A box of Johnson & Johnson Janssen COVID-19 vaccine doses 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 outweigh the risks.
“The EMA Safety Committee (PRAC) has concluded that a warning about unusual blood clots with low platelets 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 that appear within three weeks of vaccination.
The EMA investigated all available evidence, he said, including eight US reports of serious cases of unusual blood clots – one of which had a fatal outcome. More than 7 million people had received the vaccine in the United States since April 7, he said.
The US Food and Drug Administration decided earlier this month to suspend the use of J & J’s shot “out of an abundance of caution.” As a result, the pharmaceutical company decided to delay the launch of the vaccine in Europe, while regulators assessed any risks.
The EMA already said last week that, while analyzing the latest details, it was still of the opinion that the benefits of the vaccine outweighed the risks.
The J&J plan, which requires only one, was initially lit in green in the European Union on 11 March. It remains to be seen how the various countries will interpret the latest EMA guidelines. France has already indicated that it will use the vaccine only for people over the age of 55.
“COVID-19 is associated with a risk of hospitalization and death. The reported 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 J & J’s Belgian unit. .
This is not the first problem with blood clots and a Covid-19 vaccine.
More than a dozen European countries suspended the use of the AstraZeneca shotgun in March after some people who received the shot reported unusual incidents of blood clots, 18 of which were fatal.
The EMA examined the cases and also said that the vaccine is safe and should be used in the fight against coronavirus.
However, a few days later, the EMA also said that there is a “possible link to very rare cases of unusual blood clots with low blood platelets” and therefore it should be listed as “very side effects”. rare ”for the AstraZeneca vaccine.
Some countries have adjusted the implementation of this vaccine, deciding to administer it only to people over the age of 60, and Denmark has gone further, completely discontinuing its use.
To date, there have been more than 103 million doses administered in the EU, according to the European Center for Disease Prevention and Control.