Seattle, WA—PATH welcomes the decision by the board of Gavi, the Vaccine Alliance (Gavi), to approve a malaria vaccine program to support the broader rollout of RTS,S/AS01E (RTS,S).
The malaria vaccine program will provide funding for vaccine procurement, technical assistance for vaccine introduction, and other activities that will enable interested countries to apply for support to introduce the vaccine.
“Today’s decision by the Gavi board is critically important for those of us living in Africa,” said Dr. Nanthalile Mugala, Chief of Africa Region at PATH. “This commitment will make it possible for low- and middle-income countries in the region that face the greatest malaria burden to consider adding the RTS,S vaccine to their immunization programs as an additional tool to combat malaria. The program could also support other malaria vaccines that become available in the future.”
The Gavi board decision comes less than two months after the World Health Organization (WHO) recommended the RTS,S malaria vaccine for children at risk in areas of moderate to high malaria transmission of Plasmodium falciparum, the deadliest malaria parasite for people and the one most prevalent in Africa. The board’s decision provides funding through 2025 and commits Gavi to continue supporting vaccine rollout and use into the future.
“Today’s news caps a remarkable year for the RTS,S vaccine,” said Dr. Ashley Birkett, Head of Malaria Vaccine Development at PATH. “Thanks to the pilot introduction in Ghana, Kenya, and Malawi, we have solid data on feasibility, safety, and impact in routine use, and evidence that the vaccine increases access to malaria prevention for children at risk.
In addition, ongoing research in Burkina Faso and Mali has shown that RTS,S can be combined with preventive drugs to dramatically reduce disease and death in similar settings with highly seasonal transmission. And now, the international community, acting through Gavi, has stepped forward to help finance the broader rollout of this vaccine.”
“In my home country of Zambia, there were more than 2.5 million cases of malaria and nearly 8,000 deaths from malaria in 2019,” said Dr. Mugala. “Across the Africa region, we see that progress in combatting malaria has largely stalled, and hundreds of thousands of children are still dying each year. There is a clear need for new tools to get the fight back on track. With today’s decision, we are another step closer to having a vaccine widely available for use, alongside other malaria interventions.”
Dr. Mugala continued, “There is still a lot of work to be done, however. Countries will need to make their own decisions about whether to adopt the vaccine, and some may need financial support in addition to that of Gavi to ensure sustained access to the vaccine.”
Dr. Birkett also noted that the initial supply of RTS,S may not be sufficient to satisfy the potential demand in the medium term. “Additional investments will be needed to expand vaccine supply if current demand projections are realized. Together with partners and other stakeholders, PATH is working to help ensure that sufficient malaria vaccine supply will be available to meet this potential demand in the future. As with other new vaccines, it takes time and resources to expand manufacturing.”
“The experience with Covid-19 vaccines has shown the value of risk-sharing in manufacturing alongside research and development, to ensure timely access,” said Dr. Mugala. “Supply of Covid-19 vaccines, including in low resource settings, has benefited from massive, up-front investments that gave vaccine manufacturers confidence that their vaccine doses would be purchased.”
“In the case of RTS,S, we are fortunate that GSK has already committed to provide a certain amount of vaccine even before the demand is known,” said Dr. Birkett. “Other positive steps toward ensuring long-term supply of the RTS,S vaccine include the agreement to transfer the product —including manufacture of the RTS,S antigen—to Bharat Biotech.
Another was the innovative financing agreement agreed by Gavi, GSK, and MedAccess to support continued manufacturing of the RTS,S antigen bulk by GSK, to avoid an interruption of vaccine manufacturing while decisions on its future role were being made.
However, broad access to the vaccine could be accelerated by mobilization of resources to further scale up production: in the absence of a financially lucrative market, there is a need for the global community to share risk with manufacturers.”
Dr. Birkett continued, “As we approach the end of 2021, it is heartening to know that PATH’s 20 years of partnership to bring RTS,S to children at risk of malaria is bearing fruit. We look forward to working with partners to ensure access to RTS,S and to helping support malaria-endemic countries make informed decisions on the appropriate role of a malaria vaccine in their health systems.”
More info on the RTS,S/AS01 malaria vaccine
RTS,S/AS01 is the first malaria vaccine to receive a recommendation for widespread use from WHO, and to have received a positive scientific opinion from a stringent regulatory authority (the European Medicines Agency) and approval for administration through routine immunization services by the regulatory authorities of Ghana, Kenya, and Malawi.
The pilot introduction of the vaccine began in 2019 and is ongoing through 2023. RTS,S was developed by GSK over more than 30 years and in partnership with PATH since 2001, with catalytic funding provided by the Bill & Melinda Gates Foundation to PATH for late-stage development of RTS,S between 2001 and 2015.
PATH continues efforts to accelerate the development of next-generation vaccines and biologics, working with a wide range of academic, business, and governmental organizations, and continues to support research on the optimal use of RTS,S.