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FDA restricts J&J’s COVID-19 vaccine due to risk of blood clots

Virus Outbreak J And J Vaccine
Posted at 2:36 PM, May 05, 2022
and last updated 2022-05-05 21:11:00-04

The U.S. Food and Drug Administration announced on Thursday that it was limiting the authorized use of the Johnson & Johnson COVID-19 vaccine for adults due to studies showing people developing rare and potentially life-threatening blood clots.

"After conducting an updated analysis, evaluation, and investigation of reported cases, the FDA has determined that the risk of thrombosis with thrombocytopenia syndrome (TTS), a syndrome of rare and potentially life-threatening blood clots in combination with low levels of blood platelets with onset of symptoms approximately one to two weeks following administration of the Janssen COVID-19 Vaccine, warrants limiting the authorized use of the vaccine," the FDA said in a press release.

The FDA said they are limiting the vaccine to anyone over 18 who can't receive a different vaccine or elect to get J&J's vaccine.

“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," said Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research. "Our action reflects our updated analysis of the risk of TTS following administration of this vaccine and limits the use of the vaccine to certain individuals."

This isn't the first time the J&J vaccine has been hit with restrictions due to safety issues, the Associated Press reported.

In December, the Centers for Disease Control reviewed the J&J vaccine after they received reports of 54 people in the U.S. developing thrombosis with thrombocytopenia syndrome, including the reported death of seven women and two men.

The Pima County Health Department says those who have already received the J&J vaccine should not need to worry.

"I would say if you've had your vaccine and you've not had any serious issues, this is no cause for concern," said Pima County Health’s Vaccine Preventable Disease Program Manager, Crystal La Tour Rambaud. "And I would say if you're not vaccinated—you know what we're really recommending for people who have not gotten vaccinated at this point is definitely to have that conversation with a healthcare provider to really work through whatever concerns you might be having about it."

Immunologist and University of Arizona professor Dr. Janko Nikolich-Žugich, with University of Arizona Health Sciences, recommends those who got a J&J shot get a different shot for their booster, but that the Johnson & Johnson vaccine is still overall a very effective and safe vaccine.

“The risk of getting COVID, and dying from COVID or having severe COVID, or developing long COVID afterwards would be much, much, much higher than developing this very, very rare disorder, potential disorder and blood clotting," he said.

In a statement to KGUN 9, Johnson & Johnson reacted to the FDA's announcement:

"Data continue to support a favorable benefit-risk profile for the Johnson & Johnson COVID-19 vaccine in adults, when compared with no vaccine.

Johnson & Johnson continues to collaborate with health authorities and regulators around the world to ensure healthcare professionals and individuals are warned and fully informed about reports of TTS, enabling correct diagnosis, appropriate treatment, and expedited reporting.

The Johnson & Johnson COVID-19 vaccine plays a crucial role in the global fight to end the COVID-19 pandemic. The Company continues to focus its efforts on ensuring its vaccine is available during the pandemic where people are most in need."