Our approach to advancing new vaccines for low-resource settings
We strive to improve the health of people, especially infants and children living in low-income countries, by accelerating the development of vaccines that will be effective and affordable in the countries that need them most urgently. We work closely with nonprofit partners (such as universities and research institutions) and commercial partners (including vaccine manufacturers and biotechnology firms) on initial discovery through clinical trials, licensure, and World Health Organization (WHO) prequalification to shorten the timeline for new and underutilized vaccines to become available where needed most.
Our work encompasses assessing vaccine technologies, working with partners on the most promising approaches, helping ensure that successful products will be affordable and available, promoting needed policy changes and raising awareness about the need for new vaccines, conducting research activities to advance scientific understanding, and supporting manufacturers in meeting the highest quality standards.
Vaccine design to meet needs of hardest-hit communities
As appropriate, we develop a target product profile for each type of vaccine, which presents the characteristics of the product that would best meet the needs of the intended beneficiaries. Helping ensure that the vaccines we develop are practical and realistic for country-level introduction remains an important consideration through every step of the development process, including such factors as pricing, ease of administration, packaging and presentation, storage and supply chain logistics, among others. We also support our partners in the regulatory review and approval process, using our expertise to identify and navigate the most appropriate regulatory pathways for each vaccine in development.
Pioneering innovative regulatory approval pathways
In the field of malaria, our partnership with GSK has resulted in the first malaria vaccine candidate to be assessed by a stringent regulatory agency. In July 2015, the RTS,S malaria vaccine candidate received a positive scientific opinion from the European Medicines Agency (EMA) under the agency’s Article 58 procedure. This procedure enables the EMA, in cooperation with the WHO, to evaluate medicines and vaccines that are intended solely for use outside the European Union. Also in the field of malaria, we have played a leadership role in identifying a feasible regulatory approval pathway for innovative transmission-blocking vaccine candidates. This class of vaccines—considered important to malaria elimination and eradication efforts—would be expected to confer individual benefit only via broad implementation across communities.
A portfolio approach to increase chances of success
Vaccines are difficult to develop and many potential candidates do not make it successfully through the research and development process, requiring the pursuit of many candidates in the effort to develop and license a single vaccine. For this reason, we are working on multiple potential solutions in most of our projects, resulting in a broad portfolio of over two dozen vaccines in development and use across 16 disease targets.
PATH IN ACTION
A meningitis vaccine brings hope to sub-Saharan Africa
Following a particularly devastating meningitis A epidemic in the 1990s, African leaders called for an affordable vaccine that would permanently put an end to the disease. In partnership with WHO, Serum Institute of India, Pvt., Ltd, and other partners, we developed and introduced an effective, affordable meningitis A conjugate vaccine, called MenAfriVac®, in record time and at one-tenth the cost of a typical vaccine. MenAfriVac® became the first vaccine ever to be tailor made for Africa and was offered for just US$0.50 per dose.
Since its 2010 introduction, MenAfriVac® has virtually eliminated meningitis A wherever it has been used. By 2020, the vaccine is expected to protect more than 400 million people. The next step is to ensure MenAfriVac®’s introduction into routine childhood immunization programs in Africa’s meningitis belt. To inform strategies on use, we are studying MenAfriVac®’s level of protection over time. We are also advancing vaccine development against other causes of epidemic meningitis as part of a strategy to eliminate meningitis epidemics in Africa for good. [Photo: PATH/Amy MacIver]