By Thomas M. Burton and Peter Loftus
The U.S. Food and Drug Administration found that Johnson &
Johnson's single-dose Covid-19 vaccine was 66.1% effective in
preventing moderate to severe virus disease and appeared safe.
The positive report on Wednesday represents a key step toward a
possible FDA authorization of the vaccine as early as this weekend,
according to a person familiar with the matter. J&J's shot
would be the third cleared for use in the U.S.
The agency, in its review of J&J's late-stage study testing
the vaccine in about 44,000 volunteers in the U.S., South Africa
and other countries, confirmed the vaccine worked safely by a
number of measures, including against new variants.
The shot appeared to prevent severe disease. There were seven
Covid-19 deaths among study subjects getting a placebo, compared
with no deaths among those who got the vaccine. Likewise, fewer
people who got the vaccine developed critical Covid-19 cases than
volunteers on placebo did.
J&J's vaccine "met the prespecified success criteria" for
the study, the FDA said.
J&J released new information, in an analysis that the FDA
posted along with its own, suggesting the vaccine might also help
reduce asymptomatic spread of the coronavirus. The vaccine reduced
infections that didn't cause symptoms in study subjects, J&J
said.
Public-health officials say that a vaccine that can block such
infections will be critical to limit the spread of the coronavirus
and bring the pandemic to an end. One of the reasons the virus has
spread so widely is because of asymptomatic transmission.
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 shot also
doesn't require ultracold temperatures, meaning that sites without
expensive freezers can start vaccinations.
The late-stage study evaluating J&J's vaccine primarily
measured whether the vaccine prevented cases of Covid-19 that
resulted in moderate to severe symptoms.
J&J said a preliminary analysis of a subset of study
subjects suggested the vaccine was 65.5% effective in preventing
infections that caused no symptoms. J&J cautioned, however,
that more analysis is needed to confirm whether the vaccine
prevents asymptomatic infections.
Generally, the vaccine proved to be effective protecting against
moderate and severe Covid-19.
The vaccine's efficacy was roughly comparable across most
demographic subgroups in the study. However, it was only 42.3%
protective in people 60 and over who had certain medical conditions
such as diabetes and hypertension, J&J said.
The FDA found there were two Covid-19 hospitalizations starting
14 days in the vaccine group, versus 29 in the placebo group. There
were no new hospitalizations after 28 days in people vaccinated,
while in the placebo group there were 29.
In the U.S. alone, the vaccine was 72% effective, J&J said.
The shot wasn't as effective in South Africa alone, where a new and
more transmissible variant of the virus has emerged.
J&J said, in an analysis that the FDA posted along with its
own, the vaccine's efficacy ranged from 52% to 64% from two weeks
to a month after vaccination among South Africa trial subjects.
The company said its vaccine performed even better protecting
against severe disease in South Africa, with the vaccine from 73.1%
to 81.7% effective two weeks to a month after vaccination.
The vaccine's efficacy was even higher in Brazil, where another
variant has spread.
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 Pfizer-BioNTech and Moderna vaccines recorded higher
effectiveness rates in their late-stage trials than J&J's
vaccine. Those companies' trial results, however, occurred largely
before new variants are known to have emerged.
The FDA analysis and advisory-committee meeting are intended to
reinforce public confidence in the vaccine, and the FDA's
evaluation would appear to do that.
The vaccine appeared generally safe. The most common side
effects, J&J said, were headache, fatigue, muscle ache and
injection-site pain. Most weren't severe. There were no severe
allergic reactions known as anaphylactic reactions in studies of
its vaccine -- something that has occurred rarely in those
receiving the Pfizer and Moderna vaccines.
J&J said there were three non-Covid deaths among vaccine
recipients in the study but none were considered related to the
vaccine, while 16 people who had received a placebo died, some from
non-Covid causes.
J&J said one vaccine recipient in the study experienced a
condition called transverse sinus thrombosis, a type of blood clot
in the brain, resulting in cerebral hemorrhage.
This serious event led to a pause in testing of J&J's
vaccine in October because researchers initially thought it was
related to the vaccine. J&J said study investigators
subsequently determined it was related to the patient's
pre-existing medical conditions and not the vaccine. The study
resumed enrollment later in October.
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 11:23 ET (16:23 GMT)
Copyright (c) 2021 Dow Jones & Company, Inc.
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