USA – FDA briefing document backs J&J’s one-dose COVID-19 vaccine

A briefing document published ahead of a US Food and Drug Administration (FDA) expert meeting to review Johnson & Johnson’s (J&J) one-dose COVID-19 vaccine has endorsed the safety and efficacy of the jab.

The FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) is scheduled to meet tomorrow to discuss potential emergency authorisation of the J&J vaccine in the US.

In its briefing document, the FDA highlighted the vaccine efficacy of 66.1% demonstrated in a phase 3 trial of J&J’s jab.

The agency also reiterated key secondary endpoints that demonstrated vaccine efficacy against severe and critical COVID-19 of 76.7% at least 14 days after vaccination and 85.4% at least 28 days after vaccination.

The FDA also noted that analysis of safety data supported a ‘favourable safety profile with no specific safety concerns identified that would preclude issuance of an emergency use authorisation (EUA)’…