For Immediate Release: April 23, 2021 Following a thorough security review, consisting of two meetings of the CDC's Advisory Committee on Immunization Practices, the U.S. Fda and the U.S. Centers for Disease Control and Avoidance have identified that the recommended pause regarding making use of the Johnson & Johnson (Janssen) COVID-19 Vaccine in the U.S. need to be raised and usage of the vaccine need to resume. The pause was suggested after reports of six cases of a rare and severe kind of embolism in people following administration of the Janssen COVID-19 Vaccine. During the time out, medical and scientific groups at the FDA and CDC analyzed readily available data to evaluate the threat of thrombosis involving the cerebral venous sinuses, or CVST (large capillary in the brain), and other sites in the body (consisting of but not limited to the big capillary of the abdomen and the veins of the legs) along with thrombocytopenia, or low blood platelet counts.
The 2 agencies have identified the following: Use of the Janssen COVID-19 Vaccine must be resumed in the United States. The FDA and CDC have self-confidence that this vaccine is safe and reliable in avoiding COVID-19. The FDA has actually figured out that the available data reveal that the vaccine's recognized and possible benefits surpass its recognized and possible dangers in individuals 18 years of age and older. At this time, the offered data recommend that the possibility of TTS occurring is extremely low, however the FDA and CDC will stay vigilant in continuing to investigate this risk. Health care suppliers administering the vaccine and vaccine receivers or caregivers ought to review the Janssen COVID-19 Vaccine Truth Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers) and Reality Sheet for Receivers and Caregivers, which have been modified to consist of information about the danger of this syndrome, which has actually occurred in a really small number of people who have received the Janssen COVID-19 Vaccine.