MDedge Pediatrics

The Ohio measles outbreak continues to expand, with cases now totaling 81 – a 37% increase in the course of just 2 weeks.

The lead health official where the outbreak is occurring said the driving force behind the spread is vaccine hesitancy. Most of the children infected were unvaccinated but were old enough to get the measles, mumps, and rubella (MMR) shot, which is 97% effective at preventing measles.

“I think these are individuals who are making a decision not to protect their children against vaccine-preventable diseases, and some of them are making a specific decision not to use the MMR vaccine,” Columbus Public Health Commissioner Mysheika W. Roberts, MD, told JAMA.

She said that parents’ refusal to vaccinate their children was due to a misconception that the vaccine causes autism.

“We’re sounding the alarm that if your child is of age and not vaccinated, they should get vaccinated ASAP,” Dr. Roberts said, noting that she hasn’t seen that happening more.

Health officials have predicted the outbreak, which started in November, will last at least several months. Measles is so contagious that 9 out of 10 unvaccinated people in a room will become infected if exposed.

All of the infections have been in children. According to the Columbus Public Health measles dashboard, of the 81 confirmed cases:

• 29 children have been hospitalized.
• 22 cases are among children under 1 year old.
• No deaths have been reported.

Dr. Roberts said the hospitalized children have had symptoms including dehydration, diarrhea, and pneumonia. Some have had to go to the intensive care unit.

Measles infection causes a rash and a fever that can spike beyond 104° F. Sometimes, the illness can lead to brain swelling, brain damage, and even death, the CDC says.

One of the most recent cases was an infant too young to be vaccinated who lives 45 miles away from where the outbreak began, the Dayton Daily News reported. That’s the first case in Clark County in more than 20 years. At least 10% of kindergartners’ parents in the region’s elementary schools opted out of vaccines because of religious or moral objections.

“We knew this was coming. It was a matter of when, not if,” Yamini Teegala, MD, chief medical officer at Rocking Horse Community Health Center in Springfield, told the Dayton Daily News.

This is the second measles outbreak this year. Minnesota tallied 22 cases since June in an unrelated outbreak, JAMA reported.

A version of this article first appeared on WebMD.com.

The Ohio measles outbreak continues to expand, with cases now totaling 81 – a 37% increase in the course of just 2 weeks.

The lead health official where the outbreak is occurring said the driving force behind the spread is vaccine hesitancy. Most of the children infected were unvaccinated but were old enough to get the measles, mumps, and rubella (MMR) shot, which is 97% effective at preventing measles.

“I think these are individuals who are making a decision not to protect their children against vaccine-preventable diseases, and some of them are making a specific decision not to use the MMR vaccine,” Columbus Public Health Commissioner Mysheika W. Roberts, MD, told JAMA.

She said that parents’ refusal to vaccinate their children was due to a misconception that the vaccine causes autism.

“We’re sounding the alarm that if your child is of age and not vaccinated, they should get vaccinated ASAP,” Dr. Roberts said, noting that she hasn’t seen that happening more.

Health officials have predicted the outbreak, which started in November, will last at least several months. Measles is so contagious that 9 out of 10 unvaccinated people in a room will become infected if exposed.

All of the infections have been in children. According to the Columbus Public Health measles dashboard, of the 81 confirmed cases:

• 29 children have been hospitalized.
• 22 cases are among children under 1 year old.
• No deaths have been reported.

Dr. Roberts said the hospitalized children have had symptoms including dehydration, diarrhea, and pneumonia. Some have had to go to the intensive care unit.

Measles infection causes a rash and a fever that can spike beyond 104° F. Sometimes, the illness can lead to brain swelling, brain damage, and even death, the CDC says.

One of the most recent cases was an infant too young to be vaccinated who lives 45 miles away from where the outbreak began, the Dayton Daily News reported. That’s the first case in Clark County in more than 20 years. At least 10% of kindergartners’ parents in the region’s elementary schools opted out of vaccines because of religious or moral objections.

“We knew this was coming. It was a matter of when, not if,” Yamini Teegala, MD, chief medical officer at Rocking Horse Community Health Center in Springfield, told the Dayton Daily News.

This is the second measles outbreak this year. Minnesota tallied 22 cases since June in an unrelated outbreak, JAMA reported.

A version of this article first appeared on WebMD.com.

The Ohio measles outbreak continues to expand, with cases now totaling 81 – a 37% increase in the course of just 2 weeks.

The lead health official where the outbreak is occurring said the driving force behind the spread is vaccine hesitancy. Most of the children infected were unvaccinated but were old enough to get the measles, mumps, and rubella (MMR) shot, which is 97% effective at preventing measles.

“I think these are individuals who are making a decision not to protect their children against vaccine-preventable diseases, and some of them are making a specific decision not to use the MMR vaccine,” Columbus Public Health Commissioner Mysheika W. Roberts, MD, told JAMA.

She said that parents’ refusal to vaccinate their children was due to a misconception that the vaccine causes autism.

“We’re sounding the alarm that if your child is of age and not vaccinated, they should get vaccinated ASAP,” Dr. Roberts said, noting that she hasn’t seen that happening more.

Health officials have predicted the outbreak, which started in November, will last at least several months. Measles is so contagious that 9 out of 10 unvaccinated people in a room will become infected if exposed.

All of the infections have been in children. According to the Columbus Public Health measles dashboard, of the 81 confirmed cases:

• 29 children have been hospitalized.
• 22 cases are among children under 1 year old.
• No deaths have been reported.

Dr. Roberts said the hospitalized children have had symptoms including dehydration, diarrhea, and pneumonia. Some have had to go to the intensive care unit.

Measles infection causes a rash and a fever that can spike beyond 104° F. Sometimes, the illness can lead to brain swelling, brain damage, and even death, the CDC says.

One of the most recent cases was an infant too young to be vaccinated who lives 45 miles away from where the outbreak began, the Dayton Daily News reported. That’s the first case in Clark County in more than 20 years. At least 10% of kindergartners’ parents in the region’s elementary schools opted out of vaccines because of religious or moral objections.

“We knew this was coming. It was a matter of when, not if,” Yamini Teegala, MD, chief medical officer at Rocking Horse Community Health Center in Springfield, told the Dayton Daily News.

This is the second measles outbreak this year. Minnesota tallied 22 cases since June in an unrelated outbreak, JAMA reported.

A version of this article first appeared on WebMD.com.

I have assumed that being a parent has always been an anxiety-producing experience. Even back when the neonatal mortality rate was orders of magnitude greater than we are experiencing now, I suspect that each birth was still accompanied by a period of angst. However, as families no longer felt the need to produce more children to replace those lost to illness, each surviving child fell under the glare of an ever brightening spotlight.

Raising a child no longer became just something that came naturally, learned from one’s parents. Philosophers and eventually physicians felt obligated to advise parents on the best practices. My parents turned to Dr. Benjamin Spock’s classic work when they had a question, but I never got the feeling that they took his words as gospel.

By the time I started in practice the condition of being a parent was morphing into a verb. Books on “parenting” were beginning to fill the shelves of libraries and bookstores. Frustrated by what I saw as poorly conceived instruction manuals I succumbed to the temptation to spread my “better” advice for anxiety-tormented parents by writing books on how to feed picky eaters, or how to get erratic sleepers to sleep, or how to get a misbehaving child to understand the simple concept of “No!”

Back in the pre-Internet days I was competing for the attention of anxiety-driven parents not just with other self-described experts sitting at word processors, but with grandmothers, aunts, and the ladies next door. The book publishing market has cooled but the demand for advice on how to be the best parent has heated up. Into the void, enabled by the Internet, has erupted the phenomenon of social-media mom groups.

The lady next door and the mothers with strollers meeting informally at the playground are a tiny blip on the radar screen compared with the abundance of other mothers eager to listen and comment on social media–based mom groups unlimited by either geographic or temporal time restraints.

Unfortunately, as a recent article in the Wall Street Journal suggests, these support groups can often have a dark side. Researchers from Pepperdine University found in a small survey of a homogenous population of women that stress, as measured by saliva cortisol levels, increased with increasing use of “mom-centric social media” sites.

Citing anecdotal observations by mothers who did not participate in the study, the WSJ article describes episodes of shaming over topics such as steroid use in eczema and vaccine hesitancy. One mother described how she found group discussions about breastfeeding “particularly anxiety-producing.”

I have limited experience with online support groups but I have been surprised by how rude and condescending some of the contributors can be to what I could consider to be emotionally neutral subjects such as outboard motor oil pressure. I can imagine that when it comes to subjects in which there is no one best answer, the relative anonymity of the Internet provides cover for language that can be hurtful and stress inducing for someone already feeling isolated and anxious about being a parent.

Although this Pepperdine study is small, I suspect that a larger study would support the authors’ observations. For us as providers, it suggests that we need to find where parents are getting their information when we are trying to help those who seem particularly distressed. We should caution them that, while sharing information with peers can be reassuring and helpful at times, mom groups can be toxic as well. It also means that we should be careful in recommending social media sites – even those for which we have had good feedback.

And, most importantly, we must continue to work hard to make ourselves available to provide sensible and sensitive answers to those questions that are anxiety-producing for new parents.
 

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Other than a Littman stethoscope he accepted as a first-year medical student in 1966, Dr. Wilkoff reports having nothing to disclose. Email him at pdnews@mdedge.com.

I have assumed that being a parent has always been an anxiety-producing experience. Even back when the neonatal mortality rate was orders of magnitude greater than we are experiencing now, I suspect that each birth was still accompanied by a period of angst. However, as families no longer felt the need to produce more children to replace those lost to illness, each surviving child fell under the glare of an ever brightening spotlight.

Raising a child no longer became just something that came naturally, learned from one’s parents. Philosophers and eventually physicians felt obligated to advise parents on the best practices. My parents turned to Dr. Benjamin Spock’s classic work when they had a question, but I never got the feeling that they took his words as gospel.

By the time I started in practice the condition of being a parent was morphing into a verb. Books on “parenting” were beginning to fill the shelves of libraries and bookstores. Frustrated by what I saw as poorly conceived instruction manuals I succumbed to the temptation to spread my “better” advice for anxiety-tormented parents by writing books on how to feed picky eaters, or how to get erratic sleepers to sleep, or how to get a misbehaving child to understand the simple concept of “No!”

Back in the pre-Internet days I was competing for the attention of anxiety-driven parents not just with other self-described experts sitting at word processors, but with grandmothers, aunts, and the ladies next door. The book publishing market has cooled but the demand for advice on how to be the best parent has heated up. Into the void, enabled by the Internet, has erupted the phenomenon of social-media mom groups.

The lady next door and the mothers with strollers meeting informally at the playground are a tiny blip on the radar screen compared with the abundance of other mothers eager to listen and comment on social media–based mom groups unlimited by either geographic or temporal time restraints.

Unfortunately, as a recent article in the Wall Street Journal suggests, these support groups can often have a dark side. Researchers from Pepperdine University found in a small survey of a homogenous population of women that stress, as measured by saliva cortisol levels, increased with increasing use of “mom-centric social media” sites.

Citing anecdotal observations by mothers who did not participate in the study, the WSJ article describes episodes of shaming over topics such as steroid use in eczema and vaccine hesitancy. One mother described how she found group discussions about breastfeeding “particularly anxiety-producing.”

I have limited experience with online support groups but I have been surprised by how rude and condescending some of the contributors can be to what I could consider to be emotionally neutral subjects such as outboard motor oil pressure. I can imagine that when it comes to subjects in which there is no one best answer, the relative anonymity of the Internet provides cover for language that can be hurtful and stress inducing for someone already feeling isolated and anxious about being a parent.

Although this Pepperdine study is small, I suspect that a larger study would support the authors’ observations. For us as providers, it suggests that we need to find where parents are getting their information when we are trying to help those who seem particularly distressed. We should caution them that, while sharing information with peers can be reassuring and helpful at times, mom groups can be toxic as well. It also means that we should be careful in recommending social media sites – even those for which we have had good feedback.

And, most importantly, we must continue to work hard to make ourselves available to provide sensible and sensitive answers to those questions that are anxiety-producing for new parents.
 

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Other than a Littman stethoscope he accepted as a first-year medical student in 1966, Dr. Wilkoff reports having nothing to disclose. Email him at pdnews@mdedge.com.

I have assumed that being a parent has always been an anxiety-producing experience. Even back when the neonatal mortality rate was orders of magnitude greater than we are experiencing now, I suspect that each birth was still accompanied by a period of angst. However, as families no longer felt the need to produce more children to replace those lost to illness, each surviving child fell under the glare of an ever brightening spotlight.

Raising a child no longer became just something that came naturally, learned from one’s parents. Philosophers and eventually physicians felt obligated to advise parents on the best practices. My parents turned to Dr. Benjamin Spock’s classic work when they had a question, but I never got the feeling that they took his words as gospel.

