Maryland long-term care residents in both nursing homes and assisted living facilities are now eligible to receive COVID-19 booster shots under a new order announced by Gov. Larry Hogan (R) on Wednesday.
The sudden declaration has providers and pharmacies scrambling to figure out the operational and legal challenges in order to get the additional doses to residents as soon as possible.
“We all want to help protect older adults in congregate settings and appreciate that this is the intent of the governor’s announcement,” said Allison Ciborowski, president and CEO of LeadingAge Maryland. “However, this puts providers and pharmacies in a difficult position.”
Hogan’s order goes beyond the Food and Drug Administration which only approved a third dose of the Pfizer and Moderna COVID-19 vaccines for the immunocompromised, like cancer patients and organ transplant recipients. Federal health officials in mid-August said nursing home residents likely will be among the first to be eligible for the third shots, but no guidance on what other subgroups will have priority for the booster has been released yet.
Michigan Gov. Gretchen Whitmer (D) in mid-August issued an executive order directing state agencies to prioritize and fast-track COVID-19 booster shots for long-term care facilities.
Hogan said he made his decision to move forward because of the lack of clear guidance from the federal government regarding the shots.
“The limited guidance we have received has been confusing and contradictory, and it is still unclear when and how more people will become eligible,” Hogan said in a statement. “But all of the evidence makes it abundantly clear that we cannot afford to delay taking decisive action to protect our most vulnerable citizens.”
LeadingAge Maryland’s Ciborowski, however, said questions still remain around where facilities can get the additional doses and how they will be distributed. Problems are causing confusion for providers, pharmacies, residents and families, she added.
“I’ve heard from pharmacies today who say they just cannot do what the governor has announced,” she told McKnight’s Long-Term Care News on Thursday.
“Pharmacies and other COVID-19 vaccination providers are beholden to specific federal requirements. The [Centers for Disease Control and Prevention] and FDA guidance at this time only allows a third dose for immunocompromised patients with specific conditions; not a global booster dose based on residence or age,” she added. “Doing so would be an off-label use which could leave both facilities and vaccine providers open to liability.”
Ciborowski explained that federal regulations require vaccine providers administer the vaccinations in accordance with all requirements and recommendations of the CDC and its Advisory Committee on Immunization Practices.
“There are certainly individuals in nursing homes who are truly immunocompromised and to whom additional doses should be and are being provided,” she said. “[The] CDC has been clear that, ‘Age or place of residence alone (e.g., residence in a long-term care facility), independent of a patient’s medical condition, should not be used to determine the level of immune competence, as the balance of benefits and risks of an additional dose for people who are not moderately to severely immunocompromised is currently unknown.’”
The FDA is scheduled to meet this week to discuss COVID booster shots. Ciborowski said the organization feels “it would be more prudent to wait for their recommendation.”