. Mokdad said.
Second, a predominance of B.1.1.7 makes it more difficult for other emerging variants of concern like P1 [Brazil] or B.1.351 [South Africa] to gain control, Dr. Adalja said.
“B.1.1.7 is such an efficient transmitter,” he said. “That’s kind of an advantage … because the more B.1.1.7, you have the less opportunity B.1.351 and P1 have to set up shop.”
Hesitancy from misinformation
Vaccine hesitancy remains a concern, particularly at a time when some predict a drop in the number of Americans seeking vaccination. Although needle phobia plays a role in dissuading some from vaccination, the bigger issue is vaccine misinformation, Dr. Adalja said.
“Some people are just terrified when they see the needle. That’s a small part of the proportion of people who don’t want to get vaccinated,” Dr. Adalja said. In contrast, he attributed most hesitancy to misinformation about the vaccine, including reports that the vaccines are fake.
Even celebrities are getting drawn into the misinformation.
“I just had to answer something about Mariah Carey’s vaccination,” he said. Someone believed “that it was done with a retractable needle that didn’t really go into her arm.”
Vaccine hesitancy is more about people not understanding the risk-benefit analysis, taking side effects out of out of context if there are side effects, or being influenced by “arbitrary statements about microchips, infertility, or whatever it might be,” Dr. Adalja said.
The future is subject to change
“We’re expecting another rise in cases and more mortality in our winter season here in the United States,” Dr. Mokdad said, adding that the efficacy of the vaccines is likely to attenuate the mortality rate in particular.
However, as the epidemiology of the pandemic evolves, so too will the long-term predictions. Factors that could influence future numbers include the expansion of vaccination to teens 12-15 years old and (eventually) younger children, a need for booster vaccines, emerging variants, and the changing proportion of the population who are fully vaccinated or were previously infected.
Again, getting people to adhere to mask wearing come winter could be challenging if the scenario over the summer is “close to normal with less than 200 deaths a day in the United States,” he added. Asking people to wear masks again will be like “swimming upstream.”
“I think it’s a mistake to think that we’re going to get to ‘COVID zero,’ ” Dr. Adalja said. “This is not an eradicable disease. There’s only been one human infectious disease eradicated from the planet, and that’s smallpox, and it had very different characteristics.”
A version of this article first appeared on Medscape.com.
COVID-19 is likely to follow a seasonal pattern – similar to some other respiratory viruses – with fewer cases come summer 2021 followed by a jump next winter, experts predicted in a Thursday briefing.
If that pattern holds, it could mean a need to reinforce the mask-wearing message as the weather gets colder and people once again congregate indoors.
“Right now, we are projecting the United States all the way to Aug. 1 [will have] 619,000 deaths from COVID-19, with 4.7 million globally,” said Ali H. Mokdad, PhD, professor of health metrics sciences at the Institute for Health Metrics and Evaluation at the University of Washington, Seattle, during today’s media briefing sponsored by the Infectious Diseases Society of America and IHME.
The encouraging news is the vaccines appear to be working, and more Americans are getting them. “If you look at the data for these vaccines, they are extremely safe, they are extremely efficacious, and they make you basically impervious – for the most part – to getting serious disease, hospitalization, or death,” said Amesh Adalja, MD, senior scholar at Johns Hopkins University Center for Health Security in Baltimore.
“These vaccines do what they were meant to do: defang this virus,” said Dr. Adalja, who is an IDSA Fellow and adjunct assistant professor at Johns Hopkins Bloomberg School of Public Health. Emerging data out of Israel and other countries suggest a vaccinated person is less likely to transmit the virus as well, he added.
Still aiming for herd immunity
Furthermore, the U.S. Food and Drug Administration is likely to approve emergency use authorization (EUA) among teenagers 12-15 years old “imminently,” thereby expanding the pool of people potentially protected by vaccines.
Such authorization could help with overall public health efforts. “That’s simply a mathematical formula,” Dr. Adalja said. “The more people that are vaccinated, including children, the quicker we’ll get to herd immunity.”
In addition, with lower case numbers expected this summer, herd immunity might become more achievable, said Dr. Mokdad, who is also chief strategy officer for population health at the University of Washington.
As important as herd immunity is, so-called decoupling is “more important to me,” Dr. Adalja said. Decoupling refers to separating infections from the more severe outcomes, so people who get COVID-19 are less likely to need hospitalization or die from it.
