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FDA panels vote no on opioid-containing drug for MDD
A joint panel of the Food and Drug Administration voted Nov. 1 against approving a new opioid-containing drug as an adjunctive treatment for major depressive disorder.
The 21-2 vote against approval by members of the Psychopharmacologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee was based on concerns that the drug’s benefit-risk profile was not strong enough to warrant approval, according to a press release from Alkermes, developer of the drug, which is a combination of buprenorphine and samidorphan known as ALKS 5461.
“We were disappointed and surprised by the FDA’s characterization of the safety and efficacy data for ALKS 5461 and the resulting outcome of the advisory committee vote, particularly for the patients, their families and treatment providers who need and deserve access to novel therapies that work differently than currently available antidepressants, Richard Pops, chief executive officer of Alkermes, said in the release. “We remain steadfast in our commitment to make a meaningful difference in the lives of people suffering with serious mental health conditions, and will continue to work with the FDA as it completes its review of the ALKS 5461 regulatory submission.”
At the meeting, Sanjay J. Mathew, MD, a psychiatrist affiliated with the Baylor College of Medicine in Houston and a consultant for Alkermes who was paid for his time and travel to the meeting, discussed which patients might be good candidates for the new drug. He used an example of a patient who had failed on several monotherapies and would consider augmentation with a second drug. “In my view, this drug has a positive benefit-risk profile with a comparable efficacy” to currently available drugs, but with a new distinct mechanism that appears not to have certain undesirable side effects such as weight gain and sleepiness, he said.
Meanwhile, representatives from Alkermes discussed phase 3 studies, in which adults with treatment-resistant major depressive disorder were randomized to BUP/SAM in doses of 1mg/1mg or 2mg/2mg, or a placebo. In the trial, known as Study 207, changes in the MADRAS-10 total scores were significantly higher in the 2mg/2mg treatment groups, compared with placebo when data from 5 weeks and 6 weeks of treatment were combined.
However, in the FDA’s review of the data, it was noted that the efficacy was based on the MADRAS-10 average vs. the MADRAS-10 end of treatment, and the average “tends to obscure a possible drop-off in drug efficacy after the first few weeks of treatment.”
The FDA usually follows its panels’ recommendations, which are not binding.
A joint panel of the Food and Drug Administration voted Nov. 1 against approving a new opioid-containing drug as an adjunctive treatment for major depressive disorder.
The 21-2 vote against approval by members of the Psychopharmacologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee was based on concerns that the drug’s benefit-risk profile was not strong enough to warrant approval, according to a press release from Alkermes, developer of the drug, which is a combination of buprenorphine and samidorphan known as ALKS 5461.
“We were disappointed and surprised by the FDA’s characterization of the safety and efficacy data for ALKS 5461 and the resulting outcome of the advisory committee vote, particularly for the patients, their families and treatment providers who need and deserve access to novel therapies that work differently than currently available antidepressants, Richard Pops, chief executive officer of Alkermes, said in the release. “We remain steadfast in our commitment to make a meaningful difference in the lives of people suffering with serious mental health conditions, and will continue to work with the FDA as it completes its review of the ALKS 5461 regulatory submission.”
At the meeting, Sanjay J. Mathew, MD, a psychiatrist affiliated with the Baylor College of Medicine in Houston and a consultant for Alkermes who was paid for his time and travel to the meeting, discussed which patients might be good candidates for the new drug. He used an example of a patient who had failed on several monotherapies and would consider augmentation with a second drug. “In my view, this drug has a positive benefit-risk profile with a comparable efficacy” to currently available drugs, but with a new distinct mechanism that appears not to have certain undesirable side effects such as weight gain and sleepiness, he said.
Meanwhile, representatives from Alkermes discussed phase 3 studies, in which adults with treatment-resistant major depressive disorder were randomized to BUP/SAM in doses of 1mg/1mg or 2mg/2mg, or a placebo. In the trial, known as Study 207, changes in the MADRAS-10 total scores were significantly higher in the 2mg/2mg treatment groups, compared with placebo when data from 5 weeks and 6 weeks of treatment were combined.
However, in the FDA’s review of the data, it was noted that the efficacy was based on the MADRAS-10 average vs. the MADRAS-10 end of treatment, and the average “tends to obscure a possible drop-off in drug efficacy after the first few weeks of treatment.”
The FDA usually follows its panels’ recommendations, which are not binding.
A joint panel of the Food and Drug Administration voted Nov. 1 against approving a new opioid-containing drug as an adjunctive treatment for major depressive disorder.
The 21-2 vote against approval by members of the Psychopharmacologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee was based on concerns that the drug’s benefit-risk profile was not strong enough to warrant approval, according to a press release from Alkermes, developer of the drug, which is a combination of buprenorphine and samidorphan known as ALKS 5461.
“We were disappointed and surprised by the FDA’s characterization of the safety and efficacy data for ALKS 5461 and the resulting outcome of the advisory committee vote, particularly for the patients, their families and treatment providers who need and deserve access to novel therapies that work differently than currently available antidepressants, Richard Pops, chief executive officer of Alkermes, said in the release. “We remain steadfast in our commitment to make a meaningful difference in the lives of people suffering with serious mental health conditions, and will continue to work with the FDA as it completes its review of the ALKS 5461 regulatory submission.”
At the meeting, Sanjay J. Mathew, MD, a psychiatrist affiliated with the Baylor College of Medicine in Houston and a consultant for Alkermes who was paid for his time and travel to the meeting, discussed which patients might be good candidates for the new drug. He used an example of a patient who had failed on several monotherapies and would consider augmentation with a second drug. “In my view, this drug has a positive benefit-risk profile with a comparable efficacy” to currently available drugs, but with a new distinct mechanism that appears not to have certain undesirable side effects such as weight gain and sleepiness, he said.
Meanwhile, representatives from Alkermes discussed phase 3 studies, in which adults with treatment-resistant major depressive disorder were randomized to BUP/SAM in doses of 1mg/1mg or 2mg/2mg, or a placebo. In the trial, known as Study 207, changes in the MADRAS-10 total scores were significantly higher in the 2mg/2mg treatment groups, compared with placebo when data from 5 weeks and 6 weeks of treatment were combined.
However, in the FDA’s review of the data, it was noted that the efficacy was based on the MADRAS-10 average vs. the MADRAS-10 end of treatment, and the average “tends to obscure a possible drop-off in drug efficacy after the first few weeks of treatment.”
The FDA usually follows its panels’ recommendations, which are not binding.
Medical exemptions spike after vaccine policy change
according to data from interviews with health officials and immunization staff after implementation of the policy.
In a study published in Pediatrics, Salini Mohanty, DrPH, of the University of Pennsylvania School of Nursing, Philadelphia, and her colleagues conducted semistructured phone interviews with 40 health officers and immunization staff who represented 35 of 61 California heath jurisdictions. The interviews occurred between August 2017 and September 2017, and participants discussed their experiences with medical exemption requests after the policy change.
Although the percentage of fully vaccinated kindergarten students in California increased from 93% in 2015-2016 to 95% in 2017-2018, and the rate of personal belief exemptions declined, overall medical exemption requests rose 250% from 0.2% in 2015-2016 to 0.7% 2017-2018, the researchers noted.
They identified four main issues based on participant responses: the role of stakeholders, the review of medical exemptions received by schools, the medical exemptions perceived as problematic, and the general frustration and concern over medical exemptions.
Based on the interviews, one concerning subtheme involved reports that some physicians wrote medical exemptions for vaccine-hesitant parents based on conditions such as allergies and autoimmune diseases.
“The Internet provides access to physicians who are willing to sign off on exemptions and to websites used to instruct parents on how to get physicians to approve medical exemptions,” the researchers said.
“Understanding how physicians interpret the law is important because they are writing the medical exemptions,” Dr. Mohanty and her associates noted, and they proposed increased outreach and education of physicians about the law to reduce problematic medical exemptions.
Many health officials expressed frustration with their inability to review medical exemptions submitted directly to schools. In fact, interviewees cited one California jurisdiction that was named in a lawsuit for attempting to track medical exemptions, “which had an impact on other jurisdictions decision to track,” they said.
