By Rob Picheta, CNN
(CNN/KDKA) — Europe’s medicines regulator said it has found a possible link between the Johnson & Johnson Covid-19 vaccine and rare blood clots, but emphasized that the overall benefits of getting the shot outweigh the risks.READ MORE: Pennsylvania Woman Among Cases Of Johnson & Johnson Vaccine Blood Clots; State Extends Pause
The news, announced Tuesday, threw another complication into the European Union’s vaccination rollout and dealt a major blow to the company a week after its vaccine was paused in the United States.
The European Medicines Agency (EMA) concluded that “a warning about unusual blood clots with low blood platelets should be added to the product information” about the vaccine given to patients.
It said it had analyzed all currently available evidence including eight reports of serious and unusual blood clots from the United States, where more than 7 million Johnson & Johnson shots have been given. One of those cases was fatal.
“All cases occurred in people under 60 years of age within three weeks after vaccination, the majority in women,” the agency said. “Based on the currently available evidence, specific risk factors have not been confirmed.”
One of those patients is a 26-year-old woman from Pennsylvania.
The Pennsylvania Department of Health said the CDC won’t be releasing personal information on her case, but said she recovered after receiving treatment at a New Jersey hospital.
The EMA added that “the combination of blood clots and low blood platelets is very rare, and the overall benefits of COVID-19 Vaccine Janssen in preventing COVID-19 outweigh the risks of side effects.”
The agency’s findings are nonetheless a setback for the pharmaceutical giant, and come as it awaits the results of similar investigations by regulators in the United States.
The vaccine was paused in the country on April 13 after the reports came to light, and Johnson & Johnson decided to “proactively delay” the rollout of their vaccine in Europe 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 on Monday, and it is expected to announce its own conclusions on Friday.
Johnson & Johnson’s shot had been authorized for use by the EMA on March 11, but was not yet in widespread use.
The vaccine has been touted as a potential game-changer in the pandemic because it is given in one shot; most of the other approved vaccines around the world are given in two doses, spaced at least a few weeks apart.
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