Access considerations for national immunization programs

by Priyashree K Patel, Consultant, IPG Health Global Market Access

Routine immunization programs for pediatric patients, older adults and at-risk populations are a vital factor in not only safeguarding public health, but also providing wider societal and economic benefits and health equity across all communities.¹

The continued impact of vaccinations is clear as the Essential Programme on Immunization’s (EPI) celebrates its 50^th anniversary this year. Launched in 1974 by the World Health Organization (WHO), the program was established to protect all children against six childhood illnesses (i.e., tuberculosis, diphtheria, tetanus, pertussis, polio and measles).¹ Over five decades, the program’s impact has increased and as of today, there are 13 universally recommended vaccines across the life course. The EPI operates collaboratively alongside country-specific public health programs to achieve global disease control and robust, positive health outcomes.¹ In recent years, the COVID-19 pandemic brought to light the substantial importance of vaccination – in response to this, the Immunization Agenda 2030 (IA2030) was launched by WHO, setting out a need to improve awareness and develop national strategies for immunization throughout life.²

To meet these future targets, the negative impacts of the pandemic currently playing out in the low uptake of childhood vaccinations must be addressed.³ As we look to the future and face heightened risks of vaccine-preventable disease outbreaks, immunization programs for target patient populations are needed now, more than ever.³

The need for routine immunization programs

Across England, the UK Health Security Agency (UKHSA) routinely reports on vaccine uptake for children at 12 months, 24 months and five years. In a report co-authored with NHS England Digital, UKHSA found that overall, UK vaccine uptake decreased slightly between 2022 and 2023 and no vaccines met the 95% target. This target is set by the WHO to achieve 95% coverage for all routine childhood immunizations by age five.⁴Coverage of the "5-in-1" vaccine (Diphtheria, tetanus, pertussis, polio and Haemophilus influenzae type b vaccine (DTaP/IPV/Hib) in children at five years of age had the greatest year on year decrease in 2022/2023, falling to 93.2%. This is the lowest uptake level reported since 2008/2009. Geographically, vaccine uptake varied greatly, with the North East reporting the highest levels of vaccine uptake, while London trailed behind with lower levels of uptake compared to all other regions.⁴

The negative impact of declining vaccine uptake is apparent in resulting vaccine-preventable disease outbreaks, as showcased with the measles outbreak in the West Midlands. Declared a national incident by UKHSA in January 2024,⁵ UKHSA continues to monitor the outbreak on a weekly basis. UKHSA’s data release in mid-April highlighted the outbreak had stabilized in the Birmingham area, but cases had risen more widespread, including in London and smaller regional clusters.⁶ The rise in cases and spread is concerning as measles are a vaccine-preventable infection and without vaccine protection may lead to severe health conditions, including meningitis, blindness and seizures.⁷ In addition to the negative health outcomes, outbreaks can be expensive – the Merseyside measles outbreak documented in the UK between 2012 and 2013 (2458 reported cases) had a modeled total cost of £4.4 million.⁸ Of this estimated £4.4 million, 15% (~£0.7 million) accounted for direct NHS healthcare costs, 40% comprised public health costs (~£1.8 million) and 44% translated to societal productivity losses (~£2 million).⁸ Ultimately, these are healthcare costs that may have been prevented, had there been consistent uptake of routine immunizations, in this case measles, mumps and rubella (MMR) vaccination.⁸

Introducing vaccines onto national immunization programs

Planning and delivering effective national immunization programs (NIPs) involves a combined effort between governing bodies. In the UK, this involves first gaining regulatory approval from the Medicines and Healthcare products Regulatory Agency (MHRA) before the Joint Committee on Vaccination and Immunisation (JCVI) utilizes modeling to evaluate the cost effectiveness of a vaccine and publish appropriate recommendations. Once the policy is set, the procurement process for a tender can begin. However, the process is often lengthy due to required input from HM Treasury.⁹ Europe follows a similar process, as vaccines first need regulatory approval from the European Medicines Agency (EMA). Following approval, each country within the EU/EEA must decide which vaccines to include in their NIP and which may be funded by the national health system. Decisions are subject to country-specific conditions, i.e., prevalence of the disease, economic considerations.¹⁰

Considerations for improved access and uptake of vaccinations

Vaccine manufacturers can support decision makers in overcoming barriers faced when introducing much-needed vaccines into NIPs by gaining a deeper understanding of the decision-making process, identifying key target stakeholders and generating high-quality evidence.

Engage relevant stakeholders early on during the decision-making processes

A range of decision makers are involved when launching a vaccine within any given market. Understanding the points at which decision makers can influence the decision-making process and healthcare system is key to ensure tailored communications are developed by vaccine manufacturers. Across the various decision makers, there will be a range of national and regional level stakeholders, each with their own various drivers and barriers when considering a vaccine. Segmenting this target audience early in the process to understand their drivers for vaccine approval and uptake can ensure targeted communication of the relevant data and public health benefits. Ultimately, this will present decision makers with the tools and time to prepare for incorporating approved vaccines into NIPs.

Provide high-quality evidence generation

Real-world evidence (RWE) should be appropriately leveraged to demonstrate clinical efficacy, effectiveness and transparent communication of evidence gaps as opportunities for further research and health benefits. It’s fundamental that cost-effectiveness analyses and modeling factor in each market’s economic climate – utilizing appropriate estimates and data inputs i.e., annual deaths, public health events and their associated impacts.¹¹ When navigating health technology assessment (HTA) processes and discussions with decision makers,¹² comprehensive evidence from cost-effectiveness analyses can showcase the wider benefits of vaccination on society and healthcare systems.^{13, 14} Considering the wider benefits can prevent undervaluing and subsequent underfunding of vaccines. Evaluating the broader value is vital to establish efficient resource allocation in healthcare systems.¹⁵

Continue surveillance to track public health impact

Actively monitoring surveillance data enables vaccine manufacturers to stay well-informed on vaccine-preventable diseases, their evolving epidemiology in target patient populations and associated data on antimicrobial resistance. Utilizing RWE gathered from healthcare and community settings will support the development of key messaging on the optimal use of approved vaccines in addressing disease burden. By staying abreast of disease trends, vaccine manufacturers can develop thought-provoking consensus statements alongside leading vaccine experts to tackle unmet needs and advocate for national and/or regional changes to NIPs.^16-18

Final thoughts

Providing sustainable, consistent and equitable access to routine immunizations is a vital goal for today and the future. This is a goal shared by healthcare providers and decision makers worldwide, and one that should also be at the forefront of vaccine manufacturer’s minds. As we celebrate EPI’s 50^th year in championing this goal and their core mission “to ensure universal access to relevant vaccines for individuals at risk”, it has never been more important that the meaningful value of vaccines is communicated to ensure that the right product reaches the right patient at the right time and for a fair price.

If you have any questions or would like to discuss your market access challenges within the vaccines landscape, reach out to GMAinfo@ipghealth.com.

References

¹ 50th anniversary of the Expanded Programme on Immunization (EPI)

² Explaining the Immunization Agenda 2030

³ Routine Vaccination Coverage - Worldwide

⁴ Childhood Vaccination Coverage Statistics, England

⁵ Measles outbreak could spread warns UKHSA Chief Executive

⁶ Latest measles statistics published

⁷ Measles

⁸The economic cost of measles: Healthcare, public health and societal costs of the 2012–13 outbreak in Merseyside, UK

⁹ Adding new vaccinations to the NHS national immunisation programme

¹⁰ Approval of vaccines in the EU

¹¹ Joint Committee on Vaccination and Immunisation (JCVI)