The FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted unanimously with one abstention to recommend the authorization of the Pfizer-BioNTech SARS-CoV-2 vaccine for children ages 5 to 11 years. Last week, the FDA posted Pfizer-BioNTech’s briefing on the vaccine for this age group, which suggested a 2-dose series of 10μg shots delivered 3 weeks apart—one-third of the adult dose—was 91% effective in preventing symptomatic disease among this younger age group, with low incidence of adverse events. The companies said no cases of heart inflammation were reported in 3-months follow-up after the second shot, although the study population was small. In its own briefing, the FDA said the benefits of the Pfizer-BioNTech vaccine among children ages 5 to 11 clearly outweigh the risks of potential side effects. After the FDA issues a final decision—which usually follows the recommendations of its advisors—the CDC Advisory Committee on Immunization Practices will make recommendations at its next meeting, scheduled for November 2-3. Following the approval of those recommendations by CDC Director Dr. Rochelle Walensky, children ages 5 to 11 could become eligible for SARS-CoV-2 vaccination by November 3-4.
CSSE is reporting 45,603,811 positive cases in the U.S. and 738,677 deaths. DOH reported for the week ending October 21, 3,635,126 confirmed cases in Florida with 58,803 deaths.