FILE – A sign in front of the Food and Drug Administration building is seen on Dec. 10, 2020, in Silver Spring, Md. (AP Photo/Manuel Balce Ceneta, File)
By Helena Oliviero, Stephanie Lamm and Jennifer Peebles
FDA advisors approve a new method to streamline the COVID-19 vaccine formulas
A Food and Drug Administration advisory panel unanimously voted late Thursday in favor of a proposal to dramatically change and simplify its COVID-19 vaccine strategy.
The change advisors approved will phase out the first vaccine formula, created to target only the original strain of the virus that appeared in China. If approved by FDA and the Centers for Disease Control and Prevention, anyone getting their first vaccinations would get the same updated vaccine formula used for boosters. These “bivalent” vaccines protect against the original strain of the virus as well as newer variants.
A single vaccine approach would be less confusing to patients and health care providers.
FDA advisors also considered but did not vote on whether to offer a single annual vaccine for COVID designed to target the virus strain most likely to become dominant over the winter. This change would make COVID vaccines more similar to the annual vaccine for seasonal flu.
The changes discussed are aimed at making it easier to know when to get a booster, but questions remain about the best strategy to maximize immunity in the face of an ever-evolving virus.
“I think our job here is to protect against severe disease,” said Dr. Adam C. Berger, a National Institutes of Health official and member of the panel who cited research showing people who are vaccinated are far less likely to be hospitalized for COVID compared to those unvaccinated. “(This) can really make a difference. We can actually have a (booster) strain that’s matched to the currently circulating strains. … I think it would make sense to simplify the process.”
The decision will now go to the FDA for approval, and then an advisory panel to the CDC. The final step is a signoff from CDC Director Dr. Rochelle Walensky.
WATCH LIVE: Today’s VRBPAC meeting is underway where the committee will discuss whether and how the composition for primary doses of the currently available COVID-19 vaccines should be modified and whether booster doses should be adjusted moving forward. https://t.co/B1XPFmOJ4k
— U.S. FDA (@US_FDA) January 26, 2023
Making a change so that people get a single shot every year like a flu shot would not necessarily mean fewer recommended shots for older adults who are considered at the greatest risk for getting seriously ill with COVID. While most people under a simplified COVID vaccine schedule would get an annual shot, those who are older, very young or immunocompromised, or who have serious health problems, might need a second dose each year, according to an FDA briefing document.
Dr. Paul Offit, one of the advisers and director of the Vaccine Education Center at Children’s Hospital of Philadelphia, said while he thinks it’s important to get closer to circulating strains, the goal is to “keep people out of the hospital and not overwhelm hospitals.” But he said older, medically frail people may not mount a robust immune response to the vaccine, and referencing his 94-year-old mother, “I think we should always, always make a point of giving antivirals.”
Also at the FDA panel meeting Thursday, CDC officials updated information from earlier this month on a possible stroke risk seen in older age groups who have received the latest bivalent booster shots. The CDC study looked at 550,000 patients age 65 and over who received the Pfizer-BioNTech bivalent vaccine at the same time as a high-dose flu vaccine.
The study found a higher-than-expected number of ischemic strokes up to 21 days after the vaccine in people who took both vaccines at the same time. The CDC cautioned that there could be factors other than vaccination that are contributing to the finding.
An ischemic stroke is caused by blockages in arteries that carry blood to the brain. Earlier this month, Pfizer-BioNTech said in a statement that they were aware of limited reports of ischemic strokes, but said there was not enough evidence to tie the strokes to the vaccine.
In presenting the study findings to the vaccine panel, the CDC noted that the “statistical signal” does not prove that the vaccine caused the strokes. A more rigorous study is planned by the CDC and FDA. Among the considerations that need to be looked at is whether early adopters of the bivalent vaccines were those already at a greater risk of cardiovascular events.
Through the first few rounds of COVID vaccinations in Georgia, older residents were the most dependable age group to roll up their sleeves and take the shots. But seniors have largely shrugged off the latest available dose, the bivalent booster released in September.
