Tina Hesman Saey, ScienceNews: February 27, 2021
And then there were three: A single-shot vaccine is the latest weapon to join the battle against COVID-19 in the United States.
On February 27, the U.S. Food and Drug Administration gave emergency use authorization for Johnson & Johnson’s vaccine against SARS-CoV-2, the coronavirus that causes COVID-19. South Africa is the only other country to OK Johnson & Johnson’s vaccine so far, though other countries are poised to follow suit.
The FDA determined that Johnson & Johnson’s vaccine meets the criteria for safety and effectiveness and that there is clear evidence that it may prevent COVID-19, the agency said in a statement.
“With today’s authorization, we are adding another vaccine in our medical toolbox to fight this virus,” said Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research.
Its authorization for emergency use in the United States – for people age 18 and older – follows similar authorizations in December for vaccines made by Moderna and by Pfizer and its German partner BioNTech.
As of February 25, more than 52,000 people were hospitalized in the United States fighting COVID-19, according to the COVID Tracking Project. That’s down from the record-setting daily peaks of more than 130,000 in early January and the lowest since early to mid-November. More than half a million people in the United States have now died from COVID-19.
In Johnson & Johnson’s clinical trial, two of the 19,514 people in the vaccine group were hospitalized with COVID-19 starting 14 days after vaccination. That compares with 29 hospitalizations among the 19,544 people in the placebo group. None of the vaccinated people died, but there were seven deaths related to COVID-19 in the placebo group. Those numbers are small and some researchers say the data aren’t clear-cut on the benefits.
“The data indicate that the vaccine is effective, but doesn’t prove that the vaccine is especially effective against moderate to severe COVID,” said Diana Zuckerman, president of the National Center for Health Research, a Washington, D.C.–based think tank that analyzes health research.
The data were also collected after only two months of follow-up. Normally, the FDA requires a year or more of data to fully approve a vaccine. Some questions about the vaccine can’t be answered with less than six months of data, Zuckerman said during a public comment period in the Feb. 26 advisory board hearing. “Let’s be very honest with the public about what we do know and what we won’t know” for some time to come.
For all the vaccines, no one knows how long immunity will last. And what’s already authorized might need to be tweaked if resistant variants become widespread. Booster shots may be needed, Benjamin says.
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