Case Study: Research and Development

Achieving a Milestone on a Malaria Vaccine, GSK

Objectives

We are determined to help stop malaria, and along with our partner organizations, we are optimistic this goal can be achieved.

For the past three decades, GSK scientists have been collaborating with scientists around the world to develop the world’s first malaria vaccine. In 2013, we announced the results of a large-scale phase III trial, a major milestone in this vaccine’s development. Our vaccine candidate (RTS,S) aims to trigger an individual’s immune system to defend against the malaria parasite, Plasmodium falciparum.

If it approves the vaccine candidate, the World Health Organization (WHO) believes that it could make a policy recommendation about it by 2015. If that happens, we will partner with multiple stakeholders, including African governments, to ensure that the vaccine is delivered and implemented across Africa as rapidly as possible.

The price of RTS,S will cover the cost of manufacturing the vaccine and provide a small return of around 5 percent that will be reinvested in R&D for second-generation malaria vaccines or vaccines for other tropical diseases.

Lessons Learned?

GSK could not have achieved this accomplishment alone; the vaccine was developed in an innovative public-private partnership with the PATH Malaria Vaccine Initiative (MVI), supported by grants from the Bill & Melinda Gates Foundation. Overall, hundreds of people, from researchers to regulators, have dedicated many thousands of hours to bring us where we are today.

This experience has taught us that innovation is more than just the science behind finding new vaccines or medicines for developing countries. It’s also about developing new business models that allow us to tackle diseases that have a huge impact on society and public health.

Beyond researching a vaccine, we are transforming our business model to be more responsive to the developing world’s needs. This transformation includes adopting a more open approach to R&D for the diseases like malaria that affect developing countries most acutely.

Results to Date?

The health impact of the RTS,S vaccine was evaluated in the context of existing malaria control measures, such as insecticide-treated bed nets, in 11 research centers in seven African countries.

  • RTS,S almost halved the number of malaria cases in young children (aged 5 to 17 months at first vaccination) and reduced by around a quarter malaria cases in infants (aged 6 to 12 weeks at first vaccination).
  • The latest trial results found that these results lasted for at least 18 months after vaccination. Based on these findings, we plan to submit a regulatory application to the European Medicines Agency (EMA) in 2014.

More Information

www.gsk.com/explore-gsk/health-for-all/the-fight-against-malaria.html