LONDON – Europe’s Medicines Agency has found a possible link between Johnson & Johnson’s unique Covid-19 vaccine and rare blood clotting problems in adults who received the shot in the US, the watch dog said Tuesday.
A meeting of the European Medicines Agency (EMA) Safety Committee concluded that a warning about unusual blood clots with low platelets should be added to the product information for the vaccine, which is listed as a very rare side effect.
“Covid-19 is associated with a risk of hospitalization and death. The reported combination of blood clots and low platelets is very rare.” Agency said in a statement. The agency added that the “overall benefits” of the vaccine still “outweigh the risk of side effects”.
The Amsterdam-based European regulator said it took into account data from the United States, which listed six cases of unusual blood clots associated with low platelet levels – one of which was fatal. The agency also examined data regarding a seventh patient, a 59-year-old woman who developed deep vein thrombosis, as well as a case of a 25-year-old man who developed severe blood clots during J & J’s clinical trials after receiving the vaccine.
To date, more than 7 million people in the US have received the J&J vaccine.
Last week, officials in the US recommended a temporary suspension of vaccine use following a possible link to a handful of rare blood clot cases. On Friday, the Centers for Disease Control and Prevention Advisory Committee is expected to decide whether to recommend resumption of the J&J vaccine or restrict it to men or certain age groups.
Dr. Anthony Fauci, director of the National Institute of Allergies and Infectious Diseases, said Sunday he was confident that public health experts would come up with a roadmap for the troubled J&J vaccine by the end of the week and believes he doesn’t it is removed from the circulation as a whole, although new warnings may have been added.
Johnson & Johnson said in a statement in response to the European Medicines Agency’s finding On Tuesday, the company was ready to resume rollouts of its vaccine in the European Union, Iceland and Norway and to update its product information to reflect the “very rare adverse event” of blood clots.
“The safety and well-being of the people who use our products are our top priorities. We appreciate the rigorous testing,” said Paul Stoffels, chief scientific officer, in a statement.
“We firmly believe in the positive benefits of our single, easy-to-carry vaccine, Covid-19, which helps protect the health of people everywhere and reach communities in need around the world.”
The vaccination campaign in the European bloc of 27 nations is lagging behind other countries including the UK and the US due to hesitation in vaccination and slow logistical adoption as Covid-19 cases increase across the continent.
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The blood clots appeared in people under 60 within three weeks of vaccination, the majority in women, according to the European regulator. It has also been said that the clots appeared mainly in unusual places such as veins in the brain, abdomen, and arteries, along with low platelet counts and sometimes bleeding.
The results were similar to those seen in a tiny fraction of those who received AstraZeneca’s Covid-19 vaccine outside of the United States.
With the single-dose J&J vaccine being canceled for the time being, the US is relying on vaccines from Pfizer and Moderna, which have been the cornerstone of the country’s vaccination strategy.
As of Tuesday, America had more than 211 million Covid-19 vaccine doses and more than 85 million people are fully vaccinated, according to NBC News data.