CDC Adopts Recommendation for COVID-19 Vaccine in Pediatric Population

Update 6:21pm EDT: The United States Centers for Disease Control and Prevention’s (CDC) Director Rochelle Walensky has officially adopted the panel's recommendation to allow for the Pfizer-BioNTech COVID-19 vaccine to be administered in children as young as 12 years old.

"CDC now recommends that this vaccine be used among this population, and providers may begin vaccinating them right away.

Though most children with COVID-19 have mild or no symptoms, some children can get severely ill and require hospitalization. There have also been rare, tragic cases of children dying from COVID-19 and its effects, including multisystem inflammatory syndrome in children, or MIS-C," Walensky said in a statement.

The CDC Advisory Committee on Immunization Practices (ACIP) voted to recommend the Pfizer-BioNTech vaccine after meeting today. The panel vote was 14 in favor with one recusal to allow the vaccine to be used in this pediatric group.

After the vote to recommend, the CDC Director will make the final determination, which could happen this afternoon.

Earlier this week, the Food and Drug Administration (FDA) expanded the Emergency Use Authorization (EUA) for the Pfizer-BioNTech vaccine allowing administration of it in children aged 12-15 years old.

“Today’s action allows for a younger population to be protected from COVID-19, bringing us closer to returning to a sense of normalcy and to ending the pandemic,” acting FDA commissioner Janet Woodcock, MD, said in a statement at the time of the decision. “Parents and guardians can rest assured that the agency undertook a rigorous and thorough review of all available data, as we have with all of our COVID-19 vaccine emergency use authorizations.”

At the end of March, Pfizer reported topline data in a phase 3 trial in the United States that included 2260 participants aged 12-15 years old. The participants were broken up into two cohorts with one of them administered a two-dose vaccine (n = 1131) or were given a placebo (n = 1129) for the prevention of COVID-19.

Results demonstrated no one in the vaccine cohort had the virus and 18 cases of COVID-19 were confirmed in the cohort that was administered placebo.

This data in this smaller trial was the basis for Pfizer-BioNTech to apply for the EUA.