By NewsDesk @infectiousdiseasenews
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 today.
This was following a thorough safety review, including two meetings of the CDC’s Advisory Committee on Immunization Practices.
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.
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 American Medical Association (AMA) released the following statement concerning ACIPs decision:
“The AMA commends the Advisory Committee on Immunization Practices (ACIP) for today reaffirming its recommendation on the use of the Janssen COVID-19 vaccine for persons 18 years of age and older in the U.S. population under the Food and Drug Association’s (FDA) Emergency Use Authorization. The population-level data presented during ACIP’s meeting today clearly demonstrates that the benefits of this approach outweigh the risks.
“The AMA will continue to work with the FDA and the Centers for Disease Control and Prevention (CDC) to ensure physicians and patients are aware of the rare, but increased risk of thrombosis with thrombocytopenia syndrome (TTS) in women under the age of 50, as well as the appropriate treatment, so they can act quickly. The pause on the Janssen COVID-19 vaccine has demonstrated the strength of our nation’s vaccine safety monitoring system and the transparent and careful deliberations by the ACIP should raise confidence in FDA-authorized and CDC-recommended COVID-19 vaccines. The AMA continues to encourage everyone who is eligible for COVID-19 vaccines to get vaccinated as soon as possible. Even after being vaccinated, we urge everyone to continue wearing masks, maintaining physical distancing and washing hands to prevent the spread of COVID-19 to those who haven’t yet been vaccinated.”
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