The Food and Drug Administration announced that following a safety review, the agency and the Centers for Disease Control and Prevention have determined that the recommended pause regarding the use of the Johnson & Johnson COVID-19 Vaccine in the U.S. should be lifted and use of the vaccine should resume. The agencies said: “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.”
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