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With few new clotting cases, Johnson & Johnson pause could be lifted soon

The FDA is expected to attach a warning to the Johnson & Johnson vaccine’s label to inform health practitioners — and the public — about its exceedingly uncommon, but dangerous possible side effect.
The FDA is expected to attach a warning to the Johnson & Johnson vaccine’s label to inform health practitioners — and the public — about its exceedingly uncommon, but dangerous possible side effect.Eva Marie Uzcategui/Bloomberg/file

WASHINGTON — Federal health officials appear to be leaning toward lifting their recommended pause on the use of Johnson & Johnson’s coronavirus vaccine after finding only a limited number of additional cases of a rare blood clotting disorder among recipients.

Instead, the Food and Drug Administration is likely to attach a warning to the vaccine’s label to inform health practitioners — and the public — about the exceedingly uncommon, but dangerous possible side effect.

Federal health officials are waiting to act until they hear from a committee of outside experts who advise the CDC. The committee is scheduled to meet Friday to discuss whether to recommend lifting, extending, or modifying the pause that was initiated April 13.

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“We know that it’s not a good thing to leave the pause going for any longer than it absolutely has to go for,” Dr. Peter Marks, the Food and Drug Administration’s top vaccine regulator, said Thursday, adding that a protracted pause could contribute to greater vaccine hesitancy. “Once, essentially, the adequate discussion has occurred, we’re prepared to move as quickly as we possibly can.”

When top federal health officials abruptly decided early last week to recommend a temporary halt in the use of the shot, six women had been reported to have suffered from the disorder, a combination of clots in the brain that led to bleeding and low platelets, components of the blood that normally help to heal wounds.

That was fewer than 1 in 1 million recipients of Johnson & Johnson’s shot in the United States. But officials worried that more cases were hidden or could develop shortly as the new vaccine rolled out.

That fear has not materialized.

Marks and Dr. Janet Woodcock, the FDA’s acting commissioner, said the clotting disorder appeared to be nearly as rare as they hoped it would be when they recommended the pause.

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“We’ve now received more cases, but it isn’t an avalanche,” Woodcock said “We’re not seeing a big surge, which is a great relief.”

Marks declined to specify how many new cases had been confirmed, but said the rate of the disorder was not expected to be higher “in terms of the order of magnitude.”

Even if the CDC’s advisory committee decides Friday that the benefits of Johnson & Johnson’s single-dose vaccine outweigh its risks, the company will still face manufacturing hurdles at a Baltimore plant that regulators have refused to certify. That plant was supposed to deliver the bulk of the nearly 100 million doses the firm had promised to have ready by the end of May.

But it would mean a temporary surge of about 10 million shots that were effectively put on hold when the pause was announced. Some state officials had been planned to use the one-dose, easily stored vaccine to inoculate college students before the summer or for other transient or hard-to-reach populations, but had to abruptly shelve those plans.

Dr. Rochelle P. Walensky, the CDC director, said in an interview Wednesday that federal officials had found “needles in haystacks,” an indication of how thorough the government’s oversight was. “We would like to make a decision quickly after ACIP,” she said, using the acronym for the expert panel called the Advisory Committee on Immunization Practices. “America and the world are interested in moving forward.”

European regulators, presented with similar concerns, recommended earlier this week that the vaccine’s rollout continue as long as a warning is added to the product about the risks of the blood clotting disorder. If US officials follow suit, they will be reverting to a precaution that they considered early on.

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