The FDA limits the J&J vaccine. Here’s what you need to know

On May 5, the Food and Drug Administration announced that it was updating the use of the Johnson & Johnson COVID-19 vaccine. Its use is now limited to people aged 18 or over who cannot receive another COVID-19 vaccine (either because they do not have access to it or because it is not “clinically appropriate” for them – if they had a strong allergic reaction to a COVID mRNA injection in the past, for example) or who refuse to get another approved or licensed COVID-19 vaccine.

“After conducting an updated analysis, assessment, and investigation of the reported cases, the FDA has determined that the risk of thrombosis with thrombocytopenia syndrome (TTS), a rare and life-threatening blood clot syndrome in combination with low blood platelet levels with the onset of symptoms approximately one to two weeks after administration of the Janssen COVID-19 vaccine, warrants limiting the licensed use of the vaccine,” reads the FDA press release announcing the update. .

This is not the first time there have been concerns about the risks associated with the Johnson & Johnson COVID-19 vaccine. In April 2021, shortly after the Food and Drug Administration granted it emergency use authorization, federal agencies recommended a temporary pause in distribution of the J&J vaccine after six women developed this rare disorder. blood clotting after vaccination. Eleven days later, however, the break was lifted.

If you’ve received a photo from J&J, you may be concerned – understandably. Fortunately, these complications appear to be extremely rare, and the risk appears to be highest within a week or two of receiving the J&J vaccine. The FDA said it identified 60 cases of TTTS and nine deaths, but The New York Times reports that’s out of 18 million doses administered. “The FDA has determined that the notification rate for TTS is 3.23 per million doses of vaccine administered and that the notification rate for deaths from TTS is 0.48 per million doses of vaccine administered,” the report said. FDA press release.

Still, it’s good to know what symptoms to watch out for in the days and weeks after your appointment, if you’ve recently had a J&J vaccine.

For people who have received the vaccine within the past two weeks, the development of severe headache, abdominal pain, leg pain or shortness of breath is cause for concern, says Anne Schuchat, MD, deputy director. head of the Centers for Disease Control (CDC). ). If you experience these symptoms, “you should contact your health care provider and seek medical attention,” says Dr. Schuchat.

“The treatment for this specific type of blood clot is different from the treatment that might typically be given,” the Food and Drug Administration and CDC explained in an April 2021 joint statement. to treat blood clots. In this context, the administration of heparin can be dangerous and alternative treatments must be administered. Although this complication seems to be extremely rare, it is important to listen to your body and call your doctor if you are concerned.

The FDA plans to continue monitoring the safety of the J&J vaccine. “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,” said Peter Marks, MD, PhD, director of the Center for Biologics Evaluation and Research at the FDA, in the FDA statement. “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. »

In March, the CDC recommended that people who had received a J&J vaccine receive a booster shot of an mRNA vaccine. Health officials still stress the importance of getting vaccinated against COVID-19; Moderna and Pfizer both offer safe and effective mRNA vaccines against the virus.

POPSUGAR aims to provide you with the most accurate and up-to-date information on the coronavirus, but details and recommendations regarding this pandemic may have changed since publication. For the latest information on COVID-19, please consult resources from WHO, CDC, and local public health departments.

— Additional reporting by Mirel Zaman

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