The Pfizer/BioNTech COVID-19 vaccine showed a final efficacy of 91% against symptomatic illness in its phase 3 trial. Social media posts wrongly claim recently released Pfizer documents show the vaccine is “12% effective.” That appears to be a misreading of data released more than a year ago.
The Pfizer/BioNTech COVID-19 vaccine was the first to be granted emergency use authorization by the Food and Drug Administration on Dec. 11, 2020. The EUA was based on the interim results from the phase 3 randomized controlled trial involving 36,523 participants — about half receiving the vaccine and the other half getting a placebo — showing the vaccine “was 95% effective in preventing COVID-19 disease among these clinical trial participants with eight COVID-19 cases in the vaccine group and 162 in the placebo group,” the FDA said at the time.
Months later, on Aug. 23, 2021, the vaccine received full FDA approval, after a review of the manufacturing process, ongoing results from the clinical trial and safety monitoring. At that point, the FDA reviewed updated trial results on about 20,000 vaccine and 20,000 placebo recipients showing the vaccine was 91% effective in preventing symptomatic COVID-19.
Yet, various social media posts in May have claimed that “just released” Pfizer documents show the vaccine is “12% effective.” That appears to be a misunderstanding of the Pfizer FDA briefing document released in December 2020, before the EUA was granted.
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