Pfizer plans to submit its COVID-19 vaccine for FDA approval in late November
- Pfizer and its German partner BioNTech could apply for emergency-use authorization for their COVID-19 vaccine in late November, Pfizer said on Friday.
- The companies would submit their application to the FDA in the third week of November if late-stage human trials go well, Pfizer said.
- This is the first time a leading vaccine developer in the West has given a specific timeline for an emergency use authorization application.
- Pfizer's announcement means there is no chance its vaccine will be authorized for use before the election on November 3.
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Pfizer said on Friday that it would likely submit its COVID-19 vaccine to the Food and Drug Administration (FDA) for emergency approval in late November.
This is the first time a leading vaccine developer in the West has given a specific timeline for an emergency use authorization application.
Pfizer and its German partner BioNTech would submit its application in the third week of November, it said in a statement, provided the results of its late-stage human trials were positive.
This means there is no chance the vaccine will be authorized for use before the election on November 3.
Pfizer expected to know whether the vaccine is effective by the end of October, it said. However, FDA rules require companies to provide two months of safety data following the final dose of a vaccine. This data would only be ready in late November, it said.
It didn't state when it would apply for similar authorization in other countries.
"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.
Three 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.
Approval of the drug's safety is dependent on the company monitoring data from thousands of patients for two months after they receive the final vaccine. This data should be available by the third week of November, it said.
Data on manufacturing would also be available in the third week of November, it said.
Get the latest Pfizer stock price here.
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