Officials also expressed concern that parents’ use of medical exemptions to replace personal belief exemptions would reduce herd immunity. Overall, regions with high levels of personal belief exemptions showed the largest increases in medical exemptions after SB277, which could put these regions at increased risk for vaccine-preventable outbreaks, the researchers noted.
There also were reports of physicians “who advertised medical exemptions online for a fee.” Officials also reported “receiving medical exemptions signed by physicians who do not typically treat children (cardiologists, dermatologists, surgeons, and physicians at medical marijuana dispensaries) and by unauthorized nonphysician providers, including nurse practitioners,” Dr. Mohanty and her associates said.
The study findings were limited by several factors including small sample size and potential recall bias, the researchers noted. However, the study is the first to include perspectives of local health officials after a change in vaccine exemption policy.
The National Institutes of Health supported the study. Dr. Mohanty had no financial conflicts to disclose; one coauthor disclosed relationships with Merck, Pfizer, and Walgreens.
SOURCE: Mohanty S et al. Pediatrics. 2018. doi: 10.1542/peds.2018-1051.
Passage of SB277 has had a positive impact on the proportion of California kindergarteners who are fully vaccinated, Richard J. Pan, MD, MPH, and Dorit Rubinstein Reiss, LLB, PhD, wrote in an editorial.
“Vaccines are one of the greatest public health successes in history. Mandating vaccination for school is an effective strategy to prevent outbreaks,” they said. However, “this protection is undermined when unscrupulous physicians monetize their license and abuse the authority delegated to them from the state by granting unwarranted [medical exemptions (MEs)],” they said.
The editorialists emphasized that states have the authority to mandate vaccinations in the interest of public health, and that allowing physicians to grant medical exemptions is appropriate because doctors know their patients and know whether exemptions are needed.
“However, the lack of cooperation by patients’ families who desire unwarranted MEs makes disciplining physicians who are engaged in this unprofessional behavior difficult and costly because licensing boards need to subpoena patient records over families’ objections to obtain evidence. Similarly, professional standard-setting organizations, including professional associations and certification boards, have been reluctant to withdraw credentials or expel members who promote vaccine misinformation and grant unwarranted MEs,” they said. They proposed strategies including establishing a searchable database for MEs, allowing public health officials the option to review and invalidate MEs, and requiring parents to submit MEs to public health departments as well as to schools.
“Pediatricians can partner with public health advocates and proscience parents to pass laws that empower public health officers to protect our children and community. Every child needs community immunity,” they said.
Dr. Pan is a California State Senator, Sacramento, and Dr. Reiss is at the Hastings College of the Law, University of California, San Francisco. Their comments on the article by Mohanty et al. were published in Pediatrics (2018;142[5]:e20182009). Dr. Pan authored legislation (Senate Bill 277) to abolish nonmedical exemption. Dr. Reiss’s family owns regular stock in GlaxoSmithKline.
Passage of SB277 has had a positive impact on the proportion of California kindergarteners who are fully vaccinated, Richard J. Pan, MD, MPH, and Dorit Rubinstein Reiss, LLB, PhD, wrote in an editorial.
“Vaccines are one of the greatest public health successes in history. Mandating vaccination for school is an effective strategy to prevent outbreaks,” they said. However, “this protection is undermined when unscrupulous physicians monetize their license and abuse the authority delegated to them from the state by granting unwarranted [medical exemptions (MEs)],” they said.
The editorialists emphasized that states have the authority to mandate vaccinations in the interest of public health, and that allowing physicians to grant medical exemptions is appropriate because doctors know their patients and know whether exemptions are needed.
“However, the lack of cooperation by patients’ families who desire unwarranted MEs makes disciplining physicians who are engaged in this unprofessional behavior difficult and costly because licensing boards need to subpoena patient records over families’ objections to obtain evidence. Similarly, professional standard-setting organizations, including professional associations and certification boards, have been reluctant to withdraw credentials or expel members who promote vaccine misinformation and grant unwarranted MEs,” they said. They proposed strategies including establishing a searchable database for MEs, allowing public health officials the option to review and invalidate MEs, and requiring parents to submit MEs to public health departments as well as to schools.
“Pediatricians can partner with public health advocates and proscience parents to pass laws that empower public health officers to protect our children and community. Every child needs community immunity,” they said.
Dr. Pan is a California State Senator, Sacramento, and Dr. Reiss is at the Hastings College of the Law, University of California, San Francisco. Their comments on the article by Mohanty et al. were published in Pediatrics (2018;142[5]:e20182009). Dr. Pan authored legislation (Senate Bill 277) to abolish nonmedical exemption. Dr. Reiss’s family owns regular stock in GlaxoSmithKline.
Passage of SB277 has had a positive impact on the proportion of California kindergarteners who are fully vaccinated, Richard J. Pan, MD, MPH, and Dorit Rubinstein Reiss, LLB, PhD, wrote in an editorial.
“Vaccines are one of the greatest public health successes in history. Mandating vaccination for school is an effective strategy to prevent outbreaks,” they said. However, “this protection is undermined when unscrupulous physicians monetize their license and abuse the authority delegated to them from the state by granting unwarranted [medical exemptions (MEs)],” they said.
The editorialists emphasized that states have the authority to mandate vaccinations in the interest of public health, and that allowing physicians to grant medical exemptions is appropriate because doctors know their patients and know whether exemptions are needed.
“However, the lack of cooperation by patients’ families who desire unwarranted MEs makes disciplining physicians who are engaged in this unprofessional behavior difficult and costly because licensing boards need to subpoena patient records over families’ objections to obtain evidence. Similarly, professional standard-setting organizations, including professional associations and certification boards, have been reluctant to withdraw credentials or expel members who promote vaccine misinformation and grant unwarranted MEs,” they said. They proposed strategies including establishing a searchable database for MEs, allowing public health officials the option to review and invalidate MEs, and requiring parents to submit MEs to public health departments as well as to schools.
“Pediatricians can partner with public health advocates and proscience parents to pass laws that empower public health officers to protect our children and community. Every child needs community immunity,” they said.
Dr. Pan is a California State Senator, Sacramento, and Dr. Reiss is at the Hastings College of the Law, University of California, San Francisco. Their comments on the article by Mohanty et al. were published in Pediatrics (2018;142[5]:e20182009). Dr. Pan authored legislation (Senate Bill 277) to abolish nonmedical exemption. Dr. Reiss’s family owns regular stock in GlaxoSmithKline.
according to data from interviews with health officials and immunization staff after implementation of the policy.
In a study published in Pediatrics, Salini Mohanty, DrPH, of the University of Pennsylvania School of Nursing, Philadelphia, and her colleagues conducted semistructured phone interviews with 40 health officers and immunization staff who represented 35 of 61 California heath jurisdictions. The interviews occurred between August 2017 and September 2017, and participants discussed their experiences with medical exemption requests after the policy change.
Although the percentage of fully vaccinated kindergarten students in California increased from 93% in 2015-2016 to 95% in 2017-2018, and the rate of personal belief exemptions declined, overall medical exemption requests rose 250% from 0.2% in 2015-2016 to 0.7% 2017-2018, the researchers noted.
They identified four main issues based on participant responses: the role of stakeholders, the review of medical exemptions received by schools, the medical exemptions perceived as problematic, and the general frustration and concern over medical exemptions.
Based on the interviews, one concerning subtheme involved reports that some physicians wrote medical exemptions for vaccine-hesitant parents based on conditions such as allergies and autoimmune diseases.
“The Internet provides access to physicians who are willing to sign off on exemptions and to websites used to instruct parents on how to get physicians to approve medical exemptions,” the researchers said.
“Understanding how physicians interpret the law is important because they are writing the medical exemptions,” Dr. Mohanty and her associates noted, and they proposed increased outreach and education of physicians about the law to reduce problematic medical exemptions.
Many health officials expressed frustration with their inability to review medical exemptions submitted directly to schools. In fact, interviewees cited one California jurisdiction that was named in a lawsuit for attempting to track medical exemptions, “which had an impact on other jurisdictions decision to track,” they said.
