- The European Medicines Agency found a possible link between the Johnson & Johnson COVID-19 vaccine and ‘unusual’ blood clots cases with low levels of blood platelets.
- The EMA said the link should be listed as “very rare side effects of the vaccine.”
- Johnson & Johnson said it would add the information and that shipments had resumed to Europe.
- See more stories on Insider’s business page.
The European Medicines Agency found a possible link between the Johnson & Johnson COVID-19 vaccine and ‘unusual’ blood clots cases with low levels of blood platelets, according to a statement issued on Tuesday.
The agency said that the overall benefit-risk remains positive, but said the link should be listed as “very rare side effects of the vaccine.” The EMA suggested a warning be attached to product information about the shot.
Johnson & Johnson said it would add information about the “very rare adverse event” on its pamphlets for the vaccine and resume shipments to Europe.
“The safety and well-being of the people who use our products is our number one priority,” said Johnson & Johnson Chief Scientific Officer Paul Stoffels. “We appreciate the rigorous review of the PRAC and share the goal of raising awareness of the signs and symptoms of this very rare event to ensure the correct diagnosis and appropriate treatment.”
The US put a pause on the rollout of Johnson & Johnson’s single-dose COVID-19 vaccine earlier this month, citing reports of blood clots in people who received the shot.
All of the eight people who have reported blood clots were under 60 years old and the majority of them were women. They all reported the blood clots within three weeks of getting the vaccination.
More than 7.9 million people in the US have gotten the Johnson & Johnson shot, according to the Centers of Disease Control and Prevention.
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