FDA to Release Review of J&J Covid-19 Vaccine
February 24 2021 - 5:59AM
Dow Jones News
By Thomas M. Burton and Peter Loftus
The U.S. Food and Drug Administration plans to disclose on
Wednesday its detailed analysis of Johnson & Johnson's Covid-19
vaccine, a key step that could lead to authorization of the shot's
deployment against the pandemic.
The FDA has been reviewing data from a late-stage study that,
J&J said, found the vaccine was overall 66% effective
protecting people from Covid-19, and 85% effective against severe
disease.
A committee of outside medical specialists convenes Friday to
evaluate the analyses by both the FDA and the company, as the panel
did for the first two Covid-19 vaccines to be cleared for use.
The advisory committee is expected to recommend the FDA
authorize the J&J vaccine, and the agency is expected to make
its decision soon after.
The regulatory green light would bolster vaccination efforts
just as health authorities pick up the pace to get people back to
schools, offices and other establishments ahead of new strains that
threaten to evade medicines.
Health authorities expect the initial supply of the J&J
vaccine will help ease, though not eliminate, the frustration felt
by people unable to sign up for shots because there aren't enough
doses available.
J&J has said it would deliver about 20 million doses for
U.S. use by the end of March, which may be enough to boost the
countrywide capacity for completed vaccinations by about 20%.
The two other Covid-19 vaccines authorized in the U.S. come from
Moderna Inc. and from a partnership between Pfizer Inc. and
Germany's BioNTech SE. The companies have projected delivering
enough of their two-dose vaccines by the end of March to immunize
100 million people.
Each of those vaccines requires two shots to confer their full
benefit. The J&J vaccine involves only one shot, a factor that
also may ease the logistics of delivering doses.
The late-stage study evaluating J&J's vaccine looked at how
well it protected against moderate and severe Covid-19 among
43,000-plus volunteers in several countries.
In the U.S. alone, the vaccine was 72% effective. It wasn't as
effective in South Africa alone, where a new and more transmissible
variant of the virus has emerged. There, the vaccine was 57%
effective.
All those numbers exceed the FDA's originally set hurdle of 50%
efficacy, but fall short of the 94.1% and 95% marks set by Moderna
and Pfizer/BioNTech, respectively.
Those companies' trial results, however, occurred largely before
new variants are known to have emerged.
Several Covid-19 vaccine makers including Moderna and J&J
have said they are working on modified shots that could prove more
effective against new Covid-19 variants.
The expected FDA action is known as an emergency-use
authorization, a designation created by federal law to deal with
situations like the current global pandemic.
It falls short of a full FDA approval. Yet the FDA has
nevertheless required large clinical studies, as well as following
study volunteers for a median of two months following
vaccination.
J&J has said it expects to ship 100 million doses throughout
the U.S. by late June and to supply more than one billion doses
world-wide during 2021.
Pfizer and Moderna have committed to supplying enough doses by
the end of July to vaccinate 300 million people in the U.S.
Write to Thomas M. Burton at tom.burton@wsj.com and Peter Loftus
at peter.loftus@wsj.com
(END) Dow Jones Newswires
February 24, 2021 05:44 ET (10:44 GMT)
Copyright (c) 2021 Dow Jones & Company, Inc.
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