FDA restricts J&J’s COVID-19 vaccine due to risk of blood clots

WASHINGTON – U.S. regulators on Thursday tightly restricted who can receive Johnson & Johnson’s COVID-19 vaccine amid the ongoing risk of rare but serious blood clots.

The Food and Drug Administration said the shot should only be given to adults who don’t receive another vaccine or who can specifically request J&J’s vaccine. US authorities have been recommending Americans for months to get Pfizer or Moderna vaccines instead of J&J’s vaccine.

FDA vaccine chief Dr. Peter Marks, said the agency decided to restrict the vaccine after looking back at data on the risk of life-threatening blood clots and concluding it was limited to J&J’s vaccine.

“If there’s an alternative that seems equally effective in preventing serious consequences from COVID-19, we’d rather see people choose it,” Marks said. “But we said that carefully — compared to no vaccine — it’s still a better option.”


The problem occurs in the first two weeks after vaccination, he added: “So if you were vaccinated six months ago, you can sleep easy tonight knowing that this is not a problem.”

The FDA approved J&J’s Shot for adults ages 18 and older in February last year.

The vaccine was initially considered an important tool in the fight against the pandemic because it only required one vaccination. However, 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 vaccinations over J&Js because of safety issues with Moderna and Pfizer.

By mid-March, federal scientists had identified 60 cases of the side effect, including nine with a fatal outcome. This equates to 3.23 cases of blood clots per 1 million J&J vaccinations. The problem is more common in women under the age of 50, where the fatality rate was about 1 per million gunshots, according to Marks.


Marks said the FDA spent additional time analyzing the issue to make sure it wasn’t related to another issue, such as: B. Women taking birth control medications that increase their risk of clotting.

The J&J vaccine will include a clearer warning about possible “long-term and debilitating health consequences” of the side effect.

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

A J&J spokesman said in an emailed statement, “The data continue to support a favorable benefit-risk profile for Johnson & Johnson’s COVID-19 vaccine in adults compared to no vaccine.”

The clotting problems first emerged last spring with the J&J vaccine in the US and with a similar vaccine from AstraZeneca used in other countries. Back then, US regulators decided that the benefits of J&J’s one-and-done vaccine outweighed the risk, which was considered very rare — as long as recipients were warned.


COVID-19 also causes deadly blood clots. But the vaccine-associated species is different, which is believed to form due to a malignant immune response to the J&J and AstraZeneca vaccines, due to how they are manufactured. Clots form in unusual places, such as B. veins, which drain blood from the brain, and in patients who also develop abnormally low levels of blood platelets, which form clots. Symptoms of the unusual blood clots include a severe headache a week or two after the J&J vaccination—not immediately—as well as abdominal pain and nausea.

The New Brunswick, New Jersey-based company announced last month that it expects no profit from the vaccine this year and is suspending sales forecasts.

The launch of the company’s vaccine was marred by a series of problems, including manufacturing problems at a Baltimore factory that forced J&J to import millions of doses from overseas.

In addition, regulators added warnings about 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 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.


This version corrects the rate of blood clots reported with the J&J vaccine. It’s 3.23 cases per 1 million vaccinations.


The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Department of Science Education. The AP is solely responsible for all content.

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Justin Scacco

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