The European medicines regulator has found a “possible link” between the Johnson & Johnson/Janssen COVID-19 vaccine and rare but fatal blood clot cases detected in some of its recipients.
The European Medicines Agency (EMA) on April 20 concluded in its review of the vaccines and blood clot reports that a warning should be added to the vaccine’s product information.
“Healthcare professionals and people who will receive the vaccine should be aware of the possibility of very rare cases of blood clots combined with low levels of blood platelets occurring within three weeks of vaccination,” EMA said in a statement.
EMA also concluded that blood clotting should be listed as “very rare side effects” of the vaccine.
According to EMA, the blood clot cases it reviewed in some of the J&J/Janssen recipients were “very similar” to the blood clot cases of some of the AstraZeneca vaccine recipients.
EMA said it reviewed all currently available evidence, including eight reports of serious and unusual blood clots from the United States, where over seven million people had received the J&J/Janssen vaccine, as of April 13. One of the the cases had a fatal outcome.
“All cases occurred in people under 60 years of age within three weeks after vaccination, the majority in women. Based on the currently available evidence, specific risk factors have not been confirmed,” EMA stated.
However, EMA insisted that the benefits of the vaccine in preventing COVID-19 outweigh the risks of the side effects.
“Thousands of people are still dying every day of COVID-19 and these vaccines play an immensely important role in combating this pandemic,” EMA’s Executive Director Emer Cooke said, according to a report by British news website The Guardian.
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