The European Union’s drug regulatory agency said Tuesday that it found a “possible link” between Johnson & Johnson’s COVID-19 vaccine and extremely rare blood clots and that a warning should be added to the label.
But experts at the agency reiterated that the vaccine’s benefits outweigh the risks.
The European Medicines Agency made those determinations after a very small number of blood clot cases in people who had gotten the vaccine were reported in the United States. The agency said a warning about the blood clots should be added to labels for the Johnson & Johnson’s vaccine and that these rare blood disorders should be considered “very rare side effects of the vaccine.”
The EMA also recommended a label change for the AstraZeneca COVID-19 vaccine after finding a link between it and rare blood clots. In both cases, the agency said the benefits of being immunized against COVID-19 still outweighed the very small risks of recipients developing the unusual clots.
Last week, Johnson & Johnson halted its European roll-out of the vaccine after US 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 said they considered all currently available evidence from the US, which consisted of eight reports of serious cases of rare blood clots associated with low blood platelets, including one death. All of the cases occurred in people under age 60, but the EMA said that it hadn’t been able to identify any specific risk factors.