Johnson & Johnson’s Janssen division (NYSE:JNJ) has requested that FDA expand the emergency use authorization (EUA) for its Ad26.COV2.S COVID-19 vaccine to include boosters for people 18 and older.
The previous EUA covered a single dose of the vaccine.
On October 14 and 15, FDA will convene meetings of its Vaccines and Related Biological Products Advisory Committee (VRBPAC) to discuss authorization of the Janssen as well as Moderna vaccine boosters.
The submission includes data from the Phase 3 ENSEMBLE 2 study, which gave recipient a second dose of Ad26.COV2.S vaccine 56 days after the prime dose. After two weeks, the vaccine provided 94% protection against symptomatic moderate to severe/critical COVID-19 in the U.S. and 100% protection against severe/critical COVID-19.
Earlier, Janssen determined that a single dose of Ad26.COV2.S vaccine had an efficacy of 72%.
Despite its initial advantage as a single-dose vaccine, Ad26.COV2.S has failed to match the popularity of the mRNA vaccines from Pfizer and Moderna.
Authorities in the U.S. and EU have linked the vaccine to extremely rare blood clotting episodes. And recently, officials at the European Medicines Agency found another possible link between the vaccine and clotting in deep veins in Ad26.COV2.S recipients, Reuters reported.
A recent CDC study found that a single dose of the Janssen vaccine was 71% effective in preventing hospitalization from COVID-19. By contrast, the two-dose Moderna and Pfizer-BioNTech vaccines were 93% and 88% effective, respectively.
Pfizer and BioNTech have won U.S. authorization to use their vaccine as a booster in some individuals. Moderna is seeking a similar authorization.
This article, which initially ran on October 4, was updated on the following day with new information.
Filed Under: clinical trials, Drug Discovery, Infectious Disease, Uncategorized