A panel of advisers to the U.S. Food and Drug Administration on Friday voted 22-0 to recommend an emergency use authorization of the one-shot COVID-19 vaccine developed by Johnson & Johnson vaccine.
The question the advisers were answering was: Do the benefits of the Johnson & Johnson vaccine outweigh its risks for use in people 18 years of age and older?
The answer was unanimous, with all the 22 advisers voting for emergency use authorization of the one-shot vaccine during the pandemic.
The recommendation has now set the stage for the FDA to approve the Johnson & Johnson vaccine, making it the third vaccine to be approved by the agency. The FDA usually goes along with the advice of its expert advisers.
For instance, FDA approved Moderna and Pfizer-BioNtech vaccines one day after the same panel endorsed them last December, meaning the Johnson & Johnson vaccine could be approved this weekend.
The FDA confirmed that the one-shot vaccine provides strong protection against severe disease and death from COVID-19.
With more than half a million people dead from the disease in the United States, the development now provides great hope that there would be a third vaccine that could be approved as early as this weekend. Americans have been receiving shots from Pfizer-BioNtech and Moderna vaccines for several months. But those vaccines require two shots several weeks apart. The Johnson & Johnson vaccine will be the first one to require only one shot.
The Johnson & Johnson vaccine had a 72 percent overall efficacy rate in the United States. In South Africa, it was less effective at 64 percent because of a highly contagious variant there.
In the review, the efficacy of the vaccine was seven point higher than early data the company released several weeks ago.
The review found that the vaccine was 86 percent effective at preventing severe illness, including in places dominated by new variants. It said the vaccine efficacy against severe cases of COVID-19 “was similarly high across the United States, South Africa, and Brazil.”
When moderate and severe cases were combined, the vaccine was only 66 percent effective against the coronavirus, including for old and new variants.
However, FDA team of scientists concluded that there were benefits in taking the vaccine and that it could reduce the risk of symptomatic and severe cases of COVID-19 at least two weeks after vaccination.
“We know this vaccine prevents 85 percent of the severe disease,” the Washington Post quoted Nancy M. Bennet as saying. “It was 100 percent effective in preventing hospitalization and deaths, and that’s really what’s important. Those facts are the most important thing to recognize,” added Bennet, who is a professor of medicine and public health sciences at the University of Rochester School of Medicine and Dentistry.