EMA says J&J shot could 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 Pictures

LONDON — The European Medicines Company stated 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 must be added to the product data for COVID-19 Vaccine Janssen,” the company stated in a press launch.

“Healthcare professionals and individuals who will obtain the vaccine ought to pay attention to the opportunity of 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 stated, together with eight studies from the U.S. of significant instances of surprising blood clots — one in all which had a deadly end result. Greater than 7 million individuals had obtained the vaccine in the US as of April 7, it stated.

The U.S. Meals and Drug Administration earlier this month suggested states to droop using J&J’s shot “out of an abundance of warning.” Because of this, the pharmaceutical agency determined to delay the rollout of its vaccine in Europe whereas regulators assessed any dangers. On Tuesday, the corporate confirmed that it could resume shipments to the bloc after the EMA’s assessment.

The EMA already stated 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 international locations will interpret the most recent steering from the EMA. France has already indicated it’ll solely use the vaccine on individuals aged above 55.

“COVID-19 is related to a danger of hospitalisation and loss of life. 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 negative effects,” the EMA stated on Tuesday, utilizing the identify 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 international locations suspended using the AstraZeneca shot in March after some individuals who obtained the shot reported uncommon incidents with blood clots, 18 of which have been deadly.

The EMA reviewed the instances and in addition stated the vaccine was secure and must be used within the combat in opposition to the coronavirus.

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

Some international locations adjusted the rollout of this vaccine, deciding to manage it solely to individuals above 60 years of age, and Denmark went additional by utterly stopping its use.

To date, there have been greater than 103 million doses administered within the EU, in line with knowledge from the European Centre for Illness Prevention and Management.

Correction: The U.S. Meals and Drug Administration earlier this month suggested states to droop using J&J’s shot. An earlier model mischaracterized the transfer.

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