AIM Members –
Today, The FDA VRBPAC committee voted 17 YES – 1 ABSTAIN to recommend authorization of the Pfizer BioNTech 10ug COVID-19 for children 5-11 years under Emergency Use Authorization: “Based on the totality of scientific evidence available, 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 through 11 years of age.” Overall, the committee felt that voting to recommend authorization broadly is essential to increase vaccine access. The committee deferred to ACIP to create more nuanced recommendations if needed.
Please see FULL VRBPAC NOTES PFIZER 5-11 for more detailed notes and summary.
Safety and Efficacy: The committee reviewed safety, efficacy, and benefit-risk data from the CDC, Pfizer and FDA. The Pfizer pediatric 5-11 vaccine was determined to be 90.7% effective against symptomatic COVID disease and according to the FDA review of Pfizer data, there were no reports of myocarditis/pericarditis, anaphylaxis, or deaths. Common mild reactions were less common in the 5-11 cohort compared to the 16-25 cohort.
The committee brought up a number of safety concerns related to myocarditis and pericarditis. There were concerns that cases of mild myocarditis and pericarditis are underestimated and fail to be reported. Data is limited for children in this age group with mild myocardial infarctions, and voting members felt that further surveillance of myocarditis/pericarditis is needed. However, many members noted that myocarditis related to MIS-C from COVID infection leads to much higher rates of myocarditis than an mRNA vaccines.
Benefit Risk: The committee was presented a benefit risk analysis that included five scenarios, which included assumed waning vaccine effectiveness over time, another potential spike in COVID-19, and high sustained VE against hospitalization/death. Overall, the committee felt that the benefits outweigh risks when voting to recommend authorization. The committee brought up a number of concerns, including the unpredictable course of the pandemic, limitations in assumptions of sustained immunity, and lack of consideration to asymptomatic infection in the analysis.
Final Committee Discussion: The committee had robust discussion on the implementation, equity, and safety of the 5-11 Pfizer COVID vaccines, and some members expressed reservations on widespread use/implementation for the entirety of the 5-11 cohort. Some voting members felt that due to overall low rates of deaths/hospitalization and natural immunity levels, children 5-11 may not need a COVID-19 vaccine. Others felt strongly that if/when this vaccine is authorized under EUA, it should not be mandated in schools, etc. due to limited safety data and short follow-up time in phase 2 and 3 clinical trials.
However, the majority of voting members (as well as Peter Marks) noted that approving this vaccine is essential to prevent any deaths and to increase equity. Failing to approve this vaccine under EUA deprives parents the choice to vaccinate their children, and will deny this vaccine to children who may need protection from COVID disease in one way or another.
ACIP will meet on November 2nd and 3rd to discuss and vote on recommendations for the Pfizer COVID vaccine for the 5-11 cohort.