An effort to streamline the national COVID-19 vaccination approach and shift to single, annual shots for most people may have major implications for nursing home staff.
A key Food and Drug Administration panel on Thursday voted 21-0 to direct manufacturers of approved COVID vaccines to “harmonize” initial shots and the most current booster. The move paves the way for development of a single annual shot for most Americans, likely creating vaccination campaigns that mirror the nation’s approach to flu shots.
For most low-risk, non-immunocompromised individuals, a single shot would be recommended each fall, and that shot would be designed to provide immunity against COVID strains predicted to be in wide circulation over the winter season. An FDA proposal unveiled earlier this week called for two annual shots for older adults and others at high risk of severe COVID-19.
Though the changes are far from a done deal, some are already questioning what the major shift in public health policy could mean for healthcare workers. They are now required to receive only an initial COVID vaccination series. The Centers for Medicare & Medicaid Services has not updated its year-old rule to compel booster shots, even as the share of nursing home workers considered “up-to-date” lingers in the 20% range.
“This raises questions for us, like, what does this mean for the CMS vaccine requirements?” Jodi Eyigor, director of nursing home quality and policy for LeadingAge said Wednesday. “Would it be easier in this case to mandate an annual staff vaccination? I don’t know. It would still have to go through a rule-making process to change the regulation that’s currently in place. But would CMS be doing that? And if they’re going to do that, is there a chance that they might throw the flu vaccine in there?”
CMS last year added staff flu vaccination reporting to its nursing home Quality Reporting Program, using the same Centers for Disease Control and Prevention portal used to report staff members’ COVID shots. Nursing home workers have historically had the lowest flu vaccination coverage of any healthcare employee group. Still, flu shots are not federally mandated for healthcare workers, so some saw the addition of the monitoring system as a possible prelude to future agency action on the issue.
“Your flu shot’s being reported on an annual basis for your QRP,” Eyigor noted Wednesday. “Does this help pave the way to move that COVID-19 vaccine reporting to become annual reporting as well?”
Eyigor’s comments came during a routine coronavirus call with LeadingAge members Wednesday afternoon. At that time she also outlined concerns and opportunities about the new one-size-fits-most approach she anticipated federal officials taking.
Annual vaccination questions remain
As reported by Stat News Thursday afternoon, a key question for some FDA panel members was how well officials would be able to time vaccine distribution to convey powerful protection, given that coronavirus outbreaks haven’t been contained to a single season like the flu or even most common colds.
In comments before the meeting, Eyigor predicted officials would create a plan B in case of new strains that evade the seasonal COVID vaccine, still allowing for unpredictability and emergency boosters.
One thing she warned providers about: News of the panel’s decision today might complicate their current efforts to increase booster uptake both among staff and residents.
“Even though all of these changes will benefit us in the long run, and hopefully make this a less complex process and hopefully remove some of the barriers to vaccination that we might be seeing, there is inevitably going to be some discussion about, ‘Well, if it’s going to be an annual vaccine, I might as well just wait until next fall to get vaccinated,’” she acknowledged.
“That is what we need to be working very hard to address in the next couple months: the fact that these are not going to be immediate changes, that everybody needs to get boosted with the currently available bivalent boosters now, and then we will see what hopefully is available to us in September.”
The final recommendations on transitioning the national vaccine strategy will come from the CDC. But before or after, there’s still plenty of time to rethink the approach should COVID change course unexpectedly.
“We have to keep reminding ourselves that this is not influenza and we need to keep paying attention to that to make sure we don’t just follow that dogma because we’re used to doing it,” said Bruce Gellin, a temporary voting member of the Vaccines and Related Biological Products Advisory Committee. Gellen is chief of global public health strategy for the Rockefeller Foundation’s pandemic prevention institute.
“We’ll try this this time,” he added. “I don’t think we’re setting it in stone and we’ll see how it goes. We may need to adjust along the way.”