Imagine a country wants to introduce a vaccine to protect its population from a serious disease, but the doses are either not available for purchase or so expensive they are out of reach. Imagine this happens during a disease outbreak or epidemic—or even a pandemic. Country leaders would be prevented from providing essential vaccine to their citizens and saving lives.
Sound familiar? It’s exactly what happened during the COVID-19 pandemic, when low- and lower-middle-income countries across the world were last in line to receive new COVID-19 vaccines and had vaccination rates that trailed far behind those of higher-income countries once they did receive them.
It wasn’t the first time countries faced this scenario and, given the current geographical balance of vaccine manufacturing, it likely won’t be the last. Global vaccine manufacturers are mostly located in high-income countries—even though low- and middle-income countries often suffer the highest disease burdens and the greatest death tolls—which drives insufficient supply and high prices that can delay the availability of lifesaving vaccines, sometimes for decades.
There’s a solution, though.
The world needs competitive vaccine markets that include low- and middle-income country vaccine manufacturers. When more vaccine manufacturers are able to enter the market, supply often increases and costs and dependencies often decrease—and access to new and improved vaccines occurs more quickly. Lower vaccine costs also allow the international donors that help finance new vaccines for low-income countries to further stretch their limited resources and reach more people.
It's no easy task to reshape the global vaccine marketplace into one that supports equitable access. But PATH is committed to doing just that, and for decades has been supporting vaccine manufacturers worldwide in their efforts to strengthen the global vaccine supply and promote global health security.
Let’s take a step back. What does producing a vaccine for global use look like and why is it challenging?
Vaccine development and manufacturing is a long and complex process. It encompasses multiple complex stages that span everything from developing the different vaccine components to releasing the final product for use. Each step in the journey requires a multitude of additional tests to ensure the vaccine is consistently produced and controlled according to high quality standards. From discovery to development to approval, it typically takes 10 to 15 years before a vaccine makes it to market.
The process is further complicated by the need to ensure vaccines are available and appropriate for use outside their country of origin. To enter the global public vaccine market with vaccines supplied by Gavi, the Vaccine Alliance and UNICEF (which help subsidize cost for low-income countries), manufacturers must meet a stringent set of international standards, collectively known as World Health Organization (WHO) prequalification. The WHO prequalification process ensures that vaccines meet quality, safety, and efficacy standards and are relevant for the target market. It is a key step in expanding vaccine access but it's not always an easy process to navigate—especially for manufacturers that have never been through it before or that might not have the capacity to manage the complex approval requirements.
How is PATH helping?
Lab technician Tuan Anh at the IVAC vaccine manufacturing facility in Vietnam. Photo: PATH/Matthew Dakin.
Enhancing vaccine production capacity and quality
PATH has expertise at every stage of the complex process of vaccine research, development, commercial manufacturing, and introduction and supports emerging market vaccine manufacturers to improve access to new technologies and lifesaving vaccines.
Through the Sustaining Vaccine Manufacturers (SVM) program, we provide technical assistance to low- and middle-income country vaccine manufacturers who are working toward national licensure and WHO prequalification. We work with manufacturers in all corners of the world and on a wide variety of pathogens. Notably, we’ve supported work on vaccines against human papillomavirus (HPV), Japanese encephalitis, yellow fever, polio, pneumococcus, typhoid fever, rotavirus, influenza, measles/rubella, cholera, hepatitis E, COVID-19, and more.
Crucially, our support isn’t one-size-fits-all. We tailor our assistance to every manufacturer’s specific needs, listening to the challenges they’re having and opportunities they see for growth, and together develop a strategy to move forward. These partnerships help manufacturers establish and maintain robust quality systems; obtain and maintain WHO prequalification; and/or help achieve efficiencies that can lower costs, improve yields, and enable scale-up to meet national, regional, and global needs.
Common support activities include providing facility design reviews, subject-specific trainings, conducting site audits and gap analyses, supporting technology transfers, and aiding in regulatory applications.
That’s not all, though.
Since the program began in 2018, SVM program support has expanded beyond just the technical aspects of vaccine manufacturing to encompass a wide variety of activities that holistically strengthen the manufacturing environment. For instance, we ensure low- and middle-income vaccine manufacturers can access new manufacturing technologies that can improve product quality and reduce production costs; we manage global collaborations that facilitate knowledge sharing and encourage community; we coordinate and host educational opportunities that bring together global experts on critical topics related to vaccine manufacturing; we conduct landscape assessments that can help guide policymakers and investment decisions; and much more.
Real-world impact
Over the years, we’ve assisted manufacturers of more than a dozen WHO prequalified and Emergency Use Listed vaccines meet and maintain these rigorous global standards—increasing the availability of essential, high-quality, affordable vaccines. We’ve also advanced critical resources that are strengthening manufacturer knowledge and the manufacturing ecosystem.
Some SVM program successes include:
- Helping to usher two new HPV vaccines that were previously licensed in China onto the global market: Cecolin® (manufactured by Xiamen Innovax Biotech Co.) in October 2021 and Walrinvax® (manufactured by Yuxi Zerun Biotechnology Co.) in August 2024—both of which can help close the gap in the global HPV vaccine supply.
- Equipping manufacturers to maintain regulatory standards over time. Since 2013, we’ve supported the Chengdu Institute of Biological Products through facility upgrades and numerous WHO re-inspections to maintain supply of its Japanese encephalitis vaccine—an essential tool for keeping millions of children across Asia safe from disease.
- Working with the Africa Centres for Disease Control and Prevention and the Clinton Health Access Initiative to assess current and planned vaccine manufacturing capacity in Africa, insights from which define what’s needed to develop a robust and sustainable vaccine manufacturing ecosystem. Our work highlighted challenges and opportunities and presents a clear picture of gaps and needs that can ensure alignment among stakeholders and more strategic investments. Initial results were published in September 2023, with an update that provides more nuanced insight in October 2024.
- Hosting a series of webinars that offer a deep dive on critical aspects of vaccine manufacturing, with experts in the field as speakers. Past webinars have examined aluminum adjuvants and adventitious egg-based agents, with more to come.
These are just a few examples of how we’ve supported low- and middle-income vaccine manufacturers in building a reliable and continuous supply of vaccine. But we’re not done—the work is ongoing, with numerous partnerships and manufacturing projects in process.
And we want to do more. To advance our mission of health equity and to ensure affordable, sustainable vaccine access, PATH’s SVM program stands ready to partner with vaccine manufacturers worldwide. Together, we can strengthen the global vaccine supply and save lives.
