The European Medicines Agency (EMA) said Tuesday that unusual blood clots should be listed as a "very rare" side effect of Johnson & Johnson's coronavirus vaccine, but that the benefits of the shot still outweigh the risks.
Why it matters: The agency's determination of a "possible link" to a rare kind of blood clot comes ahead of an expected ruling by the U.S. FDA this week on whether to lift its pause on the J&J vaccine rollout.
Details: Since the J&J vaccine has not yet been distributed in Europe outside of clinical trials, the data that the EMA reviewed came from the eight reports of rare blood clots reported in the U.S. out of 7 million total doses administered.
- "COVID-19 is associated with a risk of hospitalisation and death. The reported combination of blood clots and low blood platelets is very rare, and the overall benefits of COVID-19 Vaccine Janssen in preventing COVID-19 outweigh the risks of side effects," the EMA said in a statement.
- The agency recently made a similar recommendation about the AstraZeneca vaccine, determining that the benefits of its protection against COVID-19 outweigh the risks of rare blood clots.
Between the lines: Most Americans support the pause in distribution of the Johnson & Johnson COVID-19 vaccine, and so far there's no evidence that it's leading to broader vaccine hesitancy, according to the latest installment of the Axios/Ipsos Coronavirus Index.
