COVID-19 brought unprecedented public attention to the development, regulation, and timeline for products that prevent deadly infections, potentially heralding an era of vaccine innovation marked by the broader adoption of new technologies, such as mRNA, and expanded disease targets.
As the winter of 2022–23 progresses and pre-pandemic activity levels have returned, media outlets have been calling attention to a “tripledemic” caused by co-circulation of influenza, COVID-19, and respiratory syncytial virus (RSV) overwhelming hospital emergency departments. The availability of safe and effective vaccines and treatments for influenza and COVID-19, coupled with strong recommendations from public health and medical authorities for their use, means that a significant fraction of the most severe outcomes of those illnesses is preventable.
A preventive option for RSV has thus far remained elusive, however, leaving high-risk populations—young infants and older adults in particular—susceptible to severe disease, hospitalization, and in some cases, death. As 2023 begins, multiple products targeting RSV are in the late stages of clinical development, with regulatory approvals possible as early as later this year. However, this promising next generation of vaccines and related interventions will look very different from historical vaccine breakthroughs such as those for measles, polio, and mumps.
These new products, several of which—such as monoclonal antibodies—move beyond the classic vaccine paradigm in their design or function, raise critical questions regarding how they will or should fit into the current national vaccine program. Health officials will need to determine what the precise intent and scope are of vaccine provisions included in existing legislation and regulation, how these policies have been translated into immunization programs previously, and what may need to change to accommodate innovations in product development. The new products will need to be integrated into regulation, implementation, financing, and promotion practices that were designed for past vaccines. If the principal objective of immunization and immunization policy is to protect individual and population health, what needs to be addressed in the delivery system to support new products that function in a manner analogous to traditional vaccines despite having differences in their underlying design or the mechanism by which they confer protection?
Adapting And Enhancing Vaccination Programs In Response To New Approaches To Prevention
In the case of RSV, for example, a recent Health Affairs Forefront article argues for the inclusion of preventive RSV monoclonal antibodies into the Vaccines for Children (VFC) safety-net program. The principal concern in this article is about patient access to preventive monoclonal antibody through the VFC program, an entitlement program that purchases and distributes vaccines recommended by the Centers for Disease Control and Prevention Advisory Committee on Immunization Practices for Medicaid-eligible and uninsured children. VFC facilitates high vaccination coverage rates in children and adolescents, particularly the underserved, regardless of insurance status. Inclusion into the VFC program means that all children are entitled to vaccination, and vaccine manufacturers have security in ensuring their product will be purchased and used, brokered through federally negotiated contracts that facilitate uptake. It is currently unclear if preventive monoclonal antibodies with broad population health recommendations will be included in this program.
Beyond considerations for children, vaccines, including RSV monoclonal antibody products, also target adult indications. The application of mandatory insurance coverage and payment provisions in the Affordable Care Act and, more recently, provisions included in the Inflation Reduction Act, mandate coverage of vaccines at first dollar (that is, at no cost to the consumer). Inclusion of monoclonal antibody products in these provisions are yet undetermined.
In addition to financing and access considerations, an additional discordance between preventive monoclonal antibodies and the current immunization delivery system relates to state and municipal immunization information systems (IIS). Many of these systems, also referred to as vaccine registries, may not currently be equipped to capture non-vaccine products, nor may many electronic health record (EHR) and pharmacy systems. During the COVID-19 pandemic, IIS were critical for tracking vaccine doses and coverage. As part of the COVID-19 vaccination program, tremendous efforts and investments were made to enhance EHRs and, particularly, registries to better track adult vaccination data. The decade ahead will provide opportunities to continue this momentum and further strengthen the adult vaccination program, which has long been weaker and less well supported than the pediatric program, as reflected in lagging coverage rates and uneven efforts to communicate the value and importance of vaccines to adults and their health care providers.
Similarly, quality measures for pediatric, adolescent, adult, and maternal vaccinations will need to facilitate the inclusion of monoclonal antibodies into composite measures to help drive and sustain vaccination coverage within our health care delivery system, particularly given the linkages between IIS and IIS and EHR systems in reporting coverage.
Vaccine Policy And The Routinization Of COVID-19 Vaccination
These approaching challenges in vaccine policy will overlap with ongoing public health and health care systems as they work to integrate COVID-19 response activities into broader disease control programs, an enormously complicated and challenging effort in its own right. The COVID-19 vaccine policy agenda is full of complicated questions that need to be answered around the long-term scope, design, and goals of routine COVID-19 vaccination, including the timing of when to get vaccinated, as well as the composition of vaccines included in those efforts. Furthermore, seamless coverage of COVID-19 vaccines at no cost to the patient is essential regardless of insurance status or type of insurance coverage. Under the current vaccine financing regime, all children—insured or uninsured—as well as adults with public or private insurance would have access to recommended COVID-19 vaccines at no cost; uninsured adults would not. Addressing this potential gap prior to the wind-down of the current model for COVID-19 vaccine purchase and delivery is imperative and may require specific action by Congress.
Lastly, COVID-19 vaccination coverage has hovered around 70 percent for the primary series and is much lower for booster doses, except among adults 65 years and older. This picture is reminiscent of the marginal gains seen over the past decade for influenza vaccination; rates have hit a similar plateau despite public health authorities encouraging vaccination each year. To adequately address these and other issues that are certain to arise with continued COVID-19 vaccination efforts, ongoing government resources in the form of personnel and financial support will remain essential—particularly through partnerships with well-respected community-based organizations.
As we emerge from an acute emergency response posture and look ahead to post-COVID-19 vaccine innovation opportunities, how public health policy and practice questions are managed will shape the success or failure of these efforts. In addition to the robust RSV pipeline, enthusiasm for mRNA vaccines and other pipeline candidates is high among scientists, public health agencies, and the biotechnology industry. Future developments may include next-generation COVID-19, influenza, and pneumococcal vaccines; multicomponent meningococcal B vaccines; vaccines against hospital-acquired infections such as Clostridium difficile; sexually transmitted diseases; vaccines to combat bioterrorism; and those aimed at emerging or reemerging threats such as mpox and chikungunya virus.
To realize the potential of innovations in the pipeline, products such as monoclonal antibodies that are intended to prevent disease and death and work like vaccines, should be aligned across programs and recognized within systems to ensure insurance coverage and access that enables broad-based and equitable uptake across intended populations. How regulators and public health authorities evaluate and implement these products, in both policy and practice, alongside the difficult work ahead supporting existing pediatric and adult vaccination programs and adapting COVID-19 vaccination to a non-emergency model, will have vast implications for the future of vaccine innovation and the long-term success of all US immunization efforts.
Authors’ Note
This work was supported by a grant from the Greenwall Foundation.
