FDA restricts use of J&J COVID-19 vaccine due to blood clot risk

WASHINGTON (AP) — U.S. regulators on Thursday strictly limited who can receive Johnson & Johnson’s COVID-19 vaccine due to the ongoing risk of rare but serious blood clots.

The Food and Drug Administration has said the vaccine should only be given to adults who cannot receive a different vaccine or who specifically request J&J’s vaccine. U.S. authorities have been recommending for months that Americans starting their COVID-19 vaccinations use the Pfizer or Moderna vaccines instead.

FDA officials said in a statement that they decided to restrict J&J’s vaccine after reviewing data on the risk of life-threatening blood clots within two weeks of vaccination.

J&J’s vaccine was initially considered an important tool in the fight against the pandemic because it required only one injection. But the single-dose option was found to be less effective than two doses of the Pfizer and Moderna vaccines.

In December, the Centers for Disease Control and Prevention recommended prioritizing injections from Moderna and Pfizer over those from J&J due to its safety concerns. Previously, US officials had treated all three vaccines the same because they had each been shown to offer strong protection.

But follow-up studies have consistently shown less efficacy for J&J’s vaccine. And while the blood clots seen with the J&J shot are rare, officials say they still happen.

Federal scientists identified 60 cases, including nine fatalities, as of mid-March. That equates to one case of a blood clot for every 3.23 million J&J injections administered, the FDA said Thursday. The vaccine will carry a harsher warning about the potential “long-term and debilitating health consequences” of the side effect.

According to new FDA instructions, J&J’s vaccine could still be given to people who have had a severe allergic reaction to one of the other vaccines and cannot receive an additional dose. J&J’s vaccine could also be an option for people who refuse to receive mRNA vaccines from Pfizer and Moderna, and who would otherwise remain unvaccinated, the agency said.

A J&J spokesperson said in an emailed statement: “Data continue to support a favorable benefit-risk profile for the Johnson & Johnson COVID-19 vaccine in adults, compared to no vaccine. “

Despite the restriction, FDA vaccine chief Dr. Peter Marks said J&J’s vaccine “still plays a role in the current pandemic response in the United States and in the global community.”

The FDA based its decision on “our safety oversight systems and our commitment to ensuring that science and data guide our decisions.”

Clotting problems first emerged last spring, with the J&J vaccine in the United States and with a similar vaccine made by AstraZeneca that is used in other countries. At that time, US regulators decided that the benefits of J&J’s unique vaccine outweighed what was considered a very rare risk – as long as recipients were warned.

COVID-19 also causes deadly blood clots. But the vaccine-related type is different, thought to form due to an adverse immune reaction to the J&J and AstraZeneca vaccines due to the way they are made. It forms in unusual places, such as veins that drain blood from the brain, and in patients who also develop abnormally low levels of platelets that form clots. Symptoms of 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 did not expect a profit from the vaccine this year and was suspending its sales projections.

The company’s vaccine rollout has been affected by a series of issues, including manufacturing issues at a Baltimore plant that forced J&J to import millions of doses from overseas.

Additionally, regulators added warnings about blood clots and a rare neurological reaction called Guillain-Barré syndrome.

Pfizer and Moderna have supplied the vast majority of COVID-19 vaccines in the United States. More than 200 million Americans have been fully vaccinated with the companies’ two-dose vaccines, while fewer than 17 million Americans have received the J&J vaccine.

The Associated Press Health and Science Department is supported by the Howard Hughes Medical Institute Department of Science Education. The AP is solely responsible for all content.


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