By the time I started in practice the condition of being a parent was morphing into a verb. Books on “parenting” were beginning to fill the shelves of libraries and bookstores. Frustrated by what I saw as poorly conceived instruction manuals I succumbed to the temptation to spread my “better” advice for anxiety-tormented parents by writing books on how to feed picky eaters, or how to get erratic sleepers to sleep, or how to get a misbehaving child to understand the simple concept of “No!”

Back in the pre-Internet days I was competing for the attention of anxiety-driven parents not just with other self-described experts sitting at word processors, but with grandmothers, aunts, and the ladies next door. The book publishing market has cooled but the demand for advice on how to be the best parent has heated up. Into the void, enabled by the Internet, has erupted the phenomenon of social-media mom groups.

The lady next door and the mothers with strollers meeting informally at the playground are a tiny blip on the radar screen compared with the abundance of other mothers eager to listen and comment on social media–based mom groups unlimited by either geographic or temporal time restraints.

Unfortunately, as a recent article in the Wall Street Journal suggests, these support groups can often have a dark side. Researchers from Pepperdine University found in a small survey of a homogenous population of women that stress, as measured by saliva cortisol levels, increased with increasing use of “mom-centric social media” sites.

Citing anecdotal observations by mothers who did not participate in the study, the WSJ article describes episodes of shaming over topics such as steroid use in eczema and vaccine hesitancy. One mother described how she found group discussions about breastfeeding “particularly anxiety-producing.”

I have limited experience with online support groups but I have been surprised by how rude and condescending some of the contributors can be to what I could consider to be emotionally neutral subjects such as outboard motor oil pressure. I can imagine that when it comes to subjects in which there is no one best answer, the relative anonymity of the Internet provides cover for language that can be hurtful and stress inducing for someone already feeling isolated and anxious about being a parent.

Although this Pepperdine study is small, I suspect that a larger study would support the authors’ observations. For us as providers, it suggests that we need to find where parents are getting their information when we are trying to help those who seem particularly distressed. We should caution them that, while sharing information with peers can be reassuring and helpful at times, mom groups can be toxic as well. It also means that we should be careful in recommending social media sites – even those for which we have had good feedback.

And, most importantly, we must continue to work hard to make ourselves available to provide sensible and sensitive answers to those questions that are anxiety-producing for new parents.
 

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Other than a Littman stethoscope he accepted as a first-year medical student in 1966, Dr. Wilkoff reports having nothing to disclose. Email him at pdnews@mdedge.com.

New COVID-19 cases in children jumped by 66% during the first 2 weeks of December after an 8-week steady period lasting through October and November, according to the American Academy of Pediatrics and the Children’s Hospital Association.

New cases reached close to 48,000 for the most recent reporting week, Dec. 9-15, after rising to just over 41,000 the previous week and totaling less than 29,000 for the week of Nov. 25 to Dec. 1. That increase of almost 19,000 cases is the largest over a 2-week period since late July, the AAP and CHA said in their weekly COVID report based on data collected from state and territorial health department websites.

[This publication has been following the AAP/CHA report since the summer of 2020 and continues to share the data for the sake of consistency, but it must be noted that a number of states are no longer updating their public COVID dashboards. As a result, there is now a considerable discrepancy between the AAP/CHA weekly figures and those reported by the Centers for Disease Control and Prevention, which has no such limitations on state data.]

The situation involving new cases over the last 2 weeks is quite different from the CDC’s perspective. The agency does not publish a weekly count, instead offering cumulative cases, which stood at almost 16.1 million as of Dec. 14. Calculating a 2-week total puts the new-case count for Dec. 1-14 at 113,572 among children aged 0-17 years. That is higher than the AAP/CHA count (88,629) for roughly the same period, but it is actually lower than the CDC’s figure (161,832) for the last 2 weeks of November.

The CDC data, in other words, suggest that new cases have gone down in the last 2 weeks, while the AAP and CHA, with their somewhat limited perspective, announced that new cases have gone up.

One COVID-related measure from the CDC that is not contradicted by other sources is hospitalization rates, which had climbed from 0.16 new admissions in children aged 0-17 years with confirmed COVID per 100,000 population on Oct. 22 to 0.29 per 100,000 on Dec. 9. Visits to the emergency department with diagnosed COVID, meanwhile, have been fairly steady so far through December in children, according to the CDC.

New COVID-19 cases in children jumped by 66% during the first 2 weeks of December after an 8-week steady period lasting through October and November, according to the American Academy of Pediatrics and the Children’s Hospital Association.

New cases reached close to 48,000 for the most recent reporting week, Dec. 9-15, after rising to just over 41,000 the previous week and totaling less than 29,000 for the week of Nov. 25 to Dec. 1. That increase of almost 19,000 cases is the largest over a 2-week period since late July, the AAP and CHA said in their weekly COVID report based on data collected from state and territorial health department websites.

[This publication has been following the AAP/CHA report since the summer of 2020 and continues to share the data for the sake of consistency, but it must be noted that a number of states are no longer updating their public COVID dashboards. As a result, there is now a considerable discrepancy between the AAP/CHA weekly figures and those reported by the Centers for Disease Control and Prevention, which has no such limitations on state data.]

The situation involving new cases over the last 2 weeks is quite different from the CDC’s perspective. The agency does not publish a weekly count, instead offering cumulative cases, which stood at almost 16.1 million as of Dec. 14. Calculating a 2-week total puts the new-case count for Dec. 1-14 at 113,572 among children aged 0-17 years. That is higher than the AAP/CHA count (88,629) for roughly the same period, but it is actually lower than the CDC’s figure (161,832) for the last 2 weeks of November.

The CDC data, in other words, suggest that new cases have gone down in the last 2 weeks, while the AAP and CHA, with their somewhat limited perspective, announced that new cases have gone up.

One COVID-related measure from the CDC that is not contradicted by other sources is hospitalization rates, which had climbed from 0.16 new admissions in children aged 0-17 years with confirmed COVID per 100,000 population on Oct. 22 to 0.29 per 100,000 on Dec. 9. Visits to the emergency department with diagnosed COVID, meanwhile, have been fairly steady so far through December in children, according to the CDC.

New COVID-19 cases in children jumped by 66% during the first 2 weeks of December after an 8-week steady period lasting through October and November, according to the American Academy of Pediatrics and the Children’s Hospital Association.

New cases reached close to 48,000 for the most recent reporting week, Dec. 9-15, after rising to just over 41,000 the previous week and totaling less than 29,000 for the week of Nov. 25 to Dec. 1. That increase of almost 19,000 cases is the largest over a 2-week period since late July, the AAP and CHA said in their weekly COVID report based on data collected from state and territorial health department websites.

[This publication has been following the AAP/CHA report since the summer of 2020 and continues to share the data for the sake of consistency, but it must be noted that a number of states are no longer updating their public COVID dashboards. As a result, there is now a considerable discrepancy between the AAP/CHA weekly figures and those reported by the Centers for Disease Control and Prevention, which has no such limitations on state data.]

The situation involving new cases over the last 2 weeks is quite different from the CDC’s perspective. The agency does not publish a weekly count, instead offering cumulative cases, which stood at almost 16.1 million as of Dec. 14. Calculating a 2-week total puts the new-case count for Dec. 1-14 at 113,572 among children aged 0-17 years. That is higher than the AAP/CHA count (88,629) for roughly the same period, but it is actually lower than the CDC’s figure (161,832) for the last 2 weeks of November.

The CDC data, in other words, suggest that new cases have gone down in the last 2 weeks, while the AAP and CHA, with their somewhat limited perspective, announced that new cases have gone up.

One COVID-related measure from the CDC that is not contradicted by other sources is hospitalization rates, which had climbed from 0.16 new admissions in children aged 0-17 years with confirmed COVID per 100,000 population on Oct. 22 to 0.29 per 100,000 on Dec. 9. Visits to the emergency department with diagnosed COVID, meanwhile, have been fairly steady so far through December in children, according to the CDC.

An investigational vaccine against respiratory syncytial virus (RSV) in pregnant women has been shown to help protect infants against severe disease, according to the vaccine’s manufacturer.

Pfizer recently announced that in the course of a randomized, double-blind, placebo-controlled phase 3 study, the vaccine RSVpreF had an almost 82% efficacy against severe RSV infection in infants from birth through the first 90 days of life, according to a company press release.

The vaccine also had a 69% efficacy against severe disease through the first 6 months of life. A total of 7,400 women had received a single dose of 120 mcg RSVpreF in the late second or third trimester of their pregnancy. There were no signs of safety issues for the mothers or infants.

Due to the good results, the enrollment in the study was halted on the recommendation of the study’s Data Monitoring Committee after achieving a primary endpoint. The company plans to apply for marketing authorization to the U.S. Food and Drug Administration by the end of 2022 and to other regulatory agencies in 2023.

“The directness of the strategy, to vaccinate expectant mothers during pregnancy so that their newborn is then later protected, is new and a very interesting approach,” commented Prof. Ortwin Adams, MD, head of virologic diagnostics at the Institute for Virology of the University Hospital of Düsseldorf (Germany) to the Science Media Centre (SMC).

In terms of the RSV vaccination strategy presented, “the unborn child has taken center stage from the outset.” Because the vaccination route is the placental transfer of antibodies from mother to child (“passive immunity”), “... the medical points of contact for this vaccination will be the gynecologists, not the pediatricians,” Dr. Adams said.

“This concept imitates the natural process, since the mother normally passes immune defenses she acquired through infections to the child via the umbilical cord and her breast milk before and after birth. This procedure is long-proven and practiced worldwide, especially in nonindustrialized countries, for a variety of diseases, including tetanus, whooping cough (pertussis), and viral flu (influenza),” explained Markus Rose, MD, PhD, head of Pediatric Pulmonology at the Olgahospital, Stuttgart, Germany.

The development of an RSV vaccine had ground to a halt for many decades: A tragedy in the 1960s set the whole field of research back. Using the model of the first polio vaccine, scientists had manufactured an experimental vaccine with inactivated viruses. However, tests showed that the vaccine did not protect the children vaccinated, but it actually infected them with RSV, they then fell ill, and two children died. Today, potential RSV vaccines are first tested on adults and not on children.
 

Few treatment options

RSV causes seasonal epidemics, can lead to bronchiolitis and pneumonia in infants, and is one of the main causes of hospital stays in young children. Monoclonal antibodies are currently the only preventive option, since there is still no vaccine. Usually, 60%-70% of infants and nearly all children younger than 2 years are infected with RSV, but the virus can also trigger pneumonia in adults.

“RSV infections constitute a major public health challenge: It is the most dangerous respiratory virus for young infants, it is also a threat to the chronically ill and immunocompromised of all ages, and [it] is the second most common cause of death worldwide (after malaria) in young children,” stated Dr. Rose.

Recently, pandemic-related measures (face masks, more intense disinfection) meant that the “normal” RSV infections in healthy adults, which usually progress like a mild cold, were prevented, and mothers were unable to pass on as much RSV immune defense to their children. “This was presumably responsible in part for the massive wave of RSV infections in fall and winter of 2021/22,” explained Dr. Rose.

Thomas Mertens, MD, PhD, chair of the Standing Committee on Vaccination at the Robert Koch Institute (STIKO) and former director of the Institute for Virology at Ulm University Hospital, Germany, also noted: “It would be an important and potentially achievable goal to significantly reduce the incidence rate of hospitalizations. In this respect, RSV poses a significant problem for young children, their parents, and the burden on pediatric clinics.”
 

Final evaluation pending

“I am definitely finding the data interesting, but the original data are needed,” Dr. Mertens said. Once the data are published at a conference or published in a peer-reviewed journal, physicians will be able to better judge the data for themselves, he said.

Dr. Rose characterized the new vaccine as “novel,” including in terms of its composition. Earlier RSV vaccines used the so-called postfusion F protein as their starting point. But it has become known in the meantime that the key to immunogenicity is the continued prefusion state of the apical epitope: Prefusion F-specific memory B cells in adults naturally infected with RSV produce potent neutralizing antibodies.

The new vaccine is bivalent and protects against both RSV A and RSV B.

To date, RSV vaccination directly in young infants have had only had a weak efficacy and were sometimes poorly tolerated. The vaccine presented here is expected to be tested in young adults first, then in school children, then young children.

Through successful vaccination of the entire population, the transfer of RS viruses to young children could be prevented. “To what extent this, or any other RSV vaccine still to be developed on the same basis, will also be effective and well tolerated in young infants is still difficult to assess,” said Dr. Rose.

Dr. Mertens emphasized that all of the study data now needs to be seen as quickly as possible: “This is also a general requirement for transparency from the pharmaceutical companies, which is also rightly criticized.”

