The United States Food and Drug Administration on Saturday granted emergency use authorization to the one-shot COVID-19 vaccine developed by Johnson & Johnson.
It is the third vaccine to be approved in the U.S. and the only one that requires only one-shot. The vaccines developed by Moderna and Pfizer-BioNtech, which were approved last December, require two shots weeks apart.
The approval comes only a day after an FDA panel of advisers on Friday voted 22-0 to recommend an emergency use authorization of the 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 set the stage for today’s approval.
President Biden was elated over the emergency use approval, saying in a statement, “This is exciting news for all Americans, and an encouraging development in our efforts to bring an end to the crisis.”
The U.S. leader wrote: “Today, after a rigorous, open, and objective scientific review process, the Food and Drug Administration issued an emergency use authorization for a third safe and effective vaccine to help us defeat the COVID-19 pandemic — the Janssen COVID-19 (Johnson & Johnson) vaccine. This is exciting news for all Americans, and an encouraging development in our efforts to bring an end to the crisis.
“We know that the more people get vaccinated, the faster we will overcome the virus, get back to our friends and loved ones, and get our economy back on track. Thanks to the brilliance of our scientists, the resilience of our people, and the eagerness of Americans in every community to protect themselves and their loved ones by getting vaccinated, we are moving in the right direction. I look forward to speaking more about today’s news and updating the American people on our progress this coming week.
“But I want to be clear: this fight is far from over. Though we celebrate today’s news, I urge all Americans — keep washing your hands, stay socially distanced, and keep wearing masks. As I have said many times, things are still likely to get worse again as new variants spread, and the current improvement could reverse. My Administration will not make the mistake of taking this threat lightly, or just assuming the best: that’s why we need the American Rescue Plan to keep this fight going in the months ahead.
“There is light at the end of the tunnel, but we cannot let our guard down now or assume that victory is inevitable. We must continue to remain vigilant, act fast and aggressively, and look out for one another — that is how we are going to reach that light together.”
An FDA review released on Wednesday found that the Johnson & Johnson is safe and efficacious. The FDA confirmed that the one-shot vaccine provides strong protection against severe disease and death from COVID-19.
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.