Two top federal agencies called for a halt on using the Johnson & Johnson/Janssen vaccine for COVID-19 after rare blood clots were reported — a pause that has the potential to slow the flow of vaccines to long-term care facilities for ongoing immunization efforts.
The Food and Drug Administration (FDA) and Centers for Disease Control and Prevention (CDC) on Tuesday put out a joint statement recommending a pause in using the J&J vaccine to allow the agencies to review six reported cases of cerebral venous sinus thrombosis (CVST), “a rare and severe type of blood clot” that was seen in combination with low levels of blood platelets, or thrombocytopenia.
More than 6.8 million doses of the J&J/Janssen vaccine have been administered in the U.S. as of April 12, the agencies noted in their statement, and the recommendation to pause was given “out of an abundance of caution” until the CDC’s Advisory Committee on Immunization Practices (ACIP) can review the cases.
The American Health Care Association (AHCA), which represents more than 14,000 primarily for-profit skilled nursing facilities and assisted living facilities, issued out a statement calling on federal officials to continue to prioritize long-term care residents and staff by “promptly” reallocating the vaccines from Pfizer (NYSE: PFE)-BioNTech and Moderna (Nasdaq: MRNA).
“Unfortunately, today’s development essentially halts vaccinations in long term care, as the federal government was primarily allocating the Johnson & Johnson vaccine to nursing homes and assisted living communities,” Dr. David Gifford, AHCA’s chief medical officer, said in a statement issued Tuesday. “Without swift action to replace these vaccines, we could see tragic consequences. We appreciate federal and state officials ensuring our most vulnerable and their caregivers have steady and rapid access to vaccines.”
It’s not clear how much long-term care vaccinations will slow down as a result of the pause. The Department of Health and Human Services (HHS) did not respond to a request for comment from Skilled Nursing News as of press time, and it is not clear from the CDC’s long-term care facilities vaccination data how much of the total consists of J&J shots.
The J&J vaccine only received its emergency use authorization (EUA) on February 27, by which point the federal Pharmacy Partnership for Long-Term Care program was wrapping up the third and final vaccine clinics in most states.
Angela Perry, the administrator at the Vernon Manor Health Care Center nursing home in Vernon, Conn., told SNN via e-mail on Tuesday that her facility was told by the state Department of Public Health (DPH) the week of April 5 that the J&J vaccines would be available to manage resident and staff needs.
The allocation would be provided to the facility with five or more individuals requiring vaccination, with an on-staff registered nurse administering the vaccines, she explained. Vernon Manor currently has six unprotected residents and an additional 50 staff out of 180 that the facility is encouraging to become immunized. However, the Connecticut DPH as of Tuesday was recommending a pause on the J&J vaccine until further guidance from the CDC and FDA, she said.
“We are working together with our pharmacy on alternatives, such as the Moderna vaccine if available, to fill the interim gap,” she told SNN.
In Texas, Touchstone Communities is still working with its “vaccination partner” to make shots available to residents, patients, and team members, COO Leslie Cunningham Campbell told SNN through a spokesperson.
“The pause in the J&J vaccine rollout should not slow down those efforts, and we will continue to follow all guidelines associated with the giving of vaccine,” she said through the spokesperson.
Phil Fogg Jr., the president and CEO of Marquis Companies in Milwaukie, Ore., stressed the fact that the effects of the J&J pause would vary by situation. If a long-term care pharmacy (LTCP) provider was approved by CDC and state to be a vaccine distributor/dispenser for the first three clinics in Phase One, they “generally have ample Pfizer or Moderna supply,” he noted.
LTCPs that were approved and designated to distribute J&J vaccines in the second phase will now have vaccine access “based on state and their supply of non-J&J vaccination supply,” Fogg said, while LTCPs who were not approved or whose approval was contingent on vaccine supply might run into disruptions.
“Final comment is that we are consistently hearing that this will not be a long term disruption,” Fogg wrote. “We are hearing projections of 2-3 weeks.”
A Walgreens Boots Alliance (Nasdaq: WBA) spokesperson noted that the pharmacy did not administer the J&J vaccine at any long-term care facilities that selected Walgreens as their provider, while use of the J&J vaccine is suspended generally at its stores and offsite clinics. A spokesperson for CVS Health indicated a similar policy.
“Our next steps will be determined by recommendations from CDC and the FDA,” the CVS spokesperson said. “The Janssen vaccine is not used during our LTC clinics as part of the federal Pharmacy Partnership for Long-Term Care program, which are 99% complete, and today’s federal guidance will not impact the completion of those efforts.”
CVS and Walgreens served as the two major partners on the federal vaccination program for long-term care facilities, though others were involved as the program unfolded.
An AHCA spokesperson told SNN via e-mail that the J&J vaccine was “he only vaccine being allocated to our settings through the federal pharmacy program.”
“Providers can work with their local pharmacies to receive the Pfizer and Moderna vaccines if they are able to secure it from their state, but we desperately need federal and state public health officials to allocate more of these vaccines to our settings,” the spokesperson wrote. “Without swift action to replace these vaccines, we could see tragic consequences.”
Tim Regan contributed reporting.