J.&J.’s vaccine should carry warning of potential risk for rare blood clots, the E.U.’s regulator says, but believes benefits outweigh risks.

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J.&J.’s vaccine should carry warning of potential risk for rare blood clots, the E.U.’s regulator says, but believes benefits outweigh risks.

BRUSSELS—The European Union’s drug regulator on Tuesday said a warning should be added to the Johnson & Johnson Covid-19 vaccine indicating a p

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BRUSSELS—The European Union’s drug regulator on Tuesday said a warning should be added to the Johnson & Johnson Covid-19 vaccine indicating a possible link to rare and unusual blood clots, but stopped short of recommending it be pulled from use, saying its benefits outweigh its risks.

“The reported combination of blood clots and low blood platelets is very rare, and the overall benefits of Covid-19 Vaccine Janssen in preventing Covid-19 outweigh the risks of side effects,” the European Medicines Agency said in a statement, referring to the division of Johnson & Johnson that develops vaccines, Janssen. The rare clots were “very similar,” the agency added, to those associated with the AstraZeneca vaccine, for which the agency made a similar recommendation.

Johnson & Johnson decided to delay its rollout in the bloc’s 27 member states last week, after regulators in the United States called for a pause on the vaccine following concerns about the rare but serious side effect.

The EMA’s recommendation is not binding, but it is the first indication of what might happen next with the European rollout of the much-anticipated, single-shot vaccine that’s already been given to nearly eight million people in the United States. The agency said that regulators in individual E.U. member states should decide how to proceed taking into account their particular case load and vaccine availability.

In its statement, the agency stressed the importance of treating the potential side effect and issued guidelines to health care professionals on the lookout for the rare clotting disease.

“Health care 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 occurring within three weeks of vaccination.”

The agency, using already available data, said one possible explanation was that the rare side effect was an immune response.

The temporary suspension of the Johnson & Johnson rollout in the European Union compounded the bloc’s woes with the similar AstraZeneca vaccine. Vaccination efforts have fallen behind in Europe partly because the British-Swedish pharmaceutical company was unable to deliver the number of doses expected in the first quarter of the year. The AstraZeneca vaccine was then suspended due to very similar blood-clotting concerns as those that regulators are now investigating for Johnson & Johnson’s product.

Even though the E.U. regulator eventually found that the benefits of the AstraZeneca vaccine outweighed risks, and that E.U. members should use it, the damage had been done. Many Europeans have been refusing to take the vaccine, and several E.U. countries have limited its use to older people.

The E.U. last week announced it was boosting its supply of the Pfizer-BioNTech vaccine, and was negotiating a new deal for future booster shots with the company for 2022 and 2023, signaling it was going to prioritize vaccines, like Pfizer’s and Moderna’s, that use the mRNA technology.

But the Johnson & Johnson vaccine has been an important component of vaccination plans from the United States to South Africa.

U.S. health officials called for a pause in the vaccine’s use on April 13 to examine a rare blood-clotting disorder that emerged in a small number of recipients. Johnson & Johnson suspended its E.U. rollout immediately afterward. E.U. countries had just began receiving their first shipments of the vaccine, and all but Poland followed company guidance and have not began administering it.

On Monday, federal health officials said they were investigating “a handful” of new, unconfirmed reports that have emerged since the nationwide pause of the Johnson & Johnson injections. Dr. Anthony S. Fauci, the United States’ leading infectious disease expert, said previously that he anticipated a decision about whether to resume administering the Johnson & Johnson vaccine this Friday, when an expert panel that is advising the Centers for Disease Control and Prevention is scheduled to meet.



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