USA – VRBPAC to hear of high – and early – efficacy for Pfizer’s COVID vaccine

In briefing documents that came online the morning of 8 December, the US Food and Drug Administration (FDA) presented its analysis of the efficacy and safety data for the first vaccine against COVID-19 to be considered for administration in the US. The agency’s assessment largely squares with the high efficacy and favorable safety profile reported by the vaccine’s co-sponsors, Pfizer and BioNTech.

The briefing documents were provided by Pfizer/BioNTech and FDA in advance of the 10 December Vaccines and Related Biological Products Advisory Committee (VRBPAC) meeting to consider the investigational messenger RNA (mRNA) vaccine BNT162b2 for emergency use authorization (EUA).
Pfizer/BioNTech and FDA agreed about the overall 95% efficacy of the two-dose vaccine regimen. FDA’s subgroup analysis of the available Phase 3 clinical trial data was also in agreement with the sponsor’s, finding high efficacy across all subgroups, including older participants and those with obesity — a prevalent risk factor for serious complications of COVID-19. Both Pfizer and FDA also highlighted analysis showing a sharp drop in COVID-19 cases after just one dose of the vaccine…