FDA review confirms safety and efficacy of single-shot Johnson & Johnson coronavirus vaccine
Source: Washington Post
A Food and Drug Administration review released Wednesday of the single-shot coronavirus vaccine made by pharmaceutical giant Johnson & Johnson found it was safe and effective and completely prevented hospitalizations and deaths in a large clinical trial. The review sets the stage for a third coronavirus vaccine to be authorized as soon as this weekend, a point of hope in the middle of a pandemic that has killed more than a half-million people in the United States.
The review, though positive, was more nuanced than regulators’ assessments of the first two coronavirus vaccines, reflecting a pandemic that has entered a more complicated phase as variants capable of slipping by some aspects of immunity have emerged. The Johnson & Johnson vaccine was more than 85 percent effective at preventing severe illness, including in a region dominated by a concerning variant, but only 66 percent protective overall when moderate cases were included.
The FDA scientists found that the “known benefits” of the vaccine included reducing the risk of symptomatic and severe cases of covid-19 at least two weeks after vaccination. The review found vaccine efficacy against severe covid-19 “was similarly high across the United States, South Africa, and Brazil.”
“We know this vaccine prevents 85 percent of the severe disease. … It was 100 percent effective in preventing hospitalization and deaths, and that’s really what’s important,” said Nancy M. Bennett, a professor of medicine and public health sciences at the University of Rochester School of Medicine and Dentistry. “Those facts are the most important thing to recognize.”
Read more: https://www.washingtonpost.com/health/2021/02/24/johnson-and-johnson-vaccine/
Full headline: FDA review confirms safety and efficacy of single-shot Johnson & Johnson coronavirus vaccine, especially against severe cases
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