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FDA Restricts Use of J&J’s COVID-19 Vaccine over Blood Clot Risk


May 9, 2022

On Thursday, the U.S. Food and Drug Administration (FDA) announced that it had limited the authorized use of the Johnson & Johnson (J&J; also referred to as Janssen) COVID-19 vaccine due to the risk of developing thrombosis with thrombocytopenia syndrome (TTS), a disorder of blood clots in combination with low levels of blood platelets, within two weeks of vaccination. In April of 2021, the Centers for Disease Control and Prevention (CDC) and FDA had paused the use of the J&J COVID-19 vaccine because of reports of rare and dangerous blood clots; however, the pause was lifted that same month.

The FDA stated in a news release that it had made the decision after "conducting an updated analysis, evaluation, and investigation of reported cases," which "warrants limiting the authorized use of the vaccine."

Use of the J&J vaccine has been limited "to individuals 18 years of age and older for whom other authorized or approved COVID-19 vaccines are not accessible or clinically appropriate, and to individuals 18 years of age and older who elect to receive the Janssen COVID-19 vaccine because they would otherwise not receive a COVID-19 vaccine. "

Peter Marks, MD, PhD, Director of the FDA's Center for Biologics Evaluation and Research, was quoted in the news release saying, "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. 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 . . . Today's action demonstrates the robustness of our safety surveillance systems and our commitment to ensuring that science and data guide our decisions. We've been closely monitoring the Janssen COVID-19 vaccine and occurrence of TTS following its administration and have used updated information from our safety surveillance systems to revise the EUA [emergency use authorization]. 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."

Click here to access the relevant FDA news release, and click here to read more on this story.

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