As public health officials brace for a potential surge in coronavirus cases due to the BA.2 variant, the federal government on Tuesday approved a second COVID-19 booster dose for higher-risk individuals.
The U.S. Food and Drug Administration amended emergency use authorizations to allow a second booster dose of the Pfizer–BioNTech or Moderna COVID-19 vaccines to be administered to adults aged 50 or more years or to immunocompromised individuals The second booster should be given at least four months after the initial booster dose of any coronavirus vaccine, the agency said.
Immunocompromised people must be at least 12 years old to receive a second Pfizer booster and at least 18 to receive a second Moderna booster.
Following the FDA action, the Centers for Disease Control and Prevention said it was updating its recommendations to allow those aged 50 or more years and certain immunocompromised individuals who received an initial booster dose at least four months ago to be eligible for another mRNA booster to increase their protection against severe disease from COVID-19. Separately and in addition, based on newly published data, the agency said, adults who received a primary vaccine and booster dose of Johnson & Johnson’s Janssen COVID-19 vaccine at least four months ago may now receive a second booster dose using an mRNA COVID-19 vaccine.
“Boosters are safe, and people over the age of 50 can now get an additional booster four months after their prior dose to increase their protection further,” CDC Director Rochelle P. Walensky, M.D., MPH, said in a statement. “This is especially important for those 65 and older and those 50 and older with underlying medical conditions that increase their risk for severe disease from COVID-19, as they are the most likely to benefit from receiving an additional booster dose at this time. CDC, in collaboration with FDA and our public health partners, will continue to evaluate the need for additional booster doses for all Americans.”
Call for help
The booster news comes as senior living advocates have been seeking financial relief and new supplies of COVID-19 tests and booster shots in anticipation of federal measures to respond to the ongoing pandemic.
Just last week in a letter to Health and Human Services Secretary Xavier Becerra, American Health Care Association / National Center for Assisted Living President and CEO Mark Parkinson called for the federal government to prioritize long-term care for access to COVID-19 testing and treatments.
“Once again, we urge the administration to establish a separate process for long-term care pharmacies to order all COVID treatments directly, so that nursing homes and assisted living communities have a streamlined process for quickly accessing them,” Parkinson wrote. “Not only can these measures save precious lives, but also reduce the burden on our nation’s healthcare system by preventing unnecessary hospitalizations.”
Facilities have been working with their long-term care pharmacies or other vaccine providers for nearly a year for ongoing access to the COVID-19 vaccines, and those partnerships will continue for the second booster, an AHCA / NCAL spokeswoman told McKnight’s Senior Living. AHCA / NCAL said it will continue to urge the Biden administration to prioritize vulnerable, elderly long-term care residents in accessing booster shots.
Monday, Argentum took its plea for assisted living residents to be prioritized for COVID-19 boosters directly to the White House. But health advisers to President Biden said that doing so would require additional relief dollars from Congress.
The White House is seeking $22.5 billion in immediate emergency funding from Congress to further execute its coronavirus response plan and prepare for the future, officials said last week at a press briefing.
“I’d like to emphasize that if cases rise from the omicron variant or any other variant, we have the tools, vaccines, boosters, tests and therapeutics to be prepared. But continued investment in these tools so that they are readily available when we need them remains critical,” Walensky said at the time.
Argentum President and CEO James Balda said that older adults and assisted living caregivers are suffering from this “unacceptable standoff.”
“For two-plus years, it is seniors in congregate care settings and their caregivers who have borne the brunt of this coronavirus tragedy,” Balda said. “These vulnerable seniors can’t simply walk into a pharmacy for this life-saving vaccine; they need our help.”
In January, Argentum asked the Biden administration for a “reliable and consistent supply” of COVID-19 test kits directly to assisted living providers. The association also asked the federal government to renew the Pharmacy Partnership for Long-Term Care so that vaccines (and now COVID-19 boosters) once again could be administered through on-site clinics.
Argentum reiterated its request to renew the public-private partnership on vaccine and booster shots last week, saying on-site clinics work and helped assisted living achieve “near-universal vaccination” last spring.
“The equation is simple: at-risk seniors plus vaccine boosters equals less illnesses and deaths,” Balda said.
According to Argentum provider surveys, resident vaccination rates tracked at approximately 95% dating back to fall 2021, whereas staff vaccination rates range from 79% to 87%. Resident COVID-19 booster rates range from 75% to 81%, whereas staff booster rates range form 38% to 47%.
“Booster doses can help to counteract waning immunity in the vaccines, but additional support is needed to ensure this largely non-ambulatory population is able to receive the shots,” Balda wrote in a letter to President Biden. “A program earlier in your administration helped achieve resident vaccination rates of over 95% and staff vaccination rates of over 85%.”
The Kaiser Family Foundation found that among severe breakthrough infections, 69% were among older adults.
According to the CDC, about two-thirds of older adults eligible for COVID-19 boosters have received them. Less than 45% of all adults have received a booster shot.
A new KFF analysis found that the federal government does not have enough vaccine doses remaining in its current supply to fully cover the U.S. population with a fourth dose, despite what the government says. More than 33 million older adults 65 and older have received a first booster and would be eligible for a second, according to the New York Times.
The FDA cited evidence of waning protection over time against serious diseases in green lighting the second booster doses.
“Based on analysis of emerging data, a second booster dose of either the Pfizer–BioNTech or Moderna COVID-19 vaccine could help increase protection levels for these higher-risk individuals,” FDA Center for Biologics Evaluation and Research Director Peter Marks, M.D., Ph.D., said in a statement. “Additionally, the data show that an initial booster dose is critical in helping to protect all adults from the potentially severe outcomes of COVID-19.”
A study in Israel with healthcare workers showed increases in neutralizing antibody levels against SARS-Co-V-2 virus, including delta and omicron variants, were reported two weeks after the second booster, compared with five months after the first booster dose, according to Reuters.
In the Israeli study, scientists found that after a fourth dose, the rate of infection in adults 60 and older was two times lower, and the rate of severe disease was four times lower, showing a fourth booster had a “meaningful impact for older adults,” according to Katelyn Jetelina, Ph.D., an epidemiologist at the University of Texas Health Science Center at Houston.
According to LeadingAge, as of Feb. 9, 25 states require COVID-19 vaccination for employees, with 21 specifying requirements for healthcare workers. Seven states now require boosters of “up to date” status of vaccines.
The FDA’s Vaccines and Related Biological Products Advisory Committee plans to meet on April 6 to discuss future COVID-19 vaccine booster doses to address current and emerging variants.