FDA restricts J&J’s COVID-19 vaccine due to rare but serious risk of blood clots – National

US regulators on Thursday strictly limited who can receive Johnson & Johnson’s COVID-19 vaccine due to the continued risk of rare but serious blood clots.

The Food and Drug Administration said the shot should only be given to adults who are unable to receive a different vaccine or specifically request the J&J vaccine. US authorities have for months recommended that Americans starting their COVID-19 vaccinations use the Pfizer or Moderna shots instead.

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

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J&J’s vaccine was initially seen as an important tool in fighting the pandemic because it only required one shot. But the single-dose option was less effective than two doses of the Pfizer and Moderna vaccines.

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

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

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

Under the new FDA instructions, the J&J vaccine could still be given to people who had a severe allergic reaction to one of the other vaccines and can’t get an extra dose. The J&J shot could also be an option for people who refuse to receive the Pfizer and Moderna mRNA vaccines and therefore would not get vaccinated, the agency said.

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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.”

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

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

Clotting problems first surfaced last spring, with the J&J injection in the US and with a similar vaccine made by AstraZeneca used in other countries. At the time, US regulators decided that the benefits of J&J’s single 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-associated type is different, it is believed to form due to a rogue immune reaction to J&J and AstraZeneca vaccines due to the way they are manufactured. It forms in unusual places, such as the veins that drain blood from the brain, and in patients who also develop abnormally low levels of clot-forming platelets. Symptoms of unusual clots include severe headaches one to two weeks after the J&J vaccine, 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 to profit from the vaccine this year and was suspending sales projections.

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

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

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

© 2022 The Canadian Press

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