This article was originally published in Medscape’s German edition and a version appeared on Medscape.com.

An investigational vaccine against respiratory syncytial virus (RSV) in pregnant women has been shown to help protect infants against severe disease, according to the vaccine’s manufacturer.

Pfizer recently announced that in the course of a randomized, double-blind, placebo-controlled phase 3 study, the vaccine RSVpreF had an almost 82% efficacy against severe RSV infection in infants from birth through the first 90 days of life, according to a company press release.

The vaccine also had a 69% efficacy against severe disease through the first 6 months of life. A total of 7,400 women had received a single dose of 120 mcg RSVpreF in the late second or third trimester of their pregnancy. There were no signs of safety issues for the mothers or infants.

Due to the good results, the enrollment in the study was halted on the recommendation of the study’s Data Monitoring Committee after achieving a primary endpoint. The company plans to apply for marketing authorization to the U.S. Food and Drug Administration by the end of 2022 and to other regulatory agencies in 2023.

“The directness of the strategy, to vaccinate expectant mothers during pregnancy so that their newborn is then later protected, is new and a very interesting approach,” commented Prof. Ortwin Adams, MD, head of virologic diagnostics at the Institute for Virology of the University Hospital of Düsseldorf (Germany) to the Science Media Centre (SMC).

In terms of the RSV vaccination strategy presented, “the unborn child has taken center stage from the outset.” Because the vaccination route is the placental transfer of antibodies from mother to child (“passive immunity”), “... the medical points of contact for this vaccination will be the gynecologists, not the pediatricians,” Dr. Adams said.

“This concept imitates the natural process, since the mother normally passes immune defenses she acquired through infections to the child via the umbilical cord and her breast milk before and after birth. This procedure is long-proven and practiced worldwide, especially in nonindustrialized countries, for a variety of diseases, including tetanus, whooping cough (pertussis), and viral flu (influenza),” explained Markus Rose, MD, PhD, head of Pediatric Pulmonology at the Olgahospital, Stuttgart, Germany.

The development of an RSV vaccine had ground to a halt for many decades: A tragedy in the 1960s set the whole field of research back. Using the model of the first polio vaccine, scientists had manufactured an experimental vaccine with inactivated viruses. However, tests showed that the vaccine did not protect the children vaccinated, but it actually infected them with RSV, they then fell ill, and two children died. Today, potential RSV vaccines are first tested on adults and not on children.
 

Few treatment options

RSV causes seasonal epidemics, can lead to bronchiolitis and pneumonia in infants, and is one of the main causes of hospital stays in young children. Monoclonal antibodies are currently the only preventive option, since there is still no vaccine. Usually, 60%-70% of infants and nearly all children younger than 2 years are infected with RSV, but the virus can also trigger pneumonia in adults.

“RSV infections constitute a major public health challenge: It is the most dangerous respiratory virus for young infants, it is also a threat to the chronically ill and immunocompromised of all ages, and [it] is the second most common cause of death worldwide (after malaria) in young children,” stated Dr. Rose.

Recently, pandemic-related measures (face masks, more intense disinfection) meant that the “normal” RSV infections in healthy adults, which usually progress like a mild cold, were prevented, and mothers were unable to pass on as much RSV immune defense to their children. “This was presumably responsible in part for the massive wave of RSV infections in fall and winter of 2021/22,” explained Dr. Rose.

Thomas Mertens, MD, PhD, chair of the Standing Committee on Vaccination at the Robert Koch Institute (STIKO) and former director of the Institute for Virology at Ulm University Hospital, Germany, also noted: “It would be an important and potentially achievable goal to significantly reduce the incidence rate of hospitalizations. In this respect, RSV poses a significant problem for young children, their parents, and the burden on pediatric clinics.”
 

Final evaluation pending

“I am definitely finding the data interesting, but the original data are needed,” Dr. Mertens said. Once the data are published at a conference or published in a peer-reviewed journal, physicians will be able to better judge the data for themselves, he said.

Dr. Rose characterized the new vaccine as “novel,” including in terms of its composition. Earlier RSV vaccines used the so-called postfusion F protein as their starting point. But it has become known in the meantime that the key to immunogenicity is the continued prefusion state of the apical epitope: Prefusion F-specific memory B cells in adults naturally infected with RSV produce potent neutralizing antibodies.

The new vaccine is bivalent and protects against both RSV A and RSV B.

To date, RSV vaccination directly in young infants have had only had a weak efficacy and were sometimes poorly tolerated. The vaccine presented here is expected to be tested in young adults first, then in school children, then young children.

Through successful vaccination of the entire population, the transfer of RS viruses to young children could be prevented. “To what extent this, or any other RSV vaccine still to be developed on the same basis, will also be effective and well tolerated in young infants is still difficult to assess,” said Dr. Rose.

Dr. Mertens emphasized that all of the study data now needs to be seen as quickly as possible: “This is also a general requirement for transparency from the pharmaceutical companies, which is also rightly criticized.”

This article was originally published in Medscape’s German edition and a version appeared on Medscape.com.

An investigational vaccine against respiratory syncytial virus (RSV) in pregnant women has been shown to help protect infants against severe disease, according to the vaccine’s manufacturer.

Pfizer recently announced that in the course of a randomized, double-blind, placebo-controlled phase 3 study, the vaccine RSVpreF had an almost 82% efficacy against severe RSV infection in infants from birth through the first 90 days of life, according to a company press release.

The vaccine also had a 69% efficacy against severe disease through the first 6 months of life. A total of 7,400 women had received a single dose of 120 mcg RSVpreF in the late second or third trimester of their pregnancy. There were no signs of safety issues for the mothers or infants.

Due to the good results, the enrollment in the study was halted on the recommendation of the study’s Data Monitoring Committee after achieving a primary endpoint. The company plans to apply for marketing authorization to the U.S. Food and Drug Administration by the end of 2022 and to other regulatory agencies in 2023.

“The directness of the strategy, to vaccinate expectant mothers during pregnancy so that their newborn is then later protected, is new and a very interesting approach,” commented Prof. Ortwin Adams, MD, head of virologic diagnostics at the Institute for Virology of the University Hospital of Düsseldorf (Germany) to the Science Media Centre (SMC).

In terms of the RSV vaccination strategy presented, “the unborn child has taken center stage from the outset.” Because the vaccination route is the placental transfer of antibodies from mother to child (“passive immunity”), “... the medical points of contact for this vaccination will be the gynecologists, not the pediatricians,” Dr. Adams said.

“This concept imitates the natural process, since the mother normally passes immune defenses she acquired through infections to the child via the umbilical cord and her breast milk before and after birth. This procedure is long-proven and practiced worldwide, especially in nonindustrialized countries, for a variety of diseases, including tetanus, whooping cough (pertussis), and viral flu (influenza),” explained Markus Rose, MD, PhD, head of Pediatric Pulmonology at the Olgahospital, Stuttgart, Germany.

The development of an RSV vaccine had ground to a halt for many decades: A tragedy in the 1960s set the whole field of research back. Using the model of the first polio vaccine, scientists had manufactured an experimental vaccine with inactivated viruses. However, tests showed that the vaccine did not protect the children vaccinated, but it actually infected them with RSV, they then fell ill, and two children died. Today, potential RSV vaccines are first tested on adults and not on children.
 

Few treatment options

RSV causes seasonal epidemics, can lead to bronchiolitis and pneumonia in infants, and is one of the main causes of hospital stays in young children. Monoclonal antibodies are currently the only preventive option, since there is still no vaccine. Usually, 60%-70% of infants and nearly all children younger than 2 years are infected with RSV, but the virus can also trigger pneumonia in adults.

“RSV infections constitute a major public health challenge: It is the most dangerous respiratory virus for young infants, it is also a threat to the chronically ill and immunocompromised of all ages, and [it] is the second most common cause of death worldwide (after malaria) in young children,” stated Dr. Rose.

Recently, pandemic-related measures (face masks, more intense disinfection) meant that the “normal” RSV infections in healthy adults, which usually progress like a mild cold, were prevented, and mothers were unable to pass on as much RSV immune defense to their children. “This was presumably responsible in part for the massive wave of RSV infections in fall and winter of 2021/22,” explained Dr. Rose.

Thomas Mertens, MD, PhD, chair of the Standing Committee on Vaccination at the Robert Koch Institute (STIKO) and former director of the Institute for Virology at Ulm University Hospital, Germany, also noted: “It would be an important and potentially achievable goal to significantly reduce the incidence rate of hospitalizations. In this respect, RSV poses a significant problem for young children, their parents, and the burden on pediatric clinics.”
 

Final evaluation pending

“I am definitely finding the data interesting, but the original data are needed,” Dr. Mertens said. Once the data are published at a conference or published in a peer-reviewed journal, physicians will be able to better judge the data for themselves, he said.

Dr. Rose characterized the new vaccine as “novel,” including in terms of its composition. Earlier RSV vaccines used the so-called postfusion F protein as their starting point. But it has become known in the meantime that the key to immunogenicity is the continued prefusion state of the apical epitope: Prefusion F-specific memory B cells in adults naturally infected with RSV produce potent neutralizing antibodies.

The new vaccine is bivalent and protects against both RSV A and RSV B.

To date, RSV vaccination directly in young infants have had only had a weak efficacy and were sometimes poorly tolerated. The vaccine presented here is expected to be tested in young adults first, then in school children, then young children.

Through successful vaccination of the entire population, the transfer of RS viruses to young children could be prevented. “To what extent this, or any other RSV vaccine still to be developed on the same basis, will also be effective and well tolerated in young infants is still difficult to assess,” said Dr. Rose.

Dr. Mertens emphasized that all of the study data now needs to be seen as quickly as possible: “This is also a general requirement for transparency from the pharmaceutical companies, which is also rightly criticized.”

This article was originally published in Medscape’s German edition and a version appeared on Medscape.com.

A systematic review of observational studies and clinical trials found dolutegravir and raltegravir to be safe and effective for treating teens and children living with HIV.

Effectiveness was higher across dolutegravir studies, the authors reported. After 12 months of treatment and observation, viral suppression levels were greater than 70% in most studies assessing dolutegravir. Viral suppression with raltegravir after 12 months varied between 42% and 83%.

“Our findings support the use of these two integrase inhibitors as part of WHO-recommended regimens for treating HIV,” said lead study author Claire Townsend, PhD, an epidemiologist and consultant to the World Health Organization HIV department in Geneva. “They were in line with what has been reported in adults and provide reassurance for the continued use of these two drugs in children and adolescents.”

The study was published in the Journal of the International AIDS Society.
 

Tracking outcomes for WHO guidelines

Integrase inhibitors, including dolutegravir and raltegravir, have become leading first- and second-line treatments in patients with HIV, largely owing to their effectiveness and fewer side effects, compared with other antiretroviral treatments.

Monitoring short- and long-term health outcomes of these widely used drugs is critical, the authors wrote. This is especially the case for dolutegravir, which has recently been approved in pediatric formulations. The review supported the development of the 2021 WHO consolidated HIV guidelines.

Dr. Townsend and colleagues searched the literature and screened trial registries for relevant studies conducted from January 2009 to March 2021. Among more than 4,000 published papers and abstracts, they identified 19 studies that met their review criteria relating to dolutegravir or raltegravir in children or adolescents aged 0-19 years who are living with HIV, including two studies that reported data on both agents.

Data on dolutegravir were extracted from 11 studies that included 2,330 children and adolescents in 1 randomized controlled trial, 1 single-arm trial, and 9 cohort studies. Data on raltegravir were extracted from 10 studies that included 649 children and adolescents in 1 randomized controlled trial, 1 single-arm trial, and 8 cohort studies.

The median follow-up in the dolutegravir studies was 6-36 months. Six studies recruited participants from Europe, three studies were based in sub-Saharan Africa, and two studies included persons from multiple geographic regions.

Across all studies, grade 3/4 adverse events were reported in 0%-50% of cases. Of these adverse events, very few were drug related, and no deaths were attributed to either dolutegravir or raltegravir.

However, Dr. Townsend cautioned that future research is needed to fill in evidence gaps “on longer-term safety and effectiveness of dolutegravir and raltegravir in children and adolescents,” including “research into adverse outcomes such as weight gain, potential metabolic changes, and neuropsychiatric adverse events, which have been reported in adults.”

The researchers noted that the small sample size of many of the studies contributed to variability in the findings and that most studies were observational, providing important real-world data but making their results less robust compared with data from randomized controlled studies with large sample sizes. They also noted that there was a high risk of bias (4 studies) and unclear risk of bias (5 studies) among the 15 observational studies included in their analysis.

“This research is particularly important because it supports the WHO recommendation that dolutegravir, which has a particularly high barrier of resistance to the HIV virus, be synchronized in adults and children as the preferred first-line and second-line treatment against HIV,” said Natella Rakhmanina, MD, PhD, director of HIV Services & Special Immunology at the Children’s National Hospital in Washington, D.C. Dr. Rakhmanina was not associated with the study.

