On Friday, an advisory panel will meet to evaluate the vaccine candidate and decide whether to recommend for emergency use authorization.
On Wednesday, the FDA released results of an analysis for Johnson & Johnson’s coronavirus disease 2019 (COVID-19) vaccine candidate that supports its authorization for emergency use.
Results of an FDA analysis of Johnson & Johnson’s coronavirus disease 2019 (COVID-19) candidate, known as Ad26.COV2.S, confirm the safety and efficacy of the single-dose vaccine.
On Friday, an advisory panel will meet to evaluate the vaccine and vote on whether to recommend it for emergency use authorization (EUA). The FDA will then decide whether to issue the EUA.
To support its EUA request, Janssen submitted safety and efficacy data based on the ongoing multi-national phase 3 randomized, double-blind, and placebo-controlled trial of approximately 40,000 participants. The coprimary efficacy end points included molecularly confirmed, moderate to severe/critical COVID-19 with onset of at least 14 and 28 days, respectively, after vaccination in participants without evidence of severe acute respiratory infection coronavirus 2 (SARS-CoV-2) prior to vaccination.
According to the data, vaccine efficacy against moderate to severe/critical COVID-19 was 66.9% (95% CI 59.0, 73.4) when considering cases occurring at least 14 days after the single-dose vaccination and 66.1% (55.0, 74.8) when considering cases occurring at least 28 days after vaccination. The vaccine was also demonstrated to be 76.6% and 85.4% effective against severe/critical cases after 14 days and 28 days, respectively.
A post hoc analysis showed no COVID-19 hospitalizations in the vaccine group after 28 days compared with 16 cases in the placebo group.
The briefing document provided a breakdown of efficacy rates in regions where the new SARS-CoV-2 variants emerged, looking at efficacy across 3 countries: United States, South Africa, Brazil. In a subgroup analysis, there was lower efficacy against moderate to severe/critical COVID-19 observed in South Africa compared with the United States. However, efficacy against severe/critical COVID-19 was comparably high across all 3 countries.
Moreover, the analysis supported a favorable safety profile for the vaccine, with no specific safety concerns.
If approved for EUA, Ad26.COV2.S would be the third COVID-19 vaccine authorized for use in the US.