Moving the Needle: May 2023 news from PATH on vaccine development

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		In this issue New tools support RSV disease prevention decision-making Novel type 1 oral polio vaccine candidate advances to Phase 2 study New panel of antibodies to support affordable pneumococcal vaccine development Q&A with Anne Schuind Clinical updates Resources and opportunities

New tools support RSV disease prevention decision-making

Respiratory syncytial virus (RSV) is the world’s top cause of severe respiratory disease and hospitalization in infants and young children. Groundbreaking products for preventing RSV in early life have recently achieved or are on the pathway to licensure, including long-acting monoclonal antibodies (mAbs) and maternal vaccines. In a special issue of BMC Medicine, new research from South Africa, Kenya, and Vietnam, conducted by a consortium of investigators including PATH, provides insights into the impact and value of these products. Results show a large burden of disease outside of hospitals and that most RSV disease occurs in young infants, more than previously recognized. The studies estimate that new prevention products could have a large health impact and be cost-effective. As a way to share this and other key information, the World Health Organization (WHO), PATH, and other partners are building a suite of communications resources that public health stakeholders and advocates can use to raise awareness about RSV, forthcoming disease prevention products, and delivery considerations. Overall, these studies and resources are part of larger efforts to support decision-making around RSV disease prevention, policy, and implementation preparedness.

Novel type 1 oral polio vaccine candidate advances to Phase 2 study

PATH and partners are advancing novel oral polio vaccines (nOPV) to provide immunity and interrupt transmission, protection already offered by the existing Sabin-strain OPV, but with a reduced risk of seeding new paralytic outbreaks. The reversion of OPV strains back to virulence is a rare occurrence, but these vaccine-associated cases now outnumber wild-type cases, and regions with low vaccine coverage are especially at risk. Because of this, since 2021, hundreds of millions of doses of nOPV against type 2 have been successfully delivered under WHO’s Emergency Use Listing (EUL) approval. In March, in partnership with icddr,b, PATH launched a Phase 2 trial of nOPV against type 1 (nOPV1) to assess its performance in pediatric populations, ultimately aiming to advance the candidate to EUL and to WHO prequalification if the data continue to be supportive. Generating this evidence will help ensure stockpiles for outbreak response are composed of safe and immunogenic vaccines with reduced risk of causing vaccine-associated paralytic polio outbreaks.

New panel of antibodies to support affordable pneumococcal vaccine development

PATH, in collaboration with the Medicines and Healthcare Products Regulatory Agency (MHRA), recently announced the availability of a new panel of 46 high-quality and affordable pneumococcal serotype-specific mAbs. Each mAb is reactive to a specific pneumococcal polysaccharide commonly integrated into licensed polyvalent pneumococcal conjugate vaccines (PCVs) and many candidates under development. The mAbs are specific to 29 serotypes that have been associated with pneumococcal pneumonia, and one mAb is specific to the conserved cell wall polysaccharide. To facilitate ease of access, the antibodies are available in 0.5 milligram aliquots, accompanied by a certificate of analysis. In regions like Africa and Asia, where most pneumococcal deaths occur, vaccine price and availability pose significant barriers to access. Additionally, many existing vaccines do not address all pneumococcal serotypes prevalent in these areas. These mAbs can be used to simultaneously analyze up to 25 polysaccharide serotypes in an affordable way, which will support testing for the identity, quantity, and stability of drug substance and product in a multiplex assay platform. Providing the mAbs to vaccine developers and the research community is a crucial step toward ensuring the successful development of polyvalent PCVs with additional serotypes and accelerating their availability to children in low- and middle-income countries (LMICs). The mAbs are now available through the MHRA via the National Institute of Biological Standards and Control online catalog of biological reference materials. For additional information, contact Cette adresse e-mail est protégée contre les robots spammeurs. Vous devez activer le JavaScript pour la visualiser..

Interview

Q&A with Anne Schuind

WHO’s cervical cancer elimination goals include 90 percent of girls by age 15 years being fully vaccinated against human papillomavirus (HPV) by 2030. Dr. Anne Schuind, PATH Initiative Team Leader for HPV Vaccines, discusses how PATH is helping to reach this goal. Q: Is this goal achievable? A: Global HPV vaccination coverage was already low before COVID-19 hit—20 percent in 2019—but the pandemic shrunk coverage to just 15 percent in 2021. WHO’s goal is ambitious, but I remain hopeful that it can be met. Q: What needs to be done? A: Increasing the number and global availability of affordable HPV vaccines is crucial, particularly for LMICs. PATH provides technical assistance to developing-country vaccine manufacturers and is also supporting countries introducing HPV vaccination programs. In addition, PATH supports a Phase 3 clinical study in Ghana and Bangladesh of an HPV vaccine that received WHO prequalification in 2021 to generate additional data on the vaccine’s performance. Further, we’re assessing several nonavalent HPV candidates (covering nine HPV strains) to be tested for immunogenicity compared to a licensed HPV vaccine with proven single-dose efficacy in a Phase 3 trial. Q: Why is the single-dose schedule important? A: PATH manages the Single-Dose HPV Vaccine Evaluation Consortium, which gathers and evaluates data on this approach to HPV vaccination. Based on the current evidence, WHO’s endorsed a single dose as an alternate schedule for 9- to 20-year-olds. Implementing this schedule in LMICs could greatly expand coverage, reaching more girls and ultimately preventing more cases of cervical cancer.

Clinical updates

March 2023

A Phase 2 age de-escalation study (NCT05644184) assessing the safety and immunogenicity of an nOPV1 candidate in healthy young children, infants, and newborns was initiated in Dhaka, Bangladesh.

Resources and opportunities

New scientific publications

Challenges and opportunities in developing a Shigella-containing combination vaccine for children in low- and middle-income countries: Report of an expert convening Cost of introducing and delivering malaria vaccine (RTS,S/AS01E) in areas of seasonal malaria transmission, Mali and Burkina Faso Introducing ROTAVAC^® to the occupied Palestinian Territories: Impact on diarrhea incidence, rotavirus prevalence and genotype composition Potential impact and cost-effectiveness of Shigella vaccination in 102 low-income and middle-income countries in children aged 5 years or younger: A modelling study Pregnancy exposure registries for drugs and vaccines in low-income and middle-income countries: Scoping review protocol Projecting the long-term economic benefits of reducing Shigella-attributable linear growth faltering with a potential vaccine: A modelling study Strengthening the evidence base to evaluate preventive interventions against respiratory syncytial virus

New and updated resources

New panel of antibodies specific to SARS-CoV-2 variants available for vaccine researchers announcement Pneumococcal conjugate vaccine cost calculator Reaching 9 million children with vaccines in Malawi web article Rotavirus vaccine cost calculator RSV vaccine and mAb snapshot Shigella vaccines for traveler and military populations: A market assessment report

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PATH’s Center for Vaccine Innovation and Access brings together our expertise across every stage of the long and complex process of vaccine research, development, and delivery to make lifesaving vaccines widely available to children and communities across the world.

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