FDA scientists to report Pfizer vaccine safe and effective, confirming early results



(NEW YORK) — Scientists from the Food and Drug Administration on Tuesday appeared set to confirm that Pfizer’s COVID-19 vaccine is safe and effective against the virus, according to documents released ahead of a crucial meeting on the vaccine this week.According to a document prepared by FDA staff, government scientists plan to tell the advisory committee that the data is adequate to determine the vaccine is both safe and effective.While that doesn’t mean the FDA is prepared to authorize it just yet, the briefing materials suggest agency staff aren’t warning of any last-minute issues.”Safety data from approximately 38,000 participants ≥16 years of age randomized 1:1 to vaccine or placebo with a median of 2 months of follow up after the second dose suggest a favorable safety profile, with no specific safety concerns identified that would preclude issuance of an EUA,” the FDA wrote.The report notes the most common reaction was a skin reaction at the injection site, followed by fatigue or headaches.The FDA released data on Pfizer’s vaccine trials and the agency’s scientific analysis ahead of an advisory committee meeting on Thursday when independent experts are set to discuss and vote on whether to recommend the vaccine be authorized for emergency use.

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