The European Medicines Agency (EMA) has concluded that “a warning should be added to the product information about unusual blood clots with low platelets” about the shot given to patients.
“All cases occurred in people under the age of 60 within three weeks of vaccination, mostly in women,” the EMA said. “Based on currently available evidence, no specific risk factors have been confirmed.”
The agency added that “the combination of blood clots and low blood platelets is very rare, and the overall benefits of the Janssen COVID-19 vaccine in preventing COVID-19 outweigh the risks of side effects.”
The agency’s findings, however, are an obstacle for the pharmaceutical giant and come as it awaits the results of similar investigations by US regulators.
The vaccine was discontinued in the country on April 13 after reports came out, and Johnson & Johnson decided to “proactively delay” the launch of the shooting in Europe on the same day.
The U.S. Centers for Disease Control and Prevention (CDC) is analyzing a “handful” of adverse events reported after people received the vaccine, it said Monday, and is expected to announce its own findings Friday.
The company will now seek to regain confidence in both the United States and Europe. Inoculation programs have increased in both regions in recent weeks; The US vaccinates millions of people every day, while the launch of the EU has improved after a rough start.
Johnson & Johnson’s shooting had been authorized for use by the EMA on March 11, but was not yet widely used.
The vaccine has been touted as a potential pandemic game changer because it is administered in a single shot; most other approved vaccines worldwide are given in two doses, at least a few weeks apart.
Several health regulators have pointed out that the overall benefits of the AstraZeneca vaccine still outweigh the risks, but some European countries restrict the use of the vaccine to older age groups, while the British authorities have recommended that people under 30 be given administer different vaccines.