Vaccines get the credit here, he added, including with the variants. “Even if you get a breakthrough infection with a variant, it’s not likely to land you in the hospital or cause serious disease or death,” Dr. Adalja said.
Masks and the uncommon cold
Wearing a mask until we reach herd immunity is important because it’s not possible to tell who is vaccinated and who isn’t, Dr. Mokdad said. “Remember, as many people are waiting to get a vaccine, all of us have access to a mask,” he said.
Dr. Adalja agreed, adding that public health guidance on masks will likely stay in place until we cross that herd immunity threshold and community circulation of the virus goes down.
“People are probably going to want to continue wearing masks, at least some proportion, because they see the benefit for other respiratory viruses,” Dr. Adalja said. “How many of you had a common cold this year?”
Variants: Some good news?
Experts are monitoring the spread of variants of concern in the United States and abroad. On a positive note, the B.1.1.7 variant first identified in the United Kingdom appears to be dominant in the United States at this time, which is potentially good for two reasons. One is that the available COVID-19 vaccines show sufficient efficacy against the strain, Dr. Mokdad said.
Second, a predominance of B.1.1.7 makes it more difficult for other emerging variants of concern like P1 [Brazil] or B.1.351 [South Africa] to gain control, Dr. Adalja said.
“B.1.1.7 is such an efficient transmitter,” he said. “That’s kind of an advantage … because the more B.1.1.7, you have the less opportunity B.1.351 and P1 have to set up shop.”
Hesitancy from misinformation
Vaccine hesitancy remains a concern, particularly at a time when some predict a drop in the number of Americans seeking vaccination. Although needle phobia plays a role in dissuading some from vaccination, the bigger issue is vaccine misinformation, Dr. Adalja said.
“Some people are just terrified when they see the needle. That’s a small part of the proportion of people who don’t want to get vaccinated,” Dr. Adalja said. In contrast, he attributed most hesitancy to misinformation about the vaccine, including reports that the vaccines are fake.
Even celebrities are getting drawn into the misinformation.
“I just had to answer something about Mariah Carey’s vaccination,” he said. Someone believed “that it was done with a retractable needle that didn’t really go into her arm.”
Vaccine hesitancy is more about people not understanding the risk-benefit analysis, taking side effects out of out of context if there are side effects, or being influenced by “arbitrary statements about microchips, infertility, or whatever it might be,” Dr. Adalja said.
The future is subject to change
“We’re expecting another rise in cases and more mortality in our winter season here in the United States,” Dr. Mokdad said, adding that the efficacy of the vaccines is likely to attenuate the mortality rate in particular.
However, as the epidemiology of the pandemic evolves, so too will the long-term predictions. Factors that could influence future numbers include the expansion of vaccination to teens 12-15 years old and (eventually) younger children, a need for booster vaccines, emerging variants, and the changing proportion of the population who are fully vaccinated or were previously infected.
Again, getting people to adhere to mask wearing come winter could be challenging if the scenario over the summer is “close to normal with less than 200 deaths a day in the United States,” he added. Asking people to wear masks again will be like “swimming upstream.”
“I think it’s a mistake to think that we’re going to get to ‘COVID zero,’ ” Dr. Adalja said. “This is not an eradicable disease. There’s only been one human infectious disease eradicated from the planet, and that’s smallpox, and it had very different characteristics.”
A version of this article first appeared on Medscape.com.
COVID-19 is likely to follow a seasonal pattern – similar to some other respiratory viruses – with fewer cases come summer 2021 followed by a jump next winter, experts predicted in a Thursday briefing.
If that pattern holds, it could mean a need to reinforce the mask-wearing message as the weather gets colder and people once again congregate indoors.
“Right now, we are projecting the United States all the way to Aug. 1 [will have] 619,000 deaths from COVID-19, with 4.7 million globally,” said Ali H. Mokdad, PhD, professor of health metrics sciences at the Institute for Health Metrics and Evaluation at the University of Washington, Seattle, during today’s media briefing sponsored by the Infectious Diseases Society of America and IHME.
The encouraging news is the vaccines appear to be working, and more Americans are getting them. “If you look at the data for these vaccines, they are extremely safe, they are extremely efficacious, and they make you basically impervious – for the most part – to getting serious disease, hospitalization, or death,” said Amesh Adalja, MD, senior scholar at Johns Hopkins University Center for Health Security in Baltimore.
