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- “OVID-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 [Johnson & Johnson] in preventing COVID-19 outweigh the risks of side effects,” EMA said.
- The EMA’s assessment included eight reports of serious and unusual blood clots from the U.S. in patients who received the Johnson & Johnson vaccine.
- Johnson & Johnson on Tuesday said it would continue the rollout of its COVID-19 vaccine in Europe following the drug regulator’s review.
The European Union’s (EU) drug regulator says a warning should be added to Johnson & Johnson’s coronavirus vaccine indicating a possible link to rare blood clots but the overall benefits of the vaccine outweigh the risk.
“EMA’s safety committee (PRAC) concluded that a warning about unusual blood clots with low blood platelets should be added to the product information for COVID-19 Vaccine Janssen,” the European Medicines Agency (EMA) said in a statement Tuesday.
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“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 [Johnson & Johnson] in preventing COVID-19 outweigh the risks of side effects,” EMA said.
The EMA’s assessment included eight reports of serious and unusual blood clots from the U.S. in patients who received the Johnson & Johnson vaccine, one of which was fatal. Those instances were reported out of the more than 7 million Johnson & Johnson shots administered in the U.S.
The EMA said those cases occurred in people under 60 years of age within three weeks of receiving the single-dose vaccine and were mostly women. The agency said “specific risk factors have not been confirmed.”
The agency said individual EU member states should decide how to move forward with the vaccine. The rare blood clots were “very similar” to those associated with the AstraZeneca vaccine, in which the EMA made a similar recommendation.
Johnson & Johnson on Tuesday said it would continue the rollout of its COVID-19 vaccine in Europe following the drug regulator’s review. The company decided to delay distribution across Europe last week after regulators in the U.S. advised states to suspend the use of the shot.
Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, said earlier this week he believes regulators will make a decision about whether to continue using the vaccine by Friday.
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