The U.S. Food and Drug Administration (FDA) granted emergency use authorization on Oct. 29 for children aged 5–11 years to receive the Pfizer-BioNTech coronavirus vaccine. Nearly 2 million children in this age group have been infected, federal health officials report, with at least 146 related deaths.
Regulators cleared them for vaccination based on clinical trial data showing that a reduced dose was 91 percent effective in preventing COVID-19 disease in this population. The agency was particularly focused on safety, because the vaccine has been tied to rare cases of heart inflammation problems in teen boys and young men. No serious adverse events were observed, however, among the estimated 3,100 children in the study who received the vaccine.
“Vaccinating younger children against COVID-19 will bring us closer to returning to a sense of normalcy,” FDA Acting Commissioner Janet Woodcock said in a statement. “Our comprehensive and rigorous evaluation of the data pertaining to the vaccine’s safety and effectiveness should help assure parents and guardians that this vaccine meets our high standards.”
Still, given the lingering concern over unknown safety risks, a Kaiser Family Foundation poll finds that only about 27 percent of parents intend to get their young children vaccinated immediately.