The U.S. Food and Drug Administration (FDA) today authorized a booster dose of the Pfizer-BioNTech COVID-19 vaccine for children ages 5 to 11, without convening its vaccine advisory panel of independent experts to discuss Pfizer’s data on 5- to 11-year-olds — and based on a study subset of only 67 children, CNBC reported.
The FDA granted Emergency Use Authorization (EUA) for the boosters despite data showing higher infection rates among fully vaccinated children in the 5 to 11 age group compared to unvaccinated children, no studies testing the efficacy of the vaccine against the current dominant BA.2 COVID-19 variant and two new studies showing that for vaccinated people who get Omicron, the infection provides better protection against future infections than a second booster dose.
The vaccine advisory panel for the Centers for Disease Control and Prevention (CDC) is scheduled to meet Thursday. The agency and its director, Dr. Rochelle Walensky, are expected to sign off on the boosters, The Washington Post reported.
Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said data increasingly show protection provided by two shots wanes over time, but the agency determined a third shot could help boost protection for children in the 5 to 11 age group and the “benefits outweigh the risks.”
The FDA authorized the third shot after analyzing data from an ongoing Pfizer clinical trial in which a small subset of only 67 children in the age group had higher antibody levels one month after receiving a booster dose.
As The Defender reported, antibody levels alone are not indicative of immune protection. When it comes to COVID-19, T cell and natural killer cell responses are the crucial part of immune protection.
Pfizer has not published its actual data, precluding experts from conducting this analysis.