FDA Issues EUA for COVID-19 Vaccine for Children

In a long-awaited move, the FDA approved a pediatric dose of Pfizer/BioNTech's COVID-19 vaccine for children aged 5 to 11 years.

The FDA announced Friday that it is issuing an emergency use authorization (EUA) for the COVID-19 vaccine from Pfizer and BioNTech for children 5 and older, saying that the benefits "outweigh the known and potential risks."

Earlier this week, a committee of outside experts voted in favor of making the vaccine available after reviewing the data.

As with the adult vaccine, the pediatric vaccine is administered as a 2-dose primary series, 3 weeks apart, but at a lower dose—10 mcg—compared with the 30 mcg given to those 12 years and older.

US COVID-19 cases in children aged 5 to 11 make up 39% of cases in individuals younger than 18 years. According to the CDC, approximately 8300 COVID-19 cases in children aged 5 through 11 resulted in hospitalization. As of October 17, 691 deaths from COVID-19 have been reported in children younger than 18, with 146 of those deaths happening in children aged between 5 and 11 years.

The CDC will meet Tuesday to decide on recommendations about how the shot should be administered. Reuters reported that deliveries of the vaccine will begin this weekend.

In a statement, the American Academy of Pediatrics (AAP) applauded the move. “More than 6 million children have been infected with this virus since the beginning of the pandemic, and children have suffered in numerous other ways. This includes disruptions to their education, harms to their mental and emotional health, and greatly diminished access to critical medical services," said Lee Savio Beers, MD, FAAP, president of the AAP. “Authorization of the vaccine for younger children is an important step in keeping them healthy and providing their families with peace of mind. The vaccine will make it safe for children to visit friends and family members, celebrate holiday gatherings, and to resume the normal childhood activities that they’ve missed during the pandemic."