DJ FDA Says Covid-19 Vaccines Remain Effective Without Boosters
2021 Dow Jones & Company, Inc.
By Jared S. Hopkins and Felicia Schwartz
The Food and Drug Administration said vaccines cleared in the U.S. currently provide protection against severe disease and death from Covid-19, potentially complicating the Biden administration's deliberations over the need for booster shots.
The FDA released the findings Wednesday in a report analyzing data submitted by Pfizer Inc. and BioNTech SE as part of their request for authorization for their vaccine to be given as a booster shot in people 16 years and older.
An outside panel of scientific advisers will review the FDA report on Friday, along with a companion analysis from Pfizer and other information, as part of a discussion over who needs booster shots and when.
The Biden administration has sought boosters to counter contagious variants such as Delta and bolster signs of waning immunity among the vaccinated. Evidence supporting the need for an extra dose, at least in the general public, hasn't been conclusive.
A favorable recommendation from the panel to authorize boosters for the general population could be followed within a few days by the FDA approving distribution of booster shots of the vaccine.
FDA scientists wrote Wednesday that they considered concerns that recent studies that show diminished levels of antibodies and weaker protection against symptomatic Covid-19 may result in additional severe disease, and that the contagious Delta variant has further spread the virus. Yet they expressed skepticism that an apparent diminished protection is rendering the vaccines ineffective, as some observational studies have suggested Pfizer-BioNTech vaccine's diminished protection against symptomatic disease or against Delta, while others haven't.
"Overall, data indicate that currently U.S.-licensed or authorized Covid-19 vaccines still afford protection against severe Covid-19 disease and death in the United States," the scientists wrote.
Write to Jared S. Hopkins at email@example.com and Felicia Schwartz at firstname.lastname@example.org
(END) Dow Jones Newswires
September 15, 2021 13:21 ET (17:21 GMT)
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