Dr. Rakhmanina agreed that the safety profile of both drugs is “very good.” The lack of serious adverse events was meaningful, she highlighted, because “good tolerability is very important, particularly in children” as it means that drug compliance and viral suppression are achievable.

Two authors reported their authorship on two studies included in the review, as well as grant funding from ViiV Healthcare/GlaxoSmithKline, the marketing authorization holder for dolutegravir.

A version of this article first appeared on Medscape.com.

A systematic review of observational studies and clinical trials found dolutegravir and raltegravir to be safe and effective for treating teens and children living with HIV.

Effectiveness was higher across dolutegravir studies, the authors reported. After 12 months of treatment and observation, viral suppression levels were greater than 70% in most studies assessing dolutegravir. Viral suppression with raltegravir after 12 months varied between 42% and 83%.

“Our findings support the use of these two integrase inhibitors as part of WHO-recommended regimens for treating HIV,” said lead study author Claire Townsend, PhD, an epidemiologist and consultant to the World Health Organization HIV department in Geneva. “They were in line with what has been reported in adults and provide reassurance for the continued use of these two drugs in children and adolescents.”

The study was published in the Journal of the International AIDS Society.
 

Tracking outcomes for WHO guidelines

Integrase inhibitors, including dolutegravir and raltegravir, have become leading first- and second-line treatments in patients with HIV, largely owing to their effectiveness and fewer side effects, compared with other antiretroviral treatments.

Monitoring short- and long-term health outcomes of these widely used drugs is critical, the authors wrote. This is especially the case for dolutegravir, which has recently been approved in pediatric formulations. The review supported the development of the 2021 WHO consolidated HIV guidelines.

Dr. Townsend and colleagues searched the literature and screened trial registries for relevant studies conducted from January 2009 to March 2021. Among more than 4,000 published papers and abstracts, they identified 19 studies that met their review criteria relating to dolutegravir or raltegravir in children or adolescents aged 0-19 years who are living with HIV, including two studies that reported data on both agents.

Data on dolutegravir were extracted from 11 studies that included 2,330 children and adolescents in 1 randomized controlled trial, 1 single-arm trial, and 9 cohort studies. Data on raltegravir were extracted from 10 studies that included 649 children and adolescents in 1 randomized controlled trial, 1 single-arm trial, and 8 cohort studies.

The median follow-up in the dolutegravir studies was 6-36 months. Six studies recruited participants from Europe, three studies were based in sub-Saharan Africa, and two studies included persons from multiple geographic regions.

Across all studies, grade 3/4 adverse events were reported in 0%-50% of cases. Of these adverse events, very few were drug related, and no deaths were attributed to either dolutegravir or raltegravir.

However, Dr. Townsend cautioned that future research is needed to fill in evidence gaps “on longer-term safety and effectiveness of dolutegravir and raltegravir in children and adolescents,” including “research into adverse outcomes such as weight gain, potential metabolic changes, and neuropsychiatric adverse events, which have been reported in adults.”

The researchers noted that the small sample size of many of the studies contributed to variability in the findings and that most studies were observational, providing important real-world data but making their results less robust compared with data from randomized controlled studies with large sample sizes. They also noted that there was a high risk of bias (4 studies) and unclear risk of bias (5 studies) among the 15 observational studies included in their analysis.

“This research is particularly important because it supports the WHO recommendation that dolutegravir, which has a particularly high barrier of resistance to the HIV virus, be synchronized in adults and children as the preferred first-line and second-line treatment against HIV,” said Natella Rakhmanina, MD, PhD, director of HIV Services & Special Immunology at the Children’s National Hospital in Washington, D.C. Dr. Rakhmanina was not associated with the study.

Dr. Rakhmanina agreed that the safety profile of both drugs is “very good.” The lack of serious adverse events was meaningful, she highlighted, because “good tolerability is very important, particularly in children” as it means that drug compliance and viral suppression are achievable.

Two authors reported their authorship on two studies included in the review, as well as grant funding from ViiV Healthcare/GlaxoSmithKline, the marketing authorization holder for dolutegravir.

A version of this article first appeared on Medscape.com.

A systematic review of observational studies and clinical trials found dolutegravir and raltegravir to be safe and effective for treating teens and children living with HIV.

Effectiveness was higher across dolutegravir studies, the authors reported. After 12 months of treatment and observation, viral suppression levels were greater than 70% in most studies assessing dolutegravir. Viral suppression with raltegravir after 12 months varied between 42% and 83%.

“Our findings support the use of these two integrase inhibitors as part of WHO-recommended regimens for treating HIV,” said lead study author Claire Townsend, PhD, an epidemiologist and consultant to the World Health Organization HIV department in Geneva. “They were in line with what has been reported in adults and provide reassurance for the continued use of these two drugs in children and adolescents.”

The study was published in the Journal of the International AIDS Society.
 

Tracking outcomes for WHO guidelines

Integrase inhibitors, including dolutegravir and raltegravir, have become leading first- and second-line treatments in patients with HIV, largely owing to their effectiveness and fewer side effects, compared with other antiretroviral treatments.

Monitoring short- and long-term health outcomes of these widely used drugs is critical, the authors wrote. This is especially the case for dolutegravir, which has recently been approved in pediatric formulations. The review supported the development of the 2021 WHO consolidated HIV guidelines.

Dr. Townsend and colleagues searched the literature and screened trial registries for relevant studies conducted from January 2009 to March 2021. Among more than 4,000 published papers and abstracts, they identified 19 studies that met their review criteria relating to dolutegravir or raltegravir in children or adolescents aged 0-19 years who are living with HIV, including two studies that reported data on both agents.

Data on dolutegravir were extracted from 11 studies that included 2,330 children and adolescents in 1 randomized controlled trial, 1 single-arm trial, and 9 cohort studies. Data on raltegravir were extracted from 10 studies that included 649 children and adolescents in 1 randomized controlled trial, 1 single-arm trial, and 8 cohort studies.

The median follow-up in the dolutegravir studies was 6-36 months. Six studies recruited participants from Europe, three studies were based in sub-Saharan Africa, and two studies included persons from multiple geographic regions.

Across all studies, grade 3/4 adverse events were reported in 0%-50% of cases. Of these adverse events, very few were drug related, and no deaths were attributed to either dolutegravir or raltegravir.

However, Dr. Townsend cautioned that future research is needed to fill in evidence gaps “on longer-term safety and effectiveness of dolutegravir and raltegravir in children and adolescents,” including “research into adverse outcomes such as weight gain, potential metabolic changes, and neuropsychiatric adverse events, which have been reported in adults.”

The researchers noted that the small sample size of many of the studies contributed to variability in the findings and that most studies were observational, providing important real-world data but making their results less robust compared with data from randomized controlled studies with large sample sizes. They also noted that there was a high risk of bias (4 studies) and unclear risk of bias (5 studies) among the 15 observational studies included in their analysis.

“This research is particularly important because it supports the WHO recommendation that dolutegravir, which has a particularly high barrier of resistance to the HIV virus, be synchronized in adults and children as the preferred first-line and second-line treatment against HIV,” said Natella Rakhmanina, MD, PhD, director of HIV Services & Special Immunology at the Children’s National Hospital in Washington, D.C. Dr. Rakhmanina was not associated with the study.

Dr. Rakhmanina agreed that the safety profile of both drugs is “very good.” The lack of serious adverse events was meaningful, she highlighted, because “good tolerability is very important, particularly in children” as it means that drug compliance and viral suppression are achievable.

Two authors reported their authorship on two studies included in the review, as well as grant funding from ViiV Healthcare/GlaxoSmithKline, the marketing authorization holder for dolutegravir.

A version of this article first appeared on Medscape.com.

LISBON – Efforts are underway to better identify which individuals with so-called “prediabetes” are at greatest risk for developing type 2 diabetes and subsequent complications, and therefore merit more intensive intervention.

“Prediabetes” is the term coined to refer to either “impaired fasting glucose (IFG)” or “impaired glucose tolerance (IGT),” both denoting levels of elevated glycemia that don’t meet the thresholds for diabetes. It’s a heterogeneous group overall, and despite its name, not everyone with prediabetes will progress to develop type 2 diabetes.

There have been major increases in prediabetes in the United States and globally over the past 2 decades, epidemiologist Elizabeth Selvin, PhD, said at the recent IDF World Diabetes Congress 2022.

She noted that the concept of “prediabetes” has been controversial, previously dubbed a “dubious diagnosis” and a “boon for Pharma” in a 2019 Science article.

Others have said it’s “not a medical condition” and that it’s “an artificial category with virtually zero clinical relevance” in a press statement issued for a 2014 BMJ article.

“I don’t agree with these statements entirely but I think they speak to the confusion and tremendous controversy around the concept of prediabetes ... I think instead of calling prediabetes a ‘dubious diagnosis’ we should think of it as an opportunity,” said Dr. Selvin, of Johns Hopkins University Bloomberg School of Public Health, Baltimore.

She proposes trying to home in on those with highest risk of developing type 2 diabetes, which she suggests could be achieved by using a combination of elevated fasting glucose and an elevated A1c, although she stresses that this isn’t in any official guidance.

With the appropriate definition, people who are truly at risk for progression to type 2 diabetes can be identified so that lifestyle factors and cardiovascular risk can be addressed, and weight loss efforts implemented.

“Prevention of weight gain is ... important. That message often gets lost. Even if we can’t get people to lose weight, preventing [further] weight gain is important,” she noted.

Asked to comment, Sue Kirkman, MD, told this news organization, “The term prediabetes – or IFG or IGT or any of the ‘intermediate’ terms – is pragmatic in a way. It helps clinicians and patients understand that they are in a higher-risk category and might need intervention and likely need ongoing monitoring. But like many other risk factors [such as] blood pressure, [high] BMI, etc., the risk is not dichotomous but a continuum.

“People at the low end of the ‘intermediate’ range are not going to have much more risk compared to people who are ‘normal,’ while those at the high end of the range have very high risk,” said Dr. Kirkman, of the University of North Carolina, Chapel Hill, and a coauthor of the American Diabetes Association’s diabetes and prediabetes classifications.

“So we lose information if we just lump everyone into a single category. For individual patients, we definitely need better ways to estimate and communicate their potential risk.”


 

Currently five definitions for prediabetes: Home in on risk

The problem, Dr. Selvin explained, is that currently there are five official definitions for “prediabetes” using cutoffs for hemoglobin A1c, fasting glucose, or an oral glucose tolerance test.

Each one identifies different numbers of people with differing risk levels, ranging from a prevalence of 4.3% of the middle-aged adult population with the International Expert Committee’s definition of A1c 6.0%-6.4% to 43.5% with the American Diabetes Association’s 100-125 mg/dL fasting glucose.

“That’s an enormous difference. No wonder people are confused about who has prediabetes and what we should do about it,” Dr. Selvin said, adding that the concern about overdiagnosing “prediabetes” is even greater for older populations, in whom “it’s incredibly common to have mildly elevated glucose.”  

Hence her proposal of what she sees as an evidence-based, “really easy solution” that clinicians can use now to better identify which patients with “intermediate hyperglycemia” to be most concerned about: Use a combination of fasting glucose above 100 mg/dL and an A1c greater than 5.7%.

“If you have both fasting glucose and hemoglobin A1c, you can use them together ... This is not codified in any guidelines. You won’t see this mentioned anywhere. The guidelines are silent on what to do when some people have an elevated fasting glucose but not an elevated A1c ... but I think a simple message is that if people have both an elevated fasting glucose and an elevated A1c, that’s a very high-risk group,” she said.

On the other hand, Dr. Kirkman pointed out, “most discrepancies are near the margins, as in one test is slightly elevated and one isn’t, so those people probably are at low risk.

“It may be that both being elevated means higher risk because they have more hyperglycemia ... so it seems reasonable, but only if it changes what you tell people.”

For example, Dr. Kirkman said, “I’d tell someone with A1c of 5.8% and fasting glucose of 99 mg/dL the same thing I’d tell someone with that A1c and a glucose of 104 mg/dL – that their risk is still pretty low – and I’d recommend healthy lifestyle and weight loss if overweight either way.”

However, she also said, “Certainly people with higher glucose or A1c are at much higher risk, and same for those with both.”
 

Tie “prediabetes” definition to risk, as cardiology scores do?

Dr. Selvin also believes that risk-based definitions of prediabetes are needed. Ideally, these would incorporate demographics and clinical factors such as age and body mass index. Other biomarkers could potentially be developed and validated for inclusion in the definition, such as C-reactive protein (CRP), lipids, or even genetic/proteomic information.  

Moreover, she thinks that the definition should be tied to clinical decision-making, as is the pooled cohort equation in cardiology.

