Moving the Needle: January 2024 news from PATH on vaccine development

World Health Organization prequalifies novel type 2 oral polio vaccine (nOPV2)

Three years after it became the first vaccine to receive a World Health Organization (WHO) Emergency Use Listing, WHO has prequalified nOPV2 for use in outbreak settings. The vaccine is designed to protect children from polio while lowering the risk of seeding new type 2 vaccine-derived outbreaks in underimmunized communities. Surveillance data from nearly a billion doses confirms that the vaccine is working as intended. PATH coordinated the nOPV2 product development consortium, sponsored a Phase 3 study that provided critical data, and integrated the clinical findings for the prequalification application.

PATH also continues to advance research into nOPV products against other types of polio, alongside other tools and resources. Most recent project additions include work to develop International Standards to harmonize nOPV products and a value proposition for next-generation non-infectious polio vaccines to inform future investments. This work will contribute to global efforts to fortify the world against polio for years to come.

Thailand-made COVID-19 vaccine receives conditional approval for emergency use

PATH applauds Thailand’s recent conditional approval for emergency use of medicinal products for the Government Pharmaceutical Organization’s (GPO) new COVID-19 vaccine (HXP-GPOVac) as a booster dose for people 18 years of age and older. The achievement marks Thailand’s first approval of a domestically produced COVID-19 vaccine—enhancing sustainable vaccine access and emergency readiness in the country. Because the vaccine is made in chicken eggs like traditional influenza vaccines, established egg-based vaccine manufacturers, like GPO, can adapt existing facilities to affordably produce it at an industrial scale. The innovative technology (NDV-HXP-S) uses another virus, Newcastle disease virus (NDV), as its building block and a stabilized spike protein (HexaPro), which trains the immune system to recognize and fight COVID-19 infection. Overall, the vaccine can help Thailand protect its population at a lower cost and reduce dependency on imported COVID-19 vaccines. Its real-world use may also inform the NDV vaccine platform’s broader potential for other countries and diseases.

The NDV-HXP-S technology stems from a consortium comprising GPO and other vaccine manufacturers in Vietnam and Brazil; the Icahn School of Medicine at Mount Sinai, who developed the NDV vaccine technology and provided the seed virus; the University of Texas at Austin, who developed HexaPro; and PATH as facilitator and technical advisor.

PATH to evaluate new malaria vaccine in African infants

PATH will sponsor a clinical study in Africa to inform an optimal infant vaccine schedule for the R21/Matrix-M™ malaria vaccine, which is expected to start in late 2024. R21 is the second malaria vaccine to achieve WHO prequalification, behind RTS,S, putting the vaccine in position to expand malaria prevention resources and reach. The multicenter Phase 2 study will be the first to evaluate R21’s safety, immunogenicity, and efficacy across two immunization schedules in infants down to six weeks old—a high-risk age group for malaria.

Updated communications toolkit now available to raise RSV prevention awareness

A growing suite of communications materials that public health stakeholders and advocates can use to raise awareness about respiratory syncytial virus (RSV) disease, new prevention products, and delivery considerations is now available to support global, regional, and country decision-making. WHO and PATH are developing and curating the toolkit with contributions from technical experts across the globe. Current materials include an RSV primer presentation (and fact sheet) complemented by an evolving series of modular slides that can be mixed and matched with the primer to dive deeper into key topics. Modules on clinical disease, health economics, and new RSV prevention products are now available, with additional modules on other topics coming soon. All are open access and free to use.

RSV is the world’s top cause of severe respiratory disease and hospitalization in infants. Groundbreaking products for preventing severe RSV disease in early life have recently achieved licensure—including long-acting monoclonal antibodies given to newborns and a vaccine given in pregnancy. With new products emerging and a need to navigate pathways to widespread and equitable use, now is the time to raise awareness around RSV prevention, policy, and implementation preparedness.

Accelerating vaccines against diseases with epidemic or pandemic potential

The Coalition for Epidemic Preparedness Innovations (CEPI) and PATH recently announced a renewed collaboration to accelerate the rapid development of vaccines against emerging infectious diseases. In support of CEPI’s 100 Days Mission, the collaboration’s goal is to reduce the time to develop safe and effective vaccines against pathogens with epidemic or pandemic potential to 100 days. PATH will help CEPI continue to enhance its capacities for project design and management, implementation, coordination, and operational oversight. In doing so, PATH will also work with CEPI partners to provide services that enable the rapid development of vaccines against pathogens with epidemic or pandemic potential, from proof of concept through to licensure. This work will include providing strategic, technical, and scientific support for the clinical and manufacturing development process of vaccines, boosting innovative technology development, and facilitating capacity-strengthening initiatives that enhance local resources to help establish or improve research preparedness and emergency evidence generation for future outbreaks.

