FDA Review Says Johnson & Johnson Coronavirus Vaccine Safe and Effective

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AURORA, CO - DECEMBER 15: (EDITORIAL USE ONLY) Rocky Mountain Regional VA Medical Center investigational pharmacy technician Sara Berech holds a dose of the Johnson & Johnson COVID-19 vaccine before it is administered in a clinical trial on December 15, 2020 in Aurora, Colorado. The Johnson & Johnson vaccine could be submitted for emergency use by late January and is the only vaccine among leading candidates given as a single dose. (Photo by Michael Ciaglo/Getty Images)

The Food and Drug Administration has released a review of the one-shot Johnson & Johnson vaccine and found that it was safe, effective and “completely prevented hospitalizations and deaths in a large clinical trial,” according to the Washington Post. An emergency use authorization could be confirmed by this weekend.

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.”

The J & J vaccine is also good news for the developing world. The New York Times reports:

Johnson & Johnson’s vaccine can be stored at normal refrigeration temperatures for at least three months, making its distribution considerably easier than the authorized vaccines made by Moderna and Pfizer-BioNTech, which require two doses and must be stored at frigid temperatures.