FDA slows down J&J vaccine after 9th reported clotting death

FDA slows down J&J vaccine after 9th reported clotting death

FDA slows down J&J vaccine after 9th reported clotting death

Boxes of Johnson & Johnson's Janssen COVID-19 vaccine at a vaccination site in Florida.
Enlarge / Boxes of Johnson & Johnson’s Janssen COVID-19 vaccine at a vaccination site in Florida.

The U.S. Food and Drug Administration restricted the use of the Johnson & Johnson (Janssen) COVID-19 vaccine late Thursday, citing the risk of a very rare but serious bleeding disorder called thrombosis with thrombocytopenia syndrome (TTS). ).

Now, the J&J vaccine should only be used in people 18 years of age and older who are unable or unwilling to receive an alternative COVID-19 vaccine. This includes people who have had a life-threatening allergic reaction (anaphylaxis) to a COVID-19 mRNA vaccine, people who have personal concerns about COVID-19 mRNA vaccines who would otherwise not be vaccinated, and people who do not have access to COVID-19 mRNA vaccines.

The limitation comes as the FDA and Centers for Disease Control and Prevention closely monitor people who have received J&J COVID-19 vaccines for TTS. To date, agencies have identified and confirmed 60 cases of vaccine-related TTTS, including nine deaths. This represents a rate of 3.23 cases of TTS per million doses of J&J vaccine administered and a rate of 0.48 deaths from TTS per million doses of vaccine administered, the FDA announced Thursday.

Although the risks are low, the FDA has determined that these are unnecessary risks for most people, given the wide availability of mRNA vaccines (made by Moderna and Pfizer-BioNTech) that are equally effective and do not carry such risks of serious illness. And the dead.

The FDA’s decision follows a downgraded recommendation from the Centers for Disease Control and Prevention last December, which said COVID-19 mRNA vaccines were preferred over the J&J vaccine. The CDC has outlined specific cases in which the J&J vaccine might be considered, which aligns with uses listed by the FDA.

Limits and risks

In a statement Thursday, top vaccine regulator Peter Marks explained the timing of the FDA’s decision. “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. Our action reflects our updated analysis of the risk of TTS after administration of this vaccine and limits the use of the vaccine to certain individuals,” he said, and “demonstrates the robustness of our safety monitoring systems and our commitment to ensuring that science and data guide our decisions.…The agency will continue to monitor the safety of the Janssen COVID-19 vaccine and all other vaccines, and as has been throughout the pandemic, thoroughly evaluate new safety information.

TTTS is a serious condition characterized by the unusual combination of blood clots blocking a blood vessel, i.e. thrombosis, and thrombocytopenia, an overall low blood platelet count, which helps in blood clotting. The condition can be particularly dangerous if the blood clot affects the brain, as in cerebral venous sinus thrombosis (CVST), which is a rare but potentially fatal type of stroke that blocks blood from flowing from the brain.

The risk of TTS from the J&J vaccine — which uses an adenovirus-based vaccine design — was first identified in early April 2021, when the CDC suspended use of the vaccine. The FDA and CDC lifted the pause later that month after determining that the benefits of the vaccine in preventing COVID-19 outweighed the low risk of developing TTS. It’s still unclear how the vaccine can trigger the disease in rare cases, but researchers have speculated that something about the adenovirus vaccine could trigger an immune response that leads to platelet activation. and low platelet levels. Another adenovirus-based COVID-19 vaccine, made by AstraZeneca, has also been linked to rare cases of TTS.

Amid TTS reports, the CDC pause and early clinical trial data showing mRNA vaccines outperforming the J&J vaccine, use of the struggling adenovirus vaccine has plummeted in the United States. Of the 577 million doses administered to date, only 18.7 million were J&J vaccines.

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