EMA adds warning to J&J’s COVID-19 vaccine, says data insufficient to determine cause of rare clotting

Although the safety warning EMA is adding to the Johnson & Johnson COVID-19 vaccine is similar to the warning it mandated for another adenoviral vector COVID-19 vaccine, AstraZeneca’s Vaxzevria — and the effects have not been observed in association with mRNA COVID-19 vaccines — the agency said Tuesday there are insufficient data to assert that there is a class effect.  

EMA has concluded that the benefits outweigh the risks for both vaccines. CDC’s Advisory Committee on Immunization Practices (ACIP) has scheduled an April 23 meeting to discuss recommendations for use of the vaccine in the U.S. following FDA’s April 13 decision to pause use of the Johnson & Johnson (NYSE:JNJ) vaccine pending investigation of rare blood clotting events. ...