Providers should pay careful attention tomorrow as a key Food and Drug Administration advisory board discusses making the fight against COVID-19 feel more like influenza by producing one vaccine each year that offers enough protection to most people.
The move comes partly in response to the slow uptake of the bivalent vaccine approved in September and targeted to variants of omicron. Just 16% of Americans ages 5 and older have received the bivalent booster, according to the Centers for Disease Control and Prevention (CDC).
“Although the use of the bivalent mRNA boosters is supported by the available evidence, their deployment has been associated with significant implementation complexities,” according to the executive summary of the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) meeting. “Given these complexities and the available data, a move to a single vaccine composition for primary and booster vaccinations should be considered.”
If the panel approves the new approach, the CDC’s Advisory Committee on Immunization Practices (ACIP) must meet and vote on it as well. If they approve, then the CDC makes the final decision.
A spokeswoman for the American Medical Association (AMA) told Fierce Healthcare that “per AMA policy, AMA supports ACIP recommendations on vaccines. We know physicians are one of the most trusted sources of information for patients and they should play an integral role in COVID-19 vaccine administration while ensuring the vaccines remain widely accessible.”
Local and retail pharmacies also gained a lot of trust during the pandemic, and they too need to play an integral role in vaccine administration, according to the National Association of Chain Drug Stores (NACDS). The organization cites a poll taken in December that found 64% of American adults believe that “learning the lessons of the pandemic means keeping in place policies that make it easier for patients to access services from pharmacists and other pharmacy team members—including vaccinations.”
NACDS commissioned data aggregating company Morning Consult to conduct the poll.
Kathleen Bashur, NACDS' senior manager of media relations, told Fierce Healthcare that “pharmacies have helped to lead the effort that has returned students to classrooms; restored livelihoods; and reunited families, friends and neighbors. Pharmacy teams continue to give two in every three COVID-19 vaccinations, with the total number at 300 million. Additionally, 50% of individuals vaccinated for COVID-19 at a pharmacy are from underserved areas.”
NACDS wants the Biden administration to keep the Public Readiness and Emergency Preparedness Act in place until October 2024. That legislation provides liability protection to pharmacists, pharmacy technicians and pharmacy interns.
Bashur also appealed to states, calling on them “to modernize their laws based on lessons learned from the pandemic, and to help prevent Americans’ loss of the pharmacy access and equity they rely on and expect.”
Meanwhile, a spokesperson with the American Academy of Family Physicians (AAFP), which represents about 127,000 physicians and medical students nationwide, pointed out that AAFP has a member representative on the FDA's advisory board.
In addition, AAFP in the past has argued (PDF) that docs should take the lead role in a vaccine distribution effort.
“Family physicians are well-equipped to administer COVID-19 vaccines, and they know a patient’s history and can easily update medical records and coordinate care between pharmacies and a patient’s medical home,” the AAFP spokesperson said. “Additionally, for families living in rural areas, receiving immunizations from an office-based, family physician may be the only option. While we are preparing for the eventual commercialization of COVID-19 vaccines, it is still crucial the government ensure vaccines and therapeutics are available for the uninsured and others who cannot access them.”
Paul Offit, M.D., the director of the Vaccine Education Center at the Children’s Hospital of Philadelphia, sits on the advisory committee and often votes against the majority. For instance, when VRBPAC last June approved the bivalent vaccine, Offit was one of two members of the 15-member panel to vote against it.
Offit told Fierce Healthcare that “I don’t necessarily agree that COVID-19 vaccine should follow the influenza vaccine model, but am open-minded to data soon to be presented at Thursday’s meeting.”
In its executive summary, the panel states that a one-and-done yearly COVID-19 vaccine “should reduce complexity, decrease vaccine administration errors due to the complexity of the number of different vial presentations, and potentially increase vaccine compliance by allowing clearer communication.”
Experts at the meeting plan to discuss using the same vaccine strain composition for primary series and booster shots, the need for periodic strain selection processes and simplifying COVID-19 vaccine schedules.
VRBPAC also notes that COVID-19 has been a moving target throughout the pandemic, with emerging variants—and a waning of vaccine-induced immunity—meaning that a simpler immunization schedule and routine updates to the vaccines' composition are key.
Like how it deals with influenza, FDA wants to assess COVID-19 strains annually and would ask VRBPAC in early June of each year for a recommendation about which strain should be used to develop an updated shot. The vaccine would be available for deployment no later than September of any given year.
Sifting through the available science about the value of the bivalent vaccine can be daunting, VRBPAC admitted in the executive summary, because of limited sample size, the differences in testing regarding the booster’s effectiveness, the population being tested and the time between vaccination and collection of blood serum to determine potency.
So why are children still getting the original monovalent version of the COVID-19 vaccine? That's a question Kevin Kavanagh, M.D., president and founder of patient advocacy organization Health Watch USA, told Fierce Healthcare he wants to see answered.
Kavanagh said he worries about imprinting, where exposure to the virus, whether it’s from a vaccine or infection, will determine the type of immune response to all future exposures. This creates a concern that those exposed only to the original variant, for instance through the monovalent vaccine, will not produce as strong a response and immune memory to new variants.
“And this may also limit then the immune system’s learning about how to respond to the new infections when they’ve been imprinted with the original variant,” said Kavanagh. “The advantage of imprinting to the body is that it provides for a very rapid immunological response, but a response that may not perfectly match the virus that individuals are exposed to.”
He expressed those concerns in a letter to VRBPAC ahead of the Thursday meeting.
Should annual COVID-19 shots be authorized, VRBPAC posited that most individuals will need to receive only one dose of vaccine to restore immunity “for a period of time.” Also, though, “two doses of an approved or authorized COVID-19 vaccine may be needed to induce the expected protective immunity for those who have a low likelihood of prior exposure (the very young) or those who may not generate a protective immune response (older and immunocompromised individuals),” according to the executive summary.
In examining the techniques used by the U.S. and the rest of the world to address the flu, VRBPAC admitted that the infrastructure for COVID-19 worldwide surveillance might need to be better developed.
In addition, the wide variety of different COVID-19 vaccines available throughout the world, and the uneven supply of vaccines to all corners of the globe, make evaluation of vaccine effectiveness quite a challenge.
“Ideally, any change in vaccine composition, when appropriate, would be implemented broadly and would be coordinated by the World Health Organization with national regulatory authorities,” the executive summary said. “However, unlike influenza, a well-established, highly coordinated infrastructure and governance of global semi-annual vaccine composition evaluation and recommendations do not currently exist for SARS-CoV-2.”