a third “booster” dose, all trial participants formally unblinded, dated results, decreased efficacy over time, Israel says vaccine efficacy has dropped to 39%, ongoing phase 3 covid-19 vaccine trial, Pfizer and BioNTech, reports from Israel’s Ministry of Health., reports on vaccine efficacy only “up to six months", rising cases of the Delta variant including among the "fully vaccinated", the trials were not designed to study severe disease, too many open questions about all covid-19 vaccines to support approving any this year, Waning efficacy can dramatically change the risk-benefit calculus
Source: The BMJ
Does the FDA think these data justify the first full approval of a covid-19 vaccine?
August 23, 2021
The FDA should demand adequate, controlled studies with long term follow up, and make data publicly available, before granting full approval to covid-19 vaccines, says Peter Doshi
On 28 July 2021, Pfizer and BioNTech posted updated results for their ongoing phase 3 covid-19 vaccine trial. The preprint came almost a year to the day after the historical trial commenced, and nearly four months since the companies announced vaccine efficacy estimates “up to six months.”
But you won’t find 10 month follow-up data here. While the preprint is new, the results it contains aren’t particularly up to date. In fact, the paper is based on the same data cut-off date (13 March 2021) as the 1 April press release, and its topline efficacy result is identical: 91.3% (95% CI 89.0 to 93.2) vaccine efficacy against symptomatic covid-19 through “up to six months of follow-up.”
The 20 page preprint matters because it represents the most detailed public account of the pivotal trial data Pfizer submitted in pursuit of the world’s first “full approval” of a coronavirus vaccine from the Food and Drug Administration. It deserves careful scrutiny.
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Continue reading this editorial here: Does the FDA think these data justify the first full approval of a covid-19 vaccine? — Peter Doshi, senior editor | The BMJ