“It seems to me today that you presented information to suggest it’s really challenging for us as a clinicians to mitigate the risk of severe complications, potentially,” advisory committee Chair Grace Lee said after the new data was presented.
CDC Director Rochelle Walensky must now decide whether to accept the panel’s recommendation. While she can overrule the group, the agency typically adopts its advisers’ suggestions.
The updated recommendation from the 15-member panel reflects efforts to communicate that the benefits of Pfizer’s and Moderna’s messenger RNA vaccines outweigh the risks much more than J&J’s. However, it also acknowledges that the J&J shot still has value when no other vaccine is available, as well as for individuals allergic to the mRNA vaccines. For those reasons, the panel recommended that the J&J shot still be offered.
“The issue of informed consent is complex, and I am concerned that many people maybe don’t have all the information that they would need to give informed consent,” said Beth Bell, a clinical professor at the University of Washington’s School of Public Health. “Having said that, I think that there legitimately are some people who may opt for the Janssen [J&J] vaccine even after being appropriately informed. And I don’t think that it’s right for us to make that option unavailable to them if, in fact, that’s what they choose to do.”
Some panel members, at least initially, suggested they were reluctant to back a recommendation that wouldn’t outright limit the J&J vaccine’s use, given the fatality rate associated with the clotting incidents.
“I really have a problem with it,” said Pablo Sanchez, a pediatric specialist at Nationwide Children’s Hospital in Columbus, Ohio. “I’m not recommending it to any of my patients’ parents. I’m telling them to stay away from it.”
Others expressed fears that a vote to explicitly limit or ban the shot’s use in the U.S. would have a chilling effect on vaccine confidence and uptake, both domestically in populations who don’t yet trust the mRNA vaccines’ safety and abroad, where the J&J product may be the only option.
“Even though there are significant risks to the vaccine, if it’s the only option, I want it to be available,” said Jamie Loehr, a family physician in Ithaca, N.Y.
The Pfizer and Moderna vaccines are linked to a heightened risk for myocarditis, an inflammation of the heart muscle, especially among males 30 and younger. The key difference between those rare cases and the J&J-associated clotting cases is that none to date has been fatal. In addition, the majority of myocarditis patients were considered fully recovered after three months.
Penny Heaton, the global R&D head for vaccines at J&J’s Janssen subsidiary, defended the shot’s safety and efficacy while acknowledging the severity of the rare blood-clotting cases.
“Based on the data, we are confident in the positive benefit-risk profile of our vaccine,” she said. “It is saving lives here in the U.S. today.”
The company, she added, is investigating what in the vaccine may contribute to the complications.
Katherine Ellen Foley contributed to this report.