Pfizer plans to submit its COVID-19 vaccine for FDA authorization in late November — if human trials show it works

Pfizer plans to submit its COVID-19 vaccine for FDA authorization in late November — if human trials show it works
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  • Pfizer and its German partner BioNTech could apply for emergency-use authorization for their COVID-19 vaccine in late November, Pfizer said Friday.
  • The companies would submit their application to the Food and Drug Administration in the third week of November if late-stage human trials go well, Pfizer said.
  • This is the most concrete time frame a leading vaccine developer in the West has given for an emergency-use-authorization application.
  • Pfizer's announcement indicates there is no chance its vaccine will be authorized for use before the US election wraps up on November 3.

Pfizer said on Friday that it would most likely submit its COVID-19 vaccine to the Food and Drug Administration for emergency approval in late November — provided late-stage human trials show the vaccine works.

This is the most concrete time frame a leading vaccine developer in the West has given for an emergency-use-authorization application.

Pfizer and its German partner BioNTech expect to submit the application in the third week of November, it said in a statement, provided the results of its late-stage human trials are positive.
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This indicates there is no chance the vaccine will be authorized for use before the US election wraps up on November 3.

Pfizer said it expected to know whether the vaccine was effective by the end of October. FDA rules, however, require companies to provide two months of safety data following the final dose of a vaccine. This data would not be ready until late November, it said.

It didn't say when it might apply for similar authorization in other countries.
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"To ensure public trust and clear up a great deal of confusion, I believe it is essential for the public to understand our estimated timelines," Pfizer's CEO Albert Bourla said.

3 sets of data

To be approved, Pfizer needs to provide the FDA data on the vaccine's efficiency, safety, and ability to be manufactured on a large scale at a high standard. Effectiveness trials monitor whether it protects the majority of vaccinated people from COVID-19. These results could be available by the end of October, Pfizer said, when it would be reviewed by independent scientists.
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Data on both the safety and the manufacturing would be available in the third week of November, it said.

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