Just 27% of Georgians 65 and older have taken the latest booster, according to the CDC. In the general population, the number is even lower, with only 9% getting the shot.
“Booster fatigue is real,” said Becky Kurtz, the Atlanta Regional Commission’s managing director for aging and independence services. “There is this sense of, ‘Aren’t we done with that now?’”
The Atlanta Regional Commission recently launched a campaign, titled “Life Is Better with a Boost,” targets both English and Spanish speakers and features digital ads, billboards, newspaper and radio ads, banners at pharmacies and supermarkets and transit ads. This effort is supported through a grant from the Georgia Department of Human Services, with funds originating from the Centers for Disease Control and Prevention.
While it’s true that there are fewer hospitalizations, fewer deaths and at least 80% of the U.S. population has some immunity now, either through vaccination or actually contracting the virus, COVID is still around and causing problems. Especially for older adults.
About 15 people a day in Georgia are dying of COVID-19, according to the most recent weekly reports from the Georgia Department of Health. Of those, roughly 83% were 65 and over, according to data from the state Department of Public Health.
Experts worry that there may be confusion about the effectiveness of the latest vaccine. Across the country, less than 40% of those 65 and older have received the updated shot, according to the CDC.
The Kaiser Family Foundation surveyed people who are in that age group and vaccinated, but have not gotten a bivalent booster. About a third said they don’t think they need it, and a similar number said they don’t think the benefit of the updated booster is worth it.
However, doctors say it’s a mistake to skip the boosters. Immunity fades over time. And the booster is aimed at the newer variants, including the strain most prevalent now, XBB.1.5, which has been better at evading immune defenses gained from vaccination and prior infection.
A December CDC study reported on the benefits of updated boosters for older Americans in 22 hospitals from early September to late November. Among people 65 and older, those who had received the updated booster were 84% less likely to be hospitalized with COVID compared to those who were unvaccinated and 73% less likely to be hospitalized compared to those who received two or more doses of the original vaccine but not the updated booster.
This is a file photo of A.G. Rhodes CEO Deke Cateau getting the COVID-19 vaccine. “We welcome effective strategies to simplify the vaccination and booster process as we continue to keep our residents healthy and safe. We look forward to learning more about the efforts that are underway,” said Cateau Thursday after the FDA panel meeting. Photo courtesy of A.G. Rhodes.
Deke Cateau, chief executive officer of A.G. Rhodes, a nonprofit nursing home provider with three communities in metro Atlanta, said “it’s been a struggle” to get high numbers of residents to take the updated booster shots.
With fewer people getting severely ill and dying from COVID, many older adults are taking “their foot off the gas,” he said.
But, he continued, “We’ve had too much devastation in our nursing homes, so our job as providers is to keep our foot on the gas pedal.”
John Abel, music director at A.G. Rhodes Nursing Home, performs during a music therapy class as resident Barbara Walker dances. Virginia Beaty, right, and Shelia Lindsey, play instruments. “So complacency is the word we do not want. We have just only just started to breathe again at the nursing home again,” Cateau said. Miguel Martinez / [email protected]
The percentage of residents up to date on their vaccinations is 84% at A.G. Rhodes Wesley Woods, 89% at A.G. Rhodes Atlanta, and 91% at A.G. Rhodes Cobb, according to a spokesperson.
Dr. Swati Gaur is the medical director of New Horizons long-term care communities, which include a rehabilitation center and a nursing home with the Northeast Georgia Health System.
She said she gets frustrated when she hears people say, “I’m going to get COVID anyway.” The boosters, she said do lower the risk of catching the virus. And they continue to save lives.
She’s still reeling from the early days of the pandemic before vaccines were available when she had 42 patients who were positive for COVID.
“I didn’t know how many of them were going to make it,” she said. “It was the most devastating time of my career, and I never want to ever be in the situation again.”
Read the original story on AJC.com.
