The U.S. Food and Drug Administration (FDA) has restricted the approved use of the Janssen COVID-19 Vaccine to people 18 years of age and older for whom other approved or authorized COVID-19 vaccines are medically unsuitable or not available and to people 18 years of age and older who choose to get the Janssen COVID-19 Vaccine due to the fact that they would otherwise not get a COVID-19 vaccine.
After performing an upgraded analysis, assessment, and examination of reported cases, the FDA has actually figured out that the threat of apoplexy with thrombocytopenia syndrome (TTS), a syndrome of possibly lethal and unusual embolism in the mix with low levels of blood platelets with the start of signs around one to 2 weeks following administration of the Janssen COVID-19 Vaccine, warrants restricting the licensed use of the vaccine.
The FDA has actually identified that the possible and recognized advantages of the vaccine for the avoidance of COVID-19 exceed the recognized and possible dangers for people 18 years of age and older for whom other licensed or authorized COVID-19 vaccines are scientifically suitable or not available, and for people 18 years of age and older who choose to get the Janssen COVID-19 Vaccine due to the fact that they would otherwise not get a COVID-19 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. 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,” said Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research. “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. 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.”
