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.
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 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. It listed symptoms to be vigilant for, including shortness of breath, chest pain, leg swelling, persistent abdominal pain, severe and persistent headaches or blurred vision, and tiny blood spots under the skin.
The temporary suspension of the Johnson & Johnson rollout in the European Union had added to the bloc’s vaccine rollout woes, but it was not as big a blow as the AstraZeneca issues have been.
- On April 13, 2021, U.S. health agencies called for an immediate pause in the use of Johnson & Johnson’s single-dose Covid-19 vaccine after six recipients in the United States developed a rare disorder involving blood clots within one to three weeks of vaccination.
- All 50 states, Washington, D.C. and Puerto Rico temporarily halted or recommended providers pause the use of the vaccine. The U.S. military, federally run vaccination sites and a host of private companies, including CVS, Walgreens, Rite Aid, Walmart and Publix, also paused the injections.
- Fewer than one in a million Johnson & Johnson vaccinations are now under investigation. If there is indeed a risk of blood clots from the vaccine — which has yet to be determined — that risk is extremely low. The risk of getting Covid-19 in the United States is far higher.
- The pause could complicate the nation’s vaccination efforts at a time when many states are confronting a surge in new cases and seeking to address vaccine hesitancy.
- Johnson & Johnson had also decided to delay the rollout of its vaccine in Europe amid concerns over rare blood clots, but it later decided to resume its campaign after the European Union’s drug regulator said a warning label should be added. South Africa, devastated by a more contagious virus variant that emerged there, suspended use of the vaccine, and Australia announced it would not purchase any doses.
Vaccination efforts have fallen behind in Europe partly because AstraZeneca, a British-Swedish pharmaceutical company that is a major component of the region’s inoculation efforts, was unable to deliver the number of doses expected in the first quarter of the year. Then its vaccine was suspended over the blood-clotting concerns.
Even though the authorities eventually declared that the benefits of the AstraZeneca vaccine outweighed risks, and advised E.U. members to use it, the damage had been done.