“These vaccines do what they were meant to do: defang this virus,” said Dr. Adalja, who is an IDSA Fellow and adjunct assistant professor at Johns Hopkins Bloomberg School of Public Health. Emerging data out of Israel and other countries suggest a vaccinated person is less likely to transmit the virus as well, he added.
Still aiming for herd immunity
Furthermore, the U.S. Food and Drug Administration is likely to approve emergency use authorization (EUA) among teenagers 12-15 years old “imminently,” thereby expanding the pool of people potentially protected by vaccines.
Such authorization could help with overall public health efforts. “That’s simply a mathematical formula,” Dr. Adalja said. “The more people that are vaccinated, including children, the quicker we’ll get to herd immunity.”
In addition, with lower case numbers expected this summer, herd immunity might become more achievable, said Dr. Mokdad, who is also chief strategy officer for population health at the University of Washington.
As important as herd immunity is, so-called decoupling is “more important to me,” Dr. Adalja said. Decoupling refers to separating infections from the more severe outcomes, so people who get COVID-19 are less likely to need hospitalization or die from it.
Vaccines get the credit here, he added, including with the variants. “Even if you get a breakthrough infection with a variant, it’s not likely to land you in the hospital or cause serious disease or death,” Dr. Adalja said.
Masks and the uncommon cold
Wearing a mask until we reach herd immunity is important because it’s not possible to tell who is vaccinated and who isn’t, Dr. Mokdad said. “Remember, as many people are waiting to get a vaccine, all of us have access to a mask,” he said.
Dr. Adalja agreed, adding that public health guidance on masks will likely stay in place until we cross that herd immunity threshold and community circulation of the virus goes down.
“People are probably going to want to continue wearing masks, at least some proportion, because they see the benefit for other respiratory viruses,” Dr. Adalja said. “How many of you had a common cold this year?”
Variants: Some good news?
Experts are monitoring the spread of variants of concern in the United States and abroad. On a positive note, the B.1.1.7 variant first identified in the United Kingdom appears to be dominant in the United States at this time, which is potentially good for two reasons. One is that the available COVID-19 vaccines show sufficient efficacy against the strain, Dr. Mokdad said.
Second, a predominance of B.1.1.7 makes it more difficult for other emerging variants of concern like P1 [Brazil] or B.1.351 [South Africa] to gain control, Dr. Adalja said.
“B.1.1.7 is such an efficient transmitter,” he said. “That’s kind of an advantage … because the more B.1.1.7, you have the less opportunity B.1.351 and P1 have to set up shop.”
Hesitancy from misinformation
Vaccine hesitancy remains a concern, particularly at a time when some predict a drop in the number of Americans seeking vaccination. Although needle phobia plays a role in dissuading some from vaccination, the bigger issue is vaccine misinformation, Dr. Adalja said.
“Some people are just terrified when they see the needle. That’s a small part of the proportion of people who don’t want to get vaccinated,” Dr. Adalja said. In contrast, he attributed most hesitancy to misinformation about the vaccine, including reports that the vaccines are fake.
Even celebrities are getting drawn into the misinformation.
“I just had to answer something about Mariah Carey’s vaccination,” he said. Someone believed “that it was done with a retractable needle that didn’t really go into her arm.”
Vaccine hesitancy is more about people not understanding the risk-benefit analysis, taking side effects out of out of context if there are side effects, or being influenced by “arbitrary statements about microchips, infertility, or whatever it might be,” Dr. Adalja said.
The future is subject to change
“We’re expecting another rise in cases and more mortality in our winter season here in the United States,” Dr. Mokdad said, adding that the efficacy of the vaccines is likely to attenuate the mortality rate in particular.
However, as the epidemiology of the pandemic evolves, so too will the long-term predictions. Factors that could influence future numbers include the expansion of vaccination to teens 12-15 years old and (eventually) younger children, a need for booster vaccines, emerging variants, and the changing proportion of the population who are fully vaccinated or were previously infected.
Again, getting people to adhere to mask wearing come winter could be challenging if the scenario over the summer is “close to normal with less than 200 deaths a day in the United States,” he added. Asking people to wear masks again will be like “swimming upstream.”
“I think it’s a mistake to think that we’re going to get to ‘COVID zero,’ ” Dr. Adalja said. “This is not an eradicable disease. There’s only been one human infectious disease eradicated from the planet, and that’s smallpox, and it had very different characteristics.”
A version of this article first appeared on Medscape.com.
