FL Residents With Clotting Conditions Who Received Janssen Vaccine Consult Doctor

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.

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.

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.

The announcement came after further study showed the Janssen vaccine could cause thrombosis with thrombocytopenia syndrome, a fatal blood clotting condition.

The FDA and Centers for Disease Control and Prevention have identified 60 confirmed cases of the syndrome, including nine fatal cases. The agencies didn't indicate if any of those cases were in Florida.

In response to the FDA's announcement, the Florida Department of Health will distribute a new Fact Sheet for Healthcare Providers Administering Vaccine to pharmacies, clinics and doctor's offices throughout the state to alert them to the FDA's finding.

Florida residents with clotting conditions who received the Janssen vaccine should consult with their doctors.

"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 that were quickly approved by emergency authorizations at the height of the epidemic.

Although 85,000 doses of the Janssen vaccine were distributed in Florida, the majority of the 15,471,714 Floridians who have been vaccinated to date received either the Pfizer or the Moderna vaccines, 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 said thrombosis with thrombocytopenia syndrome, which results in the formation of rare and potentially life-threatening blood clots in combination with low levels of blood platelets, shows up one to two weeks after receiving the Janssen COVID-19 vaccine.

However, the FDA said it isn't removing the vaccine from the market because the risks of complications from coronavirus outweigh the risks of TTS.