J. & J. to Resume E.U. Vaccine Rollout, With Warning of Rare Side Effect

BRUSSELS — Johnson & Johnson said Tuesday that it would resume the rollout of its coronavirus vaccine in Europe after the European Union’s drug regulator said that 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 company decided to delay distribution in the bloc’s 27 member states last week, after regulators in the United States suspended use of the vaccine there amid concerns about the potential side effect.

The E.U. drug regulator’s endorsement — even with the caveat — not only clears a path for Johnson & Johnson in Europe, but could presage how the United States will handle the vaccine in the days to come.

On Friday, an advisory panel to the Centers for Disease Control and Prevention is to meet for a second to time to decide whether to recommend lifting a “pause” put on the vaccine’s use in the United States, perhaps with a similar warning.

But some health experts worry that the headline-grabbing pause, which began over a week ago, might discourage some people from getting vaccinated, even though the risks from Covid-19 are far greater than the risk from a clot.

“You’ve put a scarlet letter on the Johnson & Johnson vaccine,” said Dr. Paul A. Offit, a vaccine expert at Children’s Hospital of Philadelphia.

After clotting concerns associated with another vaccine, produced by AstraZeneca, were reported in Europe, Dr. Offit noted, some grew leery of it, overestimating the threat. For the Johnson & Johnson vaccine, the clot risk has been put at an estimated one in a million.

“If you take a theoretical million people who are infected with Covid, five thousand will die,” Dr. Offit said. “Therefore, the benefits of this vaccine clearly outweigh its risks.” ...

In clearing the way for the vaccine’s use, the E.U.’s drug regulator, the European Medicines Agency, said the blood clots, which have been reported in a very small group of people, are “very similar” to those associated with the AstraZeneca vaccine.

The E.M.A.’s recommendation is not binding, but it is the first indication of what might happen next with the European rollout of the Johnson & Johnson vaccine. ...