Small clinics, practices key to COVID-19 vaccine success: State officials
Primary care physicians and providers in small offices and clinics are going to be key to ensuring that the remaining half of the nation receives a COVID-19 vaccination, state health officials said Wednesday, and the federal government will soon start shipping smaller packages of the Pfizer/BioNTech vaccine that can be more readily used by individual doctors.
According to the Centers for Disease Control and Prevention, as of April 21, more than 215 million doses have been administered. About 40% – 134 million Americans – have had at least one dose of a vaccine.
Among those who still haven’t received a shot are people who don’t have the time, may be homebound, or who have questions about the vaccine, or might say they will never be vaccinated, said Nirav Shah, MD, JD, president of the Association of State and Territorial Health Officials and director of the Maine Center for Disease Control and Prevention, on a call with reporters.
Especially for those who fall into the “not-ever” category, state officials “are working to find trusted messengers like doctors” who can connect with these individuals and give them information, he said.
Primary care physicians’ offices and other small practice settings are “where we are most likely to reach many of the remaining 50%,” Steven Stack, MD, MBA, FACEP, commissioner of the Kentucky Department for Public Health, said on the briefing.
State officials also “need to support all people to consult their personal physicians in whom they have confidence and trust to be informed of the benefits of COVID vaccination and the safety of this vaccination,” he said, adding that “this is the way we put this pandemic in the rearview mirror and move on with our lives.”
Dr. Stack said the federal government is starting by working with Pfizer to slim down its packages from 1,170 doses to 450 doses. That should happen before June, said Dr. Stack, adding that state health officials will be able to distribute the smaller packages “more widely and to smaller settings.”
Ideally, packaging for all vaccines will get down to single-dose, pre-filled syringes, he said. But that is a “journey” that the federal government has just begun, said Dr. Stack.
The White House had not responded to a request from this news organization for comment by press time.
Having vaccines onsite in a physician’s office is important, Dr. Stack said, adding that doctors “need to reach people in their persuadable moment.”
Bringing pediatricians on board
Illinois state health officials have begun a process that will let pediatricians have weekly vaccination clinics and also have vaccine on hand to meet patients in the moment, said Ngozi Ezike, MD, director of the Illinois Department of Public Health, on the briefing.
She said the distribution can start even before the Pfizer vaccine is shipped in smaller packages – and as soon as the Food and Drug Administration authorizes the vaccine for adolescents. Pfizer applied for emergency use approval for children aged 12-15 on April 9.
Local health departments will store the vaccine in their ultra-cold freezers. Pediatricians will identify how many people they hope to vaccinate each week and receive the doses on Monday, with the understanding that they must use the vaccine within 5 days, said Dr. Ezike.
The aim is to support vaccination clinics but also to ensure doctors have “doses on hand,” so that a parent or adolescent could opt for vaccination during a visit.
Although estimating the number of doses required will be difficult and likely involve some waste, Dr. Ezike said it’s important to be able to offer a vaccine in the office instead of having to refer someone elsewhere.
A version of this article first appeared on Medscape.com.
Primary care physicians and providers in small offices and clinics are going to be key to ensuring that the remaining half of the nation receives a COVID-19 vaccination, state health officials said Wednesday, and the federal government will soon start shipping smaller packages of the Pfizer/BioNTech vaccine that can be more readily used by individual doctors.
According to the Centers for Disease Control and Prevention, as of April 21, more than 215 million doses have been administered. About 40% – 134 million Americans – have had at least one dose of a vaccine.
Among those who still haven’t received a shot are people who don’t have the time, may be homebound, or who have questions about the vaccine, or might say they will never be vaccinated, said Nirav Shah, MD, JD, president of the Association of State and Territorial Health Officials and director of the Maine Center for Disease Control and Prevention, on a call with reporters.
Especially for those who fall into the “not-ever” category, state officials “are working to find trusted messengers like doctors” who can connect with these individuals and give them information, he said.
Primary care physicians’ offices and other small practice settings are “where we are most likely to reach many of the remaining 50%,” Steven Stack, MD, MBA, FACEP, commissioner of the Kentucky Department for Public Health, said on the briefing.
State officials also “need to support all people to consult their personal physicians in whom they have confidence and trust to be informed of the benefits of COVID vaccination and the safety of this vaccination,” he said, adding that “this is the way we put this pandemic in the rearview mirror and move on with our lives.”
Dr. Stack said the federal government is starting by working with Pfizer to slim down its packages from 1,170 doses to 450 doses. That should happen before June, said Dr. Stack, adding that state health officials will be able to distribute the smaller packages “more widely and to smaller settings.”
