EU regulators find possible links between J&J shots and blot clots; still support the overall benefits

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EU regulators find possible links between J&J shots and blot clots; still support the overall benefits

Tue, 2021-04-20 10:59 — mike kraft

EU regulator finds link between J&J shot and blood clots LONDON (AP) — Experts at the agency that regulates drugs for the European Union said Tuesday that they found a “possible link” between the Johnson & Johnson COVID-19 vaccine and very rare blood clots after a small number of cases were reported in the United States, but they confirmed the vaccine's benefits still outweighed the very small risks of recipients developing the unusual clots. The European Medicines Agency said a warning about the rare blood clots should be added to labels for Johnson & Johnson’s COVID-19 vaccine. The agency said these rare blood disorders should be considered as “very rare side effects of the vaccine.” Last week, Johnson & Johnson halted its European roll-out of the vaccine after U.S. officials recommended a pause in the vaccine, when they detected six very rare blood clot cases among nearly 7 million people who had been vaccinated. AP NEWS

LONDON (AP) — Experts at the agency that regulates drugs for the European Union said Tuesday that they found a “possible link” between the Johnson & Johnson COVID-19 vaccine and very rare blood clots after a small number of cases were reported in the United States, but they confirmed the vaccine’s benefits still outweighed the very small risks of recipients developing the unusual clots.

The European Medicines Agency said a warning about the rare blood clots should be added to labels for Johnson & Johnson’s COVID-19 vaccine. The agency said these rare blood disorders should be considered as “very rare side effects of the vaccine.”

Last week, Johnson & Johnson halted its European roll-out of the vaccine after U.S. officials recommended a pause in the vaccine, when they detected six very rare blood clot cases among nearly 7 million people who had been vaccinated.

European officials said they considered all currently available evidence from the U.S., which consisted of eight reports of serious cases of rare blood clots associated with low blood platelets, including one death.

Last week, J&J halted its European rollout of its one-dose vaccine after the U.S. Food and Drug Administration recommended officials pause its use while the rare blood clot cases are examined. Officials identified six cases of the highly unusual blood clots among nearly 7 million people who were immunized with the shot in the U.S.

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.

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Suspicion is rising that these rare cases may be triggered by the adenovirus component of the AstraZeneca and J&J vaccines,” said Eleanor Riley, a professor of immunology and infectious diseases at the University of Edinburgh. She said that while more data was needed, “it remains the case that for the vast majority of adults in Europe and the USA, the risks associated with contracting COVID-19 far, far outweigh any risk of being vaccinated.” ...

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