FDA Advisers Recommend Pfizer COVID-19 Vaccine For Kids Under 12

A U.S. Food and Drug Administration panel of advisers on Tuesday recommended a lower dose of the Pfizer-BioNTech COVID-19 vaccine for children ages 5 to 11 as infections among kids remain high.

During the discussion, members of the FDA’s Vaccine and Related Biological Products Advisory Committee agreed that the benefits of preventing COVID-19 infections among children outweighed the risks of side effects in the 5 to 11 age group.

“The overall analysis predicted that the numbers of clinically significant COVID-19-related outcomes prevented would clearly outweigh the numbers of vaccine-associated excess myocarditis cases,” the committee wrote in a briefing document posted on the FDA website.

The Pfizer-BioNTech and Moderna vaccines, both of which use mRNA technology, have been linked to myocarditis among young adults, especially in young men. Myocarditis is a rare condition that involves the inflammation of the heart muscle.

The panel of advisers voted 17-0 with one abstention to recommend the vaccine shot for emergency use authorization in children younger than 12. The endorsement will now be considered by the FDA, which is expected to issue a final decision within the next few days.

The committee’s recommendations are not binding, but the FDA usually follows the panel’s advice. If the FDA rules in favor of granting authorization, the Advisory Committee on Immunization Practices (ACIP) for the Centers for Disease Control and Prevention will make a recommendation. That panel is scheduled to meet on Nov. 2.

The CDC will take into consideration the ACIP’s recommendation, which is also not binding. Dr. Rochelle Walensky, the CDC director, will then issue the agency’s guidance which states health care institutions and professionals may begin administering COVID-19 vaccine shots to children ages 5 to 11.

The Biden administration has signaled it is ready to distribute the doses as soon as the shots receive emergency use authorization from the FDA and CDC. The government said it has enough shots to vaccinate 28 million children in that age group across the U.S, according to CNBC.

As of Oct. 21, nearly 6.3 million children across the U.S. have been diagnosed with COVID-19. Of the total number of infections, nearly 118,000 cases were added over the past week alone. While the figures are lower than the record 252,000 child cases added the week of Sept. 2, the numbers still remain extremely high, according to the American Academy of Pediatrics.