“I think we could do something very similar in prediabetes,” she suggested, adding that even simply incorporating age and BMI into the definition could help further stratify the risk level until other predictors are validated.

Dr. Kirkman said, “The concept of risk scores a la cardiology is interesting, although we’d have to make them simple and also validate them against some outcome.”

Regarding the age issue, Dr. Kirkman noted that although age wasn’t a predictor of progression to type 2 diabetes in the placebo arm of the landmark Diabetes Prevention Program (DPP) trial, “I do agree that it’s a problem that many older folks have the label of prediabetes because of a mildly elevated A1c and we know that most will never get diabetes.”

And, she noted, in the DPP people with prediabetes who had a BMI over 35 kg/m² did have significantly higher progression rates than those with lower BMI, while women with a history of gestational diabetes mellitus are also known to be at particularly high risk.
 

Whom should we throw the kitchen sink at?

Some of this discussion, Dr. Kirkman said, “is really a philosophical one, especially when you consider that lifestyle intervention has benefits for almost everyone on many short- and long-term outcomes.”

“The question is probably whom we should ‘throw the kitchen sink at,’ who should get more scalable advice that might apply to everyone regardless of glycemic levels, and whether there’s some more intermediate group that needs more of a [National Diabetes Prevention Program] approach.”

Dr. Selvin’s group is now working on gathering data to inform development of a risk-based prediabetes definition. “We have a whole research effort in this area. I hope that with some really strong data on risk in prediabetes, that can help to solve the heterogeneity issue. I’m focused on bringing evidence to bear to change the guidelines.”

In the meantime, she told this news organization, “I think there are things we can do now to provide more guidance. I get a lot of feedback from people saying things like ‘my physician told me I have prediabetes but now I don’t’ or ‘I saw in my labs that my blood sugar is elevated but my doctor never said anything.’  That’s a communications issue where we can do a better job.”

The meeting was sponsored by the International Diabetes Federation.

Dr. Selvin is deputy editor of Diabetes Care and on the editorial board of Diabetologia. She receives funding from the NIH and the Foundation for the NIH, and royalties from UpToDate for sections related to screening, diagnosis, and laboratory testing for diabetes. Dr. Kirkman reports no relevant financial relationships.

A version of this article first appeared on Medscape.com.

LISBON – Efforts are underway to better identify which individuals with so-called “prediabetes” are at greatest risk for developing type 2 diabetes and subsequent complications, and therefore merit more intensive intervention.

“Prediabetes” is the term coined to refer to either “impaired fasting glucose (IFG)” or “impaired glucose tolerance (IGT),” both denoting levels of elevated glycemia that don’t meet the thresholds for diabetes. It’s a heterogeneous group overall, and despite its name, not everyone with prediabetes will progress to develop type 2 diabetes.

There have been major increases in prediabetes in the United States and globally over the past 2 decades, epidemiologist Elizabeth Selvin, PhD, said at the recent IDF World Diabetes Congress 2022.

She noted that the concept of “prediabetes” has been controversial, previously dubbed a “dubious diagnosis” and a “boon for Pharma” in a 2019 Science article.

Others have said it’s “not a medical condition” and that it’s “an artificial category with virtually zero clinical relevance” in a press statement issued for a 2014 BMJ article.

“I don’t agree with these statements entirely but I think they speak to the confusion and tremendous controversy around the concept of prediabetes ... I think instead of calling prediabetes a ‘dubious diagnosis’ we should think of it as an opportunity,” said Dr. Selvin, of Johns Hopkins University Bloomberg School of Public Health, Baltimore.

She proposes trying to home in on those with highest risk of developing type 2 diabetes, which she suggests could be achieved by using a combination of elevated fasting glucose and an elevated A1c, although she stresses that this isn’t in any official guidance.

With the appropriate definition, people who are truly at risk for progression to type 2 diabetes can be identified so that lifestyle factors and cardiovascular risk can be addressed, and weight loss efforts implemented.

“Prevention of weight gain is ... important. That message often gets lost. Even if we can’t get people to lose weight, preventing [further] weight gain is important,” she noted.

Asked to comment, Sue Kirkman, MD, told this news organization, “The term prediabetes – or IFG or IGT or any of the ‘intermediate’ terms – is pragmatic in a way. It helps clinicians and patients understand that they are in a higher-risk category and might need intervention and likely need ongoing monitoring. But like many other risk factors [such as] blood pressure, [high] BMI, etc., the risk is not dichotomous but a continuum.

“People at the low end of the ‘intermediate’ range are not going to have much more risk compared to people who are ‘normal,’ while those at the high end of the range have very high risk,” said Dr. Kirkman, of the University of North Carolina, Chapel Hill, and a coauthor of the American Diabetes Association’s diabetes and prediabetes classifications.

“So we lose information if we just lump everyone into a single category. For individual patients, we definitely need better ways to estimate and communicate their potential risk.”


 

Currently five definitions for prediabetes: Home in on risk

The problem, Dr. Selvin explained, is that currently there are five official definitions for “prediabetes” using cutoffs for hemoglobin A1c, fasting glucose, or an oral glucose tolerance test.

Each one identifies different numbers of people with differing risk levels, ranging from a prevalence of 4.3% of the middle-aged adult population with the International Expert Committee’s definition of A1c 6.0%-6.4% to 43.5% with the American Diabetes Association’s 100-125 mg/dL fasting glucose.

“That’s an enormous difference. No wonder people are confused about who has prediabetes and what we should do about it,” Dr. Selvin said, adding that the concern about overdiagnosing “prediabetes” is even greater for older populations, in whom “it’s incredibly common to have mildly elevated glucose.”  

Hence her proposal of what she sees as an evidence-based, “really easy solution” that clinicians can use now to better identify which patients with “intermediate hyperglycemia” to be most concerned about: Use a combination of fasting glucose above 100 mg/dL and an A1c greater than 5.7%.

“If you have both fasting glucose and hemoglobin A1c, you can use them together ... This is not codified in any guidelines. You won’t see this mentioned anywhere. The guidelines are silent on what to do when some people have an elevated fasting glucose but not an elevated A1c ... but I think a simple message is that if people have both an elevated fasting glucose and an elevated A1c, that’s a very high-risk group,” she said.

On the other hand, Dr. Kirkman pointed out, “most discrepancies are near the margins, as in one test is slightly elevated and one isn’t, so those people probably are at low risk.

“It may be that both being elevated means higher risk because they have more hyperglycemia ... so it seems reasonable, but only if it changes what you tell people.”

For example, Dr. Kirkman said, “I’d tell someone with A1c of 5.8% and fasting glucose of 99 mg/dL the same thing I’d tell someone with that A1c and a glucose of 104 mg/dL – that their risk is still pretty low – and I’d recommend healthy lifestyle and weight loss if overweight either way.”

However, she also said, “Certainly people with higher glucose or A1c are at much higher risk, and same for those with both.”
 

Tie “prediabetes” definition to risk, as cardiology scores do?

Dr. Selvin also believes that risk-based definitions of prediabetes are needed. Ideally, these would incorporate demographics and clinical factors such as age and body mass index. Other biomarkers could potentially be developed and validated for inclusion in the definition, such as C-reactive protein (CRP), lipids, or even genetic/proteomic information.  

Moreover, she thinks that the definition should be tied to clinical decision-making, as is the pooled cohort equation in cardiology.

“I think we could do something very similar in prediabetes,” she suggested, adding that even simply incorporating age and BMI into the definition could help further stratify the risk level until other predictors are validated.

Dr. Kirkman said, “The concept of risk scores a la cardiology is interesting, although we’d have to make them simple and also validate them against some outcome.”

Regarding the age issue, Dr. Kirkman noted that although age wasn’t a predictor of progression to type 2 diabetes in the placebo arm of the landmark Diabetes Prevention Program (DPP) trial, “I do agree that it’s a problem that many older folks have the label of prediabetes because of a mildly elevated A1c and we know that most will never get diabetes.”

And, she noted, in the DPP people with prediabetes who had a BMI over 35 kg/m² did have significantly higher progression rates than those with lower BMI, while women with a history of gestational diabetes mellitus are also known to be at particularly high risk.
 

Whom should we throw the kitchen sink at?

Some of this discussion, Dr. Kirkman said, “is really a philosophical one, especially when you consider that lifestyle intervention has benefits for almost everyone on many short- and long-term outcomes.”

“The question is probably whom we should ‘throw the kitchen sink at,’ who should get more scalable advice that might apply to everyone regardless of glycemic levels, and whether there’s some more intermediate group that needs more of a [National Diabetes Prevention Program] approach.”

Dr. Selvin’s group is now working on gathering data to inform development of a risk-based prediabetes definition. “We have a whole research effort in this area. I hope that with some really strong data on risk in prediabetes, that can help to solve the heterogeneity issue. I’m focused on bringing evidence to bear to change the guidelines.”

In the meantime, she told this news organization, “I think there are things we can do now to provide more guidance. I get a lot of feedback from people saying things like ‘my physician told me I have prediabetes but now I don’t’ or ‘I saw in my labs that my blood sugar is elevated but my doctor never said anything.’  That’s a communications issue where we can do a better job.”

The meeting was sponsored by the International Diabetes Federation.

Dr. Selvin is deputy editor of Diabetes Care and on the editorial board of Diabetologia. She receives funding from the NIH and the Foundation for the NIH, and royalties from UpToDate for sections related to screening, diagnosis, and laboratory testing for diabetes. Dr. Kirkman reports no relevant financial relationships.

A version of this article first appeared on Medscape.com.

LISBON – Efforts are underway to better identify which individuals with so-called “prediabetes” are at greatest risk for developing type 2 diabetes and subsequent complications, and therefore merit more intensive intervention.

“Prediabetes” is the term coined to refer to either “impaired fasting glucose (IFG)” or “impaired glucose tolerance (IGT),” both denoting levels of elevated glycemia that don’t meet the thresholds for diabetes. It’s a heterogeneous group overall, and despite its name, not everyone with prediabetes will progress to develop type 2 diabetes.

There have been major increases in prediabetes in the United States and globally over the past 2 decades, epidemiologist Elizabeth Selvin, PhD, said at the recent IDF World Diabetes Congress 2022.

She noted that the concept of “prediabetes” has been controversial, previously dubbed a “dubious diagnosis” and a “boon for Pharma” in a 2019 Science article.

Others have said it’s “not a medical condition” and that it’s “an artificial category with virtually zero clinical relevance” in a press statement issued for a 2014 BMJ article.

“I don’t agree with these statements entirely but I think they speak to the confusion and tremendous controversy around the concept of prediabetes ... I think instead of calling prediabetes a ‘dubious diagnosis’ we should think of it as an opportunity,” said Dr. Selvin, of Johns Hopkins University Bloomberg School of Public Health, Baltimore.

She proposes trying to home in on those with highest risk of developing type 2 diabetes, which she suggests could be achieved by using a combination of elevated fasting glucose and an elevated A1c, although she stresses that this isn’t in any official guidance.

With the appropriate definition, people who are truly at risk for progression to type 2 diabetes can be identified so that lifestyle factors and cardiovascular risk can be addressed, and weight loss efforts implemented.

“Prevention of weight gain is ... important. That message often gets lost. Even if we can’t get people to lose weight, preventing [further] weight gain is important,” she noted.

Asked to comment, Sue Kirkman, MD, told this news organization, “The term prediabetes – or IFG or IGT or any of the ‘intermediate’ terms – is pragmatic in a way. It helps clinicians and patients understand that they are in a higher-risk category and might need intervention and likely need ongoing monitoring. But like many other risk factors [such as] blood pressure, [high] BMI, etc., the risk is not dichotomous but a continuum.

“People at the low end of the ‘intermediate’ range are not going to have much more risk compared to people who are ‘normal,’ while those at the high end of the range have very high risk,” said Dr. Kirkman, of the University of North Carolina, Chapel Hill, and a coauthor of the American Diabetes Association’s diabetes and prediabetes classifications.

“So we lose information if we just lump everyone into a single category. For individual patients, we definitely need better ways to estimate and communicate their potential risk.”


 

Currently five definitions for prediabetes: Home in on risk

The problem, Dr. Selvin explained, is that currently there are five official definitions for “prediabetes” using cutoffs for hemoglobin A1c, fasting glucose, or an oral glucose tolerance test.

Each one identifies different numbers of people with differing risk levels, ranging from a prevalence of 4.3% of the middle-aged adult population with the International Expert Committee’s definition of A1c 6.0%-6.4% to 43.5% with the American Diabetes Association’s 100-125 mg/dL fasting glucose.

“That’s an enormous difference. No wonder people are confused about who has prediabetes and what we should do about it,” Dr. Selvin said, adding that the concern about overdiagnosing “prediabetes” is even greater for older populations, in whom “it’s incredibly common to have mildly elevated glucose.”  

