Johnson & Johnson plans to resume Europe rollout
BRUSSELS — Johnson & Johnson said Tuesday 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 … in preventing COVID-19 outweigh the risks of side effects,” the European Medicines Agency said in a statement.
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, single-shot vaccine, which already has 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 case load 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.
The temporary suspension of the Johnson & Johnson rollout in the European Union compounded the bloc’s woes with the AstraZeneca vaccine. Vaccination efforts have fallen behind in Europe partly because the British-Swedish pharmaceutical company couldn’t deliver the number of doses expected in the first quarter of the year.
The AstraZeneca vaccine then was suspended because of very similar blood-clotting concerns as those that regulators are investigating for Johnson & Johnson’s product.
Even though the EU regulator eventually found that the benefits of the AstraZeneca vaccine outweighed risks and that EU members should use it, the damage had been done.
Many Europeans have been refusing to take the vaccine, and several EU countries have limited its use to older people, as most of those affected by the rare clots were younger than 60.