The US Food and Drug Administration is preparing to authorize Pfizer and German partner BioNTech’s COVID-19 vaccine for adolescents aged between 12 and 15 years by early next week, the New York Times reported on Monday, citing federal officials familiar with the agency’s plans.
An approval is highly anticipated after the drugmakers said in March that the vaccine was found to be safe, effective and produced robust antibody responses in 12- to 15-year-olds in a clinical trial.
Responding to a Reuters request for comment, the FDA said its review of expanding the vaccine’s emergency use authorization is ongoing, but did not provide further details.
The vaccine has already been cleared in the United States for people aged 16 and above.
Pfizer declined to comment on the NYT report.
About Pfizer vaccine
The Pfizer BioNTech COVID-19 vaccine is a messenger RNA (mRNA) vaccine that has both synthetic, or chemically produced, components and enzymatically produced components from naturally occurring substances such as proteins. The vaccine does not contain any live virus.
Its inactive ingredients include potassium chloride, monobasic potassium, phosphate, sodium chloride, dibasic sodium phosphate dihydrate, and sucrose, as well as small amounts of other ingredients