Officials also expressed concern that parents’ use of medical exemptions to replace personal belief exemptions would reduce herd immunity. Overall, regions with high levels of personal belief exemptions showed the largest increases in medical exemptions after SB277, which could put these regions at increased risk for vaccine-preventable outbreaks, the researchers noted.
There also were reports of physicians “who advertised medical exemptions online for a fee.” Officials also reported “receiving medical exemptions signed by physicians who do not typically treat children (cardiologists, dermatologists, surgeons, and physicians at medical marijuana dispensaries) and by unauthorized nonphysician providers, including nurse practitioners,” Dr. Mohanty and her associates said.
The study findings were limited by several factors including small sample size and potential recall bias, the researchers noted. However, the study is the first to include perspectives of local health officials after a change in vaccine exemption policy.
The National Institutes of Health supported the study. Dr. Mohanty had no financial conflicts to disclose; one coauthor disclosed relationships with Merck, Pfizer, and Walgreens.
SOURCE: Mohanty S et al. Pediatrics. 2018. doi: 10.1542/peds.2018-1051.
according to data from interviews with health officials and immunization staff after implementation of the policy.
In a study published in Pediatrics, Salini Mohanty, DrPH, of the University of Pennsylvania School of Nursing, Philadelphia, and her colleagues conducted semistructured phone interviews with 40 health officers and immunization staff who represented 35 of 61 California heath jurisdictions. The interviews occurred between August 2017 and September 2017, and participants discussed their experiences with medical exemption requests after the policy change.
Although the percentage of fully vaccinated kindergarten students in California increased from 93% in 2015-2016 to 95% in 2017-2018, and the rate of personal belief exemptions declined, overall medical exemption requests rose 250% from 0.2% in 2015-2016 to 0.7% 2017-2018, the researchers noted.
They identified four main issues based on participant responses: the role of stakeholders, the review of medical exemptions received by schools, the medical exemptions perceived as problematic, and the general frustration and concern over medical exemptions.
Based on the interviews, one concerning subtheme involved reports that some physicians wrote medical exemptions for vaccine-hesitant parents based on conditions such as allergies and autoimmune diseases.
“The Internet provides access to physicians who are willing to sign off on exemptions and to websites used to instruct parents on how to get physicians to approve medical exemptions,” the researchers said.
“Understanding how physicians interpret the law is important because they are writing the medical exemptions,” Dr. Mohanty and her associates noted, and they proposed increased outreach and education of physicians about the law to reduce problematic medical exemptions.
Many health officials expressed frustration with their inability to review medical exemptions submitted directly to schools. In fact, interviewees cited one California jurisdiction that was named in a lawsuit for attempting to track medical exemptions, “which had an impact on other jurisdictions decision to track,” they said.
Officials also expressed concern that parents’ use of medical exemptions to replace personal belief exemptions would reduce herd immunity. Overall, regions with high levels of personal belief exemptions showed the largest increases in medical exemptions after SB277, which could put these regions at increased risk for vaccine-preventable outbreaks, the researchers noted.
There also were reports of physicians “who advertised medical exemptions online for a fee.” Officials also reported “receiving medical exemptions signed by physicians who do not typically treat children (cardiologists, dermatologists, surgeons, and physicians at medical marijuana dispensaries) and by unauthorized nonphysician providers, including nurse practitioners,” Dr. Mohanty and her associates said.
The study findings were limited by several factors including small sample size and potential recall bias, the researchers noted. However, the study is the first to include perspectives of local health officials after a change in vaccine exemption policy.
The National Institutes of Health supported the study. Dr. Mohanty had no financial conflicts to disclose; one coauthor disclosed relationships with Merck, Pfizer, and Walgreens.
SOURCE: Mohanty S et al. Pediatrics. 2018. doi: 10.1542/peds.2018-1051.
FROM PEDIATRICS
Key clinical point: Medical exemptions for childhood vaccinations in California increased after the implementation of Senate Bill 277 (SB277) eliminating nonmedical exemptions.
Major finding: Medical exemptions in California increased by 250% after the SB277 took effect.
Study details: The data come from 34 interviews with 40 health officers and immunization staff about their experiences with medical exemptions before and after the passage of SB277.
Disclosures: The National Institutes of Health supported the study. Dr. Mohanty had no financial conflicts to disclose; one coauthor disclosed relationships with Merck, Pfizer, and Walgreens.
Source: Mohanty S et al. Pediatrics. 2018. doi: 10.1542/peds.2018-1051.
Full-dose quadrivalent flu vaccine shows increased efficacy in children
according to data from a randomized trial of nearly 2,000 children aged 6-35 months.
Data from previous studies have suggested that a full dose of vaccine may be more immunogenic in young children compared with a half dose, and Sanofi Pasteur has submitted a supplemental Biologics License Application to the Food and Drug Administration to allow use of the full 0.5-mL dose in children as young as 6 months, Monica Mercer, MD, of Sanofi Pasteur, said at a meeting of the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices in Atlanta.
Dr. Mercer presented findings from a phase IV randomized, observer-blinded study, in which the researchers assigned healthy children aged 6-35 months to receive Fluzone quadrivalent vaccine at a dose of 0.25 mL or 0.5 mL.
A total of 1,941 children (949 for the 0.25-mL dose and 992 for the 0.5-mL dose) were included in the safety analysis.
The most important safety outcome was to compare the rate of any fever, Dr. Mercer said at the meeting.
Overall, at 7 days after vaccination, the rate of fever was 11% for the half dose and 12% for the full dose, she said. The resulting difference of 0.84% met the criteria for noninferiority (less than 5%), she added.
In terms of safety, tenderness was the most frequently reported injection site reaction, noted in 47% of the half-dose group and 50% of the full-dose group. The rates of unsolicited adverse events were similar in both groups, the most common included diarrhea and cough, Dr. Mercer said.
No subjects in the full-dose group and three in the half-dose group discontinued the study because of adverse events. The only reported serious adverse event was one case of chronic urticaria in the half-dose group; no deaths were reported in either group.
As for efficacy, the full dose demonstrated noninferiority, compared with the half dose, against each of four strains: influenza A H1N1, influenza A H3N2, influenza B Victoria, and influenza B Yamagata. The geometric mean titers of the full and half doses for each of the four strains were, respectively, 310 and 214, 332 and 221, 348 and 261, and 349 and 243.
The potential action date for the supplemental Biologics License Application is January 2019, noted Dr. Mercer, who is employed by Sanofi Pasteur.
according to data from a randomized trial of nearly 2,000 children aged 6-35 months.
Data from previous studies have suggested that a full dose of vaccine may be more immunogenic in young children compared with a half dose, and Sanofi Pasteur has submitted a supplemental Biologics License Application to the Food and Drug Administration to allow use of the full 0.5-mL dose in children as young as 6 months, Monica Mercer, MD, of Sanofi Pasteur, said at a meeting of the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices in Atlanta.
Dr. Mercer presented findings from a phase IV randomized, observer-blinded study, in which the researchers assigned healthy children aged 6-35 months to receive Fluzone quadrivalent vaccine at a dose of 0.25 mL or 0.5 mL.
A total of 1,941 children (949 for the 0.25-mL dose and 992 for the 0.5-mL dose) were included in the safety analysis.
The most important safety outcome was to compare the rate of any fever, Dr. Mercer said at the meeting.
Overall, at 7 days after vaccination, the rate of fever was 11% for the half dose and 12% for the full dose, she said. The resulting difference of 0.84% met the criteria for noninferiority (less than 5%), she added.
In terms of safety, tenderness was the most frequently reported injection site reaction, noted in 47% of the half-dose group and 50% of the full-dose group. The rates of unsolicited adverse events were similar in both groups, the most common included diarrhea and cough, Dr. Mercer said.
No subjects in the full-dose group and three in the half-dose group discontinued the study because of adverse events. The only reported serious adverse event was one case of chronic urticaria in the half-dose group; no deaths were reported in either group.
