Johnson & Johnson and the FDA on Wednesday released respective detailed evaluation about the one-shot COVID-19 vaccine, with the FDA announcing the organization's information meets the requirements for the emergency use authorization review procedure.
Importantly, the data published reveals the vaccine works against all variants. The vaccine was effective at preventing symptomatic illness in South Africa, where the variant detected there is dominant, but it was highly effective at preventing acute disease there.
J&J also published preliminary statistics suggesting the vaccine probably helps stop asymptomatic infections, and that the Brazil variant doesn't seem to have as much of an impact on vaccine efficiency as the South African version.
The Johnson & Johnson vaccine would be authorized for adults over 18.
When coupled with the source of Pfizer and Moderna vaccines, which both require two doses, the U.S. is expected to have enough vaccine for 130 million adults at the end of March.
The vaccine won't be approved until Friday or later. First, there'll be a public hearing Friday, in which the FDA's independent advisory committee will give an empowerment recommendation for or against. The FDA could then make its decision as early as Friday evening.
"Although we are careful not to prejudge the results of the continuing FDA review process, we think our single dose vaccine will be a critical instrument for combating this global pandemic," Richard Nettles, vide president of medical affairs for Jannsen Pharmaceutical Firms surfaced at a congressional hearing this week.
The FDA found no significant security issues with moderate side effects like pain at the website of injection, headache, or fatigue. About 9 percent of volunteers who received the vaccine had a fever.
The data published Wednesday is a more detailed version of the company previously outlined in a press release.