The Food and Drug Administration said the shot should only
be given to adults who cannot receive a different vaccine or specifically
request J&J’s vaccine. U.S. authorities for months have recommended that
Americans get Pfizer or Moderna shots instead of J&J’s vaccine.
FDA’s vaccine chief Dr. Peter Marks said the agency decided
to restrict the vaccine after taking another look at the data on the risks of
life-threatening blood clots and concluding that they are limited to J&J’s
vaccine.
“If there’s an alternative that appears to be equally
effective in preventing severe outcomes from COVID-19, we’d rather see people
opting for that,” Marks said. “But we’ve been careful to say that-- compared to
no vaccine-- this is still a better option.”
The problem occurs in the first two weeks after vaccination,
he added: “So if you had the vaccine six months ago you can sleep soundly
tonight knowing this isn’t an issue.”
The FDA authorized J&J’s shot in February last year for
adults 18 and up.
The vaccine was initially considered an important tool in
fighting the pandemic because it required only one shot. But the single-dose
option proved less effective than two doses of the Pfizer and Moderna vaccines.
In December, the Centers for Disease Control and Prevention
recommended Moderna and Pfizer shots over J&J’s because of its safety
issues.
As of mid-March, federal scientists had identified 60 cases
of the side effect, including nine that were fatal. That amounts to 3.23 blood clot
cases per 1 million J&J shots. The problem is more common in women under
50, where the death rate was roughly 1 per million shots, according to Marks.
Marks said the FDA spent extra time analyzing the problem to
be sure it wasn’t connected to a separate issue, such as women taking birth
control medications that raise their risk of clotting.
The J&J vaccine will carry a starker warning about
potential “long-term and debilitating health consequences” of the side effect.
Under the new FDA instructions, J&J’s vaccine could
still be given to people who had a severe allergic reaction to one of the other
vaccines and can’t receive an additional dose. J&J’s shot could also be an
option for people who refuse to receive the mRNA vaccines from Pfizer and
Moderna, and therefore would otherwise remain unvaccinated, the agency said.
A J&J spokesman said in an emailed statement: “Data
continue to support a favorable benefit-risk profile for the Johnson &
Johnson COVID-19 vaccine in adults, when compared with no vaccine.”
The clotting problems first came up last spring, with the
J&J shot in the U.S. and with a similar vaccine made by AstraZeneca that is
used in other countries. At that time, U.S. regulators decided the benefits of
J&J’s one-and-done vaccine outweighed what was considered a very rare ri sk
— as long as recipients were warned.
COVID-19 causes deadly blood clots, too. But the
vaccine-linked kind is different, believed to form because of a rogue immune
reaction to the J&J and AstraZeneca vaccines because of how they’re made.
Clots form in unusual places, such as veins that drain blood from the brain,
and in patients who also develop abnormally low levels of the platelets that
form clots. Symptoms of the unusual clots include severe headaches a week or
two after the J&J vaccination — not right away — as well as abdominal pain
and nausea.
The New Brunswick, New Jersey-based company announced last
month that it didn’t expect a profit from the vaccine this year and was
suspending sales projections.
The rollout of the company’s vaccine was hurt by a series of
troubles, including manufacturing problems at a Baltimore factory that forced
J&J to import millions of doses from overseas.
Additionally, regulators added warnings about the blood
clots and a rare neurological reaction called Guillain-Barré syndrome.
Pfizer and Moderna have provided the vast majority of
COVID-19 vaccines in the U.S. More than 200 million Americans have been fully
vaccinated with the companies’ two-dose shots while less than 17 million
Americans got the J&J shot. -AP
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