Malaria vaccine trial gets green light

© Feije Riemersma via 123RF

“The prospect of a malaria vaccine is great news. Information gathered in the pilot will help us make decisions on the wider use of this vaccine”, said Matshidiso Moeti, World Health Organization (WHO) Regional Director for Africa, in a news release.

The injectable RTS,S vaccine was developed to protect young children from the most deadly form of malaria caused by Plasmodium parasites. It will be assessed in the pilot programme as a complementary malaria control tool to potentially be added to the core package of WHO-recommended measures for malaria prevention.

“Combined with existing malaria interventions, such a vaccine would have the potential to save tens of thousands of lives in Africa,” Dr Moeti added.

Africa bears the greatest burden of malaria worldwide.

The WHO pilot programme will assess whether the vaccine’s protective effect in children aged 5 – 17 months old during Phase III testing can be replicated in real-life. Specifically, it will assess the feasibility of delivering the required four doses of RTS,S, the vaccine’s potential role in reducing childhood deaths and its safety in the context of routine use.

Pilot implementation strategy

The three countries selected to participate in the pilot were based on the criteria of high coverage of long-lasting insecticidal-treated nets; well-functioning malaria and immunisation programmes – a high malaria burden even after scale-up of LLINs; and participation in the Phase III RTS,S malaria vaccine trial.

Each country will decide on the districts and regions to be included, with high-malaria-burden areas prioritised, as they are predicted to provide the broadest benefit. Information garnered from the pilot will help to inform later decisions about potential wider use of the vaccine.

The malaria vaccine will be administered via intramuscular injection and delivered through routine national immunisation programmes. WHO is working with the three countries to facilitate regulatory authorisation of the vaccine for use in the pilots through the African Vaccine Regulatory Forum. Regulatory support will also include measures to enable the appropriate safety monitoring of the vaccine and rigorous evaluation for eventual large scale use.