EU agency links J&J shot to rare clots
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.”
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.
Last week, J&J halted its European rollout of the vaccine after U.S. officials recommended a pause in its use because of six cases of a very rare type of blood clot among nearly 7 million Americans vaccinated with the formula.
European officials said they considered all available evidence from the U.S., which ultimately consisted of eight cases, including one death. All occurred in people under 60, but the EMA said that it hadn’t been able to identify any specific risk factors.
Last week, Johnson & Johnson advised European governments to store their doses until the EU drug regulator issued guidance on their use. Widespread use of the shot in Europe has not yet started.
Johnson & Johnson also has a deal to supply up to 500 million doses to the U.n.-backed COVAX program.