As for efficacy, the full dose demonstrated noninferiority, compared with the half dose, against each of four strains: influenza A H1N1, influenza A H3N2, influenza B Victoria, and influenza B Yamagata. The geometric mean titers of the full and half doses for each of the four strains were, respectively, 310 and 214, 332 and 221, 348 and 261, and 349 and 243.
The potential action date for the supplemental Biologics License Application is January 2019, noted Dr. Mercer, who is employed by Sanofi Pasteur.
according to data from a randomized trial of nearly 2,000 children aged 6-35 months.
Data from previous studies have suggested that a full dose of vaccine may be more immunogenic in young children compared with a half dose, and Sanofi Pasteur has submitted a supplemental Biologics License Application to the Food and Drug Administration to allow use of the full 0.5-mL dose in children as young as 6 months, Monica Mercer, MD, of Sanofi Pasteur, said at a meeting of the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices in Atlanta.
Dr. Mercer presented findings from a phase IV randomized, observer-blinded study, in which the researchers assigned healthy children aged 6-35 months to receive Fluzone quadrivalent vaccine at a dose of 0.25 mL or 0.5 mL.
A total of 1,941 children (949 for the 0.25-mL dose and 992 for the 0.5-mL dose) were included in the safety analysis.
The most important safety outcome was to compare the rate of any fever, Dr. Mercer said at the meeting.
Overall, at 7 days after vaccination, the rate of fever was 11% for the half dose and 12% for the full dose, she said. The resulting difference of 0.84% met the criteria for noninferiority (less than 5%), she added.
In terms of safety, tenderness was the most frequently reported injection site reaction, noted in 47% of the half-dose group and 50% of the full-dose group. The rates of unsolicited adverse events were similar in both groups, the most common included diarrhea and cough, Dr. Mercer said.
No subjects in the full-dose group and three in the half-dose group discontinued the study because of adverse events. The only reported serious adverse event was one case of chronic urticaria in the half-dose group; no deaths were reported in either group.
As for efficacy, the full dose demonstrated noninferiority, compared with the half dose, against each of four strains: influenza A H1N1, influenza A H3N2, influenza B Victoria, and influenza B Yamagata. The geometric mean titers of the full and half doses for each of the four strains were, respectively, 310 and 214, 332 and 221, 348 and 261, and 349 and 243.
The potential action date for the supplemental Biologics License Application is January 2019, noted Dr. Mercer, who is employed by Sanofi Pasteur.
REPORTING FROM AN ACIP MEETING
Vaccine protects against flu-related hospitalizations in pregnancy
A review of more than 1,000 hospitalizations revealed a 40% influenza vaccine effectiveness against laboratory-confirmed influenza-associated hospitalizations during pregnancy, Mark Thompson, MD, said at a meeting of the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices in Atlanta.
To date, no study has examined influenza vaccine effectiveness (IVE) against hospitalizations among pregnant women, said Dr. Thompson, of the CDC’s influenza division.
He presented results of a study based on data from the Pregnancy Influenza Vaccine Effectiveness Network (PREVENT), which included public health or health care systems with integrated laboratory, medical, and vaccination records in Australia, Canada (Alberta and Ontario), Israel, and three states (California, Oregon, and Washington). The study included women aged 18-50 years who were pregnant during local influenza seasons from 2010 to 2016. Most of the women were older than 35 years (79%), and in the third trimester (65%), and had no high risk medical conditions (66%). The study was published in Clinical Infectious Diseases (2018 Oct 11. doi: 10.1093/cid/ciy737).
The researchers identified 19,450 hospitalizations with an acute respiratory or febrile illness discharge diagnosis and clinician-ordered real-time reverse transcription polymerase chain reaction (rRT-PCR) testing for flu viruses. Of these, 1,030 (6%) of the women underwent rRT-PCR testing, 54% were diagnosed with either influenza or pneumonia, and 58% had detectable influenza A or B virus infections.
Overall, the adjusted IVE was 40%; 13% of rRT-PCR-confirmed influenza-positive pregnant women and 22% of influenza-negative pregnant women were vaccinated; IVE was adjusted for site, season, season timing, and high-risk medical conditions.
“The takeaway is this is the average performance of the vaccine across multiple countries and different seasons,” and the vaccine effectiveness appeared stable across high-risk medical conditions and trimesters of pregnancy, Dr. Thompson said.
The generalizability of the study findings was limited by the lack of data from low- to middle-income countries, he said during the meeting discussion. However, the ICU admission rate is “what we would expect” and similar to results from previous studies. The consistent results showed the need to increase flu vaccination for pregnant women worldwide and to include study populations from lower-income countries in future research.
Dr. Thompson had no financial conflicts to disclose.
A review of more than 1,000 hospitalizations revealed a 40% influenza vaccine effectiveness against laboratory-confirmed influenza-associated hospitalizations during pregnancy, Mark Thompson, MD, said at a meeting of the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices in Atlanta.
To date, no study has examined influenza vaccine effectiveness (IVE) against hospitalizations among pregnant women, said Dr. Thompson, of the CDC’s influenza division.
He presented results of a study based on data from the Pregnancy Influenza Vaccine Effectiveness Network (PREVENT), which included public health or health care systems with integrated laboratory, medical, and vaccination records in Australia, Canada (Alberta and Ontario), Israel, and three states (California, Oregon, and Washington). The study included women aged 18-50 years who were pregnant during local influenza seasons from 2010 to 2016. Most of the women were older than 35 years (79%), and in the third trimester (65%), and had no high risk medical conditions (66%). The study was published in Clinical Infectious Diseases (2018 Oct 11. doi: 10.1093/cid/ciy737).
The researchers identified 19,450 hospitalizations with an acute respiratory or febrile illness discharge diagnosis and clinician-ordered real-time reverse transcription polymerase chain reaction (rRT-PCR) testing for flu viruses. Of these, 1,030 (6%) of the women underwent rRT-PCR testing, 54% were diagnosed with either influenza or pneumonia, and 58% had detectable influenza A or B virus infections.
Overall, the adjusted IVE was 40%; 13% of rRT-PCR-confirmed influenza-positive pregnant women and 22% of influenza-negative pregnant women were vaccinated; IVE was adjusted for site, season, season timing, and high-risk medical conditions.
“The takeaway is this is the average performance of the vaccine across multiple countries and different seasons,” and the vaccine effectiveness appeared stable across high-risk medical conditions and trimesters of pregnancy, Dr. Thompson said.
The generalizability of the study findings was limited by the lack of data from low- to middle-income countries, he said during the meeting discussion. However, the ICU admission rate is “what we would expect” and similar to results from previous studies. The consistent results showed the need to increase flu vaccination for pregnant women worldwide and to include study populations from lower-income countries in future research.
Dr. Thompson had no financial conflicts to disclose.
A review of more than 1,000 hospitalizations revealed a 40% influenza vaccine effectiveness against laboratory-confirmed influenza-associated hospitalizations during pregnancy, Mark Thompson, MD, said at a meeting of the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices in Atlanta.
To date, no study has examined influenza vaccine effectiveness (IVE) against hospitalizations among pregnant women, said Dr. Thompson, of the CDC’s influenza division.
He presented results of a study based on data from the Pregnancy Influenza Vaccine Effectiveness Network (PREVENT), which included public health or health care systems with integrated laboratory, medical, and vaccination records in Australia, Canada (Alberta and Ontario), Israel, and three states (California, Oregon, and Washington). The study included women aged 18-50 years who were pregnant during local influenza seasons from 2010 to 2016. Most of the women were older than 35 years (79%), and in the third trimester (65%), and had no high risk medical conditions (66%). The study was published in Clinical Infectious Diseases (2018 Oct 11. doi: 10.1093/cid/ciy737).
The researchers identified 19,450 hospitalizations with an acute respiratory or febrile illness discharge diagnosis and clinician-ordered real-time reverse transcription polymerase chain reaction (rRT-PCR) testing for flu viruses. Of these, 1,030 (6%) of the women underwent rRT-PCR testing, 54% were diagnosed with either influenza or pneumonia, and 58% had detectable influenza A or B virus infections.
