FDA and CDC Lift Recommended Pause on Johnson & Johnson (Janssen) COVID-19 Vaccine Use Following Thorough Safety Review
Agencies Underscore Confidence in Vaccine’s Safety and Effectiveness Following Data Assessment; Available Data Suggest Potential Blood Clots Are Very Rare Events
Following a thorough safety review, including two meetings of the CDC’s Advisory Committee on Immunization Practices, the U.S. Food and Drug Administration and the U.S. Centers for Disease Control and Prevention have determined that the recommended pause regarding the use of the Johnson & Johnson (Janssen) COVID-19 Vaccine in the U.S. should be lifted and use of the vaccine should resume.
The pause was recommended after reports of six cases of a rare and severe type of blood clot in individuals following administration of the Janssen COVID-19 Vaccine. During the pause, medical and scientific teams at the FDA and CDC examined available data to assess the risk of thrombosis involving the cerebral venous sinuses, or CVST (large blood vessels in the brain), and other sites in the body (including but not limited to the large blood vessels of the abdomen and the veins of the legs) along with thrombocytopenia, or low blood platelet counts. The teams at FDA and CDC also conducted extensive outreach to providers and clinicians to ensure they were made aware of the potential for these adverse events and could properly manage and recognize these events due to the unique treatment required for these blood clots and low platelets, also known as thrombosis-thrombocytopenia syndrome (TTS).
The two agencies have determined the following:
- Use of the Janssen COVID-19 Vaccine should be resumed in the United States.
- The FDA and CDC have confidence that this vaccine is safe and effective in preventing COVID-19.
- The FDA has determined that the available data show that the vaccine’s known and potential benefits outweigh its known and potential risks in individuals 18 years of age and older.
- At this time, the available data suggest that the chance of TTS occurring is very low, but the FDA and CDC will remain vigilant in continuing to investigate this risk.
- Health care providers administering the vaccine and vaccine recipients or caregivers should review the Janssen COVID-19 Vaccine Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers) and Fact Sheet for Recipients and Caregivers, which have been revised to include information about the risk of this syndrome, which has occurred in a very small number of people who have received the Janssen COVID-19 Vaccine.
Additional Resources:
 The FDA is scheduled to hold a joint virtual press conference with the U.S. Centers for Disease Control and Prevention to discuss the Johnson & Johnson (Janssen) COVID-19 Vaccine.
As part of the FDA’s commitment to transparency, we invite you to watch our virtual press conference, to be live streamed over the FDA’s YouTube page. Acting FDA Commissioner, Janet Woodcock, M.D., Director of FDA’s Center for Biologics Evaluation and Research, Peter Marks, M.D., Ph.D., Director, CDC, Rochelle P. Walensky, M.D., M.P.H., and Principal Deputy Director, CDC, Anne Schuchat M.D. will be taking questions.
When: Fri., Apr. 23, 7:15 p.m. ET
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