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FDA Review Reveals J&J COVID-19 Vaccine Safe, Effective

WEDNESDAY, Feb. 24, 2021 -- A single-shot COVID-19 vaccine made by Johnson & Johnson completely prevented hospitalizations and deaths in a large clinical trial, according to the results of a new review released Wednesday by the U.S. Food and Drug Administration.

What would be the third vaccine to be authorized in the United States for emergency use could be approved as soon as this weekend, The Washington Post reported. The J&J 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.

FDA scientists found the "known benefits" of the vaccine included reducing the risk for symptomatic and severe cases of COVID-19, at least two weeks after vaccination. The review showed the vaccine's efficacy against severe illness "was similarly high across the United States, South Africa, and Brazil." The vaccine was less effective in a subgroup of adults older than 60 years who also had risk factors for severe illness, but regulators noted there were no deaths or cases requiring medical intervention a month after those older adults received vaccines. Overall, there were seven deaths in the trial, all in the group that received a placebo shot, The Post reported.

An FDA advisory panel is set to meet Friday to recommend whether the FDA should authorize the shot for emergency use.

Public health officials have eagerly awaited the arrival of the J&J vaccine because it can be stored in a refrigerator for several months, which should ease the challenges of distributing vaccines that must be stored in subzero temperatures, and it does not require a follow-up booster shot, The Post said.

The Washington Post Article

© 2021 HealthDay. All rights reserved.

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