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.
Go Retire Psychiatrist 