Europe’s vaccine rollout to resume

Johnson & Johnson said Tuesday that it would resume the rollout of its coronavirus vaccine in Europe after the European Union’s drug regulators said a warning should be added to the product indicating a possible link to rare blood clots, but that the shot’s benefits outweigh the 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 potential 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, singleshot vaccine that’s already been given to nearly 8 million people in the United States. The agency said that regulators in individual EU member states should decide how to proceed taking into account their particular caseload and vaccine availability.

The agency said it had come out with its recommendations ahead of U.S. regulators doing so because it had built some confidence in how to respond, after having spent much time reviewing similar cases that arose with the AstraZeneca vaccine.

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 disorder. Providers and vaccine recipients “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,” it said.

The agency, using already available data, said one possible explanation was that the blood disorder was an immune response.

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 EU rollout immediately afterward. EU countries had just begun receiving their first shipments of the vaccine, and only Poland has begun administering it.

Six cases of the rare blood clotting that emerged in the U.S. were all women between the ages of 18 and 48, and each developed the illness within one to three weeks of vaccination. One woman in Virginia died, and a second woman in Nebraska has been hospitalized in critical condition.