J&J Single-Dose Vaccine Gets Review From FDA Advisory Panel -- Update
February 26 2021 - 10:48AM
Dow Jones News
By Thomas M. Burton and Peter Loftus
Johnson & Johnson's single-dose Covid-19 vaccine was
effective "across demographic subgroups" in a late-stage study,
U.S. Food and Drug Administration scientists plan to tell a panel
of medical specialists meeting Friday to evaluate the shot.
The FDA officials, in other testimony prepared for the advisory
committee, also said the agency plans to continue studying the
vaccine to assess the its efficacy across specific populations, the
duration of the protection against Covid-19 provided by the shot
and its potency against new strains of the virus.
The committee's meeting is the final step before U.S. health
regulators decide whether to authorize use of a third shot. The
decision is expected Saturday.
The panel, which includes 22 medical specialists in fields like
internal medicine, pediatrics, vaccines and epidemiology, regularly
advises the U.S. Food and Drug Administration about experimental
vaccines. It voted to recommend shots from Pfizer Inc. and partner
BioNTech SE and Moderna Inc. before the agency authorized them in
December.
In other testimony prepared for the panel, the U.S. Centers for
Disease Control and Prevention said preliminary results of safety
data for the Pfizer-BioNTech and Moderna vaccines showed no
statistically significant increased risk of adverse events among
people who got those shots.
During the all-day public meeting, representatives from the FDA
and J&J will discuss the safety and effectiveness of the
company's vaccine in a 44,000-plus subject study, according to an
agenda, as well as how effective the J&J vaccine is in
preventing new cases caused by variants.
The give-and-take of questions and answers can be valuable in
bolstering public confidence in the shot, FDA officials say.
The vaccine was 66% effective at protecting people from moderate
to severe Covid-19, an FDA review found, and even more effective at
preventing severe disease alone.
J&J, citing preliminary evidence in an analysis released by
the FDA, said the vaccine was 65.5% effective in preventing
asymptomatic infections, in a subset of study subjects.
Health authorities have been watching whether Covid-19 shots can
stop people without symptoms from transmitting the virus, because
the virus has largely been spread by people who were infected but
didn't realize it because they had no symptoms.
Rollout of the J&J vaccine doses could add -- by an
estimated 20% during March -- to the total number available, as
health authorities pick up the pace of vaccinations and try to
inoculate enough people as quickly as possible so business, schools
and other establishments can fully reopen.
J&J has said it would deliver about 20 million doses for
U.S. use by the end of March.
The FDA often convenes public meetings of outside experts to
scrutinize experimental drugs, devices and vaccines up for agency
approval, in part to boost public acceptance of the products should
they be cleared for wide use.
J&J's vaccine appeared to be safe in its pivotal study, the
FDA found, aside from being effective.
The vaccine was less effective in South Africa, where a
more-transmissible Covid-19 variant has thrived, than in the U.S.
J&J is among the companies working on new shots targeting the
new strain, which several current vaccines don't appear to work as
well against.
J&J's Covid-19 shot was, however, very effective against
severe and critical cases in South Africa. The vaccine was 73.1%
effective in preventing such cases occurring at least 14 days after
vaccination, and 81.7% effective in preventing such cases at least
28 days after vaccination.
Write to Thomas M. Burton at tom.burton@wsj.com and Peter Loftus
at peter.loftus@wsj.com
(END) Dow Jones Newswires
February 26, 2021 10:33 ET (15:33 GMT)
Copyright (c) 2021 Dow Jones & Company, Inc.
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