Moving the Needle: January 2022 news from PATH on vaccine development

 

News from PATH on vaccine development
 

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In this issue

PATH assists Chinese COVID-19 vaccine suppliers to address pandemic needs

Developing the next generation of malaria vaccines Q & A with Mark Alderson

Resources and opportunities

 
   
     

PATH assists Chinese COVID-19 vaccine suppliers to address pandemic needs

To help bolster COVID-19 vaccine supplies, PATH is providing expertise to support the clinical development of Chinese COVID-19 vaccines to achieve World Health Organization (WHO) prequalification and increase global supplies. PATH is providing statistical analysis, clinical, and pharmacovigilance technical assistance to Brazil’s Instituto Butantan to help generate data that will inform vaccine decision-making. Instituto Butantan sponsored a Phase 3 clinical study of a Chinese COVID-19 vaccine, is evaluating its performance in Brazil, and is studying potential correlates of protection valuable for pandemic control efforts. PATH is also providing financial support and technical expertise to Pontificia Universidad Católica de Chile to develop an assay to understand and distinguish activity between natural COVID-19 infection and immunization with inactivated whole virus COVID-19 vaccines, some of the most widely used vaccines in the pandemic. PATH additionally provides technical assistance upon request to Chinese vaccine manufacturers covering, but not limited to, clinical, pharmacovigilance, and regulatory needs. PATH also launched a new Global Access Training for Chinese COVID-19 Vaccine Developers, available in China via the CNVAC Chinese Vaccinology Course. The first of three modules is now available and provides a vaccine development overview including topics on product design, regulatory, clinical, and communications. Overall, the project provides manufacturers with resources to navigate international standards and the global market in recognition of the Chinese vaccines’ important role in addressing pandemic supply needs.

 

Developing the next generation of malaria vaccines

In 2021, PATH and the malaria community celebrated WHO’s recommendation of the world’s first malaria vaccine, RTS,S/AS01, for children at risk in regions with moderate to high P. falciparum malaria transmission, as well as the decision by the Gavi, the Vaccine Alliance board to support eligible countries in financing vaccine introduction, procurement, and delivery, major milestones for country access to RTS,S as an additional tool to combat malaria. However, next-generation malaria vaccines that cost less, require fewer doses, and provide more durable protective efficacy are still needed. In 2020, PATH was awarded a five-year Innovations in Malaria Vaccine Development (IMV) contract from the United States Agency for International Development for the development of a next-generation malaria vaccine that prevents disease and death in young African children. The project is organized as three related workstreams targeting two different stages of the parasite lifecycle. The first targets the circumsporozoite (CS) protein (the same target as RTS,S/AS01) and includes projects in partnership with Scripps Research Institute, Statens Serum Institut, and Johns Hopkins University. The IMV program is also partnering with the University of Oxford on the blood-stage (BS) vaccine workstream, advancing their RH5 protein-based vaccine candidates that have demonstrated encouraging initial clinical data. Finally, the CS + BS combination workstream will define development strategies and advance multi-stage vaccine approaches by leveraging learnings from individual CS and BS efforts. image
 
 
 

 

Interview

Q & A with Mark Aldersonimage

Due to efforts by a number of global partners, including PATH, a more affordable pneumococcal conjugate vaccine (PCV), PNEUMOSIL®, is now helping fight deadly childhood pneumonia and other pneumococcal diseases like meningitis, sepsis, and otitis media. Dr. Mark Alderson, director of PATH’s pneumococcal vaccine project, reflects as the PATH project supporting the vaccine’s development sunsets.

Q: Why another PCV?

A: PCVs save lives but aren’t equitably accessible, mainly due to price. Even as Gavi financing has helped low-income economies introduce PCVs at discounted prices, millions of children still lack access to PCVs due to budgetary constraints—especially in middle-income and Gavi-graduating economies. More sustainably affordable PCVs have long been needed. In 2008, PATH and Serum Institute of India, Pvt. Ltd. set out to meet this need. The result was a state-of-the-art PCV that’s now available for low- and middle-income economies at just US$2 per dose—the lowest price for any PCV, ever.

Q: What strategies led to success?

A: PNEUMOSIL’s 10 serotypes achieve disease coverage in high-burden regions that matches or exceeds predecessor PCVs and keeps manufacturing costs as low as possible. Serum Institute optimized several manufacturing processes, maintaining high vaccine quality at lower cost. We also generated valuable cross-geographical data and accelerated regulatory approvals via parallel clinical development programs in The Gambia and India. MRC Unit The Gambia at London School of Hygiene and Tropical Medicine, multiple study sites in India, and other partners were central to this creative strategy’s success.

Q: What's the impact?

A: With Indian licensure and WHO prequalification, PNEUMOSIL is now used in India’s Universal Immunization Program and is being introduced in other countries. Serum Institute will also supply UNICEF with 10 million doses per year for low-income countries over the next decade, helping to free up millions of dollars each year that could be used for other health care needs. We’re proud that it’s starting to reach more children, sustaining ongoing PCV programs, and saving more lives.

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Resources and opportunities

New scientific publications

A disease severity scale for the evaluation of vaccine and other preventive or therapeutic interventions for travellers’ diarrhoea

Does anybody want an injectable rotavirus vaccine, and why? Understanding the public health value proposition of next-generation rotavirus vaccines

Fecal shedding of 2 novel live attenuated oral poliovirus type 2 vaccines candidates by healthy infants administered bivalent oral poliovirus vaccine/inactivated poliovirus vaccine: 2 randomized clinical trials

Induction of mucosal and systemic immune responses against the common O78 antigen of an oral inactivated ETEC vaccine in Bangladeshi children and infants

National stakeholder preferences for next-generation rotavirus vaccines: Results from a six-country study

A Phase IIA extension study evaluating the effect of booster vaccination with a fractional dose of RTS,S/AS01E in a controlled human malaria infection challenge

A site assessment tool for inpatient controlled human infection models for enteric disease pathogens

 

New and updated resources

300 diarrhea experts walk into a room web article

A compelling public health value proposition for injectable next-generation rotavirus vaccines brief

Deadly rotavirus and the vaccines that can stop it web article

Impact and cost-effectiveness of an injectable rotavirus vaccine candidate compared to oral rotavirus vaccines fact sheet

Injectable rotavirus vaccines—what value could they bring? web article

Nipah virus inspired the movie “Contagion.” We’re testing a vaccine web article

Polio eradication and beyond: A long-term vaccine strategy web article

RSV clinical trial tracker RSV vaccine and mAB snapshot Stakeholder preferences for a new rotavirus vaccine candidate country briefs

Toward a world without meningitis web article

When it comes to vaccines, bigger isn’t always better web article

 
 

CVIA at upcoming events

Malaria vaccine R&D and immunization – Lessons learned and considerations for global health impact


March 3


Virtual

 

 

CVIA job opportunities

Advocacy and communications officer

Project coordinator

Project manager (1, 2)

Senior program assistant (1, 2)

Senior project manager

Vaccines and immunizations lead

 
 

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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