Hence her proposal of what she sees as an evidence-based, “really easy solution” that clinicians can use now to better identify which patients with “intermediate hyperglycemia” to be most concerned about: Use a combination of fasting glucose above 100 mg/dL and an A1c greater than 5.7%.

“If you have both fasting glucose and hemoglobin A1c, you can use them together ... This is not codified in any guidelines. You won’t see this mentioned anywhere. The guidelines are silent on what to do when some people have an elevated fasting glucose but not an elevated A1c ... but I think a simple message is that if people have both an elevated fasting glucose and an elevated A1c, that’s a very high-risk group,” she said.

On the other hand, Dr. Kirkman pointed out, “most discrepancies are near the margins, as in one test is slightly elevated and one isn’t, so those people probably are at low risk.

“It may be that both being elevated means higher risk because they have more hyperglycemia ... so it seems reasonable, but only if it changes what you tell people.”

For example, Dr. Kirkman said, “I’d tell someone with A1c of 5.8% and fasting glucose of 99 mg/dL the same thing I’d tell someone with that A1c and a glucose of 104 mg/dL – that their risk is still pretty low – and I’d recommend healthy lifestyle and weight loss if overweight either way.”

However, she also said, “Certainly people with higher glucose or A1c are at much higher risk, and same for those with both.”
 

Tie “prediabetes” definition to risk, as cardiology scores do?

Dr. Selvin also believes that risk-based definitions of prediabetes are needed. Ideally, these would incorporate demographics and clinical factors such as age and body mass index. Other biomarkers could potentially be developed and validated for inclusion in the definition, such as C-reactive protein (CRP), lipids, or even genetic/proteomic information.  

Moreover, she thinks that the definition should be tied to clinical decision-making, as is the pooled cohort equation in cardiology.

“I think we could do something very similar in prediabetes,” she suggested, adding that even simply incorporating age and BMI into the definition could help further stratify the risk level until other predictors are validated.

Dr. Kirkman said, “The concept of risk scores a la cardiology is interesting, although we’d have to make them simple and also validate them against some outcome.”

Regarding the age issue, Dr. Kirkman noted that although age wasn’t a predictor of progression to type 2 diabetes in the placebo arm of the landmark Diabetes Prevention Program (DPP) trial, “I do agree that it’s a problem that many older folks have the label of prediabetes because of a mildly elevated A1c and we know that most will never get diabetes.”

And, she noted, in the DPP people with prediabetes who had a BMI over 35 kg/m² did have significantly higher progression rates than those with lower BMI, while women with a history of gestational diabetes mellitus are also known to be at particularly high risk.
 

Whom should we throw the kitchen sink at?

Some of this discussion, Dr. Kirkman said, “is really a philosophical one, especially when you consider that lifestyle intervention has benefits for almost everyone on many short- and long-term outcomes.”

“The question is probably whom we should ‘throw the kitchen sink at,’ who should get more scalable advice that might apply to everyone regardless of glycemic levels, and whether there’s some more intermediate group that needs more of a [National Diabetes Prevention Program] approach.”

Dr. Selvin’s group is now working on gathering data to inform development of a risk-based prediabetes definition. “We have a whole research effort in this area. I hope that with some really strong data on risk in prediabetes, that can help to solve the heterogeneity issue. I’m focused on bringing evidence to bear to change the guidelines.”

In the meantime, she told this news organization, “I think there are things we can do now to provide more guidance. I get a lot of feedback from people saying things like ‘my physician told me I have prediabetes but now I don’t’ or ‘I saw in my labs that my blood sugar is elevated but my doctor never said anything.’  That’s a communications issue where we can do a better job.”

The meeting was sponsored by the International Diabetes Federation.

Dr. Selvin is deputy editor of Diabetes Care and on the editorial board of Diabetologia. She receives funding from the NIH and the Foundation for the NIH, and royalties from UpToDate for sections related to screening, diagnosis, and laboratory testing for diabetes. Dr. Kirkman reports no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Aspartame, an artificial sweetener commonly found in diet drinks and food, may raise the risk for anxiety, early research suggests.

In a new preclinical study, investigators observed that mice that drank water containing aspartame exhibited pronounced anxiety-like behaviors in a variety of maze tests.

This behavior occurred at aspartame doses equivalent to less than 15% of the maximum daily human intake recommended by the U.S. Food and Drug Administration.

“It was such a robust anxiety-like trait that I don’t think any of us were anticipating we would see. It was completely unexpected. Usually you see subtle changes,” lead author Sara Jones, doctoral candidate at Florida State University, Tallahassee, said in a news release.

The findings were published online in Proceedings of the National Academy of Sciences.


 

Transgenerational transmission

When consumed, aspartame becomes aspartic acid, phenylalanine, and methanol – all of which can have potent effects on the central nervous system, the researchers point out.

Exposing the mice to aspartame also produced changes in the expression of genes regulating excitation-inhibition balance in the amygdala, a brain region that regulates anxiety and fear.

Giving the mice diazepam, which is used to treat generalized anxiety disorder, alleviated the anxiety behavior in the animals.

“The anxiety, its response to diazepam, and the changes in amygdala gene expression are not limited to the aspartame-exposed individuals but also appear in up to two generations descending from the aspartame-exposed males,” the researchers report.

“Extrapolation of the findings to humans suggests that aspartame consumption at doses below the FDA recommended maximum daily intake may produce neurobehavioral changes in aspartame-consuming individuals and their descendants,” they write.

“Thus, human population at risk of aspartame’s potential mental health effects may be larger than current expectations, which only include aspartame-consuming individuals,” they add.
 

Far from harmless?

The investigators plan to publish additional data from the study that focus on how aspartame affected memory in the mice.

In future research, they hope to identify molecular mechanisms that influence the transmission of aspartame’s effect across generations.

The Florida State University study joins several others that discount the long-held notion that aspartame and other nonnutritive sweeteners have no effect on the body.

As reported by this news organization, in a recent study researchers found that these sugar substitutes are not metabolically inert and can alter the gut microbiome in a way that can influence blood glucose levels.

Artificial sweeteners have also been linked to an increased risk for heart disease and stroke and for cancer.

The study was funded by the Jim and Betty Ann Rodgers Chair Fund at Florida State University and by the Bryan Robinson Foundation. The investigators have reported no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Aspartame, an artificial sweetener commonly found in diet drinks and food, may raise the risk for anxiety, early research suggests.

In a new preclinical study, investigators observed that mice that drank water containing aspartame exhibited pronounced anxiety-like behaviors in a variety of maze tests.

This behavior occurred at aspartame doses equivalent to less than 15% of the maximum daily human intake recommended by the U.S. Food and Drug Administration.

“It was such a robust anxiety-like trait that I don’t think any of us were anticipating we would see. It was completely unexpected. Usually you see subtle changes,” lead author Sara Jones, doctoral candidate at Florida State University, Tallahassee, said in a news release.

The findings were published online in Proceedings of the National Academy of Sciences.


 

Transgenerational transmission

When consumed, aspartame becomes aspartic acid, phenylalanine, and methanol – all of which can have potent effects on the central nervous system, the researchers point out.

Exposing the mice to aspartame also produced changes in the expression of genes regulating excitation-inhibition balance in the amygdala, a brain region that regulates anxiety and fear.

Giving the mice diazepam, which is used to treat generalized anxiety disorder, alleviated the anxiety behavior in the animals.

“The anxiety, its response to diazepam, and the changes in amygdala gene expression are not limited to the aspartame-exposed individuals but also appear in up to two generations descending from the aspartame-exposed males,” the researchers report.

“Extrapolation of the findings to humans suggests that aspartame consumption at doses below the FDA recommended maximum daily intake may produce neurobehavioral changes in aspartame-consuming individuals and their descendants,” they write.

“Thus, human population at risk of aspartame’s potential mental health effects may be larger than current expectations, which only include aspartame-consuming individuals,” they add.
 

Far from harmless?

The investigators plan to publish additional data from the study that focus on how aspartame affected memory in the mice.

In future research, they hope to identify molecular mechanisms that influence the transmission of aspartame’s effect across generations.

The Florida State University study joins several others that discount the long-held notion that aspartame and other nonnutritive sweeteners have no effect on the body.

As reported by this news organization, in a recent study researchers found that these sugar substitutes are not metabolically inert and can alter the gut microbiome in a way that can influence blood glucose levels.

Artificial sweeteners have also been linked to an increased risk for heart disease and stroke and for cancer.

The study was funded by the Jim and Betty Ann Rodgers Chair Fund at Florida State University and by the Bryan Robinson Foundation. The investigators have reported no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Aspartame, an artificial sweetener commonly found in diet drinks and food, may raise the risk for anxiety, early research suggests.

In a new preclinical study, investigators observed that mice that drank water containing aspartame exhibited pronounced anxiety-like behaviors in a variety of maze tests.

This behavior occurred at aspartame doses equivalent to less than 15% of the maximum daily human intake recommended by the U.S. Food and Drug Administration.

“It was such a robust anxiety-like trait that I don’t think any of us were anticipating we would see. It was completely unexpected. Usually you see subtle changes,” lead author Sara Jones, doctoral candidate at Florida State University, Tallahassee, said in a news release.

The findings were published online in Proceedings of the National Academy of Sciences.


 

Transgenerational transmission

When consumed, aspartame becomes aspartic acid, phenylalanine, and methanol – all of which can have potent effects on the central nervous system, the researchers point out.

Exposing the mice to aspartame also produced changes in the expression of genes regulating excitation-inhibition balance in the amygdala, a brain region that regulates anxiety and fear.

Giving the mice diazepam, which is used to treat generalized anxiety disorder, alleviated the anxiety behavior in the animals.

“The anxiety, its response to diazepam, and the changes in amygdala gene expression are not limited to the aspartame-exposed individuals but also appear in up to two generations descending from the aspartame-exposed males,” the researchers report.

“Extrapolation of the findings to humans suggests that aspartame consumption at doses below the FDA recommended maximum daily intake may produce neurobehavioral changes in aspartame-consuming individuals and their descendants,” they write.

“Thus, human population at risk of aspartame’s potential mental health effects may be larger than current expectations, which only include aspartame-consuming individuals,” they add.
 

Far from harmless?

The investigators plan to publish additional data from the study that focus on how aspartame affected memory in the mice.

In future research, they hope to identify molecular mechanisms that influence the transmission of aspartame’s effect across generations.

The Florida State University study joins several others that discount the long-held notion that aspartame and other nonnutritive sweeteners have no effect on the body.

As reported by this news organization, in a recent study researchers found that these sugar substitutes are not metabolically inert and can alter the gut microbiome in a way that can influence blood glucose levels.

Artificial sweeteners have also been linked to an increased risk for heart disease and stroke and for cancer.

The study was funded by the Jim and Betty Ann Rodgers Chair Fund at Florida State University and by the Bryan Robinson Foundation. The investigators have reported no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Two years ago, when the first COVID-19 vaccines were administered, marked a game-changing moment in the fight against the pandemic. But it also was a significant moment for messenger RNA (mRNA) technology, which up until then had shown promise but had never quite broken through. 

Now, scientists hope to use this technology to develop more vaccines, with those at the University of Pennsylvania hoping to use that technology to pioneer yet another first: a universal flu vaccine that can protect us against all flu types, not just a select few. 

It’s the latest advance in a new age of vaccinology, where vaccines are easier and faster to produce, as well as more flexible and customizable. 

“It’s all about covering the different flavors of flu in a way the current vaccines cannot do,” says Ofer Levy, MD, PhD, director of the Precision Vaccines Program at Boston Children’s Hospital, who is not involved with the UPenn research. “The mRNA platform is attractive here given its scalability and modularity, where you can mix and match different mRNAs.” 

A recent paper, published in Science, reports successful animal tests of the experimental vaccine, which, like the Pfizer-BioNTech and Moderna COVID vaccines, relies on mRNA. But the idea is not to replace the annual flu shot. It’s to develop a primer that could be administered in childhood, readying the body’s B cells and T cells to react quickly if faced with a flu virus. 

It’s all part of a National Institutes of Health–funded effort to develop a universal flu vaccine, with hopes of heading off future flu pandemics. Annual shots protect against flu subtypes known to spread in humans. But many subtypes circulate in animals, like birds and pigs, and occasionally jump to humans, causing pandemics. 

“The current vaccines provide very little protection against these other subtypes,” says lead study author Scott Hensley, PhD, a professor of microbiology at UPenn. “We set out to make a vaccine that would provide some level of immunity against essentially every influenza subtype we know about.” 

That’s 20 subtypes altogether. The unique properties of mRNA vaccines make immune responses against all those antigens possible, Dr. Hensley says. 

