A Johnson & Johnson Janssen COVID-19 vaccine dose box is on display 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 has possible links to rare incidents of blood clots, but reiterated that its benefits still outweighed the risks.
“(The EMA safety committee) concluded that a warning about unusual low-platelet blood clots should be added to the product information for the COVID-19 Janssen 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 combined with low levels of blood platelets three weeks after vaccination.”
The EMA investigated all available evidence, including eight U.S. reports of serious cases of unusual blood clots, one of which had a fatal outcome. As of April 7, more than 7 million people had received the vaccine in the United States.
The U.S. Food and Drug Administration decided earlier this month to suspend the use of the J&J shot “with great caution.” As a result, the pharmaceutical firm decided to delay the launch of the vaccine in Europe while regulators assess the risks.
The EMA already said last week that while the final details were being reviewed, the benefits of the vaccine were still considered to outweigh the risks.
J&J’s shot, which only requires one, was initially lit 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 combination of blood clots and low blood platelets is very rare and the overall benefits of the COVID-19 Janssen vaccine in preventing COVID-19 outweigh the risks of side effects, “the EMA said on Tuesday, using the name of the Belgian J&J unit.
This is not the first problem with Covid-19 blood clots and vaccine.
More than a dozen European countries suspended the use of the AstraZeneca shot in March after some people who received the shot reported unusual incidents with 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 coronavirus.
However, a few days later, the EMA also said there was a “possible link to very rare cases of unusual blood clots with low blood platelets” and should therefore be classified as “side effects”. very rare “for the AstraZeneca vaccine.
Some countries adjusted the launch of this vaccine, deciding to administer it only to people over 60, and Denmark went further by completely ceasing its use.
To date, there have been more than 103 million doses administered in the EU, according to data from the European Center for Disease Prevention and Control.