Pfizer said Friday it's submitting its application to the Food and Drug Administration for emergency use authorization of its COVID-19 vaccine. If the FDA and its independent scientific advisers decide the vaccine is safe and effective after a public meeting in early December, the first shots could go out to groups of Americans, apportioned according to criteria to be determined by a separate government advisory group. Pfizer said that it may have 25 million doses of vaccine ready in December, 30 million more in January, and another 35 million doses in February and March. People will need two doses of the vaccine.
Pfizer and its German partner BioNTech announced earlier this week that its vaccine had proved safe and 95 percent effective in its large, ongoing human trial. The FDA and its advisory board will conduct their own analysis of Pfizer's data, and emergency use authorization means the FDA will continue to monitor the vaccine. Pfizer said it has also started applications for approval in Britain and Europe. Moderna, whose vaccine also showed 95 percent efficacy in human trials, is expected to submit its FDA emergency use application in the next week or two.
"Help is on the way," Dr. Anthony Fauci, the top U.S. infectious disease expert, said Thursday, adding that in the meantime, "we need to actually double down on the public health measures as we're waiting for that help to come." If the vaccines win approval and can be efficiently distributed to Americans willing to be inoculated, the pandemic could be effectively under control by mid-spring or summer.
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