Top federal health officials said in interviews this week that the number of rare blood clotting disorders in recipients of the Johnson & Johnson vaccine has remained small.
By Noah Weiland and Sharon LaFraniere
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 C.D.C. The committee is scheduled to meet on Friday to discuss whether to recommend lifting, extending or modifying the pause that was initiated on April 13.
“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 one in a 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.
Dr. Marks and Dr. Janet Woodcock, the F.D.A.’s acting commissioner, said the clotting disorder appeared to be nearly as rare as they had hoped it would be when they recommended the pause.
“We’ve now received more cases, but it isn’t an avalanche,” Dr. Woodcock said. “We’re not seeing a big surge, which is a great relief.”
Dr. 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.”
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