LONDON – The European drug regulator has found a possible link between Johnson & Johnson’s single-dose Covid-19 vaccine and rare problems with blood clotting in adults who received the shot in the United States, the watchdog said on Tuesday.
A meeting of the Safety Committee of the European Medicines Agency (EMA) concluded that a warning about unusual low blood platelet clots should be added to the product information for the vaccine, which was listed as a very rare side effect. word.
“Covid-19 is associated with the risk of hospitalization and death. The reported combination of blood clots and low 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 European regulator in Amsterdam said the data from the US took into account six cases of unusual blood clots associated with low blood platelets, one of which was fatal. The agency also looked at 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 the J&J clinical trials. the vaccine.
More than 7 million people have received the J&J vaccine so far in the United States.
Last week, U.S. officials recommended a temporary halt in the use of the vaccine following a possible link with a handful of cases of rare blood clots. The Advisory Committee of the Centers for Disease Control and Prevention is expected to decide on Friday to recommend continuing the use of the J&J vaccine or restricting it to men or certain age groups.
Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, said on Sunday that he was hopeful that public health experts would provide a roadmap for the inflamed J&J vaccine by the end of the week, saying he believed it will not be taken out. of the circulation completely, although there may be new warnings.
Johnson & Johnson said in a statement in response to the European Medicines Agency’s finding on Tuesday that the company was ready to re-export its vaccine to the European Union, Iceland and Norway and would update its product information to address the ‘many reflect ‘rare adverse event’ which includes blood clots.
“The safety and well-being of the people who use our products is our top priority. We appreciate the careful investigation,” said Paul Stoffels, chief scientific officer, 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 worldwide.”
The vaccination campaign in the European bloc of 27 countries lags behind other countries, including the UK and the US, due to vaccine hesitation and a slow logistical implementation as Covid-19 cases increase on the continent.
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The European regulator found that the blood clots occurred in people under 60 years of age within three weeks after vaccination. It is also said that the blood clots mostly occur in unusual places, such as in veins in the brain, in the abdomen and in the veins, along with low levels of platelets and sometimes bleeding.
The findings were similar to those identified among a small fraction of people who received AstraZeneca’s Covid-19 vaccine outside the United States.
With the single-dose J & J vaccine now on the sidelines, the US is relying on vaccines from Pfizer and Moderna, which were the cornerstones of the country’s vaccination strategy.
As of Tuesday, more than 211 million doses of Covid-19 vaccine have been administered in the United States and more than 85 million people have been fully vaccinated, according to NBC News data.
Reuters contributed.