A box of Johnson & Johnson’s Janssen COVID-19 vaccine doses is pictured at Grubb’s Pharmacy on Capitol Hill on Monday, April 12, 2021.
Tom Williams | CQ-Roll Call, Inc. | Getty Images
LONDON – The European Medicines Agency said on Tuesday that the Johnson & Johnson Covid-19 vaccine may be linked to rare blood clot incidents, but reiterated that the benefits still outweighed the risks.
“(The) EMA’s Safety Committee (PRAC) concluded that a warning about unusual low platelet blood clots should be added to the product information for Janssen’s COVID-19 vaccine,” the agency said in a press release.
“Healthcare professionals and people who will receive the vaccine should be aware of the possibility of very rare cases of blood clots associated with low platelet counts occurring within three weeks of vaccination.”
The EMA has examined all available evidence, it said, including eight reports from the US of serious cases of unusual blood clots, one of which was fatal. More than 7 million people had received the vaccine in the United States since April 7, it said.
Earlier this month, the US Food and Drug Administration decided to suspend the use of J & J’s shot “with great caution.” As a result, the pharmaceutical company decided to delay the introduction of its vaccine in Europe, while regulators assessed any risks.
The EMA said last week that when looking at the latest details, it still believed that the benefits of the vaccine outweighed the risks.
The J&J admission, which only requires one, was initially given the green light in the European Union on March 11. It remains to be seen how the different countries will interpret the latest EMA guidelines. France has already indicated that it will only use the vaccine in people over 55 years of age.
COVID-19 is associated with a risk of hospitalization and death. The reported combination of blood clots and low platelets is very rare, and the overall benefits of COVID-19 vaccine Janssen in preventing COVID-19 outweigh the risks of side effects, ‘the EMA stated on Tuesday under the name of J & J’s Belgian unit.
This isn’t the first problem with blood clots and a Covid-19 vaccine.
More than a dozen European countries stopped using the AstraZeneca shot in March after some people who received the shot reported unusual incidents of blood clots, 18 of which were fatal.
The EMA reviewed the cases and also said the vaccine was safe and should be used in the fight against the coronavirus.
Nevertheless, the EMA also said a few days later that there was a “possible association with very rare cases of unusual blood clots with low platelets” and should therefore be listed as “very rare side effects” for the AstraZeneca vaccine.
Some countries have modified the introduction of this vaccine and decided to only give it to people over 60 years old, and Denmark went further to discontinue its use completely.
According to data from the European Center for Disease Prevention and Control, more than 103 million doses have been administered in the EU to date.