The Biden administration is working with states to reschedule appointments for individuals who were in line to receive shots of Johnson & Johnson’s COVID-19 vaccine in the coming days, after federal agencies recommended a pause in usage over safety concerns.
Jeff Zients, coordinator of the White House coronavirus response team, said in a statement that the federal supply of other vaccines — produced by Pfizer-BioNTech and Moderna — was enough to continue vaccinating the country at a pace of 3 million shots per day.
“We are working now with our state and federal partners to get anyone scheduled for a J&J vaccine quickly rescheduled for a Pfizer or Moderna vaccine,” Zients said. “This announcement will not have a significant impact on our vaccination plan: Johnson & Johnson vaccine makes up less than 5 percent of the recorded shots in arms in the United States to date.”
The Centers for Disease Control and Prevention and the Food and Drug Administration on Tuesday recommended a temporary pause in use of the J&J vaccine after identifying six cases of a rare blood clot known as cerebral venous sinus thrombosis — all in women under the age of 50 — out of a total 6.8 million distributed doses nationwide.
The J&J vaccine is a single-dose vaccine made with viral vector technology, a similar method used in the AstraZeneca vaccine that was similarly paused in Europe weeks ago due to scientists’ concern with a possible correlation to blood clots.
Those individuals developed blood clots in combination with low levels of blood platelets, a rare pattern that raised red flags among public health agencies, FDA officials said in a call with reporters.
“It’s plainly obvious to us already that what we’re seeing with the Jannsen [Johnson & Johnson] vaccine looks very similar to what was seen with the AstraZeneca vaccine,” said Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research. “I can’t make some broad statement yet, but obviously they are from the same general class of viral vectors.”
CRITICAL FDA ADVISORY BOARD MEETING
Anne Schuchat, principal deputy director at the CDC, told reporters that the FDA’s advisory panel on immunization practices, known as ACIP, would review data on the J&J vaccine on Wednesday and provide a risk-benefit analysis.
While FDA officials said they anticipate the advisory board will make a recommendation in a matter of days, it is possible the panel requests more time and a second meeting to continue its deliberations.
“One of the things that the ACIP deliberation will do is review the data on the cases and the context of risk benefit, and possible subsets of the population that may be in different categories,” Schuchat said.
Another CDC official told McClatchy that ACIP has a variety of options before them.
They could determine that the number of known cases of vaccinated people with blood clots is statistically so low that it is worth resuming use of the vaccine. They could pause use of the vaccine entirely, pending further investigation of the cases.
They could also pause use of the vaccine in a certain demographic, such as women ages 50 and younger.
“We have a robust safety system in this country,” the official said. “It notifies us when there are potentially things going wrong, or issues we need to take a closer look at. The system has done that.”
After the European Medicines Agency reviewed cases of blood clots affiliated with AstraZeneca’s vaccine, the European Union organization recommended the resumption of its use in all age groups.
But one country, France, issued its own guidance recommending that vaccine be used only for adults over 55 years old.
While all of the cases with complications identified in the United States have occurred in women under 50, it is possible that new cases will “come out of the woodwork” now that the federal government has flagged the problem, Marks said in a Zoom briefing with the American Medical Association.
Marks also noted that the agency identified one case of severe blood clotting in a participant of the Johnson & Johnson clinical trial. That case occurred in a man who was one of 20,000 trial participants.
STATES RESCHEDULING APPOINTMENTS
Zients said the administration was notified Monday night that the FDA would be making an announcement, but didn’t learn the details until Tuesday morning.
“As soon as we got that, our team farmed out and started contacting folks to make sure that everyone knew that was now announced by the FDA and CDC,” he said.
Zients, CDC Director Dr. Rochelle Walensky and President Joe Biden’s chief medical advisor, Dr. Anthony Fauci, spoke to governors during a regularly scheduled call Tuesday morning as well.
The governors were told that the J&J pause should not impact the pace of vaccinations, given that most of the vaccine doses available are produced by Moderna and Pfizer, and they were encouraged to convert existing J&J appointments to the other vaccines.
“It will not materially impact our ability to fulfill our expectations and commitment to provide enough vaccine to fully vaccinate all those that seek to get vaccinated,” California Gov. Gavin Newsom said after the call with White House officials.
Zients said in some places, people who had their vaccine appointments canceled had already been rescheduled. He added that the federal government will “do anything we can to support the states on the logistics of rescheduling.”
Up until this week, roughly 25 million vaccine doses were being delivered to states, pharmacies and federal vaccination sites each week. That supply already outpaces demand, even with over three million Americans getting shots each day, Zients said.
This week, the amount of vaccine doses being distributed is set to increase to 28 million.
“At the same time, the most important thing is that the supply exists to continue to vaccinate 3 million Americans a day,” Zients said. “There’s enough supply to actually accelerate that.”
Updates with comments from White House briefing.
Sophia Bollag and Lara Korte of the Sacramento Bee contributed reporting.