FDA restricts Johnson & Johnson vaccine against COVID-19 due to rare but serious risk of blood clots

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WASHINGTON – U.S. regulators on Thursday severely restricted who can get the COVID-19 vaccine from Johnson & Johnson because of the constant risk of rare but serious blood clots.

The Food and Drug Administration said vaccination should only be given to adults who cannot get another vaccine or specifically request a J&J vaccine. For several months, US authorities have recommended that Americans who start vaccinating against COVID-19 use Pfizer or Moderna.

FDA officials said in a statement that they had decided to limit the J&J vaccine after reviewing the risk of life-threatening thrombosis within two weeks of vaccination.

The J&J vaccine was originally considered an important tool in the fight against the pandemic because it required only one injection. But the single-dose option proved to be less effective than the two-dose vaccines Pfizer and Moderna.

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In December, the Centers for Disease Control and Prevention recommended that Moderna and Pfizer shoot before J&J’s because of security concerns. Previously, U.S. officials treated all three vaccines equally because each was shown to provide strong protection.

But subsequent studies have consistently shown less effectiveness of J & J’s vaccine. And although blood clots seen with J&J injections are rare, officials say they still appear.

By mid-March, federal scientists had identified 60 cases, including nine fatal. That’s one case of a blood clot in 3.23 million injections made by J&J, the FDA said Thursday. The vaccine will have a more serious warning about the possible “long-term and debilitating health effects” of the side effect.

WATCH: What do we know about vaccinations from COVID-19?

Under new FDA guidelines, the J&J vaccine can still be given to people who have had a severe allergic reaction to one of the other vaccines and cannot receive an extra dose. A J&J injection may also be an option for people who refuse Pfizer and Moderna mRNA vaccines, and therefore will otherwise remain unvaccinated, the agency said.

A J&J spokesman said in an e-mail: “The data continue to support a favorable benefit-risk profile for the Johnson & Johnson COVID-19 vaccine in adults compared to the lack of the vaccine.”

Despite the restriction, FDA vaccine chief Dr. Peter Marx said the J&J vaccine “still has a role to play in the ongoing response to the pandemic in the United States and around the world.”

The FDA based its decision on “our security oversight systems and our commitment to science and data driving our decisions.”

Coagulation problems first arose last spring when the U.S. was vaccinated with J&J, as well as with a similar AstraZeneca vaccine used in other countries. At the time, U.S. regulators decided that the benefits of the J&J vaccine “one-on-one” outweighed what was considered a very rare risk – as long as recipients were warned.

COVID-19 also causes fatal blood clots. But the vaccine-related species is different, it is believed that it is formed due to an unpleasant immune response to the J&J and AstraZeneca vaccines because of the way they are made. It is formed in unusual places, such as veins that drain blood from the brain, as well as in patients who also develop abnormally low levels of platelets that form blood clots. Symptoms of unusual clots include severe headaches a week or two after J&J vaccination – not immediately – as well as abdominal pain and nausea.

The company from New Brunswick, New Jersey, announced last month that it does not expect profits from the vaccine this year and is suspending sales forecasts.

The company’s vaccine deployment has been damaged by a number of troubles, including production problems at the Baltimore plant, which have forced J&J to import millions of doses from abroad.

In addition, regulators have added warnings about blood clots and a rare neurological reaction called Hyena-Barre 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 double-dose injections, while less than 17 million Americans have been vaccinated with J&J.
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The Associated Press Department of Health and Science receives support from the Department of Science Education of the Howard Hughes Medical Institute. AP is solely responsible for all content.

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