Johnson & Johnson applied for Emergency Use Authorization (EUA) for their candidate vaccine last Thursday. Their candidate is a single dose vaccine that uses a weakened cold virus as the vehicle for the antigen that stimulates the immune response.
The FDA has scheduled a Vaccines and Related Biological Products Advisory Committee (VRBPAC) on Feb. 26, 2021, to discuss the request. They will likely make a recommendation whether to authorize or not during that meeting. The FDA Commissioner will then likely make a decision shortly thereafter.
Note: Former FDA Commissioner Hahn resigned and has been replaced by Acting Commissioner Janet Woodcock M.D. Dr. Woodcock is a Career FDA professional – having served at the FDA since 1984.
The company says they have vaccine immediately ready for shipment as soon as the FDA authorizes emergency use of the vaccine. The FDA hasn’t posted the application data on their website yet, but I’ll keep an eye out for it.
An NIH and J&J press release (not the full published data) said that their clinical trial of 43,783 participants “met all primary and key secondary endpoints”. The topline safety and efficacy data are based on 43,783 participants accruing 468 symptomatic cases of COVID-19.
Both the NIH and J&J have stated that their vaccine candidate:
“… is 66% effective overall in preventing moderate to severe COVID-19, 28 days after vaccination. The onset of protection was observed as early as day 14. The level of protection against moderate to severe COVID-19 infection was 72% in the United States, 66% in Latin America and 57% in South Africa, 28 days post-vaccination.”
