Vaccine boosters for seniors living in group settings OK’d
Hogan: State authorizing another dose ahead of formal approval from feds
Maryland is moving forward with allowing COVID-19 vaccine booster shots for seniors and others living in nursing homes and other group settings, even though the federal government has not yet issued formal rules for when most Americans should get them.
Gov. Larry Hogan announced Wednesday that the state is immediately authorizing booster doses for those age 65 and older in nursing homes, assisted living centers, residential treatment centers and group homes for people with disabilities.
The state’s move expands the U.S. Food and Drug Administration’s mid-August decision to allow third doses for immune-compromised individuals who have had transplants, cancer treatment, advanced HIV or otherwise have weakened immune systems and can’t fight infections.
In essence, Hogan is applying a broad reading of the federal approval of third doses to include seniors in group living situations, regardless of their health.
“We are interpreting that view to deem the seniors in congregate care settings as immunocompromised,” Hogan spokesman Mike Ricci said.
The Republican governor’s announcement at the State House in Annapolis comes amid confusion over eligibility for additional doses of the vaccine.
“To be clear, these facilities in Maryland will not have to wait to offer boosters,” said Hogan, who received a third dose himself as a cancer survivor and has been pushing for
broader use of them.
The discussion of booster shots, also known as third or supplemental doses, has so far focused primarily on the two-dose Pfizer/BioNTech and Moderna vaccines. The single-dose Johnson & Johnson vaccine, which works differently, was approved later, and it’s not yet known when or whether additional doses will be required.
President Joe Biden’s administration has said it plans to begin authorizing additional vaccine doses to all adults who are at least eight months out from their first vaccine regimen starting Sept. 20, but final approval hasn’t come through yet.
Federal regulators will meet Sept. 17 to determine whether to authorize booster shots of the Pfizer/BioNTech vaccine in people ages 16 and older. The FDA would have to approve expanding third doses to more people, and a CDC committee also would have to issue a formal recommendation for it to go into effect.
An FDA spokeswoman declined to comment directly on Maryland’s latest order, but instead referred to publicly available information regarding the COVID-19 vaccines, including a “fact sheet” about the Pfizer vaccine last updated Aug. 23.
“A third dose of the Pfizer-BioNTech COVID-19 Vaccine administered at least 28 days following the second dose of this vaccine is authorized for administration to individuals at least 12 years of age who have undergone solid organ transplantation, or who are diagnosed with conditions that are considered to have an equivalent level of immunocompromise,” according to the document.
This includes cancer patients and those currently receiving “immunosuppressant therapies” such as chemotherapy.
Still, Hogan said the federal guidance has not been clear, and what directives have been made have been “confusing and contradictory.”
Hogan said the state Department of Health has sent guidance to pharmacies and medical providers, instructing them to give third doses “to anyone who considers themselves to be immunocompromised.”
Joseph DeMattos Jr., president of Health Facilities Association of Maryland, which represents nursing homes in the state, said the governor’s announcement would be “welcome news” for older adults living and being treated in such settings, as well as those who care for them. But the move also would be met with some challenges, he said, as it does not fully align with federal guidance.
“It’s important to remember ... that being age 65 does not equate with being immunocompromised,” DeMattos said. “Anyone ages 65 and over should consult with a physician and health care practitioners to seek advice on how soon they should receive a third dose.”
Logistically, offering supplemental doses to adults in congregate facilities also could pose hurdles in terms of scheduling and manpower, he added.
“Even before the COVID-19 pandemic, our workforce faced worker availability challenges, and we all know now the pandemic amplified those challenges,” DeMattos said. “It was only with the help of the Maryland state government, and the National Guard working together on the initial rollout, we were able to succeed.”
Hogan said Wednesday that state health officials have assured him that booster shots will be able to be administered at a smaller scale, and using fewer resources, than during the initial rollout, which operated with a combination of mass vaccination sites, pharmacies, retail partners and targeted clinics to immunize the state’s eligible population.
Maryland has administered more than 28,000 booster doses so far, according to state data.
Medical providers will be required to report booster doses, just as they have with other vaccine doses, Hogan said. He said there are sufficient vaccine doses available. He also encouraged people who have questions about whether they should get a booster to talk to their doctor.
As for the need for booster vaccine doses for seniors in group settings, Hogan referenced a program that’s testing antibody levels in nursing home residents. He said more than 60% of those tested showed “some form of waning immunity” and up to a third showed “a higher level of vulnerability.”
The testing program is designed to be a yearlong project conducted by LabCorp at a cost of $842,000. The contract was awarded without competitive bidding on an emergency basis but has not yet been approved by the state Board of Public Works, which reviews state spending and contracts.
Dr. Eric Toner, senior scholar at the Johns Hopkins Center for Health Security, said the state’s data, coupled with studies run in other countries, indicates a clear waning of vaccine protection in older adults after a months-long span. Given the severity of COVID-19 inside congregate care facilities during the pandemic, Toner said the state’s decision stemmed from well-informed logic.
He also said the FDA’s full approval of the Pfizer vaccine means that health care providers can use it “off label,” or using their best clinical judgement.
“For the Pfizer vaccine, it seems clear to me that it can be done and it should be done,” Toner said. “It may be a little more complicated for Moderna, which is still being used with emergency use authorization. So, it’s not clear to me that we have the same latitude for off-label use.”
Toner expects Pfizer boosters will be made available for all older adults as soon as this month.
Hogan’s remarks on booster shots came as Maryland continues to experience a surge in infections and hospitalizations associated with the delta variant of the coronavirus.
On Wednesday, 817 people were being treated for the coronavirus in Maryland hospitals — a patient load that is eight times what the state experienced just two months ago. The state reported 701 new positive cases Wednesday, with the positivity rate at 4.68%. The state has a high level of community spread of the virus, according to the U.S. Centers for Disease Control and Prevention.
Maryland’s vaccination rate remains better than most states, with 62.1% of the state’s residents fully vaccinated with one dose of the Johnson & Johnson vaccine or two doses of either the Pfizer/BioNTech or Moderna vaccines, according to the CDC. When children younger than 12 who are not yet eligible for vaccines are excluded, the state’s full vaccination rate is 72.8%.
Hogan, however, prefers to tout the rates of residents who have received at least one vaccine dose, which is 68.9% of the total population and 80.6% of the eligible population aged 12 and older.
“We’re proud of the fact that we’re in much better shape here in Maryland and we have been able to avoid the spiking numbers other states are experiencing,” Hogan said.
Hogan and other political and health leaders have urged people to get vaccinated, characterizing the pandemic as a race between vaccines and variants. The majority of people getting sick with the virus and landing in the hospital or dying are not vaccinated, according to state health officials.
Some, including AARP Maryland, which represents older adults, have been calling on the state to implement a “strong system for booster shots” that prioritizes state residents ages 50 and up, especially those in congregate settings.
In an Aug. 31 letter to Hogan, the organizations urged the governor to include in the booster rollout an education campaign to show older residents how to sign up for shots.
“We asked him to prioritize older Marylanders and it appears that’s what he is doing, so we applaud those efforts,” said Hank Greenberg, state director for AARP Maryland. “We hope that it will run more smoothly than the original rollout.”
Hogan also said that the state will spend $3 million doing door-to-door canvassing to encourage more Marylanders to get vaccinated.