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# Pfizer/BioNTech Filing Covid Vaccine EUA in Days
- URL: https://www.fdaweb.com/pfizer-biontech-filing-covid-vaccine-eua-in-days/
- Published: 2020-11-18T12:00:00.000Z
- Updated: 2026-09-14T16:36:58.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5148110

Pfizer and BioNTech say they are planning to submit within days an Emergency Use Authorization request for their Covid-19 vaccine candidate BNT162b2 after a final analysis showed a vaccine efficacy rate of 95%, which was a significant improvement from the 90% reported in a preliminary analysis last week ([see earlier story](https://www.fdaweb.com/pfizer-biontech-covid-vaccine-90-effective-vaccine-early-data/)). The latest analysis is based on 170 Covid cases, of which 162 were observed in the placebo group versus eight in the vaccine group. The companies say the data demonstrate that the vaccine was well tolerated across all populations in the 43,000-participant trial. Additionally, there were no serious safety concerns observed, with the only Grade 3 adverse events greater than 2% in frequency being fatigue (3.8%) and headache (2.0%).

Pfizer also says that based on current projections, the companies expect to produce globally up to 50 million vaccine doses in 2020 and up to 1.3 billion doses by the end of 2021\. Four of Pfizer’s facilities are part of the manufacturing and supply chain — St. Louis, MO, Andover, MA, Kalamazoo, MI and Puurs, Belgium. BioNTech’s German sites will also be leveraged for global supply, it says.