Long-term care pharmacies and clinicians have temporarily halted their use of Johnson & Johnson’s COVID vaccine while federal agencies review six cases of blood clots linked to the shots. Guidance is needed quickly in order to keep residents safe, they say.
Pharmacy giants CVS Health and Walgreens, along with their LTC affiliates Omnicare and PharMerica and community pharmacies said they had complied on Tuesday with the government’s request for a pause by putting their scheduled J&J shots on hold. They were joined by at least two dozen states orders by mid-day, according to CNBC.
Chad Worz, PharmD, chief executive of the American Society of Consultant Pharmacists, said that most community pharmacies are waiting to see what happens while independent federal advisers convene Wednesday and health agencies contemplate next steps. But Worz noted that the pause is a recommendation and not a mandated stoppage by the Food and Drug Administration and the Centers for Disease Control and Development.
“The issue seems to be in younger, female patients, and it may be that guidance from FDA will make that more clear, reopening the vaccine to older adults in a few days,” Worz said. “Some long-term care pharmacies receive the other vaccines, and the pause is not expected to last long, so the impact may not be significant in long-term care.”
“That will become more apparent this week,” Worz told McKnight’s.
Eldercare provider PharMerica, meanwhile, has cancelled its Tuesday and Wednesday clinics in anticipation of new guidance, T.J. Griffin, RPh., chief pharmacy officer, told McKnight’s. But if the pause is extended, the company will “move quickly to secure doses of the Moderna and/or Pfizer vaccines in order to ensure that our long-term care patients have access,” he said.
CVS Health and its Omnicare business, meanwhile, said that the J&J vaccine is not used in companies’ LTC clinics as part of the federal Pharmacy Partnership for Long-Term Care program, which are 99% complete. Tuesday’s federal guidance will not impact the completion of those efforts, according to a spokesman.
But the J&J vaccine has figured into the federal government’s next phase of vaccinations in long-term care settings, said industry advocates. And some fear that the industry may stand to lose significant gains in infection control if federal health agencies don’t continue prioritizing LTC residents for shots.
Don’t leave residents behind, advocates urge White House
The Biden administration should “promptly” start supplying more Pfizer and Moderna vaccines to nursing homes and assisted living facilities, according to the The American Healthcare Association / National Center for Assisted Living.
The federal government has begun allocating primarily Johnson & Johnson vaccines to this population, although not at the levels necessary to ensure all facilities and pharmacies had consistent and immediate access, AHCA/NCAL said in a Tuesday statement. The early vaccine rollout featured the Pfizer and Moderna vaccines.
“There is this notion among some that vaccines were administered in long-term care, so we’re done, and that would be a perilous mistake,” said David Gifford, M.D., MPH, the chief medical officer of AHCA / NCAL. There is a “constant flow” of new residents and employees who will need vaccinations, he emphasized in a Tuesday statement.
Clinicians should take heed of rare risk
Blood clot events tied to the J&J vaccine appear so far to be exceedingly rare. The FDA says it knows of six out of 6.8 million administered nationwide, and these were in younger adult women, so it may be unlikely that an eldercare clinician will come across a case.
Still, clinicians should be aware that any clots occurring within three weeks of a J&J vaccination could be cerebral venous sinus thrombosis, according to the FDA. It may be unsafe to treat this condition with the anticoagulant heparin, a standard of care for blood clots, the agency said in a joint statement with the CDC.
“Alternative treatments need to be given,” the agencies stated.
The temporary action to halt the vaccine’s use “is important, in part, to ensure that the healthcare provider community is aware of the potential for these adverse events and can plan for proper recognition and management due to the unique treatment required with this type of blood clot,” officials stated.
The CDC plans to convene a meeting of its independent immunization advisory committee on Wednesday to scrutinize the reported blood clot cases, with the outcome to be reviewed by the FDA.
Danielle Brown, Kimberly Marselas, Kimberly Bonvissuto and James M. Berklan contributed to this story.