• By Robin Foster and Ernie Mundell HealthDay Reporters
• Posted May 5, 2022

FDA Limits Use of J&J COVID Vaccine Due to Blood Clot Risk

Citing the accumulated data on a raised risk for a type of dangerous blood clot, the U.S. Food and Drug Administration on Thursday greatly restricted the recommended use of the Johnson & Johnson COVID-19 vaccine.

With safer two-dose vaccines such as Pfizer and Moderna widely available, the one-dose J&J shot should be limited "to individuals 18 years of age and older for whom other authorized or approved COVID-19 vaccines are not accessible or clinically appropriate," the agency said in a statement.

It may also be used by "individuals 18 years of age and older who elect to receive the Janssen COVID-19 Vaccine because they would otherwise not receive a COVID-19 vaccine [at all]," the FDA advised.

While the J&J vaccine has appealed to some because it only requires one-dose, data soon emerged suggesting a higher risk in users of a rare form of blood clot known as thrombocytopenia syndrome (TTS).

According to the FDA, TTS is "a syndrome of rare and potentially life-threatening blood clots in combination with low levels of blood platelets."

Some people -- often young males -- typically developed symptoms about a week or two after getting the J&J shot. The data accumulated on this risk now "warrants limiting the authorized use of the vaccine," the agency said.

Getting the J&J vaccine can still help prevent serious illness with COVID-19, so the shot "still has a role in the current pandemic response in the United States and across the global community," Dr. Peter Marks, director of the FDA's Center for Biologics Evaluation and Research, said in the statement.

But "our action reflects our updated analysis of the risk of TTS following administration of this vaccine," he said, "and limits the use of the vaccine to certain individuals."

Marks added that "the agency will continue to monitor the safety of the Janssen [J&J] COVID-19 Vaccine and all other vaccines, and as has been the case throughout the pandemic, will thoroughly evaluate new safety information."

The vaccine first received an emergency use authorization in late February of 2021. But after six cases of TTS were reported, the FDA placed a temporary "pause" on use of the J&J shot as it gathered more data.

That pause was lifted on April 23, 2021, when a total of 15 cases of TTS were reported from the more than 8 million vaccine doses doled out across across the United States.

At the time, "the known and potential benefits of Janssen [J&J] COVID-19 Vaccine outweighed its known and potential risks in individuals 18 years of age and older," the FDA said.

However, by December, the agency advised that mRNA COVID vaccines (those made by Pfizer or Moderna) were now preferred over the J&J shot.

In the latest assessment, the FDA noted that by March 18, 2022, "the FDA and CDC have identified 60 confirmed cases, including nine fatal cases," of TTS in people who'd received the J&J vaccine.

The risk still remains extremely rare: About three cases for every 1 million doses of vaccine administered. It's remains unclear if any specific factors place an individual at heightened risk for the blood clots after receiving the vaccine.

While very rare, TTS can quickly prove dangerous, however. Patients "may rapidly deteriorate, despite prompt diagnosis and treatment," the FDA said, and the clots "can lead to long-term and debilitating health consequences," including a high risk for death.

So, the latest recommendation is that the J&J vaccine be used only by people who might have a serious allergic reaction to the Pfizer or Moderna vaccines, or those who (for whatever reason) do not wish to receive an mRNA vaccine and who would therefore otherwise remain unvaccinated.

More information

Find out more about COVID-19 vaccines at the U.S. Centers for Disease Control and Prevention.

SOURCE: U.S. Food and Drug administration, news release, May 5, 2022