Regulatory Quick Takes: FDA authorizes Pfizer-BioNTech booster for ages 12-15

Children aged 12-15 years can now be boostered with Comirnaty vaccine from Pfizer Inc. (NYSE:PFE) and BioNTech SE (NASDAQ:BNTX) five months after completion of the primary vaccination series, following FDA’s expansion of its EUA. The agency also authorized a third dose of Comirnaty for children aged 5-11 years who are immunocompromised, and updated the booster interval for people 12 years and older from six to five months.

On the last day of 2021, Novavax Inc. (NASDAQ:NVAX) completed the submission of its data to FDA ahead of its planned formal request for an emergency use authorization of its protein-based COVID-19 vaccine NVX-CoV2373. The company plans to enter that request late January. On Dec. 28, Novavax and partner Serum Institute of India Pvt. Ltd. said India’s drug regulator granted an EUA for the vaccine under the name Covovax...