Shipments to African countries herald final steps toward broader vaccination against malaria: Gavi, WHO and UNICEF

• More than 330 000 doses of WHO-recommended RTS,S malaria vaccine arrived last night in Cameroon – a historic step towards broader vaccination against one of the deadliest diseases for African children
• Malaria burden is the highest on the African continent, which accounted for approximately 95% of global malaria cases and 96% of related deaths in 2021
• With several African countries now finalizing roll-out plans, an additional 1.7 million doses are set for delivery to Burkina Faso, Liberia, Niger and Sierra Leone in the coming weeks
• These shipments signal that malaria vaccination is moving out of its pilot phase, and lay the groundwork for countries to begin vaccinations through Gavi-supported routine immunization programmes in Q1 2024 

Shipments of the world’s first WHO-recommended malaria vaccine, RTS,S, have begun with 331 200 doses landing last night in Yaoundé, Cameroon. The delivery is the first to a country not previously involved in the malaria vaccine pilot programme and signals that scale-up of vaccination against malaria across the highest-risk areas on the African continent will begin shortly.

Nearly every minute, a child under five dies of malaria. In 2021, there were 247 million malaria cases globally, which led to 619 000 deaths. Of these deaths, 77 per cent were children under 5 years of age, mostly in Africa. Malaria burden is the highest on the African continent, which accounts for approximately 95% of global malaria cases and 96% of related deaths in 2021.

A further 1.7 million doses of the RTS,S vaccine are expected to arrive in Burkina Faso, Liberia, Niger and Sierra Leone in the coming weeks, with additional African countries set to receive doses in the months ahead. This reflects the fact that several countries are now in the final stage of preparations for malaria vaccine introduction into routine immunisation programmes, which should see first doses administered in Q1 2024.

Comprehensive preparations are needed to introduce any new vaccine into essential immunisation programmes – such as training of healthcare workers, investing in infrastructure, technical capacity, vaccine storage, community engagement and demand, and sequencing and integrating rollout alongside the delivery of other vaccines and health interventions. Delivering the malaria vaccine has the added challenge of a four-dose schedule which requires careful planning to effectively deliver.

Since 2019, Ghana, Kenya, and Malawi have been administering the vaccine in a schedule of 4 doses from around 5 months of age in selected districts as part of the pilot programme, known as the Malaria Vaccine Implementation Programme (MVIP). More than 2 million children have been reached with the malaria vaccine in the three African countries through MVIP – resulting in a remarkable 13% drop in all-cause mortality in children age-eligible to receive the vaccine, and substantial reductions in severe malaria illness and hospitalizations. Other key findings from the pilot programme show that vaccine uptake is high, with no reduction in use of other malaria prevention measures or uptake of other vaccines. MVIP is coordinated by WHO in collaboration with PATH, UNICEF and other partners, and funded by Gavi, the Global Fund, and UNITAID, with donated doses from GSK, the manufacturer of the RTS,S vaccine.

The data from the pilot have shown the impact and safety of the RTS,S vaccine and provided important evidence on vaccine acceptability and uptake that helped inform the recent WHO recommendation of a second malaria vaccine – R21, manufactured by the Serum Institute of India (SII). Results of a phase 3 trial for R21 showed that the vaccine has a good safety profile in the clinical trial setting and reduces malaria in children. It is expected that, like RTS,S, when R21 is implemented it will have similar high public health impact.  The choice of which vaccine to be used in a country should be based on programmatic characteristics, vaccine supply, and affordability.

The R21 vaccine is currently under review by WHO for prequalification. The availability of two malaria vaccines is expected to increase supply to meet the high demand from African countries and result in sufficient vaccine doses to benefit all children living in areas where malaria is a public health risk. In preparation for scaled-up vaccination, Gavi, WHO, UNICEF and partners are working with countries that have expressed interest and/or have confirmed rollout plans on the next steps.

These developments mean that broad implementation of malaria vaccination in endemic regions has the potential to be a gamechanger for malaria control efforts, and could save tens of thousands of lives each year. However, malaria vaccines are not a standalone solution. They should be introduced in the context of the WHO-recommended package of malaria control measures which include insecticide-treated nets, indoor residual spraying, intermittent preventive treatment in pregnant women, antimalarials, effective case management, and treatment, all of which have helped to reduce malaria-related deaths since 2000. Importantly, the MVIP showed that delivering vaccines alongside non-vaccine interventions can reinforce the uptake of other vaccines and the use of insecticide treated nets, and overall boost access to malaria prevention measures.

“The world needs good news – and this a good news story,” said David Marlow, CEO of Gavi, the Vaccine Alliance. “Gavi is proud that our Alliance of stakeholders, with African countries at the forefront, took the decision to invest in the malaria vaccine as a public health priority, and that this support has played a part in the availability of a new tool that can save the lives of thousands of children each year. We are excited to rollout this historic vaccine through Gavi programmes and work with partners to ensure it is delivered alongside other vital measures.”

“This could be a real gamechanger in our fight against malaria,” said UNICEF Executive Director Catherine Russell. “Introducing vaccines is like adding a star player to the pitch. With this long-anticipated step, spearheaded by African leaders, we are entering a new era in immunization and malaria control, hopefully saving the lives of hundreds of thousands of children every year.”

“This is another breakthrough moment for malaria vaccines and malaria control, and a ray of light in a dark time for so many vulnerable children in the world. The delivery of malaria vaccines to new countries across Africa will offer life-saving protection to millions of children at risk of malaria,” said WHO Director-General Dr Tedros Adhanom Ghebreyesus. “But we must not stop here. Together, we must find the will and the resources to bring malaria vaccines to scale, so more children can live longer, healthier lives.”