Aug. 23 Quick Takes: Pfizer, BioNTech look ahead to pediatric data after FDA approval of Comirnaty
Approval for COVID-19 vaccines from Zydus Cadila, Medigen-Dynavax; plus Sabatini fired, Clover’s U.S. beachhead and more
Pfizer Inc. (NYSE:PFE) and partner BioNTech SE (NASDAQ:BNTX) are now looking ahead to reporting the first pediatric data in children younger than 12 years of age after FDA approved a BLA for COVID-19 vaccine Comirnaty in individuals 16 and older. First data from a Phase I/II/III trial in healthy children six months to 11 years old is expected this quarter and next quarter. The partners also plan to submit an sBLA for a third booster dose, although the timeline for the plans were not disclosed.
Adolescents in India aged 12-18 years will now be able to receive a COVID-19 vaccine after the Drug Controller General of India granted emergency use authorization to ZyCoV-D from Zydus Cadila Group (NSE:CADILAHC; BSE:532321). The company said the intradermal vaccine, given in three doses via a needle-free applicator, is the first plasmid DNA vaccine for COVID-19 in the world. Zydus also plans to see authorization of a two-dose vaccine...