The RSV immunization pipeline to global policy an

The historic gap in introduction of new vaccines Source: WHO/UNICEF coverage estimates 2018 revision, July 2019. Immunization Vaccines and Biologicals, (IVB), World Health Organization (WHO). 194 WHO Member States. Date of slide: July 8, 2019. EXAMPLE
PNEUMOCOCCAL VACCINE INTRODUCTION
by country strata EXAMPLE
ROTAVIRUS VACCINE INTRODUCTION
by country strata Original slide developed by the World Health Organization. Last updated: June 2024<br>

Reasons for this historic delay Cost Delayed introduction in low- and middle-income countries (LMICs) Competing immunization and health priorities Knowledge gap Protracted policy process Original slide developed by the World Health Organization. Last updated: June 2024<br>

A more protracted policy pathway in LMICs LIC/LMIC markets MOH = ministry of health
SAGE = World Health Organization (WHO) Strategic Advisory Group of Experts
WHO PQ = WHO prequalification Efforts to minimize delays to LMIC markets are critical. High-income markets Pre-clinical Clinical Licensure MOH approval Country decision* Pre-clinical Clinical Licensure SAGE recommendations WHO
PQ MOH approval Financing support Country decision * High-income countries are self-financing. Cost-effectiveness analysis might influence country decisions. Original slide developed by the World Health Organization. Last updated: June 2024<br>

New products for RSV disease prevention in early life RATIONALE HOW IT WORKS TIMING PRODUCT CHARACTERISTICS Original slide developed by the World Health Organization and PATH. Last updated: June 2024<br>

First regulatory approvals HICs of PFS First product rollout in some HICs WHO (SAGE)
policy recommend-ation UNICEF tender & Gavi co-financing (contingent on affordable pricing & supply) mAb roll-out in Gavi-eligible countries First regulatory approvals HICs of PFS First product rollout in some HICs & UMICs WHO (SAGE)
policy recommend-ation SDV WHO prequalified MDV available & WHO prequalified UNICEF tender & Gavi co-financing Vaccine roll-out in Gavi-eligible countries RSV immunization product availability for Gavi-eligible countries MATERNAL
VACCINE MONOCLONAL ANTIBODIES Needs: Product presentation suitable for Gavi-eligible countries developed & price commitments made 2022-2023 Sept 2024 2023-2024 Estimated 2025 Estimated 2026 Estimated 2027 onwards Definitions: HIC = high-income country; PFS = pre-filled syringe; UMIC = upper- and middle-income country; WHO SAGE = World Health Organization Strategic Advisory Group of Experts; SDV = single-dose vial; MDV = multi-dose vial Original slide developed by the World Health Organization. Last updated: June 2024<br>

Status of RSV prevention product introductions (as of April 2024)a need to enable informed product choice shorten LMIC introduction timelines Original slide developed by the World Health Organization. Last updated: June 2024<br>

Getting to a global recommendation WHO’s Strategic Advisory Group of Experts (SAGE)<br>

WHO’s Strategic Advisory Group of Experts on Immunization (SAGE) Principal advisory group to WHO on vaccine policy.
Up to 20 independent members serving 3- to 6-year terms.
SAGE recommendations become WHO Vaccine Position Papers on optimal vaccine use.
A SAGE recommendation is required by Gavi, the Vaccine Alliance and UNICEF. Original slide developed by the World Health Organization. Last updated: June 2024<br>

What is the status of SAGE reviews for RSV immunization products? 2016 SAGE requested preparations be made to support global policy-making for RSV immunization. October 2022 March 2024 SAGE was updated on
RSV products.