Old-school vaccines introduce a weakened or dead bacteria or virus into the body, but mRNA vaccines use mRNA encoded with a protein from the virus. That’s the “spike” protein for COVID, and for the experimental vaccine, it’s hemagglutinin, the major protein found on the surface of all flu viruses.

Mice and ferrets that had never been exposed to the flu were given the vaccine and produced high levels of antibodies against all 20 flu subtypes. Vaccinated mice exposed to the exact strains in the vaccine stayed pretty healthy, while those exposed to strains not found in the vaccine got sick but recovered quickly and survived. Unvaccinated mice exposed to the flu strain died. 

The vaccine seems to be able to “induce broad immunity against all the different influenza subtypes,” Dr. Hensley says, preventing severe illness if not infection overall. 

Still, whether it could truly stave off a pandemic that hasn’t happened yet is hard to say, Dr. Levy cautions. 

“We are going to need to better learn the molecular rules by which these vaccines protect,” he says.

But the UPenn team is forging ahead, with plans to test their vaccine in human adults in 2023 to determine safety, dosing, and antibody response.

A version of this article first appeared on WebMD.com.

Two years ago, when the first COVID-19 vaccines were administered, marked a game-changing moment in the fight against the pandemic. But it also was a significant moment for messenger RNA (mRNA) technology, which up until then had shown promise but had never quite broken through. 

Now, scientists hope to use this technology to develop more vaccines, with those at the University of Pennsylvania hoping to use that technology to pioneer yet another first: a universal flu vaccine that can protect us against all flu types, not just a select few. 

It’s the latest advance in a new age of vaccinology, where vaccines are easier and faster to produce, as well as more flexible and customizable. 

“It’s all about covering the different flavors of flu in a way the current vaccines cannot do,” says Ofer Levy, MD, PhD, director of the Precision Vaccines Program at Boston Children’s Hospital, who is not involved with the UPenn research. “The mRNA platform is attractive here given its scalability and modularity, where you can mix and match different mRNAs.” 

A recent paper, published in Science, reports successful animal tests of the experimental vaccine, which, like the Pfizer-BioNTech and Moderna COVID vaccines, relies on mRNA. But the idea is not to replace the annual flu shot. It’s to develop a primer that could be administered in childhood, readying the body’s B cells and T cells to react quickly if faced with a flu virus. 

It’s all part of a National Institutes of Health–funded effort to develop a universal flu vaccine, with hopes of heading off future flu pandemics. Annual shots protect against flu subtypes known to spread in humans. But many subtypes circulate in animals, like birds and pigs, and occasionally jump to humans, causing pandemics. 

“The current vaccines provide very little protection against these other subtypes,” says lead study author Scott Hensley, PhD, a professor of microbiology at UPenn. “We set out to make a vaccine that would provide some level of immunity against essentially every influenza subtype we know about.” 

That’s 20 subtypes altogether. The unique properties of mRNA vaccines make immune responses against all those antigens possible, Dr. Hensley says. 

Old-school vaccines introduce a weakened or dead bacteria or virus into the body, but mRNA vaccines use mRNA encoded with a protein from the virus. That’s the “spike” protein for COVID, and for the experimental vaccine, it’s hemagglutinin, the major protein found on the surface of all flu viruses.

Mice and ferrets that had never been exposed to the flu were given the vaccine and produced high levels of antibodies against all 20 flu subtypes. Vaccinated mice exposed to the exact strains in the vaccine stayed pretty healthy, while those exposed to strains not found in the vaccine got sick but recovered quickly and survived. Unvaccinated mice exposed to the flu strain died. 

The vaccine seems to be able to “induce broad immunity against all the different influenza subtypes,” Dr. Hensley says, preventing severe illness if not infection overall. 

Still, whether it could truly stave off a pandemic that hasn’t happened yet is hard to say, Dr. Levy cautions. 

“We are going to need to better learn the molecular rules by which these vaccines protect,” he says.

But the UPenn team is forging ahead, with plans to test their vaccine in human adults in 2023 to determine safety, dosing, and antibody response.

A version of this article first appeared on WebMD.com.

Two years ago, when the first COVID-19 vaccines were administered, marked a game-changing moment in the fight against the pandemic. But it also was a significant moment for messenger RNA (mRNA) technology, which up until then had shown promise but had never quite broken through. 

Now, scientists hope to use this technology to develop more vaccines, with those at the University of Pennsylvania hoping to use that technology to pioneer yet another first: a universal flu vaccine that can protect us against all flu types, not just a select few. 

It’s the latest advance in a new age of vaccinology, where vaccines are easier and faster to produce, as well as more flexible and customizable. 

“It’s all about covering the different flavors of flu in a way the current vaccines cannot do,” says Ofer Levy, MD, PhD, director of the Precision Vaccines Program at Boston Children’s Hospital, who is not involved with the UPenn research. “The mRNA platform is attractive here given its scalability and modularity, where you can mix and match different mRNAs.” 

A recent paper, published in Science, reports successful animal tests of the experimental vaccine, which, like the Pfizer-BioNTech and Moderna COVID vaccines, relies on mRNA. But the idea is not to replace the annual flu shot. It’s to develop a primer that could be administered in childhood, readying the body’s B cells and T cells to react quickly if faced with a flu virus. 

It’s all part of a National Institutes of Health–funded effort to develop a universal flu vaccine, with hopes of heading off future flu pandemics. Annual shots protect against flu subtypes known to spread in humans. But many subtypes circulate in animals, like birds and pigs, and occasionally jump to humans, causing pandemics. 

“The current vaccines provide very little protection against these other subtypes,” says lead study author Scott Hensley, PhD, a professor of microbiology at UPenn. “We set out to make a vaccine that would provide some level of immunity against essentially every influenza subtype we know about.” 

That’s 20 subtypes altogether. The unique properties of mRNA vaccines make immune responses against all those antigens possible, Dr. Hensley says. 

Old-school vaccines introduce a weakened or dead bacteria or virus into the body, but mRNA vaccines use mRNA encoded with a protein from the virus. That’s the “spike” protein for COVID, and for the experimental vaccine, it’s hemagglutinin, the major protein found on the surface of all flu viruses.

Mice and ferrets that had never been exposed to the flu were given the vaccine and produced high levels of antibodies against all 20 flu subtypes. Vaccinated mice exposed to the exact strains in the vaccine stayed pretty healthy, while those exposed to strains not found in the vaccine got sick but recovered quickly and survived. Unvaccinated mice exposed to the flu strain died. 

The vaccine seems to be able to “induce broad immunity against all the different influenza subtypes,” Dr. Hensley says, preventing severe illness if not infection overall. 

Still, whether it could truly stave off a pandemic that hasn’t happened yet is hard to say, Dr. Levy cautions. 

“We are going to need to better learn the molecular rules by which these vaccines protect,” he says.

But the UPenn team is forging ahead, with plans to test their vaccine in human adults in 2023 to determine safety, dosing, and antibody response.

A version of this article first appeared on WebMD.com.

More than a quarter of patients who were shot by assailants with guns had their injuries mislabeled as “unintentional” at hospital discharge, according to a review of more than 1,200 cases at three U.S. trauma centers.

These coding inaccuracies could distort our understanding of gun violence in the United States and make it seem like accidental shootings are more common than they really are, researchers reported in JAMA Network Open.

“The systematic error in intent classification is not widely known or acknowledged by researchers in this field,” Philip J. Cook, PhD, of Duke University, Durham, N.C., and Susan T. Parker, of the University of Michigan, Ann Arbor, wrote in an invited commentary about the new findings. “The bulk of all shootings, nonfatal and fatal together, are assaults, which is to say the result of one person intentionally shooting another. An accurate statistical portrait thus suggests that gun violence is predominantly a crime problem.”

In 2020, 79% of all homicides and 53% of all suicides involved firearms, the CDC reported. Gun violence is now the leading cause of death for children in the United States, government data show.

For the new study, Matthew Miller, MD, ScD, of Northeastern University and the Harvard Injury Control Research Center in Boston, and his colleagues examined how International Classification of Diseases (ICD) codes may misclassify the intent behind gunshot injuries.

Dr. Miller’s group looked at 1,227 incidents between 2008 and 2019 at three major trauma centers – Brigham and Women’s Hospital and Massachusetts General Hospital, both in Boston, and Harborview Medical Center in Seattle.

Of those shootings, 837 (68.2%) involved assaults, 168 (13.5%) were unintentional, 124 (9.9%) were deliberate self-harm, and 43 (3.4%) were instances of legal intervention, based on the researchers’ review of medical records.

ICD codes at discharge, however, labeled 581 cases (47.4%) as assaults and 432 (35.2%) as unintentional.

The researchers found that 234 of the 837 assaults (28%) and 9 of the 43 legal interventions (20.9%) were miscoded as unintentional. This problem occurred even when the “medical narrative explicitly indicated that the shooting was an act of interpersonal violence,” such as a drive-by shooting or an act of domestic violence, the researchers reported.

Hospital trauma registrars, who detail the circumstances surrounding injuries, were mostly in agreement with the researchers.

Medical coders “would likely have little trouble characterizing firearm injury intent accurately if incentives were created for them to do so,” the authors wrote.

Trends and interventions

Separately, researchers published studies showing that gun violence tends to affect various demographics differently, and that remediating abandoned houses could help reduce gun crime.

Lindsay Young, of the University of Cincinnati, and Henry Xiang, MD, PhD, director of the Center for Pediatric Trauma Research at Nationwide Children’s Hospital in Columbus, Ohio, analyzed rates of firearm deaths from 1981 to 2020.

They found that the rate of firearm-related homicide was five times higher among males than females, and the rate of suicide involving firearms was nearly seven times higher for men, they reported in PLOS ONE.

Black men were the group most affected by homicide, whereas White men were most affected by suicide, they found.

To see if fixing abandoned properties would improve health and reduce gun violence in low-income, Black neighborhoods in Philadelphia, Eugenia C. South, MD, of the University of Pennsylvania, Philadelphia, and colleagues conducted a randomized trial.

They randomly assigned abandoned properties in some areas to undergo full remediation (installing working windows and doors, cleaning trash, and weeding); trash cleanup and weeding only; or no intervention.

“Abandoned houses that were remediated showed substantial drops in nearby weapons violations (−8.43%), gun assaults (−13.12%), and to a lesser extent shootings (−6.96%),” the researchers reported.

The intervention targets effects of segregation that have resulted from “historical and ongoing government and private-sector policies” that lead to disinvestment in Black, urban communities, they wrote. Abandoned houses can be used to store firearms and for other illegal activity. They also can engender feelings of fear, neglect, and stress in communities, the researchers noted.

Dr. Miller’s study was funded by the National Collaborative on Gun Violence Research; coauthors disclosed corporate, government, and university grants. The full list of disclosures can be found with the original article. Editorialists Dr. Cook and Dr. Parker report no relevant financial relationships. Dr. South’s study was funded by the National Institutes of Health. Dr. South and some coauthors disclosed government grants.
 

A version of this article first appeared on Medscape.com.

More than a quarter of patients who were shot by assailants with guns had their injuries mislabeled as “unintentional” at hospital discharge, according to a review of more than 1,200 cases at three U.S. trauma centers.

These coding inaccuracies could distort our understanding of gun violence in the United States and make it seem like accidental shootings are more common than they really are, researchers reported in JAMA Network Open.

“The systematic error in intent classification is not widely known or acknowledged by researchers in this field,” Philip J. Cook, PhD, of Duke University, Durham, N.C., and Susan T. Parker, of the University of Michigan, Ann Arbor, wrote in an invited commentary about the new findings. “The bulk of all shootings, nonfatal and fatal together, are assaults, which is to say the result of one person intentionally shooting another. An accurate statistical portrait thus suggests that gun violence is predominantly a crime problem.”

In 2020, 79% of all homicides and 53% of all suicides involved firearms, the CDC reported. Gun violence is now the leading cause of death for children in the United States, government data show.

For the new study, Matthew Miller, MD, ScD, of Northeastern University and the Harvard Injury Control Research Center in Boston, and his colleagues examined how International Classification of Diseases (ICD) codes may misclassify the intent behind gunshot injuries.

Dr. Miller’s group looked at 1,227 incidents between 2008 and 2019 at three major trauma centers – Brigham and Women’s Hospital and Massachusetts General Hospital, both in Boston, and Harborview Medical Center in Seattle.

Of those shootings, 837 (68.2%) involved assaults, 168 (13.5%) were unintentional, 124 (9.9%) were deliberate self-harm, and 43 (3.4%) were instances of legal intervention, based on the researchers’ review of medical records.

ICD codes at discharge, however, labeled 581 cases (47.4%) as assaults and 432 (35.2%) as unintentional.

