FDA Postpones Meeting to Discuss Pfizer Covid-19 Vaccine for Children Less Than 5 years Old

The FDA announced today that the meeting to discuss Pfizer’s request for authorization of Pfizer-BioNTech COVID-19 Vaccine for children 6 months through 4 years of age, originally scheduled February 15, 2022, will be postponed. This will give Pfizer time to evaluate a third dose of the vaccine in this age group.

Great YouTube Q&A on Covid-19 Vaccine for Children Ages 5-11: It’s better than a stick in the nose!

There was a great live stream YouTube Q&A presentation today on the Covid-19 vaccine for kids ages 5-11 through the University of Iowa Stead Family Children’s Hospital this afternoon at 2:15 and it ran for about 30 minutes (scrub the play button forward to about a minute to start the recorded video). There were excellent questions and informative answers as well as helpful guidance for parents by Chief Medical Officer Dr. Theresa Brennan, MD and Pediatrician Dr. Rami Boutros, MD.

Parents have been eager to bring their kids in to the pediatric clinic to get the vaccine. Dr. Boutros shared a funny anecdote about his interaction with a child who had just got his shot yesterday. It’s about 34 minutes into the video. After the child received the shot, Dr. Boutros asked him, “How was it?” The child replied, “The vaccine is better than a stick in the nose!” Anybody who’s been tested for Covid-19 can relate to that.

How’s that for a meme? Get the vaccine; it’s better than a stick in the nose!

CDC Recommends COVID-19 Vaccine for Children Ages 5-11

Following the Advisory Committee for Immunization Practices (ACIP) vote yesterday recommending the Pfizer Covid-19 vaccine for children ages 5-11, CDC formally announced agreement with the committee’s decision after the meeting.

CDC Advisory Committee Meeting Today on COVID-19 Vaccine for Children Ages 5-11

Today the Advisory Committee on Immunization Practices (ACIP) had the meeting today to discuss the Pfizer Covid-19 vaccine for children aged 5-11 years of age. Presentation slides are here. The Policy Question to be voted on for today is:

“Should vaccination with Pfizer-BioNTech COVID-19 vaccine (2-doses, 10µg, IM) be recommended for children 5–11 years of age, under an Emergency Use Authorization?”

Dr. Kevin Chatham-Stevens’ presentation on implementation of the vaccination program for children in the age group was informative. Most children will likely be vaccinated in their regional doctors’ office. Dr. Woodworth presented very helpful, practical, and reassuring information about the practical aspects of vaccination, see slides from “Interim Clinical Considerations for COVID-19 Vaccine in Children Ages 5–11 Years.”

Dr. Oliver’s presentation “EtR Framework: Pfizer-BioNTech COVID-19 vaccine in children aged 5–11 years” as part of the evidence to framework details.

Ҥ Children are at least as likely to be infected with SARS-CoV-2 as adults

– Over 1.9 million reported cases; seroprevalence estimated ~38% among 5–11 years in Sept 2021

– Infections in children less likely to be reported as cases than infections in adults

§ Children 5-11 years of age are at risk of severe illness from COVID-19

– >8,300 COVID-19 related hospitalizations as of mid-October

– Cumulative hospitalization rate is similar to pre-pandemic influenza seasons

– Severity comparable among children hospitalized with influenza and COVID-19, with approximately 1/3 of children 5–11 years requiring ICU admission

– MIS-C most frequent among children 5–11 years

– Post-COVID conditions have been reported in children

§ Secondary transmission from young school-aged children occurs in household and school settings”

The negative impact on children is considerable, especially for those of color. Vaccine efficacy was 90.9% in the Pfizer randomized controlled trial. The bottom line was that the balance and risks is favorable for vaccinations of all children. Post authorization safety monitoring will continue. The Work Group proposed to recommend the intervention.

After discussion, the committee voted on the ACIP Interim Recommendation below:

“The Pfizer-BioNTech COVID-19 vaccine (2-doses, 10µg, IM) is recommended for children 5–11 years of age, in the U.S. population under the FDA’s Emergency Use Authorization.”

The vote on the interim recommendation passed unanimously (14 yes votes).

The meeting was adjourned at approximately 5:00 PM, ET.

CDC Advisory Committee Meeting November 2nd on Pfizer Covid-19 Vaccine for Children Ages 5-11

The Advisory Committee on Immunization Practices (ACIP) have scheduled a meeting for November 2, 2021 from 10 AM-5 PM, ET to discuss the Covid-19 vaccine for children ages 5-11.

This follows the FDA authorization for the vaccine in this age group, which was announced today on their web site.

FDA Advisory Committee Meeting Today on Pfizer COVID-19 Vaccine for Children Ages 5-11

The meeting will go from 7:30 AM-5:00 PM, ET, and the Voting Question will be:

“Based on the totality of scientific evidence available, do the benefits of the Pfizer BioNTech COVID-19 Vaccine when administered as a 2-dose series (10 µg each dose, 3 weeks apart) outweigh its risks for use in children 5-11 years of age.” Please vote yes or no.

This is about extending the EUA for the Pfizer vaccine for this age group. It would be administered as a 2-dose vaccine, 10 micrograms each, 3 weeks apart. COVID-19 causes substantial morbidity and mortality in this age group.

Unlike the other recent FDA presentations I’ve seen, today there was a reminder that, in view of the polarized opinions pro and con about this question, all participants should do their best to observe the utmost civility at all times during the proceedings.

