New financing agreement for malaria vaccine
Geneva and London, August 4, 2021. Gavi, the Vaccine Alliance, GlaxoSmithKline (GSK), and MedAccess have announced the signing of a major agreement. This innovative financing deal aims to ensure the continued production of the antigen for the RTS,S/AS01e vaccine, pending decisions regarding its broader rollout.
This new mechanism will prevent initial shortages, ensuring that vaccine availability does not hinder immunization efforts should the WHO recommend wider use and Gavi approve the program.
Dr. Seth Berkley stated: “This is a prime example of what innovative financing can achieve: mitigating risks associated with uncertainty to ensure access to what could become an important additional tool in the fight against malaria.”
A promising outlook for the RTS,S/AS01e vaccine
RTS,S/AS01e is the first malaria vaccine to demonstrate both safety and efficacy, with results validated through an extensive Phase 3 clinical trial. It is currently being evaluated in pilot studies in Ghana, Kenya, and Malawi as part of the Malaria Vaccine Implementation Programme (MVIP).
The World Health Organization (WHO) is expected to make a decision this year regarding the expansion of its use, based on findings from the MVIP. Subsequently, the Gavi Board will determine whether to fund a new program in sub-Saharan Africa.
It is worth noting that GSK has invested approximately $700 million in the development of the RTS,S vaccine and has also donated 10 million doses for the ongoing pilot programs. How does this financing mechanism work?
Given the uncertainty surrounding future demand, Gavi, GSK, and MedAccess have created a novel financing model. It ensures the continued production of the antigen and its immediate availability should positive decisions be reached.
Gavi’s role: Gavi is funding the production of the antigen by GSK for a period of up to three years.
In the event of approval: If Gavi approves the vaccination program—following guidance from the WHO—this funding will be used to purchase the doses.
In the event of rejection: If Gavi decides not to fund the program, MedAccess will reimburse the majority of the funds already committed.
This bulk production avoids a lengthy ramp-up phase, ensuring that the vaccine can be accessed very quickly if authorities grant their approval. According to an analysis by MedAccess, this continuity will help protect an additional 7.5 million children.
Reactions from key partners
Dr. Seth Berkley, CEO of Gavi, highlights the potential impact of the vaccine:
“This vaccine could truly be a game-changer. Malaria kills more than 250,000 children every year. We must keep production lines running now, while awaiting decisions. This is a prime example of the best that innovative financing can offer.”
Michael Anderson, CEO of MedAccess, adds:
“Risk-bearing finance can accelerate the delivery of new vaccines to market, as we saw in 2020. This agreement is based on the same principle. It is a unique partnership that combines science, public health, and innovative finance to save lives.”
Thomas Breuer, Chief Global Health Officer at GSK, concludes:
“This agreement is a remarkable success. The continued production of the RTS,S vaccine is the key to a rapid response. We will be ready the moment the WHO, Gavi, and the countries involved decide to scale up demand.” »
Technology Transfer and Future Outlook
Regardless of this agreement, GSK is continuing the technology transfer process. The production of the antigen will be entrusted to the Indian company Bharat Biotech. Under an agreement announced earlier this year by GSK, Bharat, and PATH, the latter will become the exclusive supplier of the vaccine by 2029. Meanwhile, GSK will continue to produce the adjuvant (AS01e).
Efficacy and Results of Pilot Studies
The Phase 3 trial took place over a five-year period, from 2009 to 2014. Administering four doses of RTS,S/AS01e to children aged 5 to 17 months yielded robust results:
Preventing approximately 4 out of every 10 malaria cases (39%) over a 4-year follow-up period.
Preventing approximately 3 out of every 10 cases of severe malaria (29%).
Significantly reducing the overall number of hospitalizations.
Reducing hospitalizations due to malaria or severe anemia.
Reducing by 29% the number of blood transfusions required to treat life-threatening malaria-related anemia.
Currently, pilot studies in Ghana, Kenya, and Malawi are showing high levels of coverage—levels that have been maintained despite the COVID-19 pandemic. As of July 2021, after two years of vaccination:
More than 2 million doses of RTS,S/AS01e had been administered.
More than 740,000 children had received at least one dose of the vaccine.
The Ministries of H
