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Pfizer CEO says vaccine has reached a key safety milestone

November 17, 2020. Summarized by summa-bot.

Pfizer has accumulated enough safety data on its Covid-19 vaccine and is preparing to file for emergency use authorization from the US Food and Drug Administration, company CEO Albert Bourla said Tuesday.

(CNN)Pfizer has accumulated enough safety data on its Covid-19 vaccine and is preparing to file for emergency use authorization from the US Food and Drug Administration, company CEO Albert Bourla said Tuesday.

Last week, the company released early clinical trial data showing its vaccine is more than 90% effective, and said it was waiting to apply to the FDA until it had gathered sufficient data on the safety of the vaccine.

The FDA has scheduled a meeting of its Vaccines and Related Biological Products Advisory Committee, a group of outside experts, for December 8, 9 and 10, a source familiar with the process told CNN Tuesday.

The agency could make a decision at the end of the meeting on December 10 about whether to issue emergency use authorizations for the vaccines, the source said.

"It will make sense that in all likelihood the FDA will consider both applications together," the source said, considering that both vaccines use the same technology and appear to have very similar safety and efficacy results from their large-scale Phase 3 clinical trials.

If the FDA authorizes the vaccines, they can then be immediately distributed to states, according to a presentation made last month at the US Centers for Disease Control and Prevention.

However, no one can be vaccinated until a CDC advisory committee reviews the data, recommends the vaccine, and says which groups will receive it first.

If the FDA authorizes the vaccines, the CDC's Advisory Committee on Immunization Practices, an independent panel of experts, will meet within 24 to 48 hours, according to a CDC spokesperson.

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