By Thomas M. Burton and Peter Loftus
The U.S. Food and Drug Administration said Johnson &
Johnson's single-dose Covid-19 vaccine works safely, paving the way
for the approval of a third vaccine in the U.S. as early as this
weekend.
The vaccine was 66.1% effective in preventing moderate to severe
disease and appeared safe, the U.S. Food and Drug Administration
said Wednesday, and the shot also showed tantalizing signs of
slowing the spread of the virus.
J&J's shot would be the third cleared for use in the U.S.,
as health authorities pick up the pace of vaccinations and try to
lock in gains reducing daily cases, hospitalizations and deaths
while staying ahead of any new variants that threaten to evade
treatment.
Health authorities have been looking forward to adding a new
Covid-19 vaccine to their arsenal. J&J's shot wasn't quite as
effective in its late-stage trial as the pair already in use, but
it worked safely by a number of measures, the FDA said, after
reviewing a 44,000-subject study.
J&J's vaccine "met the prespecified success criteria" for
the study, the FDA said.
Health experts say people shouldn't hold out for the other shots
and get the J&J vaccine if it is authorized and offered,
because it provides protection, especially against severe
disease.
Aside from effectiveness, the J&J vaccine comes with
advantages over the available shots that could help it accelerate
and broaden mass vaccination efforts. Unlike the two vaccines in
use, J&J's shot requires just a single dose.
Intriguingly, 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 ease the pandemic. 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 analyses of the vaccine's pivotal-study results 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. FDA authorization could come as early as
this weekend, according to a person familiar with the matter.
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. The study took place in
the U.S., South Africa and other countries.
FDA issued its analysis of the data, and the agency also posted
J&J's analysis.
On the vaccine's ability to curb the spread of the virus,
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 in the study, the vaccine proved to be effective
protecting against moderate and severe Covid-19. There were seven
Covid-19 deaths among study subjects getting a placebo, compared
with no deaths among those who got the vaccine, the FDA said.
Likewise, fewer people who got the vaccine developed critical
Covid-19 cases than volunteers on placebo did.
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 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. South
Africa has begun rolling out vaccinations with J&J's shot.
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 -- 95% and 94.1% respectively -- 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.
Health authorities have said that the J&J vaccine was
sufficiently protective -- especially against severe disease --
which, together with its single-dose regimen and favorable
temperature requirements, should help make a difference in the
pandemic.
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 was 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 14:44 ET (19:44 GMT)
Copyright (c) 2021 Dow Jones & Company, Inc.
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