Pfizer Inc. and BioNTech SE May 17th announced the U.S. Food and Drug Administration (FDA) expanded emergency use authorization (EUA) to include a booster dose after completion of the primary series of the Pfizer-BioNTech COVID-19 Vaccine in children 5 through 11 years of age.
The booster dose is given at least five months after the second dose of the two-dose primary series and is the same 10-µg dose of the Pfizer-BioNTech COVID-19 Vaccine. To date, more than 8 million 5- to 11-year-olds in the U.S. have completed a primary series, the company states.
Pfizer stock rose 0.6% in mid-afternoon trading on Tuesday and BioNTech SE (NASDAQ:BNTX) shares rose 5.5%. Shares of their rival in mRNA vaccines against Covid, Moderna Inc (NASDAQ:MRNA), jumped 3.7%.
The FDA said that the data show the protection provided by two shots fades with time and that a third shot can shore up protection for children. It added that the benefits outweigh the risks.
Still, parents seem to be holding off on vaccinating this school-aged group. Less than 30% of children 5 to 11 have gotten their primary two doses as of April, according to the Centers for Disease Control and Prevention, which is expected to meet Thursday to sign off on the boosters as well.
The advisory committee on vaccines for the FDA plans to meet in June to review requests from Pfizer and Moderna to approve the Covid vaccines for children under age 5.