EU Agency Links J&J Shot to Rare Clots, Says Odds Favour Use
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The European Union's drug regulatory agency said that it found a “possible link" between Johnson & Johnson's COVID-19 vaccine and extremely rare blood clots and that a warning should be added to the label. But experts at the agency reiterated that the vaccine's benefits outweigh the risks.

The European Medicines Agency made those determinations after a very small number of blood clot cases in people who had gotten the vaccine were reported in the United States. The agency said a warning about the blood clots should be added to labels for the Johnson & Johnson's vaccine and that these rare blood disorders should be considered “very rare side effects of the vaccine."

The EMA also recommended a label change for the AstraZeneca COVID-19 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 still outweighed the very small risks of recipients developing the unusual clots.

Last week, J&J halted its European rollout of its one-dose vaccine after the US 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 US.

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. The delay was a further blow to vaccination efforts in the European Union, which have been plagued by supply shortages, logistical problems and concerns over unusual blood clots also in a small number of people who received the AstraZeneca COVID-19 vaccine.

Experts worry the temporary halt on J&J's shot could further shake vaccine confidence and complicate worldwide COVID-19 immunization efforts. In its statement, the EMA said the cases it reviewed of unusual blood clots in people who received the J&J shot “were very similar to the cases that occurred with the COVID-19 vaccine developed by AstraZeneca."

“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."

Source:
https://www.livemint.com/science/health/covid19-vaccine-eu-agency-links-j-j-shot-to-rare-clots-says-odds-favour-use-11618935560232.html
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