Ideally, packaging for all vaccines will get down to single-dose, pre-filled syringes, he said. But that is a “journey” that the federal government has just begun, said Dr. Stack.
The White House had not responded to a request from this news organization for comment by press time.
Having vaccines onsite in a physician’s office is important, Dr. Stack said, adding that doctors “need to reach people in their persuadable moment.”
Bringing pediatricians on board
Illinois state health officials have begun a process that will let pediatricians have weekly vaccination clinics and also have vaccine on hand to meet patients in the moment, said Ngozi Ezike, MD, director of the Illinois Department of Public Health, on the briefing.
She said the distribution can start even before the Pfizer vaccine is shipped in smaller packages – and as soon as the Food and Drug Administration authorizes the vaccine for adolescents. Pfizer applied for emergency use approval for children aged 12-15 on April 9.
Local health departments will store the vaccine in their ultra-cold freezers. Pediatricians will identify how many people they hope to vaccinate each week and receive the doses on Monday, with the understanding that they must use the vaccine within 5 days, said Dr. Ezike.
The aim is to support vaccination clinics but also to ensure doctors have “doses on hand,” so that a parent or adolescent could opt for vaccination during a visit.
Although estimating the number of doses required will be difficult and likely involve some waste, Dr. Ezike said it’s important to be able to offer a vaccine in the office instead of having to refer someone elsewhere.
A version of this article first appeared on Medscape.com.
Primary care physicians and providers in small offices and clinics are going to be key to ensuring that the remaining half of the nation receives a COVID-19 vaccination, state health officials said Wednesday, and the federal government will soon start shipping smaller packages of the Pfizer/BioNTech vaccine that can be more readily used by individual doctors.
According to the Centers for Disease Control and Prevention, as of April 21, more than 215 million doses have been administered. About 40% – 134 million Americans – have had at least one dose of a vaccine.
Among those who still haven’t received a shot are people who don’t have the time, may be homebound, or who have questions about the vaccine, or might say they will never be vaccinated, said Nirav Shah, MD, JD, president of the Association of State and Territorial Health Officials and director of the Maine Center for Disease Control and Prevention, on a call with reporters.
Especially for those who fall into the “not-ever” category, state officials “are working to find trusted messengers like doctors” who can connect with these individuals and give them information, he said.
Primary care physicians’ offices and other small practice settings are “where we are most likely to reach many of the remaining 50%,” Steven Stack, MD, MBA, FACEP, commissioner of the Kentucky Department for Public Health, said on the briefing.
State officials also “need to support all people to consult their personal physicians in whom they have confidence and trust to be informed of the benefits of COVID vaccination and the safety of this vaccination,” he said, adding that “this is the way we put this pandemic in the rearview mirror and move on with our lives.”
Dr. Stack said the federal government is starting by working with Pfizer to slim down its packages from 1,170 doses to 450 doses. That should happen before June, said Dr. Stack, adding that state health officials will be able to distribute the smaller packages “more widely and to smaller settings.”
Ideally, packaging for all vaccines will get down to single-dose, pre-filled syringes, he said. But that is a “journey” that the federal government has just begun, said Dr. Stack.
The White House had not responded to a request from this news organization for comment by press time.
Having vaccines onsite in a physician’s office is important, Dr. Stack said, adding that doctors “need to reach people in their persuadable moment.”
Bringing pediatricians on board
Illinois state health officials have begun a process that will let pediatricians have weekly vaccination clinics and also have vaccine on hand to meet patients in the moment, said Ngozi Ezike, MD, director of the Illinois Department of Public Health, on the briefing.
She said the distribution can start even before the Pfizer vaccine is shipped in smaller packages – and as soon as the Food and Drug Administration authorizes the vaccine for adolescents. Pfizer applied for emergency use approval for children aged 12-15 on April 9.
Local health departments will store the vaccine in their ultra-cold freezers. Pediatricians will identify how many people they hope to vaccinate each week and receive the doses on Monday, with the understanding that they must use the vaccine within 5 days, said Dr. Ezike.
The aim is to support vaccination clinics but also to ensure doctors have “doses on hand,” so that a parent or adolescent could opt for vaccination during a visit.
Although estimating the number of doses required will be difficult and likely involve some waste, Dr. Ezike said it’s important to be able to offer a vaccine in the office instead of having to refer someone elsewhere.
A version of this article first appeared on Medscape.com.