EU agency links J&J shot to rare clots, but says benefits outweigh risks

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MTVA - Media Service Support and Asset Management Fund

FILE - In this April 13, 2021, file photo, a box of Johnson & Johnson vaccines are shown by pharmacist Zsolt Szenasi at a warehouse of Hungaropharma, a Hungarian pharmaceutical wholesale company, in Budapest, Hungary. Experts at the European Medicines Agency are preparing to present the conclusions of their investigation later on Tuesday, April 20, 2021, into possible links between the Johnson & Johnson coronavirus vaccine and very rare cases of unusual clotting disorders detected in the U.S. (Szilard Koszticsak/MTI via AP, File)

LONDON – The European Union’s drug regulatory agency said Tuesday that it found a “possible link” between Johnson & Johnson’s COVID-19 vaccine and extremely rare blood clots and recommended a warning be added to the label. But experts at the agency reiterated that the vaccine’s benefits outweigh the risks.

The European Medicines Agency made its determination after examining a small number of clot cases in people vaccinated in the U.S. It said these problems should be considered “very rare side effects of the vaccine.”

J&J immediately announced it will revise its label as requested and resume vaccine shipments to the EU, Norway and Iceland. In a statement, it said: “The safety and well-being of the people who use our products is our number one priority.”

Following the EMA's decision, EU Health and Food Safety Commissioner Stella Kyriakides tweeted that vaccinations save lives and added: “I urge Member States to follow the opinion of our experts.”

Dutch health minister Hugo de Jonge said the Netherlands would start immunizing with the J&J vaccine on Wednesday.

In March, the EMA, which oversees the use of pharmaceutical products in 27 countries across the continent with a combined population of about 448 million, likewise recommended a label change for AstraZeneca's vaccine after finding a link between it and rare blood clots.

In both cases, the agency said the benefits of being immunized against COVID-19 outweigh the very small risks of developing the unusual clots.

“There is untold human suffering behind all of these (coronavirus) cases," said Emer Cooke, the EMA's executive director, noting that 3 million people worldwide have died in the outbreak. "These vaccines play an immensely important role in combating this pandemic.”