Europe’s drug regulator said Tuesday that the benefits of J&J’s vaccine outweigh the risks of a possible link to the clots, intensifying the spotlight on the U.S. advisers.
Advisers to the Centers for Disease Control and Prevention are under pressure to decide whether the U.S. can resume use of Johnson & Johnson’s Covid-19 vaccine, perhaps with some limits, 10 days into a pause on using it.
Members of CDC’s Advisory Committee on Immunization Practices will reconvene Friday to decide whether they have enough data to say who should — or shouldn’t — receive J&J’s shot. Options include a full resumption, restrictions by age or gender, or extending the pause.
Wilbur Chen, a voting member of the committee and a professor at the University of Maryland School of Medicine, said he would like to see the vaccine used.
“I don’t want to have it sit on the shelf for any longer,” Chen said in an interview.
Last week the panel took no action, choosing to wait and see whether more cases turned up of rare blood clots observed in several people who received J&J’s immunization. The decision left millions of doses sitting in refrigerators across the country, igniting debate over whether the adverse reaction — seen in fewer than one in a million recipients — should delay use of a vaccine against the infection that’s killed more than 3 million people globally.
“Clearly they have to make a decision,” said Marci Drees, a liaison representative to the panel from the Society of Healthcare Epidemiology of America. “They can’t keep extending the pause for more data, because there will always be more data as we gain more time with the vaccine.”
Some have questioned how much additional information will emerge. Europe’s drug regulator said Tuesday that the benefits of J&J’s vaccine outweigh the risks of a possible link to the clots, intensifying the spotlight on the U.S. advisers.
New Brunswick, New Jersey-based J&J didn’t respond to questions about expectations for the meeting. Its vaccine came under additional scrutiny when U.S. regulators put a hold on production at a plant run by Emergent Biosolutions Inc. following an inspection. J&J said it has stepped up oversight and is establishing a manufacturing network of 10 sites to supply vaccine worldwide.
The CDC advisory committee shapes how vaccines are used in the U.S. State and local health departments and individual doctors rely on ACIP’s recommendations. Its 15 voting members include immunologists and public-health experts from outside the agency.
While the six cases of vaccine-linked clotting CDC advisers reviewed last week were all in women from 18 to 48 years old, there weren’t any obvious connections among the small sample of patients. Clouding the issue further is a clotting incident involving a young man during a late-stage clinical trial. Panel chair Jose Romero has raised the possibility that the pause may be extended if no more information comes to light.
When the panel met earlier, half of the J&J vaccine administered in the U.S. had been given in the past few weeks. Chen, the ACIP voting member, supported the pause because he didn’t feel the panel had enough data to make a clear set of recommendations. He also worried that providing interim guidelines only to change them later would create mistrust.
However, another extension of the pause would send a clear message against using the vaccine, said Drees, who’s also chief infection prevention officer and hospital epidemiologist at ChristianaCare, a Wilmington, Delaware-based health system.
“The committee definitely wants to make a decision one way or another whether or not to change anything,” she said.
In March, the advisers recommended J&J’s vaccine for anyone 18 and older. Some see a case for restricting its use by age, as European nations have done in response to similar clotting incidents linked to AstraZeneca Plc’s shot. Both inoculations use an adenovirus — a cold virus — that some researchers have said may be linked to the clotting reaction.
The U.S. has extensive supplies of shots that haven’t been linked to clots from Moderna Inc. and the partnership of Pfizer Inc. and BioNTech SE, and those may be a better option for people under 50, who appear more vulnerable to the side effect, said Martin Kulldorff, a member of the panel’s Vaccine Safety Technical subgroup.
“The big problem to pause this is for people over 50,” said Kulldorff, who’s also a biostatistician and epidemiologist at Harvard Medical School. “They really need this vaccine; it’s older people who are dying, and we need to vaccinate as many as possible.”
The European Medicines Agency, the EU’s drug regulator, said the blood clots should be listed as a very rare side effect so doctors and people who receive the shot can be aware of the symptoms. A Food and Drug Administration representative suggested a similar idea at last week’s ACIP meeting, saying the agency thought J&J’s shot could be used with some new warning language.
In a statement this week, the FDA said it and the CDC are continuing to review safety data for J&J’s vaccine and that ACIP will reconvene as quickly as possible to review additional scientific evidence.
“It’s important that these deliberative processes that protect patients are followed so that the American public has confidence in vaccine safety and effectiveness,” an FDA spokesperson said in an emailed statement.
Chen said he doesn’t know what the panel’s suggestion for how to use J&J’s vaccine will be without seeing the data. There are “a lot of scenarios that could play out,” he said.
J&J’s shot accounts for just 6% of the 272 million doses delivered in the U.S., according to CDC data, but its single-shot format is preferred for hard-to-reach populations like the homeless and people who live in remote areas.
States are disappointed about the pause because there was so much demand for J&J’s shot, which is also easy to store, needing only refrigeration, said Marcus Plescia, chief medical officer of the Association of State and Territorial Health Officials.
“The concern is if they have a hard time making a decision this Friday,” he said, “what is the end point that will allow them to come to a decision?”
(Except for the headline, this story has not been edited by our staff and is published from a syndicated feed.)