CDC advisory panel delays decision on Johnson & Johnson Covid-19 vaccine

The U.S. government’s recommended pause on use of the Johnson & Johnson Covid-19 vaccine is unlikely to be lifted for at least another week or 10 days, after a committee of independent experts declined Wednesday to vote on whether use of the vaccine should resume.

The Food and Drug Administration and the Centers for Disease Prevention and Control urged states to stop using the J&J vaccine on Tuesday to seek advice from the expert panel on some rare but serious clotting problems seen in a small number of people who received the vaccine. Six cases have been identified — and J&J officials indicated a possible seventh is being investigated. One person has died.

Many members of the Advisory Committee on Immunization Practices said they felt they had too little information to be able to estimate the benefits and risks of the vaccine, or to recommend its use be restricted to people in certain age groups.

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“To be very frank, I do not want to vote on this issue today. I do not want to vote not to recommend the vaccine — I think that is not really something I necessarily believe. But I do not feel that we have … enough information to make an evidence-based decision,” Beth Bell, a global health professor at the University of Washington who is the chair of the committee’s Covid vaccines work group, said near the end of an afternoon of presentations and discussion.

The committee’s executive secretary, CDC scientist Amanda Cohn, appeared to try to steer the committee toward lifting the pause for certain subsets of the population, but the group sidestepped that suggestion. One member of the committee, Drexel University pediatrics professor Sarah Long, recommended the pause be extended for at least a month, but CDC staff suggested additional data could be pulled together over a shorter time frame.

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While most voting members of the committee — which advises the CDC — appeared to support extending the pause, some warned that inaction will have serious consequences for the effort to vaccinate people against Covid, both in the United States and beyond.

Camille Kotton, clinical director of the transplant and immunocompromised host infectious diseases program at Massachusetts General Hospital, called the decision to suspend use of the vaccine “devastating” to efforts to vaccinate difficult-to-reach populations such as people who are housebound.

And Nirav Shah, president of the Association of State and Territorial Health Officers, also expressed concern about the committee’s approach.

“We are in a situation where not making a decision is tantamount to making a decision,’’ said Shah, who is a non-voting representative to the ACIP. “Any decision to pause will invariably result in the fact that the most vulnerable individuals in the United States, who were prime candidates for the Johnson & Johnson vaccine, will remain vulnerable. The most at risk will remain at risk.”

Some outside experts who were watching the proceedings were also highly critical.

“What they did is they punted,” said Paul Offit, a vaccine expert from Philadelphia Children’s Hospital who is on an FDA advisory committee that originally recommended the J&J vaccine be given emergency use authorization.

“People look to recommending bodies … to make a recommendation. And I just think they didn’t do that. And now we’re just floating out there,” he said.

The decision to recommend that states stop using the J&J vaccine came after scientists monitoring a reporting system for adverse events following vaccination spotted what appeared to be a signal of a rare but serious problem experienced by some people who got the J&J vaccine. Tom Shimabukuro, a vaccines safety scientist at the CDC, called it “a success story” for the surveillance systems set up to look for rare side effects possibility linked to vaccination.

The illnesses all occurred in women, though one man in the clinical trial of J&J’s vaccine also experienced these symptoms. The women were aged 18 to 48.

Within a week or two of being vaccinated with the J&J vaccine, these women developed serious blood clots, while also having thrombocytopenia — low platelet levels in their blood. That is an unusual combination of conditions, because platelets help the blood to clot. The most troubling manifestation of the syndrome is something called cerebral venous sinus thrombosis or CVST, though some people also had pulmonary embolisms or clots in their lungs and clots in limbs.

“These are significant blood clots,” Shimabukuro said. “This is unusual.”

In announcing the decision to pause use of the vaccine, Peter Marks, the director of the FDA’s Center for Biologics Evaluation and Research, noted that there was a serious need to inform health care providers of the possibility that patients seeking care might be suffering from this syndrome. The normal course of treatment — a blood thinner called heparin — would actually be dangerous to use in these patients.

A similar problem has been seen with AstraZeneca’s Covid vaccine, which led to a temporary pause of its use in some countries. Most now have resumed using the vaccine but many have limited its use to older adults.

Many ACIP members stressed that the U.S. has other vaccine options. Neither of the mRNA vaccines, made by Moderna and the Pfizer-BioNTech partnership, have been seen to induce this problem. But several other committee members expressed concern about the message the U.S. pause could be sending about the J&J vaccine to the rest of the world, where the one-dose, inexpensive vaccine is expected to play a key role.

“I recognize that our responsibility at ACIP is to individuals in the U.S. But I also feel the weight of the burden of a global responsibility that we all have and the impact that our decision making could potentially worsen inequities,” said Grace Lee, a pediatrician at Stanford University School of Medicine.

Bell stressed that people shouldn’t interpret the ACIP’s decision not to recommend lifting the hold as evidence that the problem is more serious than first believed or that there is something fundamentally wrong with the vaccine. “That’s not the message that I want to send,” she said.

But Offit said there was little other way to read the committee’s move.

“I think you can’t help but interpret it as that,” he said.

Correction: A previous version of this story misspelled Amanda Cohn’s surname.

Source: STAT