The researchers found that 234 of the 837 assaults (28%) and 9 of the 43 legal interventions (20.9%) were miscoded as unintentional. This problem occurred even when the “medical narrative explicitly indicated that the shooting was an act of interpersonal violence,” such as a drive-by shooting or an act of domestic violence, the researchers reported.

Hospital trauma registrars, who detail the circumstances surrounding injuries, were mostly in agreement with the researchers.

Medical coders “would likely have little trouble characterizing firearm injury intent accurately if incentives were created for them to do so,” the authors wrote.

Trends and interventions

Separately, researchers published studies showing that gun violence tends to affect various demographics differently, and that remediating abandoned houses could help reduce gun crime.

Lindsay Young, of the University of Cincinnati, and Henry Xiang, MD, PhD, director of the Center for Pediatric Trauma Research at Nationwide Children’s Hospital in Columbus, Ohio, analyzed rates of firearm deaths from 1981 to 2020.

They found that the rate of firearm-related homicide was five times higher among males than females, and the rate of suicide involving firearms was nearly seven times higher for men, they reported in PLOS ONE.

Black men were the group most affected by homicide, whereas White men were most affected by suicide, they found.

To see if fixing abandoned properties would improve health and reduce gun violence in low-income, Black neighborhoods in Philadelphia, Eugenia C. South, MD, of the University of Pennsylvania, Philadelphia, and colleagues conducted a randomized trial.

They randomly assigned abandoned properties in some areas to undergo full remediation (installing working windows and doors, cleaning trash, and weeding); trash cleanup and weeding only; or no intervention.

“Abandoned houses that were remediated showed substantial drops in nearby weapons violations (−8.43%), gun assaults (−13.12%), and to a lesser extent shootings (−6.96%),” the researchers reported.

The intervention targets effects of segregation that have resulted from “historical and ongoing government and private-sector policies” that lead to disinvestment in Black, urban communities, they wrote. Abandoned houses can be used to store firearms and for other illegal activity. They also can engender feelings of fear, neglect, and stress in communities, the researchers noted.

Dr. Miller’s study was funded by the National Collaborative on Gun Violence Research; coauthors disclosed corporate, government, and university grants. The full list of disclosures can be found with the original article. Editorialists Dr. Cook and Dr. Parker report no relevant financial relationships. Dr. South’s study was funded by the National Institutes of Health. Dr. South and some coauthors disclosed government grants.
 

A version of this article first appeared on Medscape.com.

More than a quarter of patients who were shot by assailants with guns had their injuries mislabeled as “unintentional” at hospital discharge, according to a review of more than 1,200 cases at three U.S. trauma centers.

These coding inaccuracies could distort our understanding of gun violence in the United States and make it seem like accidental shootings are more common than they really are, researchers reported in JAMA Network Open.

“The systematic error in intent classification is not widely known or acknowledged by researchers in this field,” Philip J. Cook, PhD, of Duke University, Durham, N.C., and Susan T. Parker, of the University of Michigan, Ann Arbor, wrote in an invited commentary about the new findings. “The bulk of all shootings, nonfatal and fatal together, are assaults, which is to say the result of one person intentionally shooting another. An accurate statistical portrait thus suggests that gun violence is predominantly a crime problem.”

In 2020, 79% of all homicides and 53% of all suicides involved firearms, the CDC reported. Gun violence is now the leading cause of death for children in the United States, government data show.

For the new study, Matthew Miller, MD, ScD, of Northeastern University and the Harvard Injury Control Research Center in Boston, and his colleagues examined how International Classification of Diseases (ICD) codes may misclassify the intent behind gunshot injuries.

Dr. Miller’s group looked at 1,227 incidents between 2008 and 2019 at three major trauma centers – Brigham and Women’s Hospital and Massachusetts General Hospital, both in Boston, and Harborview Medical Center in Seattle.

Of those shootings, 837 (68.2%) involved assaults, 168 (13.5%) were unintentional, 124 (9.9%) were deliberate self-harm, and 43 (3.4%) were instances of legal intervention, based on the researchers’ review of medical records.

ICD codes at discharge, however, labeled 581 cases (47.4%) as assaults and 432 (35.2%) as unintentional.

The researchers found that 234 of the 837 assaults (28%) and 9 of the 43 legal interventions (20.9%) were miscoded as unintentional. This problem occurred even when the “medical narrative explicitly indicated that the shooting was an act of interpersonal violence,” such as a drive-by shooting or an act of domestic violence, the researchers reported.

Hospital trauma registrars, who detail the circumstances surrounding injuries, were mostly in agreement with the researchers.

Medical coders “would likely have little trouble characterizing firearm injury intent accurately if incentives were created for them to do so,” the authors wrote.

Trends and interventions

Separately, researchers published studies showing that gun violence tends to affect various demographics differently, and that remediating abandoned houses could help reduce gun crime.

Lindsay Young, of the University of Cincinnati, and Henry Xiang, MD, PhD, director of the Center for Pediatric Trauma Research at Nationwide Children’s Hospital in Columbus, Ohio, analyzed rates of firearm deaths from 1981 to 2020.

They found that the rate of firearm-related homicide was five times higher among males than females, and the rate of suicide involving firearms was nearly seven times higher for men, they reported in PLOS ONE.

Black men were the group most affected by homicide, whereas White men were most affected by suicide, they found.

To see if fixing abandoned properties would improve health and reduce gun violence in low-income, Black neighborhoods in Philadelphia, Eugenia C. South, MD, of the University of Pennsylvania, Philadelphia, and colleagues conducted a randomized trial.

They randomly assigned abandoned properties in some areas to undergo full remediation (installing working windows and doors, cleaning trash, and weeding); trash cleanup and weeding only; or no intervention.

“Abandoned houses that were remediated showed substantial drops in nearby weapons violations (−8.43%), gun assaults (−13.12%), and to a lesser extent shootings (−6.96%),” the researchers reported.

The intervention targets effects of segregation that have resulted from “historical and ongoing government and private-sector policies” that lead to disinvestment in Black, urban communities, they wrote. Abandoned houses can be used to store firearms and for other illegal activity. They also can engender feelings of fear, neglect, and stress in communities, the researchers noted.

Dr. Miller’s study was funded by the National Collaborative on Gun Violence Research; coauthors disclosed corporate, government, and university grants. The full list of disclosures can be found with the original article. Editorialists Dr. Cook and Dr. Parker report no relevant financial relationships. Dr. South’s study was funded by the National Institutes of Health. Dr. South and some coauthors disclosed government grants.
 

A version of this article first appeared on Medscape.com.

The percentage of people in the U.S. getting the latest COVID-19 booster shot has crept up by single digits in the past couple months, despite health officials pleading for people to do so before the Christmas holiday. 

Now, a new poll shows why so few people are willing to roll up their sleeves again.

The most common reasons people give for not getting the latest booster shot is that they “don’t think they need one” (44%) and they “don’t think the benefits are worth it” (37%), according to poll results from the Kaiser Family Foundation. 

The data comes amid announcements by the Centers for Disease Control and Prevention that boosters reduced COVID-19 hospitalizations by up to 57% for U.S. adults and by up to 84% for people age 65 and older. Those figures are just the latest in a mountain of research reporting the public health benefits of COVID-19 vaccines.

Despite all of the statistical data, health officials’ recent vaccination campaigns have proven far from compelling. 

So far, just 15% of people age 12 and older have gotten the latest booster, and 36% of people age 65 and older have gotten it, the CDC’s vaccination trackershows.

Since the start of the pandemic, 1.1 million people in the U.S. have died from COVID-19, with the number of deaths currently rising by 400 per day, The New York Times COVID tracker shows.

Many experts continue to note the need for everyone to get booster shots regularly, but some advocate that perhaps a change in strategy is in order.

“What the administration should do is push for vaccinating people in high-risk groups, including those who are older, those who are immunocompromised and those who have comorbidities,” Paul Offitt, MD, director of the Vaccine Education Center at Children’s Hospital of Philadelphia, told CNN.

Federal regulators have announced they will meet Jan. 26 with a panel of vaccine advisors to examine the current recommended vaccination schedule as well as look at the effectiveness and composition of current vaccines and boosters, with an eye toward the make-up of next-generation shots.

Vaccines are the “best available protection” against hospitalization and death caused by COVID-19, said Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research, in a statement announcing the planned meeting.

“Since the initial authorizations of these vaccines, we have learned that protection wanes over time, especially as the virus rapidly mutates and new variants and subvariants emerge,” he said. “Therefore, it’s important to continue discussions about the optimal composition of COVID-19 vaccines for primary and booster vaccination, as well as the optimal interval for booster vaccination.”

A version of this article first appeared on WebMD.com.

The percentage of people in the U.S. getting the latest COVID-19 booster shot has crept up by single digits in the past couple months, despite health officials pleading for people to do so before the Christmas holiday. 

Now, a new poll shows why so few people are willing to roll up their sleeves again.

The most common reasons people give for not getting the latest booster shot is that they “don’t think they need one” (44%) and they “don’t think the benefits are worth it” (37%), according to poll results from the Kaiser Family Foundation. 

The data comes amid announcements by the Centers for Disease Control and Prevention that boosters reduced COVID-19 hospitalizations by up to 57% for U.S. adults and by up to 84% for people age 65 and older. Those figures are just the latest in a mountain of research reporting the public health benefits of COVID-19 vaccines.

Despite all of the statistical data, health officials’ recent vaccination campaigns have proven far from compelling. 

So far, just 15% of people age 12 and older have gotten the latest booster, and 36% of people age 65 and older have gotten it, the CDC’s vaccination trackershows.

Since the start of the pandemic, 1.1 million people in the U.S. have died from COVID-19, with the number of deaths currently rising by 400 per day, The New York Times COVID tracker shows.

Many experts continue to note the need for everyone to get booster shots regularly, but some advocate that perhaps a change in strategy is in order.

“What the administration should do is push for vaccinating people in high-risk groups, including those who are older, those who are immunocompromised and those who have comorbidities,” Paul Offitt, MD, director of the Vaccine Education Center at Children’s Hospital of Philadelphia, told CNN.

Federal regulators have announced they will meet Jan. 26 with a panel of vaccine advisors to examine the current recommended vaccination schedule as well as look at the effectiveness and composition of current vaccines and boosters, with an eye toward the make-up of next-generation shots.

Vaccines are the “best available protection” against hospitalization and death caused by COVID-19, said Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research, in a statement announcing the planned meeting.

“Since the initial authorizations of these vaccines, we have learned that protection wanes over time, especially as the virus rapidly mutates and new variants and subvariants emerge,” he said. “Therefore, it’s important to continue discussions about the optimal composition of COVID-19 vaccines for primary and booster vaccination, as well as the optimal interval for booster vaccination.”

A version of this article first appeared on WebMD.com.

The percentage of people in the U.S. getting the latest COVID-19 booster shot has crept up by single digits in the past couple months, despite health officials pleading for people to do so before the Christmas holiday. 

Now, a new poll shows why so few people are willing to roll up their sleeves again.

The most common reasons people give for not getting the latest booster shot is that they “don’t think they need one” (44%) and they “don’t think the benefits are worth it” (37%), according to poll results from the Kaiser Family Foundation. 

The data comes amid announcements by the Centers for Disease Control and Prevention that boosters reduced COVID-19 hospitalizations by up to 57% for U.S. adults and by up to 84% for people age 65 and older. Those figures are just the latest in a mountain of research reporting the public health benefits of COVID-19 vaccines.

Despite all of the statistical data, health officials’ recent vaccination campaigns have proven far from compelling. 

So far, just 15% of people age 12 and older have gotten the latest booster, and 36% of people age 65 and older have gotten it, the CDC’s vaccination trackershows.

Since the start of the pandemic, 1.1 million people in the U.S. have died from COVID-19, with the number of deaths currently rising by 400 per day, The New York Times COVID tracker shows.

Many experts continue to note the need for everyone to get booster shots regularly, but some advocate that perhaps a change in strategy is in order.

“What the administration should do is push for vaccinating people in high-risk groups, including those who are older, those who are immunocompromised and those who have comorbidities,” Paul Offitt, MD, director of the Vaccine Education Center at Children’s Hospital of Philadelphia, told CNN.

Federal regulators have announced they will meet Jan. 26 with a panel of vaccine advisors to examine the current recommended vaccination schedule as well as look at the effectiveness and composition of current vaccines and boosters, with an eye toward the make-up of next-generation shots.

Vaccines are the “best available protection” against hospitalization and death caused by COVID-19, said Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research, in a statement announcing the planned meeting.

“Since the initial authorizations of these vaccines, we have learned that protection wanes over time, especially as the virus rapidly mutates and new variants and subvariants emerge,” he said. “Therefore, it’s important to continue discussions about the optimal composition of COVID-19 vaccines for primary and booster vaccination, as well as the optimal interval for booster vaccination.”

A version of this article first appeared on WebMD.com.