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Real-world trial of Pfizer COVID vaccine finds high 2-dose, good 1-dose protection

A pre–emergency use authorization randomized, controlled trial published online in NEJM on Dec 10, 2020, found a vaccine efficacy against symptomatic COVID-19 of 95%. The Israeli study was designed to investigate real-world effectiveness in diverse populations with different underlying medical conditions amid the challenges of imperfect compliance with vaccination schedules, the need for cold storage, and complex deployment logistics. Analysis of proxy data showed vaccine effectiveness of 29% against asymptomatic infection 14 to 20 days after the first dose, climbing to 52% during days 21 to 27, and 90% 7 or more days after the second dose. The authors noted that the previous trial estimated vaccine effectiveness of 52% against asymptomatic infection. The difference, they said, may be explained by the rapid spread of coronavirus in Israel at the time of their study, which affected vaccinees and controls alike in the first 12 days after the first dose. To counter this potential

Three-shot combo? Pfizer, BioNTech roll COVID-19 booster trial as real world data back first vaccine

Feb 25, 2021 11:55am Pfizer and BioNTech dive into a third-dose Comirnaty vaccine trial, while a study out of Israel marks its initial success. (Getty/Meyer & Meyer) As Pfizer and BioNTech start testing whether a third dose of their COVID-19 shot can help fend off new coronavirus variants, a massive real-world study has confirmed that its first, two-dose regimen is 94% effective. The third-dose study now underway will gauge the effects of that follow-up dose on circulating and new COVID-19 virus variants. At the same time, the companies are in talks with the FDA and EMA about studying a new booster specifically designed to tackle new variants. They re hoping to validate  future modified mRNA vaccines with a regulatory pathway similar to what is currently in place for flu vaccines,” according to a press release.

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