National Institute of Allergy and Infectious Diseases Director Anthony Fauci testifying before a Senate committee in early November. Chip Somodevilla / Staff/Getty Images.

More than a week after federal health officials greenlighted booster shots for all American adults, questions remain about what it means to be “fully vaccinated” against COVID-19 — and whether that definition might change for healthcare workers regulated by a federal vaccine mandate.

The uncertainty looms as nursing homes and others near the initial deadline for the new federal vaccination mandate for healthcare workers.

Top U.S. infectious disease official Dr. Anthony Fauci said last week that an additional dose of a COVID-19 vaccine could eventually become the country’s standard.

“We’d like to get as many people who were originally vaccinated with the first regimen boosted,” Fauci told Reuters Tuesday. “Right now, officially, fully vaccinated equals two shots of the mRNA and one shot of the J&J, but without a doubt that could change. That’s on the table for discussion.”

The Centers for Medicare & Medicaid Services vaccination rule calls for all nursing home workers to receive one Johnson & Johnson dose or two doses of either mRNA vaccine — the first of which is required by next Monday. An agency spokesman said CMS is for now sticking with that regimen, even as COVID Infections are rising again and creating spikes in nursing homes whose residents and workers were among the first in the nation to be offered vaccinations.

“CMS’ healthcare staff vaccination rule presents an opportunity to continue driving down COVID-19 infections, stabilize the nation’s healthcare system, and ensure safety for anyone seeking care,” the spokesman told McKnight’s in an email. “Because the science and clinical recommendations around additional doses and boosters (are) evolving rapidly, we refer individuals to CDC’s Interim Clinical Considerations for Use of COVID-19 Vaccines Currently Approved or Authorized in the United States for additional details. For the purposes of the CMS rule, documented receipt of additional or booster doses is not needed for staff who have completed a COVID-19 primary vaccination series authorized or licensed by the FDA, or listed by the WHO for emergency use.”

Breakthroughs and boosters 

November outbreaks hit nursing homes in Connecticut, Vermont and Virginia this month, even as resident vaccination rates hovered around 87% and staff rates approached 75% nationally. Those breakthroughs were the target of a New York Times article this weekend that questioned why nursing homes have lagged behind in offering additional doses.

Prior to Thanksgiving, about 36 million Americans had received a booster dose. On Nov. 19, the government expanded eligibility to all U.S. adults.

Long-term care pharmacies and nursing homes have quickly scheduled clinics to get boosters to residents, said Jim Lewis, director of policy and advocacy for the American Society of Consultant Pharmacists. Most providers are following current federal immunization policy that allows booster doses for healthcare workers but does not mandate them, “largely because of limited data in younger populations,” Lewis added.

“Given the current ACIP (Advisory Committee on Immunization Practices) recommendations, pending legal challenges and lack of data, we don’t believe that the CMS Interim Final Rule will be amended to require boosters,” Lewis told McKnight’s. “In large part, the data on initial vaccine regimens continues to show strong efficiency in preventing hospitalization and death.”

Since the Nov. 19 approval of boosters for all adults, Lewis said ASCP pharmacist members have seen requests for new clinics.

Tina Sandri is CEO of Forest Hills of DC, which reached a 98% staff vaccination rate with two exemptions to comply with a Washington, D.C., mandate effective Sept. 30. The facility, offering largely skilled nursing, will hold its first booster clinic for workers this week. 

“It’s not going to be as much of an uphill battle,” Sandri told LeadingAge members on a coronavirus call Nov. 22. “A: It’s not mandatory, so we’re not pushing people up against  a wall. B: They’ve already seen the good, so the emotional resistance is just not there as much. Most people are just asking, ‘When is the booster coming?’ ”

Still, few providers are looking to mandate a third shot given the focus on getting 100% of workers their primary series in time to comply with the CMS rule.

Leigh Ann Barney, president and CEO of Louisville, KY-based Trilogy Health Services, told McKnight’s Senior Living prior to Thanksgiving that the organization had offered six weeks of booster opportunities at ongoing vaccine clinics in conjunction with Synchrony Pharmacy.

“We continue to see the level of participation from residents and employees increase each week,” Barnet said. “Currently, the booster is not mandated; however, we are monitoring CDC guidelines and recommendations.”

The organization mandated COVID vaccinations before the federal rule. 

South Dakota-based Evangelical Lutheran Good Samaritan Society, meanwhile, is working closely with its pharmacy partners to offer boosters to residents and staff members, said Gregory Johnson, M.D., chief medical officer.

“Nearly 60% of eligible residents across our 300 locations in 22 states have already received a booster,” he said. “We continue to educate our people on the benefits, and more are choosing to get a booster every day.”

Emerging concerns

While much of the early push for boosters was related to waning immunity from shots given more than six months ago, other concerns remain. Chief among them now: whether additional shots will help slow the transmission of omicron, a worrisome new variant spotted around the world in the last week.

“Right now if you talk to people in vaccine circles, people who are working on the vaccine, they have a pretty good degree of confidence that a boosted vaccine, so three full doses of vaccine, is going to be fairly protective against this new variant,” Scott Gottlieb, former FDA commissioner, said on CBS’ “Face the Nation” Sunday. “That third dose of the vaccine provides a much broader level of immunity. It’s not just more antibodies that you develop. You develop antibodies against more parts of the virus …. That could give a really strong impetus to try to get more people boosted.” 

Even if federal officials don’t expand their expectations, state and local officials will no doubt be watching immunity and variant issues closely. Some may be moved to enact new rules of their own.

New Mexico Gov. Michelle Grisham (D) earlier this month said the rising share of COVID cases among vaccinated residents — 29% in mid-November —  may lead to a new public health order regarding the definition of “fully vaccinated.”
“We know vaccinations are the most effective tool to both blunting the spread of the virus and to protecting yourself and our families,” Grisham said Nov. 17. “So we are analyzing what we can do to create those incentives — and potentially mandates — for making sure that people are fully vaccinated, which means three vaccines.”