By Peter Doshi

The U.S. Food and Drug Administration should have demanded adequate, controlled studies with long-term follow up, and made data publicly available, before granting full approval to COVID-19 vaccines, says British Medical Journal Associate Editor Peter Doshi.

EDITOR’S NOTE: 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…