COVID-19 vaccine: Pfizer to seek FDA authorization late November - Business Insider

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

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. "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.

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.

 

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Great news for Pfizer,and hopefully for all of us

Great news! 👏👍🙏

wow

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