FDA Says Pfizer Vaccine ‘Meets Success Criteria,’ Vaccines Could Be Out by Weekend

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The Food and Drug Administration said Monday that a Covid-19 vaccine developed by Pfizer and its German partner, BioNTech, met “prescribed success criteria” for public distribution.

An assessment published by agency staff noted the the vaccine was effective in 52 percent of cases after a first dose had been administered, with 94.8 percent efficacy seven days after a second dose had been administered. Pfizer recommends taking the second dose within three weeks of the first.

Study participants did report some side effects. More than half of volunteers aged 16-55 said they developed fatigue after taking the vaccine, with half reporting headaches and more than a third developing chills or muscle pain.

Health and Human Services Secretary Alex Azar said in a Sunday interview with ABC News that the FDA could approve the vaccine “within days” if Thursday’s panel approves it for distribution. “But it’s going to go according to FDA’s gold-standard process, and I’m going to make sure it does,” he added.

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