LONDON — Europe's drug regulator has found a possible link between Johnson & Johnson's one-dose Covid-19 vaccine and rare blood clotting issues in adults who received the shot in the United States, the watchdog said Tuesday.
A meeting of the safety committee of the European Medicines Agency (EMA) concluded that a warning about unusual blood clots with low blood platelets should be added to the product information for the vaccine, 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 blood platelets is very rare," the agency said in a statement. The agency added that the "overall benefits" of the vaccine still "outweigh the risks of side effects."
The Amsterdam-based European regulator said it took into account data from the U.S. that listed six cases of unusual blood clots associated with low levels of blood platelets — one of which was fatal. The agency also looked at data involving 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 the J&J clinical trials after receiving the vaccine.
More than 7 million people have received the J&J vaccine in the United States, so far.
Last week, officials in the U.S. recommended a temporary pause in the vaccine's usage after a possible link to a handful of cases of rare blood clots. On Friday, the Centers for Disease Control and Prevention's advisory committee is expected to decide whether to recommend resuming use of the J&J vaccine or whether to restrict it to men or certain age groups.
Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, said Sunday that he was hopeful public health experts would provide a roadmap for the troubled J&J vaccine by the end of the week, saying he believes it will not be taken out of circulation altogether, although there may be new warnings attached.
Johnson & Johnson said in a statement in response to the European Medicines Agency finding Tuesday that the company was ready to resume rolling out its vaccine to the European Union, Iceland and Norway and would update its product information to reflect the "very rare adverse event" involving blood clots.
"The safety and well-being of the people who use our products is our number one priority. We appreciate the rigorous review," Chief Scientific Officer Paul Stoffels said in a statement.
"We strongly believe in the positive benefits of our single-shot, easily transportable Covid-19 vaccine to help protect the health of people everywhere and reach communities in need globally."
The vaccination campaign in the 27-nation European bloc lags behind other countries, including the United Kingdom and the U.S., due to vaccine hesitancy and a slow logistical rollout, as Covid-19 cases rise on the continent.
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The blood clots occurred in people under 60 years of age within three weeks after vaccination, the majority in women, the European regulator found. It also said the clots occurred mostly at unusual sites such as in veins in the brain, the abdomen and in arteries, together with low levels of blood platelets and sometimes bleeding.
The findings were similar to those identified among a tiny fraction of people who received AstraZeneca's Covid-19 vaccine outside the United States, it said.
With the single-dose J&J vaccine sidelined for now, the U.S. has been leaning on vaccines from Pfizer and Moderna, which have been the cornerstones of the country's vaccination strategy.
As of Tuesday, there have been more than 211 million total Covid-19 vaccine doses administered in America and more than 85 million people are fully vaccinated, according to NBC News data.