Research & Development
US FDA likely to authorise Pfizer/BioNTech's COVID-19 vaccine for ages 12 to 15 early next week
4 May 2021 -

The US Food and Drug Administration (FDA) is preparing to authorise a COVID-19 vaccine for adolescents aged between 12 and 15 years made by US pharmaceutical company Pfizer Inc (NYSE:PFE) and its partner German biotechnology company BioNTech SE (Nasdaq:BNTX), by early next week, the New York Times reported on Monday, citing federal officials familiar with the agency's plans.

According to Reuters news agency, an approval is highly anticipated after the companies said in March 2021 that the vaccine was found to be safe, effective and produced robust antibody responses in 12 to 15-year-olds in a clinical trial.

In the event an approval for 12-15 year olds is granted, the CDC's vaccine advisory panel will likely meet the following day to review the clinical trial data and make recommendations for the vaccine's use in adolescents, the New York Times report added.

Responding to a Reuters request for comment, the FDA said its review of expanding the vaccine's emergency use authorisation is ongoing, but did not provide further details.

Currently, the vaccine has already been cleared in the United States for people aged 16 and above.

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