By Thomas M. Burton and Peter Loftus
Johnson & Johnson's single-dose Covid-19 vaccine worked
safely and should be authorized for use in the U.S., a panel of
experts advised federal health regulators Friday.
The advisory committee's unanimous vote in support of the
vaccine's authorization is the last step before the U.S. Food and
Drug Administration issues a decision, which is expected
The panel, a group of 22 medical specialists in such fields as
internal medicine, pediatrics, vaccines and epidemiology, regularly
advises the FDA about experimental vaccines. It voted to recommend
shots from Pfizer Inc. and partner BioNTech SE and Moderna Inc.
before the agency authorized those two-dose vaccines in
The vaccine's effectiveness and safety results were "way over
the bar," said panel member Eric Rubin, who is editor in chief of
the New England Journal of Medicine. "The demand is so large that
this vaccine clearly has a place."
Arnold Monto, the panel's acting chairman and a professor of
public health and epidemiology at the University Michigan, said
people should welcome getting J&J's shot if it is authorized.
"In this environment, whatever you can get, get," he said.
During the all-day public meeting, representatives from the FDA
and J&J discussed the safety and effectiveness of the company's
vaccine in a 44,000-plus subject study, as well as how effective
the J&J vaccine is in preventing new cases caused by
The give-and-take of questions and answers can be valuable in
bolstering public confidence in the shot, according to FDA
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.
"If authorized, Janssen's vaccine candidate would play a pivotal
role in the global effort to fight Covid-19," Johan Van Hoof,
global head of vaccines research at J&J's Janssen
pharmaceutical unit, said during the panel's meeting. "A
single-dose regimen offers the ability to vaccinate a population
A rollout of the J&J vaccine could add enough shots in the
U.S. by the end of March to boost the total number of people
vaccinated by 20%. Health authorities are pushing to inoculate
enough people as quickly as possible so that 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 known and potential benefits of Ad26 outweigh the known and
potential risks," Macaya Douoguih, head of clinical development and
medical affairs at J&J's Janssen unit, said during Friday's
meeting, using a code name for J&J's vaccine.
FDA medical officer Yosefa Hefter said there are still unknowns
about the vaccine, including duration of immune protection and the
safety and effectiveness in use with children.
An FDA analysis for the committee meeting also said rare cases
of deep vein clots and of blockages in lung arteries were slightly
more common in vaccine recipients than in placebo patients, and
that the FDA considers these to be "of clinical interest."
The vaccine was effective "across demographic subgroups," the
FDA said. The demographic subgroups in the large study of J&J's
shot included racial and ethnic groups such as Black, Latino and
Asian people, and age groups such as those 60 years and older.
Researchers also assessed efficacy in people who had underlying
medical conditions including obesity and high blood pressure before
entering the clinical trial. Sometimes vaccines don't work as well
in older people because of weakened immune systems. The J&J
vaccine appeared to be less effective in people 60 and older who
had certain medical conditions like diabetes and high blood
The Pfizer-BioNTech and Moderna vaccines also worked effectively
across various demographic subgroups.
The J&J vaccine was less effective in South Africa than in
the U.S. J&J is among the companies working on new shots
targeting a more-transmissible Covid-19 variant that has thrived in
South Africa and against which several current vaccines don't
appear to work as well.
J&J's shot, however, was 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
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. The virus
has largely been spread by people who were infected but didn't
realize it because they had no symptoms.
Write to Thomas M. Burton at firstname.lastname@example.org and Peter Loftus
(END) Dow Jones Newswires
February 26, 2021 18:00 ET (23:00 GMT)
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