Ten days after they recommended a pause in the use of the Johnson & Johnson (Janssen) anti-COVID vaccine, the US Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) have issued a joint statement lifting the pause.
The FDA and CDC say the decision was taken “following a thorough safety review, including two meetings of the CDC’s Advisory Committee on Immunization Practices,” and that they “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.”
As we have reported previously, the pause followed complaints of blood clots among six women who had been administered the vaccine. Explaining how they went about analyzing the risk, they said, “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).”
They, therefore, recommended, “Use of the Janssen COVID-19 Vaccine should be resumed in the United States,” and that they “have confidence that this vaccine is safe and effective in preventing COVID-19.” On the subject of risks, they said, “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.”
“We’ve lifted the pause based on the FDA and CDC’s review of all available data and in consultation with medical experts and based on recommendations from the CDC’s Advisory Committee on Immunization Practices. We have concluded that the known and potential benefits of the Janssen COVID-19 Vaccine outweigh its known and potential risks in individuals 18 years of age and older. We are confident that this vaccine continues to meet our standards for safety, effectiveness and quality,” said Janet Woodcock, M.D., Acting FDA Commissioner.
*Feature image by Ney York National Guard via Wikimedia Commons.