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The US Food and Drug Administration (FDA) committee voted on whether the emergency use authorization should be extended to children aged 5 to 11 years.
Following a day of presentations and discussions, the Vaccines and Related Biological Products Advisory Committee held a general discussion on the voting question “based on the totality of scientific evidence, do the benefits of Pfizer/BioNTech 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?”
One of the major concerns discussed by the voting members was the risk of myocarditis, which has been seen in the populations who are already eligible to receive the vaccine. Peter W. Marks, MD, PhD, Director of the Center for Biologics and Research for the US Food and Drug Administration (FDA), and Captain Amanda Cohn, MD, chief medical officer for National Center for Immunizations and Respiratory Diseases at the Centers for Disease Control and Prevention (CDC) discussed how the overlapping safety monitoring programs that the FDA and the CDC would be able to rapidly track serious adverse events.
The impact of the vaccine on education was discussed, with many members stating that the expansion could lead to less interruption. Furthermore, COVID-19 is likely here to stay and a number of mitigation strategies are likely not sustainable for a long period.
During the discussion, the committee was overwhelmingly in favor of the vaccine being made available to children with co-morbidities in the age group. For children who are otherwise healthy, many stated that they would be happy to provide the option to parents, but hoped that mandates would not follow. In light of the caveats of committee members, Captain Cohn stated that the Advisory Committee on Immunization Practices could limit their recommendation for the vaccine if it was deemed necessary.
Following the discussion, the committee voted with 17 members voting yes and 1 member abstaining from the vote.