COVID-19 has brought unprecedented public attention to the development, regulation and timelines of products to prevent deadly infections. Era of vaccine innovation characterized by widespread adoption of new technologies such as mRNA, and expanded disease targets.
As the winter of 2022-23 progresses and pre-pandemic activity levels return, the media are calling attention to: “Triple Demic” Caused by the co-circulation of influenza, COVID-19, and respiratory syncytial virus (RSV), it is overwhelming hospital emergency departments. The availability of safe and effective vaccines and treatments for influenza and his COVID-19, coupled with strong recommendations for their use from public health and medical authorities, has led to significant reductions in the most serious consequences of these diseases. is preventable.
Prevention options for RSV have so far remained elusive, and high-risk populations, especially young infants and the elderly, can suffer severe illness, hospitalization, and possibly death. As 2023 begins, Several products targeting RSV are in late-stage clinical development and may receive regulatory approval at the earliest this year. But this promising next-generation vaccine and related interventions will be very different from historic vaccine breakthroughs such as measles, polio and mumps.
These new products (such as monoclonal antibodies) transcend traditional vaccine paradigms in design and function, and raise important questions about how they fit or should fit into current national vaccine programmes. Health officials should consider the exact intent and scope of vaccine provisions contained in existing laws and regulations, how these policies have previously been translated into immunization programs, and what changes have been made to accommodate innovation in product development. You have to decide if you need to. New products must be integrated into the regulatory, enforcement, funding and promotional practices designed for past vaccines. Where the primary purpose of immunization and immunization policy is to protect the health of individuals and populations, new products that function in a similar manner to conventional vaccines, albeit with differences in underlying design and mechanism. What needs to be addressed in the delivery system to support Do they give protection?
Adapting and strengthening vaccination programs to meet new approaches to prevention
For example, for RSV, recent Medical front line This article advocates the inclusion of prophylactic RSV monoclonal antibodies in Vaccines for Children (VFC) safety net programs. It is to Eligible Program to Purchase and Distribute Vaccines Recommended by The Centers for Disease Control and Prevention Advisory Committee is a committee on immunization practices for Medicaid-eligible and uninsured children. VFC promotes high immunization coverage among children and adolescents, especially underserved populations, regardless of insurance status. Participating in the VFC program means that every child has the right to be vaccinated, and vaccine manufacturers must comply with federally negotiated contracts to ensure that their products are purchased, used, and facilitated uptake. We guarantee to be mediated through It is currently unknown whether prophylactic monoclonal antibodies with broad population health recommendations will be included in this program.
Vaccines, including RSV monoclonal antibody products, are intended for adult indications as well as considerations for children.Application of mandatory insurance coverage and payment provisions in the Affordable Care Act and more recently provisions contained in the Inflation Reduction Act, Mandate vaccine coverage for the first $1 (i.e., at no cost to the consumer). It remains to be determined whether these provisions will include monoclonal antibody products.
In addition to funding and access considerations, a further discrepancy between prophylactic monoclonal antibodies and current immunization delivery systems relates to state and local immunization information systems (IIS). Many of these systems, also called vaccine registries, may not currently be equipped to capture non-vaccine products, nor are many electronic health record (EHR) and pharmacy systems. 19 During the pandemic, IIS was important for tracking vaccine dose and coverageAs part of the COVID-19 vaccination program, significant efforts and investments have been made to strengthen the EHR, especially the registry to better track adult vaccination data. The next decade offers an opportunity to maintain this momentum and further strengthen adult vaccination programs. Lagging Coverage and Uneven Efforts Communicate the value and importance of vaccines to adults and their health care providers.
Similarly, quality measures for vaccination of children, adolescents, adults and mothers, especially given the linkages between IIS and IIS and EHR, are our priorities, especially given the linkages between IIS and IIS and EHR. There is a need to promote the inclusion of monoclonal antibodies in compounded measures that help promote and maintain vaccination coverage within the healthcare delivery system. System for reporting coverage.
Vaccine policy and routine COVID-19 vaccination
These looming challenges in vaccine policy overlap with ongoing public health and healthcare systems as we work to integrate COVID-19 response efforts into broader disease control programmes.which is itself a very complex and challenging undertakingThe COVID-19 vaccine policy agenda is filled with complex questions that need to be answered regarding the long-term scope, design and goals of routine COVID-19 vaccination. Vaccines included in those efforts. Additionally, it is imperative that the COVID-19 vaccine be seamlessly applied to patients free of charge, regardless of insurance status or type of insurance. Under the current vaccine funding regime, all children and adults with public or private insurance, whether insured or not, have free access to the recommended COVID-19 vaccine. can. Uninsured adults do not. Addressing this potential gap is imperative and may require specific action by Congress before the current model for purchasing and delivering COVID-19 vaccines is curtailed.
Finally, COVID-19 vaccination coverage is Excluding adults 65 years and older, it hovered around 70% in the primary series and was much lower in the booster doses.This figure is reminiscent of the modest increase in flu vaccination seen over the past decade. Infection rates have similarly plateaued, despite public health officials encouraging annual vaccination. Ongoing government resources in the form of human and financial support continue to be essential to adequately address these and other issues that will certainly arise from the ongoing COVID-19 vaccination efforts. is.
As we emerge from the acute emergency preparedness and look ahead to opportunities for post-COVID-19 vaccine innovation, the success or failure of these efforts will depend on how we manage public health policies and practices.In addition to Robust RSV pipeline, enthusiasm for mRNA vaccines and other pipeline candidates runs high among scientists, public health agencies, and the biotechnology industry. Future developments could include the next generation of his COVID-19, influenza, and pneumococcal vaccines.Vaccines against nosocomial infections, such as the multicomponent meningococcal B vaccine; Clostridium difficilesexually transmitted diseases; vaccines to combat bioterrorism. Others target emerging or re-emerging threats such as mpox and chikungunya virus.
Realizing the pipeline’s innovation potential will require products such as monoclonal antibodies intended to prevent disease and death and act like vaccines to be coordinated across programs, recognized within the system, and We need to ensure insurance coverage and access and enable broad and equitable insurance coverage. Entire target population uptake. Along with the difficult task of supporting existing pediatric and adult vaccination programs and adapting COVID-19 vaccination to a non-emergency model, regulatory and public health authorities are asking how these products can be used in both policy and practice. How it is evaluated and implemented will have a big impact on the future. Vaccine innovation and the long-term success of all US immunization efforts.
author’s note
This work was supported by a grant from the Greenwall Foundation.
