Short overview of the malaria vaccine implementation programme

Malaria context

In recent years, African countries have made tremendous progress in the fight against malaria using core disease-cutting tools such as insecticide-treated mosquito nets, indoor spraying with insecticides and antimalarial medicines. But in some areas where these approaches have been adopted, malaria illness and death remain stubbornly high. According to the latest data from WHO, there were an estimated 435 000 malaria-related deaths and 219 million new cases of the disease in 2017. Sub-Saharan Africa carries more than 90% of the global disease burden.

New and complementary tools are needed to further drive down malaria cases and deaths, with a view to ultimately achieving the vision of a world free of malaria. Today, a first- generation vaccine known as RTS,S/AS01 (RTS,S) has the potential to strengthen efforts to control malaria in Africa and save tens of thousands of young lives.

RTS,S: a new tool with promise for Africa

Vaccine efficacy

The RTS,S vaccine is the first and, to date, the only vaccine to show partial protection against malaria in young children. It acts against Plasmodium falciparum, the most deadly malaria parasite globally and the most prevalent in Africa. Rigorous clinical testing in 7 African countries has shown its potential to boost malaria prevention and save lives. Among children who received 4 doses in large-scale clinical trials, the vaccine prevented:

4 in 10 cases of malaria over a 4-year period;

3 in 10 cases of life-threatening severe malaria.

Recommended by global experts for phased introduction

In view of its public health potential, WHO’s top advisory committees for malaria and immunization have jointly called for phased introduction of the vaccine in several settings in sub-Saharan Africa.

The vaccine will be used as a complementary malaria control tool, added to the core package of WHO-recommended measures for malaria prevention.

It will be made available to young children in selected areas of high malaria transmission in 3 pilot countries – Ghana, Kenya and Malawi – through routine immunization services.

Vaccine safety

Safety of the vaccine is a top priority. In large-scale clinical testing involving thousands of African children, the vaccine was generally well tolerated, with adverse reactions similar to those of other childhood vaccines.

In 2015, the European Medicines Agency – a stringent regulatory authority – issued a positive scientific opinion of RTS,S, indicating that the benefits of the vaccine in preventing malaria outweigh potential risks.

The national regulatory authorities in the 3 pilot countries have since reviewed and authorized the RTS,S vaccine for use in phased introductions in their countries.

Vaccine development

RTS,S was developed over a 30-year period by GSK, including through a collaboration, begun in 2001, with PATH’s Malaria Vaccine Initiative (MVI) and a network of African research centres.

A 5-year Phase 3 efficacy and safety trial was conducted between 2009 and 2014 through a partnership that involved GSK, MVI and research centres at 11 sites in 7 African countries.

The Malaria Vaccine Implementation Programme

This pilot implementation programme is a country-led, WHO-coordinated initiative. It is a collaborative effort with Ministries of Health in Ghana, Kenya, and Malawi and a range of in-country and international partners, including PATH, a non-profit organization, and GSK, the vaccine manufacturer.

The vaccine programme will reach approximately 360 000 children each year in selected areas across the 3 countries.

It will address several outstanding questions related to the use of the vaccine in real-life settings, including:

how best to deliver the required 4 doses of RTS,S;



the vaccine’s potential role in reducing childhood deaths; and



its safety in the context of routine use.

Financing for the pilot programme has been mobilized through an unprecedented collaboration among three key global health funding bodies: Gavi, the Vaccine Alliance, the Global Fund to Fight AIDS, Tuberculosis and Malaria, and Unitaid. WHO and GSK are providing additional in-kind contributions.