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.
manufacturing hurdles at a Baltimore plant that regulators have refused so far 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 C.D.C. director, said in an interview on 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.”
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 American officials follow suit, they will be reverting to a precaution that they considered early on.
In the days before the pause was initiated, F.D.A. officials had drafted a brief warning about possible rare blood clots to attach to the section of the vaccine’s emergency use authorization describing possible side effects.