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Editor’s note: Here’s an excerpt from an article in The BMJ. To read the piece in its entirety, click here.
This analysis was published Monday before the U.S. Food and Drug Administration announced it had granted full approval to Pfizer’s COVID vaccine. The information in this piece provides insightful arguments for why the FDA should not have rushed to license Pfizer’s COVID vaccine.
On July 28, 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 (March 13, 2021) as the April 1 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 U.S. Food and Drug Administration. It deserves careful scrutiny.
Read the entire The BMJ article here.
