RTS,S Malaria Vaccine Candidate

Partnership objective

Development of vaccine to defend against P falciparum malaria parasite in children.

Closing the gap left by mosquito nets and treatments, particularly in the face of growing resistance to anti-malarials and insecticides, a vaccine against malaria could prove an essential tool in the fight against the disease. Closing the gap left by mosquito nets and treatments, particularly in the face of growing resistance to anti-malarials and insecticides, a vaccine against malaria could prove an essential tool in the fight against the disease. Copyright GSK

What are the health needs and challenges?

Malaria is endemic in over 100 countries. Most infections occur in sub-Saharan Africa, South East Asia and Latin America; 90% of all malaria deaths occur in sub-Saharan Africa.

Malaria transmitted by female members of the Anopheles mosquito family, which feed on human blood. The initial symptoms of the disease include fever, headache, malaise, fatigue, nausea, muscular pains and mild diarrhoea. Infection can rapidly progress, leading to more severe symptoms, including delirium and convulsions, followed by coma and death.

People living in areas permanently affected by malaria can develop a partial immunity to the illness. In such individuals, infection leads to illness and inability to work or attend school, but it is less likely to prove fatal. Young children do not yet have such partial immunity, while pregnant women lose immunity they had, leaving them vulnerable. This is why most malaria deaths are in children under five years and in pregnant women.

Malaria continues to exact a heavy burden on the health and economies of communities across Africa. Economic research shows that malaria slows economic growth in Africa by up to 1.3 per cent each year. Malaria related illnesses and mortality cost Africa’s economy alone US$12 billion per year.

Malaria can be prevented by controlling the breeding of malaria carrying mosquitoes and sleeping under insecticide-treated mosquito nets. It can be treated effectively too, using effective drugs at the correct dose for the right length of time. However, vaccines offer an economical and effective means of preventing diseases. Closing the gap left by mosquito nets and treatments, particularly in the face of growing resistance to anti-malarials and insecticides, a vaccine against malaria could prove an essential tool in the fight against the disease. Even a modestly efficacious malaria vaccine has the potential to protect hundreds of thousands from disease and death each year.

Description of partnership activities and how they address needs and challenges

For the past 30 years, GSK scientists have been working with others around the world to try to develop a vaccine against malaria. The RTS,S malaria vaccine candidate is currently the most advanced in development globally. It was created in 1987 by scientists working at GSK’s laboratories with scientists from the Walter Reed Army Institute of Research (WRAIR) and developed in partnership with PATH Malaria Vaccine Initiative (MVI) since 2001, with grant monies from the Bill & Melinda Gates Foundation. If approved, the RTS,S vaccine would be the first human vaccine against a parasite.

RTS,S aims to trigger the body’s immune system to defend against the P. falciparum malaria parasite when it first enters the human host’s bloodstream and/or when the parasite infects liver cells. The vaccine is designed to prevent the parasite from infecting, maturing and multiplying in the liver, after which time the parasite would re-enter the bloodstream and infect red blood cells, leading to disease symptoms.

RTS,S is intended exclusively for use against the Plasmodium falciparum malaria parasite, which is most prevalent in sub-Saharan Africa.

GSK has taken the lead in the overall development of RTS,S and has invested more than $350 million to date and expects to invest a further $260 million until development is completed. With more than $200 million in grant monies from the Bill & Melinda Gates Foundation, the PATH Malaria Vaccine Initiative (MVI) contributes financial, scientific, managerial, and field expertise to the development of RTS,S. GSK has committed that the eventual price of RTS,S will cover the cost of manufacturing the vaccine together with a small return of around 5% that will be reinvested in research and development for second-generation malaria vaccines, or vaccines against other neglected tropical diseases.

Summary of impact and forward looking information

Results from a large-scale Phase III trial presented in 2013 in Durban demonstrated that RTS,S helped to protect young children and infants from clinical malaria up to 18 months after vaccination. These results demonstrated that over 18 months of follow-up, RTS,S almost halved the number of malaria cases in young children (aged 5-17 months at first vaccination) and to reduce by around a quarter the malaria cases in infants (aged 6-12 weeks at first vaccination). Vaccine efficacy was also assessed separately at each of the trial sites, which represent a wide range of malaria transmission settings; efficacy was found to be statistically significant at all sites in young children and at four out of eleven sites in infants.

Based on these data, GSK submitted in June 2014 a regulatory application to the European Medicines Agency (EMA). The EMA submission is the first step in the regulatory process toward making the RTS,S vaccine candidate available as an addition to existing tools currently recommended for malaria prevention. An effective vaccine for use alongside other measures such as bednets and anti-malarial medicines would represent an advance in malaria control. If a positive scientific opinion from the EMA is granted, the WHO has indicated a policy recommendation may be possible by end of 2015. 

Videos

Malaria Vaccine Initiative: Investing in the Future to Defeat Malaria

Partnership information

Company(ies) GlaxoSmithKline

Partner(s) Bill and Melinda Gates Foundation, PATH Malaria Vaccine Initiative (MVI)

Type of Partner(s) NGOs, PDPs

Therapeutic Focus Women and Children's Health, Infectious Diseases

Disease(s) Children's Health, Malaria

Program Type(s) Prevention Programs - Vaccines, Research & Development - Development of Treatments, Research & Development - Pediatric R&D

Targeted Population(s) Children, People with low income

Region(s) Sub-Saharan Africa

Number of Countries 8

Country(ies) Burkina Faso, Gabon, Ghana, Kenya, Malawi, Mozambique, Nigeria, Tanzania

Start Date 2001

More information GSK Malaria Vaccine

Anticipated completion date Ongoing

« This is a key moment in GSK’s 30-year journey to develop RTS,S and brings us a step closer to making available the world’s first vaccine that can help protect children in Africa against malaria. »

Dr Sophie Biernaux, Head of the Malaria Vaccine Franchise, GSK