U.S. Pfizer and its German partner BioNTech have applied to the European Medicines Agency (EMA) for the authorization of the BNT162b2 vaccine candidate, according to press release. If approved, the authorization will enable the use of the vaccine in Europe this month.
- EMA will complete reviews of Pfizer and BioNTech vaccine candidate by December 29 and January 12
- EMA grants conditional marketing authorization for medicines that address unmet medical needs of patients based on less comprehensive data than normally required
- Pfizer has also initiated rolling submissions worldwide, including Australia, Canada, and Japan, and targets other regulatory agencies worldwide.
- Two weeks ago, Pfizer and BioNTech announced from a late-stage clinical trial that its coronavirus vaccine is 95% effective in preventing COVID-19 vaccine
- The vaccine, BNT162b2, is highly effective against coronavirus 28 days after the first dose, and effectiveness was consistent across all ages, races, and ethnicities.
- Pfizer and BioNTech also applied for emergency use authorization from the U.S. Food and Drug Administration on November 20.
Pfizer stock is gaining as BioNTech losses. PFE: NYSE is up 2.04% on premarket, BNTX: NASDAQ is down 1.00% on premarket
