WASHINGTON — Pfizer said it plans to request emergency authorization of its COVID-19 vaccine next month, though that’s if everything goes well.
The request will be made through the Food and Drug Administration.
Pfizer’s CEO, Albert Bourla, repeatedly pointed to the possibility of a vaccine in October. The company now says November is the company’s best estimate, though it could change again. The vaccine must still be proven safe.
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To qualify for an “emergency use authorization,” a COVID-19 vaccine must track at least half the participants in large-scale studies for two months after their second dose.
Bourla estimates Pfizer’s study with 44,000 participants will reach that milestone in the third week of November.
“I’m still pretty guardedly optimistic that by the end of the year, we’ll have one or more vaccines that are safe and effective and we can start distributing it but even that is not a guarantee,” Dr. Francis Collins, National Institutes of Health director, said.
Pfizer developed its vaccine candidate with German partner, BioNTech. The vaccine is among four candidates in late-stage clinical trials in the US right now.
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