FDA places limits on Johnson & Johnson’s COVID vaccine

Use of Johnson & Johnson’s COVID-19 vaccine in the United States should be limited to people who cannot take COVID-19 vaccines from Pfizer or Moderna, the US Food and Drug Administration said Thursday, citing a risk for a rare but life-threatening disease. blood clotting disorder.

Johnson & Johnson’s vaccine may also be reserved for people who do not have access to a COVID-19 vaccine other than J&J, or those who still choose Johnson & Johnson because they do not have the mRNA vaccines of Pfizer or Moderna, notes the FDA. Indeed, the benefits of being vaccinated against COVID-19 still outweigh the rare risk seen with Johnson & Johnson’s vaccine, according to the agency.

The FDA’s decision echoes a similar December recommendation from the US Centers for Disease Control and Prevention, which says people should get COVID-19 vaccines or boosters from Pfizer and Moderna instead of Johnson & Johnson. .

Both the FDA update and the CDC recommendation address thrombosis with thrombocytopenia, or TTS, which is a rare, dangerous, and specific blood clotting disorder that causes low platelet counts in addition to blood clots. This can make treatment with a common blood-clotting drug, heparin, dangerous. The risk is highest for women between the ages of 30 and 49, a CDC roundtable concluded in December before issuing the recommendation, but cases have been identified in both sexes and in multiple age groups. The FDA said Thursday that 60 cases had been identified through March 2022 and nine people had died from the disease. That’s about 3 cases per million Johnson & Johnson doses, the FDA said. Nearly one million people have died from COVID-19 in the United States.

“Today’s action demonstrates the robustness of our safety oversight systems and our commitment to ensuring that science and data guide our decisions,” said Dr Peter Marks, Director of Assessment and FDA Biologics Research, in a press release. “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.”

According to an FDA fact sheet, symptoms of TTTS usually begin one to two weeks after vaccination. They don’t appear in people who had a J&J injection months ago.

“Our number one priority is the safety and well-being of those using the Johnson & Johnson COVID-19 vaccine,” Johnson & Johnson said. “Johnson & Johnson, in close coordination with the U.S. Food and Drug Administration (FDA), has updated its U.S. COVID-19 vaccine fact sheet to increase awareness of the risk of thrombosis with thrombocytopenia syndrome (TTS), a rare but life-threatening condition.”

The company said the data continued to show a favorable benefit-risk profile compared to no vaccine.

When the CDC recommended vaccines from Pfizer and Moderna over those from Johnson & Johnson, part of the reason given was the wide availability of the two mRNA vaccines. Earlier in the pandemic, when COVID-19 vaccines became available in waves and were in short supply in some places, public health advice was to get whatever vaccine you can.

Johnson & Johnson is widely used in low- and middle-income countries, often as the only vaccine available. According to Our World in Data, only 15.8% of people in low-income countries have received a dose of the COVID-19 vaccine.

“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,” Marks said in Thursday’s press release.

The information in this article is for educational and informational purposes only and is not intended to constitute medical or health advice. Always consult a physician or other qualified health care provider with any questions you may have about a medical condition or health goals.

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