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As another pandemic wave staggers Europe, the continent’s top drug regulator said on Thursday that the AstraZeneca vaccine was safe, hoping to allay fears of possible side effects from a shot that is a vital weapon in the anti-coronavirus arsenal, and prompt more than a dozen countries to resume using it.

But the regulator, the European Medicines Agency, said a new warning label would be added to the vaccine so that people in the medical community could be on the lookout for a potential rare complication leading to blood clots and bleeding in the brain.

Despite reports of a small number of cases of dangerous blood clots in people who had received the vaccine, a review of millions of cases found that it does not increase the overall risk of clots, though “there are still some uncertainties,” said Dr. Sabine Straus, who heads the agency’s risk assessment committee.

The E.M.A., an arm of the European Union, signaled that even if that threat proves to be real it is a small one, and the AstraZeneca shot, like many other drugs considered effective and safe, will prevent vastly more illness and death than it might cause — the same message conveyed by the World Health Organization and independent experts. Officials want to bolster confidence in a crucial vaccine, and in a stumbling European inoculation campaign that has fueled mistrust of governments across the continent.