Europe’s drug regulator, the European Medicines Agency (EMA) said Tuesday it found a possible link between the Johnson & Johnson COVID-19 vaccine and rare forms of blood clots, but that the drug’s benefits outweigh its risks.
In its statement Tuesday, the EMA said that its drug safety group, the Pharmacovigilance Risk Assessment Committee (PRAC), after reviewing all available evidence, concluded that the Johnson & Johnson vaccine’s product information should include a warning about unusual blood clots with low blood platelets.
The committee concluded that the events should be listed as very rare side effects of the vaccine.
The EMA gave a similar assessment of the AstraZeneca vaccine which also was found to have a possible link to rare blood clots.
The EMA reviewed the Johnson & Johnson vaccine following a small number of reports from the United States of serious cases of unusual blood clots associated with low levels of blood platelets among people who had received the vaccine – one of which had a fatal outcome. As of April 13, more than 7 million people in the U.S. had received Johnson and Johnson’s vaccine.
All cases occurred in people under 60 years of age within three weeks of vaccination, the majority in women.
The reports prompted the U.S. Centers for Disease Control (CDC) and the Food and Drug Administration to recommend a “pause” in the use of the vaccine in the United States while further evaluations were carried out.
On Monday, top U.S. immunologist and Chief Presidential Medical Advisor Anthony Fauci told reporters the pause on the use of the vaccine could be lifted as early as this week.
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