EMA says J&J shot might be rolled out throughout EU

A field of Johnson & Johnson’s Janssen COVID-19 vaccine doses are pictured at Grubb’s Pharmacy on Capitol Hill on Monday, April 12, 2021.

Tom Williams | CQ-Roll Name, Inc. | Getty Photographs


LONDON — The European Medicines Company mentioned Tuesday the Johnson & Johnson Covid-19 vaccine has potential hyperlinks to uncommon blood clot incidents, however reiterated that its advantages nonetheless outweighed the dangers.

“(The) EMA’s security committee (PRAC) concluded {that a} warning about uncommon blood clots with low blood platelets needs to be added to the product info for COVID-19 Vaccine Janssen,” the company mentioned in a press launch.

“Healthcare professionals and individuals who will obtain the vaccine ought to pay attention to the potential for very uncommon instances of blood clots mixed with low ranges of blood platelets occurring inside three weeks of vaccination.”

The EMA researched all out there proof, it mentioned, together with eight experiences from the U.S. of significant instances of bizarre blood clots — one in every of which had a deadly consequence. Greater than 7 million folks had acquired the vaccine in the US as of April 7, it mentioned.

The U.S. Meals and Drug Administration earlier this month suggested states to droop the usage of J&J’s shot “out of an abundance of warning.” Consequently, the pharmaceutical agency determined to delay the rollout of its vaccine in Europe whereas regulators assessed any dangers.

The EMA already mentioned final week that whereas reviewing the most recent particulars, it was nonetheless of the view that the advantages of the vaccine outweighed the dangers.

The J&J shot, which solely requires one does, was initially greenlit within the European Union on March 11. It now stays to be seen how the completely different nations will interpret the most recent steering from the EMA. France has already indicated it’ll solely use the vaccine on folks aged above 55.

“COVID-19 is related to a threat of hospitalisation and demise. The reported mixture of blood clots and low blood platelets could be very uncommon, and the general advantages of COVID-19 Vaccine Janssen in stopping COVID-19 outweigh the dangers of unwanted effects,” the EMA mentioned on Tuesday, utilizing the title of J&J’s Belgian unit.

This isn’t the primary concern with blood clots and a Covid-19 vaccine.

Greater than a dozen European nations suspended the usage of the AstraZeneca shot in March after some individuals who acquired the shot reported uncommon incidents with blood clots, 18 of which have been deadly.

The EMA reviewed the instances and likewise mentioned the vaccine was secure and needs to be used within the combat in opposition to the coronavirus.

Nonetheless, just a few days later, the EMA additionally mentioned there was a “potential hyperlink to very uncommon instances of bizarre blood clots with low blood platelets” and this could subsequently be listed as “very uncommon unwanted effects” for the AstraZeneca vaccine.

Some nations adjusted the rollout of this vaccine, deciding to manage it solely to folks above 60 years of age, and Denmark went additional by fully stopping its use.

To this point, there have been greater than 103 million doses administered within the EU, based on information from the European Centre for Illness Prevention and Management.

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