Overall, the adjusted IVE was 40%; 13% of rRT-PCR-confirmed influenza-positive pregnant women and 22% of influenza-negative pregnant women were vaccinated; IVE was adjusted for site, season, season timing, and high-risk medical conditions.
“The takeaway is this is the average performance of the vaccine across multiple countries and different seasons,” and the vaccine effectiveness appeared stable across high-risk medical conditions and trimesters of pregnancy, Dr. Thompson said.
The generalizability of the study findings was limited by the lack of data from low- to middle-income countries, he said during the meeting discussion. However, the ICU admission rate is “what we would expect” and similar to results from previous studies. The consistent results showed the need to increase flu vaccination for pregnant women worldwide and to include study populations from lower-income countries in future research.
Dr. Thompson had no financial conflicts to disclose.
FROM AN ACIP MEETING
ACIP resuscitates pertussis working group
The recent rise in pertussis rates may have peaked, but the experts are responding by reinstating a working group.
The new working group for pertussis was announced at a meeting of the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices. The ACIP’s new group, led by Fiona Havers, MD, of the CDC, heard data on the currently available pertussis vaccines and solicited ideas from ACIP members about what other data they would like before the February meeting.
One question on the agenda is whether the current recommendation that nonpregnant adults receive a single lifetime dose of Tdap and then tetanus-diphtheria (Td) boosters every 10 years be expanded to allow either Tdap or Td as the booster. Reasons for considering the change include possible changes in the circulating pertussis strain, improved diagnosis and reporting, and the waning of protection under the current guidelines, as well as the potential economic impact, Dr. Havers said.
This change could make booster administration easier for many physicians who do not routinely stock Td, some committee members noted. In addition, the Food and Drug Administration has approved a label change for one Tdap manufacturer to remove “single use” language.
In a study presented by David P. Greenberg, MD, associate vice president of Sanofi Pasteur, seroprotection rates to tetanus and diphtheria were similar in a comparison between groups of adults aged 18 years and older, receiving either Tdap (Adacel) or Td as a booster. “Seroprotection was greater than 99% in both groups,” he said.
Pain was the most common injection site reaction in both groups, rates of serious adverse events were similarly low (0.8% and 0.3%, respectively), and no deaths occurred in patients given either vaccine.
The postvaccination antipertussis geometric mean concentrations were noninferior in the Tdap group, compared with the Td group, Dr. Greenberg said.
A phase III open label study presented by Leonard Silverstein, MD, of GlaxoSmithKline also showed similar seroprotection rates for adults revaccinated with Tdap after an initial vaccination with either of two different Tdap vaccines.
Also at the February meeting, the committee will address whether any vaccine that contained Td should be allowed for use as tetanus prophylaxis in the setting of wound management, said Dr. Havers.
The committee members expressed interest in more information on several topics including pregnancy and pertussis, whether manufacturers could discuss vaccines in the pipeline, data on responses to multiple doses and if there is a point of diminishing returns, and whether some states are covering Tdap for adults.
The committee members had no financial conflicts to disclose.
The recent rise in pertussis rates may have peaked, but the experts are responding by reinstating a working group.
The new working group for pertussis was announced at a meeting of the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices. The ACIP’s new group, led by Fiona Havers, MD, of the CDC, heard data on the currently available pertussis vaccines and solicited ideas from ACIP members about what other data they would like before the February meeting.
One question on the agenda is whether the current recommendation that nonpregnant adults receive a single lifetime dose of Tdap and then tetanus-diphtheria (Td) boosters every 10 years be expanded to allow either Tdap or Td as the booster. Reasons for considering the change include possible changes in the circulating pertussis strain, improved diagnosis and reporting, and the waning of protection under the current guidelines, as well as the potential economic impact, Dr. Havers said.
This change could make booster administration easier for many physicians who do not routinely stock Td, some committee members noted. In addition, the Food and Drug Administration has approved a label change for one Tdap manufacturer to remove “single use” language.
In a study presented by David P. Greenberg, MD, associate vice president of Sanofi Pasteur, seroprotection rates to tetanus and diphtheria were similar in a comparison between groups of adults aged 18 years and older, receiving either Tdap (Adacel) or Td as a booster. “Seroprotection was greater than 99% in both groups,” he said.
Pain was the most common injection site reaction in both groups, rates of serious adverse events were similarly low (0.8% and 0.3%, respectively), and no deaths occurred in patients given either vaccine.
The postvaccination antipertussis geometric mean concentrations were noninferior in the Tdap group, compared with the Td group, Dr. Greenberg said.
A phase III open label study presented by Leonard Silverstein, MD, of GlaxoSmithKline also showed similar seroprotection rates for adults revaccinated with Tdap after an initial vaccination with either of two different Tdap vaccines.
Also at the February meeting, the committee will address whether any vaccine that contained Td should be allowed for use as tetanus prophylaxis in the setting of wound management, said Dr. Havers.
The committee members expressed interest in more information on several topics including pregnancy and pertussis, whether manufacturers could discuss vaccines in the pipeline, data on responses to multiple doses and if there is a point of diminishing returns, and whether some states are covering Tdap for adults.
The committee members had no financial conflicts to disclose.
The recent rise in pertussis rates may have peaked, but the experts are responding by reinstating a working group.
The new working group for pertussis was announced at a meeting of the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices. The ACIP’s new group, led by Fiona Havers, MD, of the CDC, heard data on the currently available pertussis vaccines and solicited ideas from ACIP members about what other data they would like before the February meeting.
One question on the agenda is whether the current recommendation that nonpregnant adults receive a single lifetime dose of Tdap and then tetanus-diphtheria (Td) boosters every 10 years be expanded to allow either Tdap or Td as the booster. Reasons for considering the change include possible changes in the circulating pertussis strain, improved diagnosis and reporting, and the waning of protection under the current guidelines, as well as the potential economic impact, Dr. Havers said.
This change could make booster administration easier for many physicians who do not routinely stock Td, some committee members noted. In addition, the Food and Drug Administration has approved a label change for one Tdap manufacturer to remove “single use” language.
In a study presented by David P. Greenberg, MD, associate vice president of Sanofi Pasteur, seroprotection rates to tetanus and diphtheria were similar in a comparison between groups of adults aged 18 years and older, receiving either Tdap (Adacel) or Td as a booster. “Seroprotection was greater than 99% in both groups,” he said.
Pain was the most common injection site reaction in both groups, rates of serious adverse events were similarly low (0.8% and 0.3%, respectively), and no deaths occurred in patients given either vaccine.
The postvaccination antipertussis geometric mean concentrations were noninferior in the Tdap group, compared with the Td group, Dr. Greenberg said.
A phase III open label study presented by Leonard Silverstein, MD, of GlaxoSmithKline also showed similar seroprotection rates for adults revaccinated with Tdap after an initial vaccination with either of two different Tdap vaccines.
Also at the February meeting, the committee will address whether any vaccine that contained Td should be allowed for use as tetanus prophylaxis in the setting of wound management, said Dr. Havers.
The committee members expressed interest in more information on several topics including pregnancy and pertussis, whether manufacturers could discuss vaccines in the pipeline, data on responses to multiple doses and if there is a point of diminishing returns, and whether some states are covering Tdap for adults.
The committee members had no financial conflicts to disclose.
AT AN ACIP MEETING
Technology offers new tools, challenges for rare-disease patients
WASHINGTON – Genetic developments may create a new medical model for patients with rare diseases and the doctors who treat them, according to Marshall Summar, MD, chief of genetics and metabolism at Children’s National Medical Center in Washington, D.C.
In an interview at the NORD Rare Summit, held by the National Organization for Rare Disorders, Dr. Summar and Peter L. Saltonstall, president and CEO of NORD, discussed hot topics in the rare disease field. Those include new knowledge of the natural history of rare diseases, made possible by the creation of patient databases and the expansion of genetic technology. In addition, some DNA therapies “are finally crossing the finish line,” said Dr. Summar. That means clinicians will be looking at some rare diseases as acute conditions rather than chronic.
However, patients with rare diseases continue to face challenges in terms of the need for prior authorization and for drug access. One of NORD’s missions is to help patients access treatment. “We are seeing these prior authorizations take weeks or even longer,” Mr. Saltonstall said – and meanwhile, patients aren’t receiving therapy.
