Pfizer asks FDA to authorize COVID booster for children 5 to 11
Pfizer and BioNTech asked the Food and Drug Administration (FDA) on Tuesday to authorize a COVID vaccine booster dose for children ages 5 through 11.
Why it matters: If approved, it would be the first booster accessible to children of this age group, who have been hit hard in recent months. Infections rose most sharply among children and adolescents during the Omicron surge, according to the Centers for Disease Control and Prevention.
Details: Data from a clinical trial showed that children ages 5 through 11 who received a booster about six months after their second Pfizer shot developed a "strong immune response," according to the company.
- Boosters are currently only authorized for people who are 12 and older in the U.S.
- The FDA authorized Pfizer's two-shot vaccine for kids ages 5 through 11 in October.
Worth noting: Pfizer said it plans to also submit the data to the European Medicines Agency and other global regulatory agencies for authorization in the coming weeks.
The big picture: The FDA said Monday it had expanded approval of the COVID-19 treatment Veklury, also known as remdesivir, for children 28 days and older in an effort to boost protections for young kids.
- A majority of Americans, including three in four children, have had COVID-19 as a result of the Omicron surge this past winter.