As COVID-19 evolves, so do the vaccines used to fight it, a point underscored yesterday at a White House press briefing in which public health officials said the U.S. may be entering a stage where getting a vaccine that protects against SARS-CoV-2 will become an annual preventive event, like getting a flu shot.
The cause for such optimism centers around the new, updated bivalent boosters approved for use last week by the Centers for Disease Control and Prevention (CDC).
“We fully expect that the updated bivalent vaccine containing BA.4 and BA.5 sequences will offer greater protection against currently circulating variants than the original vaccine, although it is difficult to predict at this point how much better that protection will be,” said Anthony Fauci, M.D., director of the National Institute of Allergy and Infectious Diseases and President Joe Biden’s chief medical adviser.
Fauci also added another caveat: While the bivalent vaccine will work better against original COVID-19 and the omicron subvariants, there’s no guarantee that it would work against a “dramatically” different variant that might emerge. It’s been the emergence of those sorts of variants that have fueled a continuation of the pandemic that now seems to be dying out.
Still, the one-and-done approach to COVID-19 vaccination should enhance uptake, says Richard Stefanacci of the Jefferson College of Population Health at Thomas Jefferson University.
“Regarding the COVID vaccination process as a geriatrician, it’s much appreciated as it provides much-needed clarity and simplicity,” Stefanacci tells Fierce Healthcare. “All stakeholders from patients, payers and [healthcare professionals] have been confused by the complex and ever-changing vaccine recommendations. Getting to be the same as influenza vaccinations will make it easy to implement. This will even be easier next year when we have a single fall/winter vaccine which combines COVID and influenza in a single shot.”
The bivalent vaccine produced by Pfizer will be available to everybody 12 and older; the Moderna version will be available to everybody 18 and older, and both are expected to be widely available around the country this week at pharmacies (including retail pharmacies such as Walgreens and CVS), clinics and doctor’ offices.
CDC Director Rochelle Walensky, M.D., pointed out that hospitalizations, though decreasing, are still too high at nearly 380 per day. She also stressed the importance of being up to date with COVID-19 vaccines, especially for people most at risk, including those over 50 and “others at high risk for significant disease.”
Healthcare workers on the front lines also benefit from being vaccinated, Walensky stressed. She cited a recent research letter in JAMA demonstrating that healthcare workers who receive one, two or three doses of the vaccine were less likely to develop long COVID compared with those healthcare workers who were not vaccinated.
The research letter concludes that among healthcare workers “with SARS-CoV-2 infections not requiring hospitalization, 2 or 3 doses of vaccine, compared with no vaccination, were associated with lower long COVID prevalence. Study limitations include that symptoms and duration were self-reported, and causality cannot be inferred.”
Walensky said yesterday that “modeling projections show that an uptake of updated COVID-19 vaccine doses similar to an annual flu vaccine coverage early this fall could prevent as many as 100,000 hospitalizations and 9,000 deaths and save billions of dollars in direct medical costs.” She added that people should get the updated bivalent boosters two months after their last COVID-19 vaccine.
Fauci said that “we fully expect that the updated bivalent vaccine containing BA.4 and BA.5 sequences will offer greater protection against currently circulating variants than the original vaccine, although it is difficult to predict at this point how much better that protection will be.”
While health officials expressed optimism that getting vaccinated against COVID-19 might become a yearly occurrence, some populations—such as the immunocompromised—might have to get vaccinated more frequently.
In addition, some medical experts think that the CDC may be taking too aggressive an approach when it comes to administrating updated bivalent boosters. For instance, Monica Gandhi, M.D., an infectious disease expert and a professor at the University of California, San Francisco, thinks that the lag time between the bivalent boosters and the last vaccine a person got should be six months, not two months, a point she made in a recent article in Time magazine.
“The antibody level plateau at the six-month mark would thus signal an ideal time to boost with a BA.4/5-focused vaccine since a low pre-boost antibody level actually [correlates] with a greater fold increase post-boosting,” Gandhi tells Fierce Healthcare. “To put it another way—high levels of circulating antibodies from short interval boosting may limit the added protection of another booster.”
Gandhi also doesn’t believe that everybody needs to get the bivalent boosters. “I would recommend this omicron specific booster for older people (65 and older) and immunocompromised who benefit from an ‘antibody boost’ during times of high viral circulation,” she tells Fierce Healthcare. “This is because B cells typically take 2-4 days to make neutralizing antibodies, which may be too long to wait for those who are more susceptible to severe disease. At some point, we need to clarify the goals of our booster strategy; if this is to prevent severe disease (like in other countries), we likely will only be giving regular boosters to older and immunocompromised individuals only.”
Yet one more red flag that Gandhi raises concerns on is some of the research upon which the CDC relies.
“Although there is absolutely biologic plausibility that the BA.4/BA.5 plus ancestral strain booster shots will increase neutralizing antibody data in humans, we only have mice data at this point (in <10 mice) that neutralizing antibody titers to BA.5 are increased above the original booster shot,” Gandhi tells Fierce Healthcare. “We also have clinical data from the BA.1/bivalent vaccines in humans from which the CDC is extrapolating. Although we do use mice data for updating flu shots every year, this is the first time that the mRNA booster has been updated [using mice data]. So getting human data with the BA.4/BA.5/ancestral strain bivalent vaccine may increase confidence in the vaccine.”
Another element playing into the vaccine debate that’s coming this fall: The question of just how much it will cost patients is yet to be decided. The Biden administration announced last month that it will stop supplying COVID-19 vaccines and tests for free to the public, shifting the cost to health insurance companies.
F. Randy Vogenberg, Ph.D., principal at the Institute for Integrated Healthcare, told Fierce Healthcare recently that the vaccines will be covered under a health plan’s medical benefit, not pharmacy benefit, and that insurers and the employers who contract with them should expect an increase in costs as a result.
Fauci said worldwide monitoring of the disease shows that vaccination demonstrates a “remarkable “94% to 95% efficacy against symptomatic disease. … My message to you is simple: Get your updated COVID-19 shot has soon as you are eligible to receive it in order to protect yourself, your family, and your community this fall and winter against COVID-19.”