Dr. Fiona Havers presented the epidemiology of COVID-19 in this age group. It showed increasing infections and severe disease and hospitalization rates, which were higher among African American and other minority children than among white. Secondary transmission can and does occur among children and adults. See the slides.

Dr. Matthew Oster’s presentation on mRNA vaccine associated myocarditis showed that myocarditis is a rare but important adverse event following COVID-19 vaccination. See the slides.

Break.

The Pfizer presentation highlighted safety and efficacy data for the vaccine. See Dr. Gruber’s briefing document and slides. The FDA presentation by Dr. Leslie Ball, MD, summarized the immunogenicity and safety data (see summary slides 34 and 35). The supplemental descriptive efficacy analysis showed 90.7% vaccine effectiveness against symptomatic COVID-19 after the second dose. There were no cases of myocarditis/pericarditis after the data cutoff time.

FDA presenter Dr. Hong Yang, PhD presented the Benefit-Risk Analysis. Slide 22 summary:

“• For Scenarios 1 (Base), 2 (Recent COVID-19 Peak Incidence), 4 (Higher Vaccine Efficacy), 5 (Higher COVID-19 Death Rate), and 6 (Lower Excess Myocarditis Rate) the model predicts that benefits of the Pfizer-BioNTech COVID-19 Vaccine 2-dose primary series clearly outweigh the risks for ages 5-11 years.

• For Scenario 3 (The Lowest COVID-19 Incidence), the model predicts more excess hospitalizations and ICU stays due to vaccine-related myocarditis/pericarditis compared to prevented hospitalizations and ICU stays due to COVID-19 in males and in both sexes combined.

• Considering the different implications and length of stay for COVID-19 hospitalization versus hospitalization for vaccine-associated myocarditis/pericarditis, and benefits related to prevention of cases of COVID-19 with significant morbidity, the overall benefits of the vaccine may still outweigh the risks under this lowest incidence scenario.

• If the myocarditis/pericarditis risk in this age group is lower than the conservative assumption used in the model, the benefit-risk balance would be even more favorable.”

“Major Limitations of the Benefit/Risk Model:

• Model assumption about constant incidence rate generates great uncertainty on the estimate of benefits.

• Vaccine efficacy may change due to new emerging variants of virus

• Hospitalizations and ICU stays from COVID-19 and myocarditis are not equivalent and cannot directly compared

• The benefit of reducing COVID related multisystem inflammatory syndrome in children may not be fully captured by preventable hospitalizations, ICU stays and deaths due to COVID-19

• This BR risk assessment does not consider potential long-term adverse effects due to either COVID-19 or myocarditis

• This BR assessment does not include secondary benefits (reducing COVID-19 disease transmission) and risks”

Break.

There were complicated questions about the applicability of the Benefit/Risk model assumptions, partly because it can be influenced by a low incidence of disease-readily acknowledged by the presenter, Dr. Yang. After extensive discussion, including the about the number of doses (One or Two?), concern for the difficult decisions this presents to parents (not just related to side effects), concern about the FDA approval being interpreted as a mandate, discomfort with the binary choice-type question.

A representative from the CDC Advisory Committee (ACIP) expressed that it seems the benefits outweigh the risks. The ACIP representative summarized the safety monitoring and reporting systems available, including but not limited to Vaccine Adverse Effects Reporting System (VAERS). The FDA can make a broad authorization; the ACIP (which may meet on this issue as soon as next week) can make implementation recommendations that could be more restrictive but could not be broader. University of Iowa representative, coronavirus expert with over 40 years’ experience and temporary voting member Dr. Stanley Perlman, indicated, in light of the thorough discussion, that he would vote in favor of the question.

“Based on the totality of scientific evidence available, do the benefits of the Pfizer BioNTech COVID-19 Vaccine when administered as a 2-dose series (10 µg each dose, 3 weeks apart) outweigh its risks for use in children 5-11 years of age.” Please vote yes or no.

The Vote: The votes were 94% (17) Yes, and there was one abstention, out of 18 votes.

The meeting was formally adjourned at 4:35 PM, ET.

FDA Advisory Committee Reminder: Meeting October 26, 2021 to Discuss COVID-19 Vaccine for Children Ages 5-11

This is just a reminder of the FDA Advisory Committee meeting scheduled for tomorrow, October 26, 2021, 8:30 AM-5:00 PM, ET, to discuss the Pfizer COVID-19 vaccine for children, ages 5-11. Some documents are available to preview, including the FDA briefing document. Section 8 is the Benefit-Risk Assessment summary, beginning on page 32.

FDA Advisory Committee to Discuss Pfizer COVID-19 Vaccine for Children 5 Through 11 Years of Age

On October 26, 2021 the FDA Vaccines and Related Biological Products Advisory Committee will meet to discuss the extension of the Pfizer EUA for the COVID-19 vaccine for children 5 through 11 years of age. Some event materials are already available. The meeting is scheduled for at 8:30 AM-5:00 PM, ET.

FDA Advisory Committee Meetings on COVID-19 Vaccine EUA Amendments for Moderna, J&J Boosters and Heterologous Boosters, Pfizer Vaccine for Children

The FDA Advisory Committee will hold a meeting October 14-15 to discuss amendments to the Emergency Use Authorization (EUA) for Moderna and J&J COVID-19 boosters as well as heterologous boosting (mix and match). New data is available, including NIH preliminary results on the mix and match study.

The FDA also announced a meeting to discuss Pfizer COVID-19 vaccine for children age 5-11, which is scheduled for October 26, 2021.

Links to the livestream meetings details are in the press announcement (link above).

Meeting materials are posted here.

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