Europe’s drug regulator says there is an extra dose in BioNTech/Pfizer’s COVID-19 vaccine vials
The European Medicines Agency said Friday that the product information for BioNTech SE
BNTX,
and Pfizer Inc.’s
PFE,
COVID-19 vaccine should be updated to say there are six doses in each vial. The authorization granted to the vaccine, which is referred to as Comirnaty in Europe, on Dec. 21 in the European Union says there are five doses in each vial. The EMA, which is the E.U.’s drugs regulator, said health care providers should use low dead-volume syringes or needles to extract what it says is an extra dose. The European Commission must next endorse the EMA’s recommendation for it to move forward into clinical practice. Since the first COVID-19 vaccines have been authorized in the E.U., the United Kingdom, and the U.S., government health officials in some regions have suggested changes to the vaccines’ dosing schedules in order to speed up the number of first doses administered to their populations as the virus continues to spread. This includes spacing out the time between the first and second doses, and a proposal in the U.S. to give half-doses of Moderna Inc.’s
MRNA,
COVID-19 vaccine to adults younger than 55 years old. Over the last year, shares of BioNTEch have soared 107.7%, while Pfizer’s stock has gained 0.1%. The S&P 500
SPX,
is up 17.5%.
