The drug regulatory agency of the European Union said there it had found a “possible link,” between Johnson & Johnson’s COVID-19 vaccine and extremely rare blood clots. It says a warning should be added to the lavel. However, experts at the agency repeated that the vaccine’s benefits outweigh the risks.
A very small number of blood clot cases in people who have gotten the vaccine were reported in the United States, leading to investigation. The agency said that these rare blood disorders should be considered “very rare side effects of the vaccine.”
The European Medicines Agency, which oversees pharmaceutical products in 27 countries with a combined population of around 448 million also said that it recommends a label change for the AstraZeneca COVID-19 vaccine after finding a link between it and extremely rare blood clots. The agency said that the benefits of being immunized against COVID-19 still outweighed the very small risks in both cases.
J&J halted its European roll-out of the vaccine after US officials recommended a pause in the vaccine last week, after detecting six blood clot cases among nearly 7 million people vaccinated.
All of the cases occurred in people under age 60, but the EMA has been unable to find any risk factors.
The delays have further weakened vaccination efforts in the EU, which have suffered from supply shortages as well as concerns from the extremely rare blood clots in a small number of people who have received the AstraZeneca vaccine.
Experts worry that the temporary halts could damage vaccine confidence.