Interview

Q&A with Deborah Atherly

The Board of Directors for Gavi, the Vaccine Alliance, recently announced the shortlist for their next Vaccine Investment Strategy (VIS). Deborah Atherly, Global Head of Policy, Access and Introduction for CVIA discusses why this is important.

Q: What is Gavi’s VIS?
A: The VIS guides how Gavi prioritizes the inclusion of and investment in new and underused vaccines in their programming for low- and middle-income countries. It operates on a five-year cycle to provide Gavi implementing countries, manufacturers, donors, and partners with support to their long-term strategic planning. 

Q: How does this relate to CVIA’s work?
A: The Gavi Board’s recent confirmation of the shortlist for their 2024 VIS indicates the new vaccines they plan to prioritize for investment over the period of 2026 to 2030. We were excited to see that the shortlist includes vaccines against Shigella and group B Streptococcus (GBS), which CVIA has focused on for years. 

Results from our Shigella vaccine value proposition project indicate their potential health impact and economic value may be greater than previously estimated, due to the pathogen’s long-term health effects and growing resistance to antibiotics. And, our GBS vaccine development work, if successful, could provide protection against the leading cause of sepsis and meningitis in newborns. We hope that including these vaccines on the VIS shortlist, along with tuberculosis and dengue, will accelerate further investment in these critical vaccines.

CLINICAL UPDATE

December 2023

• A Phase 2 dose-ranging clinical study (NCT06077656) of a 25-valent pneumococcal conjugate vaccine (PCV) candidate completed vaccination of all study participants. The study is being conducted in four sites in Canada and is evaluating three different dose levels of the PCV candidate compared to a licensed PCV in 220 young adults 18 to 49 years of age. Satisfactory results in the young adult population will support initiation of a Phase 2 study in infants.

Resources and opportunities

New and updated resources

Bangladesh takes major step to reduce cervical cancer deaths web article

Center for Vaccine Innovation and Access web page

Cost and operational context of HPV vaccine delivery in six countries fact sheets

COVID-19 maternal immunization resource library website

Developing and delivering vaccines to advance health equity fact sheet

Evaluating the costs and context of ongoing HPV vaccination programs brief

Frequently asked questions about single-dose HPV vaccination brief

On the verge of RSV disease prevention toolkit

Putting an end to epidemic meningitis in Africa fact sheet

2022 VASE Conference: Abstracts booklet

What can we learn from HPV vaccine delivery costs? web article

What does new maternal vaccine delivery look like? web article

CVIA at upcoming events

RSVVW’24 – A Global Conference on Novel RSV Preventive and Therapeutic Interventions
February 13 to 16, 2024
Mumbai, India​​​​​

6th International Neonatal & Maternal Immunization Symposium
March 12 to 14, 2024
San Jose, Costa Rica
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13th Meeting of the International Society of Pneumonia & Pneumococcal Diseases (ISPPD)
March 17 to 20, 2024
Cape Town, South Africa

New scientific publications

A candidate antibody drug for prevention of malaria

The Challenge Non-Typhoidal Salmonella (CHANTS) Consortium: Development of a non-typhoidal Salmonella controlled human infection model: Report from a consultation group workshop, 05 July 2022, London, UK

Cost and operational context for national human papillomavirus (HPV) vaccine delivery in six low- and middle-income countries

Cost-effectiveness of human papillomavirus (HPV) vaccination in Burkina Faso: A modelling study

Estimating the global impact of rotavirus vaccines on child mortality

The height premium: A literature review and meta-analysis
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A human monoclonal antibody binds within the poliovirus receptor-binding site to neutralize all three serotypes

Pfs230 Domain 7 is targeted by a potent malaria transmission-blocking monoclonal antibody

Reassessing potential economic value and health impact of effective Shigella vaccines

Report of the WHO technical consultation on the evaluation of respiratory syncytial virus prevention cost effectiveness in low- and middle-income countries, April 7–8, 2022

Shigella and childhood stunting: Evidence, gaps, and future research directions

The 2022 Vaccines Against Shigella and Enterotoxigenic Escherichia coli (VASE) Conference: Summary of abstract-based presentations

The 2022 Vaccines Against Shigella and Enterotoxigenic Escherichia coli (VASE) Conference: Summary of breakout workshops

Vaccine Value Profiles for Pathogens of Public Health Importance, Volume 1: enterotoxigenic Escherichia coli (ETEC); Group B streptococcus; respiratory syncytial virus vaccines and monoclonal antibodies; Shigella

CVIA job opportunities

Director, project implementation

Pharmacovigilance manager

Senior technical officer