FDA places strict limits on Johnson & Johnson Covid-19 vaccine

The FDA said in a statement that the change is being made because of the risk of a rare and dangerous bleeding disorder called thrombosis with thrombocytopenia syndrome (TTS) after receiving the vaccine.

“We closely monitored the Janssen COVID-19 vaccine and the occurrence of TTS after its administration and used updated information from our safety monitoring systems to revise the EUA,” said Dr Peter Marks. , director of the Center for Biologics Evaluation and Research, said in the statement. “We recognize that the Janssen COVID-19 vaccine continues to play a role in the current pandemic response in the United States and in the global community. …Today’s action demonstrates the robustness of our surveillance systems safety and our commitment to ensuring that science and data guide our actions.”

The agency confirmed to CNN that the updated authorization also applies to booster doses.

The FDA says it has determined that the benefits of the J&J vaccine outweigh the risks for some people. Here are some examples of people who might get the vaccine:

  • Those who have had a severe allergic reaction to an mRNA vaccine such as those from Pfizer/BioNTech or Moderna
  • Those with personal concerns about mRNA vaccines who would remain unvaccinated without the J&J vaccine
  • Those with limited access to Covid-19 mRNA vaccines

As of Thursday, more than 18.7 million doses of the J&J vaccine have been administered in the United States, according to the United States Centers for Disease Control and Prevention.

After a meeting in December, the CDC’s vaccine advisory committee released an updated vaccine recommendation from Johnson & Johnson, saying it makes a “preferential recommendation for the use of COVID-19 mRNA vaccines by compared to Janssen adenoviral vector COVID-19 vaccine in all persons ≥ 18 years of age in the United States.”

The committee cited the same concerns about TTS.

The CDC and FDA had previously recommended a pause in the use of this vaccine over reports of TTS. The pause was lifted, but the move came with a warning about rare clotting events.

Johnson & Johnson said in a statement at the time: “The safety and well-being of people who use our products is our number one priority. We are aware of an extremely rare disorder involving people with blood clots in combination with low platelets a small number of people who have received our COVID-19 vaccine…. We have worked closely with medical experts and health authorities, and we strongly support the open communication of this information to health professionals and the public.

In an updated vaccine fact sheet, the FDA says 15% of TTS cases have been fatal.

The agency’s updated analysis of the vaccine includes cases reported to its Vaccine Adverse Events Reporting System (VAERS) database through March 18. The FDA says it has confirmed 60 cases of TTS, including nine deaths.

Overall, the risk of TTTS is extremely rare: approximately three cases for every million doses of vaccine administered. The highest rate of TTS was observed in women aged 30 to 49. About eight cases per 1 million doses of vaccine administered are in women in this age group.

Cases of TTTS usually start one or two weeks after vaccination. Symptoms include shortness of breath, chest pain, swelling in the legs, persistent abdominal pain, neurological symptoms like headache or blurred vision, or red spots just under the skin called petechiae beyond the vaccination site .

The new warning on the vaccine information sheet states that “the Janssen Covid-19 vaccine may cause thrombosis with thrombocytopenia syndrome (TTS) which may be life-threatening”.

CNN’s Brenda Goodman and Amanda Sealy contributed to this report.


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