FDA restricts use of J&J’s COVID-19 vaccine over blood clot risk

WHAT YOU NEED TO KNOW:

• The FDA on Thursday limits the use of J&J’s COVID-19 vaccine due to the risk of rare blood clots.
• The agency said it should only be given to adults who cannot receive a different vaccine or specifically choose the Janssen vaccine.
• U.S. regulators made the decision after “conducting an updated analysis, evaluation and investigation of reported cases” of the blood clots.”

The U.S. Food and Drug Administration (FDA) announced Thursday that it is limiting the authorization for the use of Johnson & Johnson’s COVID-19 vaccine, or the Janssen vaccine.

Citing the risk of rare blood clots, U.S. regulators said the Janssen vaccine is now limited to people for whom other vaccines “are not accessible or clinically appropriate,” or “who elect to receive the Janssen COVID-19 Vaccine because they would otherwise not receive a COVID-19 vaccine.” 

The agency said people can still receive the J&J vaccine if they are allergic to either Pfizer or Moderna mRNA vaccines, or if personal concerns with different vaccines would lead to foregoing inoculation.

On April 13, 2021, the FDA and the CDC recommended a pause in using the J&J vaccine “out of an abundance of caution” after cases of blood clots have been reported. Ten days later, after “following a thorough safety review,” the recommended pause was lifted.

In December 2021, both federal health agencies called again for another pause in the use of the Janssen vaccine.

The FDA said Thursday that the limited authorization was made after “conducting an updated analysis, evaluation and investigation of reported cases” of the blood clots — formally known as thrombosis with thrombocytopenia syndrome (TTS).

The agency stressed that Pfizer and Moderna mRNA vaccines do not carry blood clot risks because they use different technology to manufacture the vaccines.

Sixty confirmed cases of the blood clots have been confirmed after the administration of the J&J vaccine. There were nine reported deaths.

The J&J single-dose COVID‑19 vaccine has not been fully authorized or licensed by the FDA but it has been issued Emergency Use Authorization (EUA) in February 2021.

About 18 million doses of J&J vaccine have been administered already in the United States.

Source: The Hill