GUARANTEE PORTFOLIO

Gavi: RTS,S malaria vaccine

In August 2021, MedAccess, GSK and Gavi, the Vaccine Alliance announced a unique financing partnership to support the continued production of antigen for the RTS,S/AS01e malaria vaccine ahead of key policy and funding decisions.

The partnership

The partnership was comprised of two agreements.

  1. Gavi and GSK: Gavi provided funding to GSK to enable continued production of the antigen for its RTS,SAS01e malaria vaccine in advance of a WHO decision on recommending the vaccine for use and a Gavi Board decision on opening a funding window for country rollout.
  2. Gavi and MedAccess: MedAccess agreed to replenish Gavi for 90% of funds committed to support RTS,S antigen production in the event of a negative decision on opening a funding window.

The policy and funding decisions came towards the end of 2021: WHO recommended the vaccine for use in October, and the Gavi Board approved a funding window in December.

Through this partnership, GSK’s continued production of RTS,S antigen has enabled Gavi to be able to make the finished vaccine available to countries much more quickly that would otherwise have been possible if production had been halted and restarted following a decision.

Photo: Mothers line-up and wait for their children to receive the malaria vaccine, Mkaka Primary School Outreach, Malawi. Credit: PATH

Development impact

We projected that up to additional 7.5 million children could receive the RTS,S/AS01e vaccine as a result of continued production in advance of policy and funding decisions. These children would have missed out on the vaccine if countries had to wait to introduce it into their routine immunisation schedules while production was restarted. We estimate that this would lead to 8.7 million cases of malaria and 36,000 deaths being averted.

How we calculate the impact of this guarantee

All development impact estimates were dependent on the exact timing of WHO’s policy decision and Gavi’s funding decision. We projected impact across various timelines between 2021 and 2028 to ensure we captured the full range of potential impact.

Lives changed: inputs used to estimate expected additional children vaccinated through the accelerated access to RTS’S include: timing of key policy and funding decisions, expected production schedules, and projected demand following a Gavi decision. Deaths and cases averted are estimated using modelling published by Penny et al. in 2016 and assume available vaccine doses will be used to fully vaccinate fewer children rather than partially vaccinate a greater number.

Money saved: impact is estimated based on the additional costs associated with a stop-and-start production scenario, which was used to calculate an average price per dose for projected doses purchased between 2021 and 2028 across various timelines.

Markets shaped: we work with partners, including donors, procurers and ministries of health, to track changes in health markets where our investments are supporting access to products. We monitor for changes to policy, procurement practices and supplier movement, all of which affect markets and contribute to the long-term sustainability of impact.

A mother smiles holding her baby

The product

RTS,S/AS01e was approved by the European Medicines Agency in 2015. Since 2019, an ongoing pilot of the vaccine has been in place in three African countries (Ghana, Kenya, and Malawi) and, despite COVID-19, has achieved and maintained high coverage levels. As of April 2022, more than 1 million children have received one or more RTS,S/AS01e doses across the three countries.

A Phase 3 trial conducted over 5 years from 2009 to 2014 found that among children aged 5–17 months who received four doses of RTS,S/AS01e, the vaccine prevented approximately 4 in 10 (39%) cases of malaria over 4 years of follow-up and about 3 in 10 (29%) cases of severe malaria, with significant reductions also seen in overall hospital admissions as well as in admissions due to malaria or severe anaemia. The vaccine also reduced the need for blood transfusions, which are required to treat life-threatening malaria anaemia, by 29%.

Photo: Mother and child who received the first dose of the malaria vaccine at Mitundu Community Health Center. Credit: PATH

Why we acted

Malaria kills more than 627,000 people a year worldwide and causes illness in tens of millions more, with most deaths (96%) occurring among young children living in sub-Saharan Africa. Although existing interventions have helped to reduce malaria deaths significantly over the past 15 years, a vaccine could add an important complementary tool for malaria control efforts.

Vaccine development is expensive and risky. The RTS,S/AS01e vaccine was developed by GSK over more than three decades, costing hundreds of millions of dollars. Following the vaccine’s approval, the risk shifted from development to deployment. There is no market for RTS,S/AS01e in high-income countries and it is unlikely that low-resource settings would generate enough demand to make long-term production viable. If production had been halted awaiting of policy and funding decisions, millions of children may not have received the vaccine while production was restarted and scaled up. Our innovative financing partnership has reduced the risks for all parties and enabled continued production of the vaccine antigen.