Imagine a country wants to introduce a vaccine to protect their population from a serious disease, but the doses are either not available for them to purchase, or it is so expensive that it remains out of reach, preventing leaders from providing it to their citizens and missing opportunities to save lives. This scenario is not hypothetical, but has been the reality for many countries, where insufficient supply and high price can delay the availability of lifesaving vaccines in low- and middle-income countries―sometimes for decades.
Vaccine supply and affordability can improve when additional manufacturers―including those in emerging markets, which is often where diseases hit hardest―enter the market. Building competitive markets that include emerging country vaccine manufacturers is critical to lowering prices and accelerating the availability of new and lifesaving vaccines. Lower vaccine costs will also allow international donors that help finance new vaccines in low-income countries to further stretch limited resources and reach more people.
Vaccine manufacturing is complex
Vaccine manufacturing is a long and complex process that spans everything from development of the different vaccine components to purification, all the way through filling, packaging, and release for use. Along the way, each step has a multitude of additional tests to ensure that the vaccine is consistently produced and controlled according to quality standards. To enter the global public vaccine market, manufacturers must also meet a stringent set of international standards, collectively known as World Health Organization (WHO) prequalification. The prequalification process is intended to ensure that vaccines meet quality, safety, and efficacy standards, is relevant for the target market, and is a key step in expanding vaccine access. WHO prequalification not only takes into account the final vaccine product, but extends to the manufacturing company’s policies and practices throughout the production of the vaccine as well.
Enhancing global vaccine production capacity and quality
PATH’s Center for Vaccine Innovation and Access partners with emerging market vaccine manufacturers around the world to help ensure sustainable manufacturing for the supply of safe, effective, and affordable vaccines of international quality. With our technical vaccine manufacturing expertise, PATH has supported emerging market vaccine manufacturers for many years in China, Brazil, India, and other countries to provide technical assistance to establish and maintain robust quality systems, to obtain and maintain WHO prequalification, and to help achieve efficiencies that can lower costs, improve yields, and enable scale-up to meet national, regional, and global needs. This includes training on quality control and quality assurance, mock-audits to help prepare for WHO prequalification procedures, and other requests specific to the needs of each manufacturer.
Additionally, through our Sustaining Vaccine Manufacturers project, we now are expanding our support to emerging market vaccine manufacturers around specific high-value and high-impact vaccines for five disease targets― human papillomavirus, Japanese encephalitis, yellow fever, polio, and cholera. PATH will provide in-depth technical support as well as life-cycle management support, where we will help develop robust manufacturing plans designed to enable a reliable and continuous supply of these vaccines. Through these efforts, we aim to increase the supply of safe, effective, and affordable vaccines for these disease targets as well as strengthen the capacity of our partners to sustainably supply the global public market, particularly countries eligible for Gavi, the Vaccine Alliance support.