EU Regulator: Benefits Of J&J Vaccine Outweigh Risks Despite 'Possible' Clot Link
The European Medicines Agency says a warning about blood clots should be added to labels for Johnson & Johnson’s COVID-19 vaccine.
Experts at the agency that regulates drugs for the European Union say they found a “possible link” between the Johnson & Johnson COVID-19 vaccine and very rare blood clots after a small number of cases were reported in the United States.
But they say the vaccine’s benefits still outweigh the very small risks of recipients developing the unusual clots.
EMA’s safety committee (#PRAC) recommends adding ‘very rare cases of unusual blood clots with low blood platelets’ to the list of side effects for Janssen #vaccine.— EU Medicines Agency (@EMA_News) April 20, 2021
Overall benefit-risk remains positive.
The European Medicines Agency said Tuesday that a warning about blood clots should be added to labels for Johnson & Johnson’s vaccine.
The agency says these rare blood disorders should be considered as “very rare side effects of the vaccine.”
Last week, Johnson & Johnson halted its European roll-out of the vaccine after U.S. officials recommended a pause in the vaccine, when they detected six very rare blood clot cases among nearly 7 million people who had been vaccinated.
European officials say they considered all available evidence from the U.S. of the rare blood clots associated with low blood platelets, including one death.
All cases occurred in people under 60 years of age within three weeks after vaccination, the majority in women. Based on the currenly available evidence, specific risk factors have not been confirmed.
"One plausible explanation for the combination of blood clots and low blood platelets is an immune response, leading to a condition similar to one seen sometimes in patients treated with heparin called heparin induced thrombocytopenia, HIT," the agency said.