J&J Covid-19 Vaccine Gets Review From FDA Advisory Panel
February 26 2021 - 5:59AM
Dow Jones News
By Thomas M. Burton and Peter Loftus
A committee of independent medical experts convenes Friday to
review Johnson & Johnson's Covid-19 single-dose vaccine, the
final step before U.S. health regulators decide whether to
authorize use of a third shot.
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 Moderna
Inc. before the agency authorized them in December.
If the panel votes to endorse the J&J shot, the agency is
expected to permit the product's wide use as soon as Saturday.
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.
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.
The advisory committee also will delve into how effective the
J&J vaccine is in preventing new cases caused by Covid-19
mutations and to what extent the shot might reduce asymptomatic
spread of the coronavirus.
That issue of silent contagion is crucial, since the virus has
largely been spread by people who were infected but didn't realize
it because they had no symptoms.
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.
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 05:44 ET (10:44 GMT)
Copyright (c) 2021 Dow Jones & Company, Inc.
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