West Virginia raced ahead of the country last winter to vaccinate people in nursing homes against Covid-19, but with cases and hospitalizations on the rise again, state officials want to know whether immunity levels are falling for residents who have had their shots.
Starting in August, the state plans to begin measuring the levels of disease-fighting antibodies in the blood of vaccinated nursing home residents, which could help indicate whether they need booster shots. The process will be voluntary, and the data will be shared with federal health agencies evaluating the need for boosters.
Some experts question the strategy, particularly because the federal government hasn't yet authorized the extra shots.
Covid cases in West Virginia and nationally have more than tripled in the past month. Much of the surge is blamed on the delta variant, a highly contagious form of the coronavirus sweeping the country. In June, about 10 percent of hospitalized Covid patients in West Virginia and 12 percent of Covid deaths were among fully vaccinated people, said the state's coronavirus response coordinator, Dr. Clay Marsh, executive dean for health sciences at West Virginia University. Nationally, about 3 percent of hospitalizations and 1 percent of deaths in July have been among people vaccinated against Covid.
Still, deaths attributed to Covid remain very rare in West Virginia, which is averaging two a day. Hospitalizations have risen from 65 patients on July 1 to 133 as of Wednesday, according to state data.
"In West Virginia, we were very aggressive in vaccinating our long-term care population, but we now worry and are paying more attention about whether we have sufficient immunity in those fully vaccinated," said Marsh, who is often referred to as the state's coronavirus czar.
Antibodies not the only defense
The question of the need for a booster has gained much attention lately. Israel announced plans Thursday to start providing booster shots this weekend to adults over age 60 who have received their second shots at least five months earlier. Executives at Pfizer, one of the companies producing a vaccine, released a paper Wednesday that found a slight dip in efficacy against any symptomatic cases of Covid four months after immunization is completed. The paper, which hasn't been peer-reviewed, predicted that a third shot could boost disease-fighting antibodies many times more than the level achieved from a two-shot regimen.
Pfizer said it plans to seek Food and Drug Administration authorization for a booster shot by mid-August.
Some health experts cautioned that information about antibody levels may not be helpful.
Dr. Michael Wasserman, a geriatrician who is a member of the California vaccine advisory committee, said lower antibody levels don't automatically mean less immunity. "The fact that antibodies are going down is normal, and it doesn't mean that those people are not immune to the virus," he said.
Antibodies decrease over time, "but that doesn't tell us if you're exposed to Covid whether your body will move into gear and produce more. ... The question of whether antibodies are a marker of adequate immunity is one we have not answered yet," he said.
West Virginia officials say their nursing home antibody testing could help the FDA and other regulators evaluate the need for boosters.
"We want to gather this information and, pending what we find, work with Centers for Disease Control and Prevention and the Food and Drug Administration on an appropriate response," Marsh said. "This is a complicated issue, as antibodies are not the only defense against Covid."
An antibody test will be used to measure levels against what was expected after immunization and whether levels are high enough to neutralize the delta variant, he said.
Focus on first doses, not third
The state will also look at breakthrough infections and how many vaccinated people have ended up in the hospital or dead.
The state's nursing home industry supports the initiative, although officials say they've seen no increase in vaccinated Covid residents' getting sick. "Our goal is to advance knowledge and information that exists about the vaccines," said Marty Wright, CEO of the West Virginia Health Care Association, which represents nursing homes. He said antibody testing will offer one indicator of how well vaccines are still working.
I argued strongly against vaccine mandates when the vaccine came out, but I am in favor of them now.
Dr. David Wohl, a professor of medicine and director of the vaccine clinics at the University of North Carolina School of Medicine, said that even if the West Virginia initiative shows that antibody levels have dropped, states can't provide booster shots until the federal government authorizes them. "You do not do a test unless there is something you can do with the information that you get from the test," he said.
Wohl said that booster shots are likely to be needed eventually and that higher-risk populations — such as those who are immunocompromised or those in nursing homes — would be likely to be the first to get them.
Dr. Mark Roberts, a professor and former chair of the health policy and management department at the University of Pittsburgh Graduate School of Public Health, said immunity protection is much more complicated than just the level of antibodies. "It looks like protection from the vaccine wanes, but we don't know exactly how fast, and if protection wanes it may still protect people from getting sick and dying," he said.
Wasserman said a bigger question is whether officials are seeing more breakthrough infections in nursing homes and whether unvaccinated staff members are to blame.
"I argued strongly against vaccine mandates when the vaccine came out, but I am in favor of them now" for nursing home workers, Wasserman said.
California requires unvaccinated nursing home staffers to be tested regularly and to wear N95 masks. West Virginia requires all nursing home employees to get vaccinated or face twice-a-week testing.
In a joint statement in July, the FDA, the CDC and the National Institutes of Health said the government is analyzing laboratory data, clinical trial data and other data — which can include data from specific pharmaceutical companies — as they evaluate the need for booster shots.
"We continue to review any new data as it becomes available and will keep the public informed," they said. "We are prepared for booster doses if and when the science demonstrates that they are needed."
In a media call Thursday, state health officials in Maine, Louisiana and Delaware told reporters that they are paying attention to the booster shot issue and waiting for CDC guidance but that it's not their top priority.
"Right now our focus is getting folks first doses, not third doses," said Dr. Nirav Shah, director of the Maine Center for Disease Control and Prevention.
"There will be a time for booster shots, but there are still folks who do not have a first dose, and that is where our team is focused," said Shah, who is also president of the Association of State and Territorial Health Officials.