With the Johnson & Johnson vaccine paused in the United States, the European Union drug regulator found that the benefits outweigh the rare risk of blood clots.
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. That would free up millions of doses for a country still waging a fierce battle against the pandemic, and where almost eight million Americans have already had the Johnson & Johnson vaccine. 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.” A loss of confidence in the Johnson & Johnson vaccine may carry a particular cost. The vaccine has been greeted warmly by many health workers because it requires just a single shot, unlike the ones from Moderna or Pfizer-BioNTech, and is easier to store than some other vaccines. It is especially useful for hard-to-reach or transient populations. “There is no doubt in my mind that there are groups for whom this vaccine is of benefit,” Dr.
