How Partnerships Have Shaped the Malaria Vaccine Market

April 25, 2023

Malaria is a disease spread by specific types of mosquitoes, found predominantly in tropical countries. The disease can be mild or life threatening, but is curable when treated correctly. To date,  Africa continues to report the highest number of cases – in 2021, the continent accounted for 95% of global malaria cases, and for 96% of the malaria death toll globally, out of which 80% were children. Four African countries accounted for just over half of all malaria deaths worldwide: Nigeria (31.3%), the Democratic Republic of the Congo (12.6%), the United Republic of Tanzania (4.1%) and Niger (3.9%). The geographical disproportion of malaria deaths is a prime example of health inequity, particularly in sub-Saharan Africa.

Although notable interventions such as vector control, insecticide-treated bed nets and antimalarial treatments have been successful in reducing the rates of malaria cases and deaths, new tools, such as vaccines, are needed. The production of a successful vaccine against malaria has been in the making for more than three decades. By comparison, vaccines against COVID-19 were developed and authorized for use in less than one year. Why the difference? The answer involves the complex biology of the malaria parasite against which it has proven difficult to develop an effective vaccine. Other important factors have been challenges around funding, as well as a lack of sense of urgency.

As the world commemorates World Malaria Day, it is essential to recognize the importance of different stakeholders coming together to participate in the malaria vaccine market to ensure timely availability and broad access for those who need it most.

The world’s first malaria vaccine rollout

The World Health Organization (WHO)’s most recent World malaria report shows that the increase in malaria cases following the COVID-19 pandemic has started to normalize. However, much more remains to be done and it is essential to find ways to immunize those most vulnerable to severe cases of malaria.

The world’s first malaria vaccine, RTS,S/AS01E, is a groundbreaking step and has been well accepted in African communities in a relatively short time frame. The vaccine acts against the parasite Plasmodium falciparum which is the deadliest malaria parasite and most prevalent in Africa. Four doses of the RTS,S/AS01E vaccine reduces clinical malaria cases by 39% and severe malaria by 30%. It has been developed by GSK for more than 30 years and in partnership with PATH, a global nonprofit organization, since 2001. To date it is the only malaria vaccine prequalified by the WHO.

While the vaccine was on the development pathway for many years, its rollout on a larger scale has also taken time. In August 2021, in an effort to address the uncertainty around future demand, Gavi, the Vaccine Alliance, GSK and MedAccess announced an innovative financing agreement to guarantee continued production of the antigen for the RTS,S/AS01E malaria vaccine. This agreement was made in anticipation of the WHO’s recommendation for the widespread use of the vaccine and allowed GSK to ramp up production immediately following the WHO recommendation in October 2021. GSK expects to produce 18 million doses of RTS,S/AS01E between 2023 and 2025, with 4 million doses being available from late 2023.

Despite GSK’s trailblazing efforts, having only one supplier will be insufficient to respond to the staggering demand for the vaccine. Over 25 million children are born every year in areas where the vaccine is recommended.  In January 2021, GSK, PATH and Indian biotechnology company, Bharat Biotech (BBIL), signed a product transfer agreement to ensure long term supply of the RTS,S/AS01E vaccine. This grants BBIL a license to commercialize and supply the RTS,S/AS01E vaccine – enabling its continued production and availability.

The RTS,S/AS01E vaccine is currently being piloted in Ghana, Kenya and Malawi under the Malaria Vaccine Implementation Programme. Since 2019, more than 1 million children have received the vaccine. Ministries of health are in charge of vaccine implementation, with support from the WHO, GSK, PATH, Gavi, the Vaccine Alliance and other partners. 

Looking at these essential multi-stakeholder approaches to fund, manufacture and distribute the vaccine, it is evident that it takes a village to ensure the health and safety of those most at risk. So what are the next steps?

The malaria vaccine pipeline

Only one vaccine will be insufficient to respond to the long-term need to reduce cases of malaria. Fortunately, in addition to the efforts underway to scale up the supply of the RTS,S/AS01E vaccine,  other malaria vaccines are also expected on the market. According to the WHO, as of 2021, there are 102 ongoing studies (although the majority (91%) are in the discovery, pre-clinical or Phase I stage).

One vaccine demonstrating high potential is the R21/Matrix-M malaria vaccine developed by the University of Oxford. Data from the Phase II trials shows an efficacy of 77%, following a fourth booster dose. Results from the ongoing Phase III trials are expected to be reported in late 2023. The WHO is currently assessing its safety and effectiveness and it has already been approved for use by the Ghanaian and Nigerian regulatory authorities.

The Serum Institute of India Pvt. Ltd. (SIIPL) is the manufacturing and commercialization license holder for the vaccine and aims to produce up to 200 million doses annually. Additionally, SIIPL has announced a technology transfer deal to produce the vaccine in Ghana. This will contribute to the goal set by the African Union to enable the African vaccine manufacturing industry to produce 60 % of all vaccine doses required on the continent by 2040.

Global health partnerships continue to be important in malaria production and distribution

The estimated demand for malaria vaccines by 2036 is approximately 110 million doses per year. According to the United Nations Children's Fund (UNICEF), malaria vaccine supply is expected to meet demand sometime between 2026 and 2028, depending on the scale-up of the RTS,S/AS01E vaccine, the results of R21/Matrix-M Phase III trials and subsequent licensing and WHO prequalification.  To mitigate the supply constraints, the WHO established a vaccine allocation framework to facilitate transparent and equitable allocation of the limited vaccines.

How can global health partnerships accelerate the development and roll-out of malaria vaccines?

• Donors, governments, manufacturers and international procurement agencies should continue to work together on incentives that increase production capacity. For example, licensing and technology transfer would promote regional diversification of manufacturers, increase competition and reduce prices in the long term.
• The WHO continues to provide technical assistance to vaccine manufacturers to speed up attainment of WHO prequalification and other relevant regulatory approvals. Thus, UNICEF would be able to procure from a wide range of manufacturers.
• Global health organizations such as Gavi, the Vaccine Alliance are continuously monitoring the malaria vaccine pipeline to identify the most promising candidates.
• Countries need to plan the introduction of the malaria vaccine into their national immunization programs and malaria control strategies. This would create demand forecasts, which would communicate the need for additional supply in the market as soon as possible.

The World Intellectual Property Organization (WIPO) continues to work with stakeholders in the global health space. For instance, WIPO’s ‘Dialogue on Intellectual Property and Health‘ series, brings together Geneva-based international organizations whose operational work touches on the intersection of IP and health. The purpose of the series is to provide a forum to share experiences and challenges, and to strengthen WIPO’s support to innovation access initiatives.