The European Medicines Agency (EMA) has concluded that ‘a warning about abnormal platelets with low platelets should be added to the product information’ about the shot given by patients.
“All cases occurred within three weeks of vaccination in those under 60 years of age, the majority in women,” the EMA said. “Based on the currently available evidence, specific risk factors have not been confirmed.”
The agency added that “the combination of blood clots and low platelets is very rare, and that the overall benefits of COVID-19 Vaccine Janssen to prevent COVID-19 outweigh the risks of side effects.”
The agency’s findings are nonetheless a setback for the pharmaceutical giant, and it comes as it awaits the results of similar investigations by regulators in the United States.
The vaccine was suspended in the country on April 13 after reports came to light, and Johnson & Johnson decided to ‘proactively postpone’ the rollout of the shot on the same day.
The U.S. Centers for Disease Control and Prevention (CDC) is looking at a “handful” of reported adverse events after people received the vaccine, it said Monday, and they are expected to announce its own conclusions Friday.
The company will now try to restore confidence in the United States and Europe. Vaccination programs have increased in both regions over the past few weeks; the US vaccinates millions of people every day, while EU implementation has improved after a bumpy start.
Johnson & Johnson’s survey was approved by the EMA on March 11, but was not yet widespread.
The vaccine was considered a possible game changer in the pandemic because it is given in one shot; most other approved vaccines around the world are given in two doses, at a distance of at least a few weeks.
Several health regulators have stressed that the overall benefits of the AstraZeneca vaccine outweigh the risks, but some European countries limit the use of the shot to older age groups, while UK authorities have advised people to get under 30 different vaccines.