“On April 13, 2021, the CDC and the Food and Drug Administration (FDA) recommended pausing use of the Janssen COVID-19 vaccine after reports of thrombosis with thrombocytopenia syndrome (TTS) among vaccine recipients. On April 23, 2021, the Advisory Committee on Immunization Practices concluded that the benefits of resuming Janssen COVID-19 vaccination among persons aged ≥18 years outweighed the risks and reaffirmed its interim recommendation under FDA’s Emergency Use Authorization, which includes a new warning for rare clotting events among women aged 18-49 years.
TTS is a rare syndrome that involves acute venous or arterial thrombosis and new onset thrombocytopenia in patients with no recent known exposure to heparin. Although the mechanism that causes TTS is not fully understood, TTS appears to be similar to heparin-induced thrombocytopenia, a rare reaction to heparin treatment. In the United States, 12 of 15 persons with TTS that occurred after Janssen COVID-19 vaccination had CVST with thrombocytopenia.
While evaluating the evidence to support updated interim recommendations for the use of the Janssen COVID-19 vaccine in the United States, ACIP reviewed a risk-benefit assessment of TTS events after vaccination. This assessment took into account:
– The rate and characteristics of TTS cases
Updated Recommendations from the Advisory Committee on Immunization Practices for Use of the Janssen (Johnson & Johnson) COVID-19 Vaccine After Reports of Thrombosis with Thrombocytopenia Syndrome Among Vaccine Recipients — United States, April 2021
– Recent COVID-19 epidemiology
– Modeling and risk-benefit analysis results to quantify COVID-19 vaccinaton programs regarding whether changes to ACIP recommendations would disproportionately affection certain populations.”
Read the research and outcomes on the CDC’s Morbidity and Mortality Weekly Report. Remember, get vaccinated; it is the only way we are going to beat this invisible monster!
Stay well, mask up indoors, and stay tuned!