Use of Johnson & Johnson's COVID-19 vaccine in the US should be limited to people who can't take Pfizer's or Moderna's COVID-19 vaccines, the US Food and Drug Administration said Thursday, citing a risk for a rare but potentially life-threatening blood-clotting disorder.
Johnson & Johnson's vaccine can also be reserved for people who don't have access to a COVID-19 vaccine other than J&J, or those who still choose Johnson & Johnson because they don't want Pfizer's or Moderna's mRNA vaccines, the FDA notes. That's because the benefits of the vaccine still outweigh the risks of not being vaccinated against COVID-19, the agency said.
The FDA move echoes a December recommendation from the US Centers for Disease Control and Prevention, which says people should receive Pfizer's and Moderna's COVID-19 vaccines or booster shots instead of Johnson & Johnson.
Both the FDA update and CDC recommendation center on thrombosis with thrombocytopenia or TTS, which is a rare, dangerous and specific blood clotting disorder which causes low platelets in addition to blood clots. This can make treating it with common blood clotting drug, heparin, dangerous. The risk is highest for women ages 30 to 49, a CDC panel discussion concluded in December before issuing the recommendation, but cases have been identified in both sexes and more age groups. The FDA said Thursday that 60 cases have been identified through March 2022 and nine people have died from the disorder. That's about 3 cases per million doses of Johnson & Johnson, the FDA said. Nearly 1 million people have died from COVID-19 in the US.
"Today's action demonstrates the robustness of our safety surveillance systems and our commitment to ensuring that science and data guide our decisions," Dr. Peter Marks, director of the FDA's Biologics Evaluation and Research, said in a press release. "We've been closely monitoring the Janssen COVID-19 Vaccine and occurrence of TTS following its administration and have used updated information from our safety surveillance systems to revise the EUA."
Symptoms of TTS usually begin within one to two weeks after vaccination according to an FDA fact sheet. They don't turn up in people who had a J&J shot months ago.
"Our number one priority is the safety and well-being of those who use 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 about the risk of thrombosis with thrombocytopenia syndrome (TTS), a rare but potentially life-threatening condition."
The company said data continues to show a favorable benefit-risk profile compared to no vaccine.
When the CDC panel recommended Pfizer's and Moderna's vaccines over Johnson & Johnson's, part of the reason it gave was the wide availability and impressive safety record of both mRNA vaccines. Earlier in the pandemic, when COVID-19 vaccines became available in waves and were scarce in some places, the public health advice was to get whatever vaccine you could.
Johnson & Johnson is widely used in low- and middle-income countries -- oftentimes as the only available vaccine. As few as 15.8% of people in low-income countries have received a dose of COVID-19 vaccine, according to Our World in Data.
"We recognize that the Janssen COVID-19 Vaccine still has a role in the current pandemic response in the United States and across the global community," Marks said in Thursday's press release.
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