Visit rarediseases.org for more information about NORD’s ongoing research and advocacy efforts.
Dr. Summar and Mr. Saltonstall had no financial conflicts to disclose.
WASHINGTON – Genetic developments may create a new medical model for patients with rare diseases and the doctors who treat them, according to Marshall Summar, MD, chief of genetics and metabolism at Children’s National Medical Center in Washington, D.C.
In an interview at the NORD Rare Summit, held by the National Organization for Rare Disorders, Dr. Summar and Peter L. Saltonstall, president and CEO of NORD, discussed hot topics in the rare disease field. Those include new knowledge of the natural history of rare diseases, made possible by the creation of patient databases and the expansion of genetic technology. In addition, some DNA therapies “are finally crossing the finish line,” said Dr. Summar. That means clinicians will be looking at some rare diseases as acute conditions rather than chronic.
However, patients with rare diseases continue to face challenges in terms of the need for prior authorization and for drug access. One of NORD’s missions is to help patients access treatment. “We are seeing these prior authorizations take weeks or even longer,” Mr. Saltonstall said – and meanwhile, patients aren’t receiving therapy.
Visit rarediseases.org for more information about NORD’s ongoing research and advocacy efforts.
Dr. Summar and Mr. Saltonstall had no financial conflicts to disclose.
WASHINGTON – Genetic developments may create a new medical model for patients with rare diseases and the doctors who treat them, according to Marshall Summar, MD, chief of genetics and metabolism at Children’s National Medical Center in Washington, D.C.
In an interview at the NORD Rare Summit, held by the National Organization for Rare Disorders, Dr. Summar and Peter L. Saltonstall, president and CEO of NORD, discussed hot topics in the rare disease field. Those include new knowledge of the natural history of rare diseases, made possible by the creation of patient databases and the expansion of genetic technology. In addition, some DNA therapies “are finally crossing the finish line,” said Dr. Summar. That means clinicians will be looking at some rare diseases as acute conditions rather than chronic.
However, patients with rare diseases continue to face challenges in terms of the need for prior authorization and for drug access. One of NORD’s missions is to help patients access treatment. “We are seeing these prior authorizations take weeks or even longer,” Mr. Saltonstall said – and meanwhile, patients aren’t receiving therapy.
Visit rarediseases.org for more information about NORD’s ongoing research and advocacy efforts.
Dr. Summar and Mr. Saltonstall had no financial conflicts to disclose.
REPORTING FROM NORD SUMMIT 2018
Education and support enhance care for rare-disease patients
WASHINGTON – Physicians in primary and specialty care can provide guidance and support to patients with rare diseases by educating themselves about the resources available, according to Tim Boyd, director of state policy for the National Organization for Rare Disorders (NORD).
In an interview at the NORD Rare Summit, held by the National Organization for Rare Disorders, Mr. Boyd and Melinda Burnworth, PharmD, a pharmacist and NORD state volunteer from Arizona, discussed challenges faced by patients with rare diseases, including securing a correct diagnosis, accessing medication, and managing treatment going forward.
Physicians who understand some of the barriers to medication access can help advocate for their patients, explained Mr. Boyd, and those who know about resources for rare disorders can help make a diagnosis.
“All health care providers have an opportunity to enhance care for patients with rare disorders,” said Dr. Burnworth, author of the Rare Disease eResource Guide, available through the American Society of Health-System Pharmacists. Visit rarediseases.org for more information about NORD’s ongoing research and advocacy efforts.
Mr. Boyd and Dr. Burnworth had no financial conflicts to disclose.
WASHINGTON – Physicians in primary and specialty care can provide guidance and support to patients with rare diseases by educating themselves about the resources available, according to Tim Boyd, director of state policy for the National Organization for Rare Disorders (NORD).
In an interview at the NORD Rare Summit, held by the National Organization for Rare Disorders, Mr. Boyd and Melinda Burnworth, PharmD, a pharmacist and NORD state volunteer from Arizona, discussed challenges faced by patients with rare diseases, including securing a correct diagnosis, accessing medication, and managing treatment going forward.
Physicians who understand some of the barriers to medication access can help advocate for their patients, explained Mr. Boyd, and those who know about resources for rare disorders can help make a diagnosis.
“All health care providers have an opportunity to enhance care for patients with rare disorders,” said Dr. Burnworth, author of the Rare Disease eResource Guide, available through the American Society of Health-System Pharmacists. Visit rarediseases.org for more information about NORD’s ongoing research and advocacy efforts.
Mr. Boyd and Dr. Burnworth had no financial conflicts to disclose.
WASHINGTON – Physicians in primary and specialty care can provide guidance and support to patients with rare diseases by educating themselves about the resources available, according to Tim Boyd, director of state policy for the National Organization for Rare Disorders (NORD).
In an interview at the NORD Rare Summit, held by the National Organization for Rare Disorders, Mr. Boyd and Melinda Burnworth, PharmD, a pharmacist and NORD state volunteer from Arizona, discussed challenges faced by patients with rare diseases, including securing a correct diagnosis, accessing medication, and managing treatment going forward.
Physicians who understand some of the barriers to medication access can help advocate for their patients, explained Mr. Boyd, and those who know about resources for rare disorders can help make a diagnosis.
“All health care providers have an opportunity to enhance care for patients with rare disorders,” said Dr. Burnworth, author of the Rare Disease eResource Guide, available through the American Society of Health-System Pharmacists. Visit rarediseases.org for more information about NORD’s ongoing research and advocacy efforts.
Mr. Boyd and Dr. Burnworth had no financial conflicts to disclose.
REPORTING FROM NORD SUMMIT 2018
ACIP votes unanimously in favor of immunization schedule update and redesign
Clinicians consulting the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices vaccination schedules for children, adolescents, and adults in 2019 will find a simpler design and more useful product, according to David Kim, MD, of the Immunization Services Division of the Centers for Disease Control and Prevention, Atlanta.
In a single vote to cover both adult and child/adolescent schedules, the committee voted unanimously in favor of a redesign of the schedules and several clinical updates.
In 2016, the working group for vaccination schedules conducted an ad hoc evaluation of the adult schedule to assess its usability, Dr. Kim said at a meeting of the CDC’s ACIP.
The design of the adult schedule was fully evaluated in 2018 via a three-step process – interviews with 48 health care providers, a redesign of the schedule, and a survey after the redesign. Design changes to the child/adolescent schedule were harmonized with the adult schedule, Dr. Kim explained.
The adult vaccination schedule itself includes several updates in ACIP recommendations in addition to the aesthetic design changes.
The 2019 Adult Immunization Schedule includes the option of the live attenuated influenza vaccine (LAIV) for influenza, the addition of homelessness as an indication for hepatitis A vaccination, and the use of CpG-adjuvanted hepatitis B vaccine, Dr. Kim said.
The additions to the 2019 Child and Adolescent Immunization Schedule are the optional use of the LAIV for influenza, the addition of homelessness as an indication for hepatitis A vaccination, the use of CpG-adjuvanted hepatitis B vaccine (a cytosine phosphoguanosine oligodeoxynucleotide adjuvant), and the addition of the Tdap vaccination of individuals who received Tdap at age 7-10 years.
Some of the key design changes include the use of bright purple on the child/adolescent schedule to more easily distinguish it from the adult version, said Dr. Kim.
Other changes to both schedules include shorter titles, lists of vaccines and trade names, and compartmentalized information for easier reference. Figures have been replaced by tables, and footnotes are simply “Notes” at the end of the schedule, compartmentalized for easier reading, he said. In addition, the schedules include resources for vaccination in outbreak situations and a section on how to report vaccine preventable disease outbreaks.
The ACIP committee members had no relevant financial conflicts to disclose.
Clinicians consulting the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices vaccination schedules for children, adolescents, and adults in 2019 will find a simpler design and more useful product, according to David Kim, MD, of the Immunization Services Division of the Centers for Disease Control and Prevention, Atlanta.