Requested formation of an RSV working group. SAGE was updated on licensure and introduction status of RSV immunization products. Original slide developed by the World Health Organization. Last updated: June 2024<br>

SAGE working group on RSV Reference: WHO. SAGE Working Group on Respiratory Syncytial Virus (RSV) Immunization Products (established December 2023). WHO website. Accessed May 8, 2024. Original slide developed by the World Health Organization. Last updated: June 2024<br>

Evaluating RSV products for global use WHO prequalification & impact study<br>

What is WHO prequalification (PQ) for immunization products? Started 1987, on request by UNICEF and PAHO to evaluate quality, safety, and efficacy of vaccines.
Facilitates immunization product registration in LMICs.
Countries rely on independence of PQ assessment.
UNICEF cannot buy and Gavi cannot fund immunization products without PQ. > 150 vaccines prequalified to-date Original slide developed by the World Health Organization. Last updated: June 2024<br>

What happens during the WHO PQ process? Original slide developed by the World Health Organization. Last updated: June 2024<br>

Ensuring programmatic suitability Common considerations for programmatic suitability: Ensure that vaccines used in LMICs can be used safely and effectively, given the constraints and conditions of their immunization systems
Mandatory criteria must be met; critical criteria reviewed on case-by-case basis Original slide developed by the World Health Organization. Last updated: June 2024<br>

A maternal RSV vaccine impact study is moving forward Requested by SAGE in October 2022 based on rationale: Four African countries
To start in Q4 2024
More “real-world” than Phase 3 study
Individually randomized, controlled trial
Few exclusion criteria
Primary outcomes
RSV-associated and all-cause severe lower respiratory tract infections and hospitalizations
Preterm birth and low birth weight documenting the full potential public health impact of RSV products on child health & health systems in LMICs Study features Enormous potential of these interventions Many competing health priorities in LMICs Pivotal trials might not provide sufficient evidence for decision-making in LMICs Study conducted “in parallel with regulatory, policy and financing decisions …” Original slide developed by the World Health Organization. Last updated: June 2024<br>

Immunization financing for RSV Gavi, the Vaccine Alliance and other mechanisms to support affordability & access<br>

Global access will depend on support from Gavi, the Vaccine Alliance Gavi is an international organization created in 2000 to improve access to new and underused vaccines for children living in the poorest parts of the world.
As of 2024, 54 countries are eligible for Gavi support.1 RSV product costs/prices are still unclear; however, the leading products are not anticipated to be affordable for LICs without Gavi subsidies.
Gavi approved RSV prevention in infants as part of its Vaccine Investment Strategy (VIS) for 2021-2025 funding. Renewed support for 2026-2030 if five criteria are met. 1. Availability of licensed product
WHO prequalification
SAGE recommendation
Cost within predicted range
Available funding 2018 VIS RECOMMENDATIONS SUPPORT FOR RSV MATERNAL IMMUNIZATION OR MAB
PRODUCTS CONTINGENT ON: 1 www.gavi.org/types-support/sustainability/eligibility Renewed support for RSV in VIS 2024 Original slide developed by the World Health Organization. Last updated: June 2024<br>

Pooled procurement can also bring down costs of vaccinecombines the financial and other resources across countries to create greater purchasing power Examples
UNICEF Supply Division
PAHO revolving fund Original slide developed by the World Health Organization. Last updated: June 2024<br>

Country decision-making mechanisms NRAs, RITAGs, & NITAGs<br>

Country decision-making bodiesthe role of NRAs, RITAGs, and NITAGs Original slide developed by the World Health Organization. Last updated: June 2024<br>

Global status of National Immunization Technical Advisory Groups (NITAGs)(as of October 2023) Original slide developed by the World Health Organization. Last updated: June 2024<br>

Key takeaways Historic lags in availability of new immunization products in LMICs is due, in part, to a more protracted policy pathway.
WHO plays a role in the policy pathway to introduction in LMICs.
SAGE makes recommendation for optimal use in LMICs.
Prequalification evaluates the quality, safety and efficacy of immunization products for use.
Gavi provides necessary funding for introduction of more expensive new immunization products.
Ultimately, NITAGs and other country decision-makers must decide on new RSV immunization product introductions. Original slide developed by the World Health Organization. Last updated: June 2024<br>