Federal advisory panel to meet Wednesday on J&J vaccine

A federal advisory panel will meet Wednesday to debate whether and how Johnson & Johnson's Covid-19 vaccine should continue to be used in the U.S., following reports of rare but severe blood clots among a few recipients.

The Advisory Committee on Immunization Practices, or ACIP, is expected to review clinical data gathered to date on six women between the ages of 18 and 48 years who developed blood clots after receiving J&J's vaccine, according to a draft agenda of the meeting posted online Tuesday.

The committee's virtual emergency meeting, scheduled for three hours Wednesday afternoon, will be open to the public.

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Its findings and decisions will help determine how the federal government moves forward with the J&J vaccine at a difficult juncture in the pandemic. The U.S. is racing to vaccinate more people to damp the impact of more-infectious and rapidly spreading variants of the Covid-19 virus.

J&J has said it is aware of the cases involving blood clots and low platelet counts and is working with health authorities. It is unclear whether the vaccine is the cause. President Biden said the U.S. has sufficient supplies of other vaccines to inoculate all eligible adults in the U.S.

The ACIP advises the U.S. Centers for Disease Control and Prevention on who should get vaccines and how they should be used.

The recommendations made by its 14 voting members--medical and public-health experts from outside the agency--go to the CDC director, who decides whether to make them policy. The U.S. Food and Drug Administration will also review the committee's recommendations on the J&J vaccine.

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The ACIP recommended who should be given priority for Covid-19 vaccines and in which order. After the FDA authorized Covid-19 vaccines from Pfizer Inc. and partner BioNTech SE, Moderna Inc. and then Johnson & Johnson, the panel recommended the shots.

Only a few details about the six blood-clot cases are known publicly. The patients developed symptoms including headaches, abdominal pain, nausea and neurological symptoms six to 13 days after vaccination. All six were diagnosed with blood clots in vessels draining blood from the brain; two also had clots in vessels that drain the intestines.

One of the women died and another is in critical condition, according to federal health officials.

One of the six, a woman in her late 40s from Douglas County, Neb., developed blood clots two weeks after receiving her vaccine. Nebraska public health officials announced an investigation into that case on April 9.

More than 6.8 million J&J doses have been administered to date in the U.S. The six women's cases were reported to the federal government's vaccine adverse-event reporting system in late March and early April.

The CDC issued an alert to healthcare providers Tuesday warning them to screen patients for the blood-clotting condition if they recently received the J&J vaccine and have severe headache or abdominal pain, shortness of breath, backache, leg swelling, new neurological symptoms or new or easy bruising. The condition requires a unique treatment, different from the standard protocol involving the anticoagulant heparin, the agency also warned.

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The ACIP's task will be to try to establish whether the vaccine caused the blood clots, and then how it should be used going forward, said Walter Orenstein, associate director of the Emory Vaccine Center at Emory University and a former head of the CDC's U.S. Immunization Program.

That will mean weighing the benefits of protecting people against a deadly disease, particularly with new surges in the pandemic under way, against the risks posed by the vaccine, Dr. Orenstein said.

"That will be a fundamental issue," he said. "Even if they're not sure if it's causal, do the benefits outweigh the risks?"

The committee could recommend continuing vaccination with the J&J product "at full throttle," he said. It could decide that the J&J vaccine be discontinued for certain groups--such as younger adult women--or halt its use altogether, given that two other vaccines are available, he said.

It is possible more data will become available before the meeting to help the ACIP panel make a recommendation, if more cases come to light, Dr. Orenstein said. "All of the publicity may get people to report who hadn't previously reported," he said.

Jason Schwartz, assistant professor of health policy and the history of medicine at the Yale School of Public Health, said he expects the ACIP panel to offer more medical guidance to healthcare providers about the risk of blood clots and how to treat them rather than make big changes.

"I'm not sure the committee would want to take broad steps," he said, given the small number of cases.

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Additional guidance would be important, he said, because the condition the six women experienced--blood clots and low blood platelet counts--requires treatment that is different from what some doctors might typically provide.

Vaccination and infectious disease experts praised the government's quick recommendation to pause the use of J&J's vaccine and then hold an open meeting to evaluate the data.

"It shows that our regulatory agencies are working properly," said Krutika Kuppalli, assistant professor of infectious diseases at the Medical University of South Carolina. "They picked up a signal and they jumped on top of it. They want to be careful; they want to be transparent."