EMA says J&J shots could be rolled out across EU

A box containing Johnson & Johnson’s Janssen COVID-19 vaccine doses will be displayed on Monday, April 12, 2021 at Grubb’s Pharmacy on Capitol Hill.

Tom Williams | CQ-Roll Call, Inc. | Getty Images

LONDON – The European Medicines Agency said on Tuesday that the vaccine Johnson & Johnson Covid-19 has possible links to rare blood clots, but reiterated that its benefits outweigh the risks.

“(The) EMA’s Safety Committee (PRAC) has concluded that a warning about unusual low blood platelet clots should be added to the product information for COVID-19 vaccine Janssen,” the agency said in a press release.

“Healthcare professionals and people receiving the vaccine should be aware of the possibility of very rare cases of blood clots occurring within three weeks of vaccination in combination with low platelet counts.”

The EMA investigated all available evidence, including eight U.S. reports of serious cases of unusual blood clots, one of which was fatal. More than 7 million people have received the vaccine in the United States since April 7.

The U.S. Food and Drug Administration earlier this month decided to suspend the use of J & J’s lap “out of an abundance of caution.” As a result, the pharmaceutical company decided to delay the vaccination of its vaccine in Europe, while regulators assessed any risks.

The EMA already said last week that the benefits of the vaccine outweigh the risks during the review of the latest details.

The J&J survey, which requires only one, was initially given the green light in the European Union on 11 March. It remains to be seen how the different countries will interpret the latest leadership of the EMA. France has already indicated that it will only use the vaccine on people over 55.

“COVID-19 is associated with the 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 to prevent COVID-19 outweigh the risks of side effects, ‘the EMA said on Tuesday with the name of the Belgian unit of J&J.

This is not the first problem with blood clots and a vaccine against Covid-19.

More than a dozen European countries suspended 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 that the vaccine is safe and should be used in the fight against coronavirus.

A few days later, however, the EMA also said that there was a “possible link with very rare cases of unusual low-platelet clots” and should therefore be listed as “very rare side effects” for the AstraZeneca vaccine.

Some countries have adapted the deployment of this vaccine and decided to administer it only to people over 60 years of age, and Denmark went further by stopping its use altogether.

To date, more than 103 million doses have been administered in the EU, according to data from the European Center for Disease Prevention and Control.

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