FDA plans to decide on full formal approval of Pfizer's COVID-19 shot by January

July 16 (Reuters) - The U.S. health regulator will review Pfizer (PFE.N) and German partner BioNTech SE's (22UAy.DE) application for full approval of their COVID-19 vaccine in people 16 years and older by January, the companies said on Friday.

The target action date does not mean the approval will not happen before January, the U.S. Food and Drug Administration's Acting Commissioner Janet Woodcock said on Twitter. (https://bit.ly/36Ixfkm)

"Quite to the contrary, the review of this BLA (biologics license application) has been ongoing, is among the highest priorities of the agency, and the agency intends to complete the review far in advance of the PDUFA Goal Date."

The vaccine is among the three being used in the United States under the FDA's emergency use authorization, alongside shots from Johnson & Johnson (JNJ.N) and Moderna Inc (MRNA.O).

If approved, it would be the first shot to get the agency's full approval based on longer-term data on safety and effectiveness, potentially helping ease vaccine hesitancy as the country witnesses new outbreaks in some parts, mainly due to the highly infectious Delta coronavirus variant. read more   ...