In a single vote to cover both adult and child/adolescent schedules, the committee voted unanimously in favor of a redesign of the schedules and several clinical updates.
In 2016, the working group for vaccination schedules conducted an ad hoc evaluation of the adult schedule to assess its usability, Dr. Kim said at a meeting of the CDC’s ACIP.
The design of the adult schedule was fully evaluated in 2018 via a three-step process – interviews with 48 health care providers, a redesign of the schedule, and a survey after the redesign. Design changes to the child/adolescent schedule were harmonized with the adult schedule, Dr. Kim explained.
The adult vaccination schedule itself includes several updates in ACIP recommendations in addition to the aesthetic design changes.
The 2019 Adult Immunization Schedule includes the option of the live attenuated influenza vaccine (LAIV) for influenza, the addition of homelessness as an indication for hepatitis A vaccination, and the use of CpG-adjuvanted hepatitis B vaccine, Dr. Kim said.
The additions to the 2019 Child and Adolescent Immunization Schedule are the optional use of the LAIV for influenza, the addition of homelessness as an indication for hepatitis A vaccination, the use of CpG-adjuvanted hepatitis B vaccine (a cytosine phosphoguanosine oligodeoxynucleotide adjuvant), and the addition of the Tdap vaccination of individuals who received Tdap at age 7-10 years.
Some of the key design changes include the use of bright purple on the child/adolescent schedule to more easily distinguish it from the adult version, said Dr. Kim.
Other changes to both schedules include shorter titles, lists of vaccines and trade names, and compartmentalized information for easier reference. Figures have been replaced by tables, and footnotes are simply “Notes” at the end of the schedule, compartmentalized for easier reading, he said. In addition, the schedules include resources for vaccination in outbreak situations and a section on how to report vaccine preventable disease outbreaks.
The ACIP committee members had no relevant financial conflicts to disclose.
Clinicians consulting the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices vaccination schedules for children, adolescents, and adults in 2019 will find a simpler design and more useful product, according to David Kim, MD, of the Immunization Services Division of the Centers for Disease Control and Prevention, Atlanta.
In a single vote to cover both adult and child/adolescent schedules, the committee voted unanimously in favor of a redesign of the schedules and several clinical updates.
In 2016, the working group for vaccination schedules conducted an ad hoc evaluation of the adult schedule to assess its usability, Dr. Kim said at a meeting of the CDC’s ACIP.
The design of the adult schedule was fully evaluated in 2018 via a three-step process – interviews with 48 health care providers, a redesign of the schedule, and a survey after the redesign. Design changes to the child/adolescent schedule were harmonized with the adult schedule, Dr. Kim explained.
The adult vaccination schedule itself includes several updates in ACIP recommendations in addition to the aesthetic design changes.
The 2019 Adult Immunization Schedule includes the option of the live attenuated influenza vaccine (LAIV) for influenza, the addition of homelessness as an indication for hepatitis A vaccination, and the use of CpG-adjuvanted hepatitis B vaccine, Dr. Kim said.
The additions to the 2019 Child and Adolescent Immunization Schedule are the optional use of the LAIV for influenza, the addition of homelessness as an indication for hepatitis A vaccination, the use of CpG-adjuvanted hepatitis B vaccine (a cytosine phosphoguanosine oligodeoxynucleotide adjuvant), and the addition of the Tdap vaccination of individuals who received Tdap at age 7-10 years.
Some of the key design changes include the use of bright purple on the child/adolescent schedule to more easily distinguish it from the adult version, said Dr. Kim.
Other changes to both schedules include shorter titles, lists of vaccines and trade names, and compartmentalized information for easier reference. Figures have been replaced by tables, and footnotes are simply “Notes” at the end of the schedule, compartmentalized for easier reading, he said. In addition, the schedules include resources for vaccination in outbreak situations and a section on how to report vaccine preventable disease outbreaks.
The ACIP committee members had no relevant financial conflicts to disclose.
AT AN ACIP MEETING
ACIP supports hepatitis A vaccine for homeless individuals
Homeless individuals aged 1 year and older should be vaccinated against hepatitis A, based on a unanimous vote at a meeting of the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices.
“It is important that we take a national approach to vaccinating homeless” people, Noele Nelson, MD, PhD, MPH, of the CDC’s Division of Viral Hepatitis, said in a presentation prior to the vote, in which all 11 committee members voted in favor of hepatitis A vaccination for the homeless population.
Even limited vaccination will increase the herd immunity of the homeless population over time, she said.
Dr. Nelson presented data on the pros and cons of routine hepatitis A vaccination for homeless individuals aged 1 year and older. The Hepatitis Vaccines Work Group convened four meetings in advance of the October ACIP meeting and reached a consensus that homelessness is an independent indication for hepatitis A vaccination, she said.
If the hepatitis A vaccine is included as an ACIP recommendation, “it is more likely to be considered by homeless service providers,” noted Dr. Nelson. She also cited a low quality of evidence for adverse events associated with hepatitis A vaccination.
The work group considerations in the wake of a nationwide hepatitis A outbreak earlier in 2018 included the challenges of controlling outbreaks, which can spread quickly among the homeless population because of poor personal hygiene, limited sanitation, and tight living quarters. These factors make the homeless population more reliant on a vaccine for protection. An outbreak in San Diego, Calif., in particular, occurred largely in the homeless population.
“Routine vaccination is a more feasible approach to reach the homeless over time through regular homeless care providers,” Dr. Nelson said. As for costs, integrating vaccination into routine care for the homeless is cheaper and much less disruptive than the cost of responding to an outbreak.
The “cons” of recommending routine hepatitis A vaccination for the homeless population included the challenges of administrative record keeping. However, during the public comment period, Mae Morgan, MD, an internist who is medical director of Mercy Care Decatur Street & City of Refuge in Atlanta, emphasized that local homeless care organizations have procedures to manage routine vaccination. “If anyone is concerned that there is not a network in place, there are health centers to do this [that] would implement the vaccine.”
The ACIP committee members had no financial conflicts to disclose.
Homeless individuals aged 1 year and older should be vaccinated against hepatitis A, based on a unanimous vote at a meeting of the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices.
“It is important that we take a national approach to vaccinating homeless” people, Noele Nelson, MD, PhD, MPH, of the CDC’s Division of Viral Hepatitis, said in a presentation prior to the vote, in which all 11 committee members voted in favor of hepatitis A vaccination for the homeless population.
Even limited vaccination will increase the herd immunity of the homeless population over time, she said.
Dr. Nelson presented data on the pros and cons of routine hepatitis A vaccination for homeless individuals aged 1 year and older. The Hepatitis Vaccines Work Group convened four meetings in advance of the October ACIP meeting and reached a consensus that homelessness is an independent indication for hepatitis A vaccination, she said.
If the hepatitis A vaccine is included as an ACIP recommendation, “it is more likely to be considered by homeless service providers,” noted Dr. Nelson. She also cited a low quality of evidence for adverse events associated with hepatitis A vaccination.
The work group considerations in the wake of a nationwide hepatitis A outbreak earlier in 2018 included the challenges of controlling outbreaks, which can spread quickly among the homeless population because of poor personal hygiene, limited sanitation, and tight living quarters. These factors make the homeless population more reliant on a vaccine for protection. An outbreak in San Diego, Calif., in particular, occurred largely in the homeless population.
“Routine vaccination is a more feasible approach to reach the homeless over time through regular homeless care providers,” Dr. Nelson said. As for costs, integrating vaccination into routine care for the homeless is cheaper and much less disruptive than the cost of responding to an outbreak.
The “cons” of recommending routine hepatitis A vaccination for the homeless population included the challenges of administrative record keeping. However, during the public comment period, Mae Morgan, MD, an internist who is medical director of Mercy Care Decatur Street & City of Refuge in Atlanta, emphasized that local homeless care organizations have procedures to manage routine vaccination. “If anyone is concerned that there is not a network in place, there are health centers to do this [that] would implement the vaccine.”
The ACIP committee members had no financial conflicts to disclose.
Homeless individuals aged 1 year and older should be vaccinated against hepatitis A, based on a unanimous vote at a meeting of the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices.
