Janssen COVID-19 Vaccine Could Cause Blood Clots, Officials Warn
FLORIDA — Further testing shows that one of the vaccines used to protect people against COVID-19 could cause blood clots, according to the Florida Department of Health, which is providing a new Fact Sheet for Healthcare Providers Administering Vaccine noting the risks of the vaccine to pharmacies, clinics and doctor's offices throughout the state.
On Thursday, the U.S. Food and Drug Administration limited the authorized use of the Janssen COVID-19 Vaccine to people 18 years of age and older who have no access to any other vaccine or voluntarily choose to use the Janssen 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 Dr. Peter Marks, 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."
He said the FDA's announcement doesn't mean the agency made a mistake when it authorized the vaccine for emergency use on Feb. 27, 2021. Instead, it shows how closely the agency is monitoring the coronavirus vaccines quickly approved at the height of the epidemic.
Although the Janssen vaccine has been distributed in Florida, the majority of the 15,471,714 Floridians vaccinated have received either the Pfizer or the Moderna vaccines. Florida received 37,000 single-dose allocations of the Janssen vaccine in April 2021 and 48,100 doses of the Janssen vaccine in May 2021, according to the CDC.
“Today’s action demonstrates the robustness of our safety surveillance systems and our commitment to ensuring that science and data guide our decisions," he said. "We’ve been closely monitoring the Janssen COVID-19 vaccine and occurrence of TTS (thrombosis with thrombocytopenia syndrome) following its administration, and have used updated information from our safety surveillance systems to revise the EUA. The agency will continue to monitor the safety of the Janssen COVID-19 vaccine and all other vaccines, and as has been the case throughout the pandemic, will thoroughly evaluate new safety information.”
After conducting an updated analysis, evaluation and investigation of reported cases, the FDA has determined that the risk of thrombosis with thrombocytopenia syndrome, 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.
Nevertheless, the FDA added in its announcement that the known and potential benefits of the vaccine for the prevention of COVID-19 outweigh the known and potential risks for people 18 years of age and older who don't have access to another manufacturer's vaccine.
In an updated analysis of TTS cases following administration of the Janssen COVID-19 vaccine through March 18, the FDA and Centers for Disease Control and Prevention have identified 60 confirmed cases, including nine fatal cases.
Janssen COVID-19 Vaccine Could Cause Blood Clots, Officials Warn originally appeared on the Tampa Patch