“It is important that we take a national approach to vaccinating homeless” people, Noele Nelson, MD, PhD, MPH, of the CDC’s Division of Viral Hepatitis, said in a presentation prior to the vote, in which all 11 committee members voted in favor of hepatitis A vaccination for the homeless population.
Even limited vaccination will increase the herd immunity of the homeless population over time, she said.
Dr. Nelson presented data on the pros and cons of routine hepatitis A vaccination for homeless individuals aged 1 year and older. The Hepatitis Vaccines Work Group convened four meetings in advance of the October ACIP meeting and reached a consensus that homelessness is an independent indication for hepatitis A vaccination, she said.
If the hepatitis A vaccine is included as an ACIP recommendation, “it is more likely to be considered by homeless service providers,” noted Dr. Nelson. She also cited a low quality of evidence for adverse events associated with hepatitis A vaccination.
The work group considerations in the wake of a nationwide hepatitis A outbreak earlier in 2018 included the challenges of controlling outbreaks, which can spread quickly among the homeless population because of poor personal hygiene, limited sanitation, and tight living quarters. These factors make the homeless population more reliant on a vaccine for protection. An outbreak in San Diego, Calif., in particular, occurred largely in the homeless population.
“Routine vaccination is a more feasible approach to reach the homeless over time through regular homeless care providers,” Dr. Nelson said. As for costs, integrating vaccination into routine care for the homeless is cheaper and much less disruptive than the cost of responding to an outbreak.
The “cons” of recommending routine hepatitis A vaccination for the homeless population included the challenges of administrative record keeping. However, during the public comment period, Mae Morgan, MD, an internist who is medical director of Mercy Care Decatur Street & City of Refuge in Atlanta, emphasized that local homeless care organizations have procedures to manage routine vaccination. “If anyone is concerned that there is not a network in place, there are health centers to do this [that] would implement the vaccine.”
The ACIP committee members had no financial conflicts to disclose.
FROM AN ACIP MEETING
New Registry Offers Insight Into Opsoclonus-Myoclonus Syndrome
WASHINGTON – a rare disease affecting only 1 in 5,000,000 individuals, mostly aged 1-5 years, based on data from a new patient registry.
In partnership with the National Organization of Rare Disorders (NORD) the nonprofit OMSLife Foundation has created a patient registry to better understand the disease experience in patients, wrote Mike Michaelis, chairman of OMSLife, and his colleagues. Early data from 275 enrolled patients were presented in a poster at the NORD Rare Summit, held by the National Organization for Rare Disorders.
The registry patients were mainly born in the United States (86%) and white (74%); approximately half were female. Of 150 patients who indicated symptoms at onset, 87% reported ataxia. Additional symptoms at onset were myoclonus (61%), opsoclonus (59%), tremors (46%), sleep disturbances (45%), temper tantrums (38%), vomiting (27%), fever (13%), headache (9%) and other symptoms (13%).
The researchers reviewed associations of symptoms at onset to determine the frequency of other symptoms for each individual symptom. Ataxia was present with 89% or higher instances of the other reported symptoms. Of note, some symptoms occurred more frequently than expected, such as temper tantrums and tremors in approximately 70% of patients with sleep disturbances. Myoclonus and opsoclonus, as well as fever and vomiting, also were significantly associated with the presence of other symptoms.
Two-thirds of the registry patients (69%) were diagnosed within 3 months of symptom onset, and 83% of these were diagnosed by a neurologist. Based on the Mitchell-Pike OMS severity scale, 59% of the patients met criteria for severe disease, 34% were classified as moderate, and 7% were mild. The registry is ongoing, but the current data provide insight on the clinical picture and common symptoms of OMS, the researchers said.
OMS Life was established in 2012 to support patients, caregivers, and researchers in raising awareness of opsoclonus-myoclonus syndrome as well as funds for research.
The study was supported by the OMSLife Foundation, NORD, and Trio Health Analytics. The researchers are employed by these organizations.
WASHINGTON – a rare disease affecting only 1 in 5,000,000 individuals, mostly aged 1-5 years, based on data from a new patient registry.
In partnership with the National Organization of Rare Disorders (NORD) the nonprofit OMSLife Foundation has created a patient registry to better understand the disease experience in patients, wrote Mike Michaelis, chairman of OMSLife, and his colleagues. Early data from 275 enrolled patients were presented in a poster at the NORD Rare Summit, held by the National Organization for Rare Disorders.
The registry patients were mainly born in the United States (86%) and white (74%); approximately half were female. Of 150 patients who indicated symptoms at onset, 87% reported ataxia. Additional symptoms at onset were myoclonus (61%), opsoclonus (59%), tremors (46%), sleep disturbances (45%), temper tantrums (38%), vomiting (27%), fever (13%), headache (9%) and other symptoms (13%).
The researchers reviewed associations of symptoms at onset to determine the frequency of other symptoms for each individual symptom. Ataxia was present with 89% or higher instances of the other reported symptoms. Of note, some symptoms occurred more frequently than expected, such as temper tantrums and tremors in approximately 70% of patients with sleep disturbances. Myoclonus and opsoclonus, as well as fever and vomiting, also were significantly associated with the presence of other symptoms.
Two-thirds of the registry patients (69%) were diagnosed within 3 months of symptom onset, and 83% of these were diagnosed by a neurologist. Based on the Mitchell-Pike OMS severity scale, 59% of the patients met criteria for severe disease, 34% were classified as moderate, and 7% were mild. The registry is ongoing, but the current data provide insight on the clinical picture and common symptoms of OMS, the researchers said.
OMS Life was established in 2012 to support patients, caregivers, and researchers in raising awareness of opsoclonus-myoclonus syndrome as well as funds for research.
The study was supported by the OMSLife Foundation, NORD, and Trio Health Analytics. The researchers are employed by these organizations.
WASHINGTON – a rare disease affecting only 1 in 5,000,000 individuals, mostly aged 1-5 years, based on data from a new patient registry.
In partnership with the National Organization of Rare Disorders (NORD) the nonprofit OMSLife Foundation has created a patient registry to better understand the disease experience in patients, wrote Mike Michaelis, chairman of OMSLife, and his colleagues. Early data from 275 enrolled patients were presented in a poster at the NORD Rare Summit, held by the National Organization for Rare Disorders.
The registry patients were mainly born in the United States (86%) and white (74%); approximately half were female. Of 150 patients who indicated symptoms at onset, 87% reported ataxia. Additional symptoms at onset were myoclonus (61%), opsoclonus (59%), tremors (46%), sleep disturbances (45%), temper tantrums (38%), vomiting (27%), fever (13%), headache (9%) and other symptoms (13%).
The researchers reviewed associations of symptoms at onset to determine the frequency of other symptoms for each individual symptom. Ataxia was present with 89% or higher instances of the other reported symptoms. Of note, some symptoms occurred more frequently than expected, such as temper tantrums and tremors in approximately 70% of patients with sleep disturbances. Myoclonus and opsoclonus, as well as fever and vomiting, also were significantly associated with the presence of other symptoms.
Two-thirds of the registry patients (69%) were diagnosed within 3 months of symptom onset, and 83% of these were diagnosed by a neurologist. Based on the Mitchell-Pike OMS severity scale, 59% of the patients met criteria for severe disease, 34% were classified as moderate, and 7% were mild. The registry is ongoing, but the current data provide insight on the clinical picture and common symptoms of OMS, the researchers said.
OMS Life was established in 2012 to support patients, caregivers, and researchers in raising awareness of opsoclonus-myoclonus syndrome as well as funds for research.
The study was supported by the OMSLife Foundation, NORD, and Trio Health Analytics. The researchers are employed by these organizations.
REPORTING FROM NORD SUMMIT 2018
Key clinical point: Most patients with OMS experienced multiple symptoms at disease onset; ataxia was the most common.
Major finding: Approximately 87% of patients with OMS reported ataxia at disease onset and 59% experienced severe disease.
Study details: The data come from a registry including 275 OMS patients.
Disclosures: The study was supported by the OMSLife Foundation, NORD, and Trio Health Analytics. The researchers are employed by these organizations.