WHO Approves First Ever Malaria Vaccine
Children under the age of five years in sub-Saharan Africa continued to account for approximately two-thirds of global deaths from malaria.

The World Health Organization (WHO) has given the go-ahead for children to get the first-ever malaria vaccine in areas where there is a high to moderate risk of infection.

The vaccine, known as RTS,S, is the first to have been approved against a parasitic disease.

It has been tested on 800,000 children in Ghana, Kenya and Malawi over two years as part of routine immunisations and found to reduce severe malaria-related hospitalisation by 30% and clinical malaria by 40%, researchers revealed at a WHO press conference on Wednesday.

“This is a historic moment. The long-awaited malaria vaccine for children is a breakthrough for science, child health and malaria control,” said WHO Director-General Dr Tedros Adhanom Ghebreyesus, who started his medical career as a malaria researcher. 

“Using this vaccine on top of existing tools to prevent malaria could save tens of thousands of young lives each year.”

The WHO recommends that the vaccine – which acts against P. falciparum, the deadliest malaria parasite – is given in four doses to children from the age of five months to around 18 months.

Tedros said that progress against malaria “has stalled at an unacceptably high level, with more than 200 million cases, and 400,000 deaths every year – two-thirds of which are children under five in Africa”.

“Every two minutes, a child under five dies of malaria,” said Dr Matshidiso Moeti, WHO Regional Director for Africa, adding that 94% of malaria cases were in Africa.

Dr Matshidiso Moeti, WHO Regional Director of Africa.

“We have long hoped for an effective malaria vaccine and now for the first time ever, we have such a vaccine recommended for widespread use.”

Moeti added that the WHO would support the production of the vaccine in Africa.

However, GlaxoSmithKline (GSK), which has invested US$ 700 million in the development of RTS,S and donated up to 10 million doses for the pilot programme, will be working with an Indian generic producer to manufacture the vaccine for the foreseeable future. 

“GSK was clear at the time, as we’ve proceeded with this vaccine that, having provided a large degree of development funding and producing the vaccine for the implementation programme, was nevertheless seeking a tech transfer partner for the long term production of this vaccine,” said Dr Kate O’Brien, WHO head of immunisation.

“There was a programme opened up to initiate interest from vaccine manufacturers and the partner who will be with GSK for this tech transfer is Bharat Biotech in India.”

Protect children’s development

Dr Alejandro Cravioto, Chair of the WHO Strategic Advisory Group of Experts on Immunization (SAGE), said that his group recommended the use of the vaccine to ensure the healthy growth and development of children.

“The experience we have had before with other infections showed us clearly that a child that is repetitively sick is maimed for life,” said Cravioto.  “He or she is not capable of developing the capacities that he or she is born with, in the sense of achieving an adulthood that will be meaningful. So having anything that protects them, or helps them to be less sick during this growth phase, is essential.”

Global vaccine alliance, Gavi, health agency Unitaid and the Global Fund to Fight AIDS, Tuberculosis and Malaria committed nearly US$ 70 million to fund the pilot, which was designed to address several outstanding questions related to the public health use of the vaccine following the Phase 3 trial showing efficacy of RTS,S.

“We welcome this new tool in the fight against malaria,” said Peter Sands, Executive Director of the Global Fund. “In countries where the Global Fund invests, we have reduced malaria deaths by 45% since 2002 with testing, treatment and prevention tools such as mosquito nets.

“In the vaccine pilots, the RTS,S vaccine was most effective when used together with these existing tools. Significant additional resources will be necessary to enable wide deployment of the vaccine alongside other innovations, and as part of a sustained and comprehensive response in the countries that need it the most.”

Following the WHO recommendation, global stakeholders, including Gavi, will consider whether and how to finance a new malaria vaccination programme for countries in sub-Saharan Africa, according to a statement by Gavi, the Global Fund and Unitaid.

The vaccine will complement other WHO-recommended measures for malaria prevention, including the use of insecticide-treated bed nets, indoor spraying with insecticides, malaria chemoprevention strategies, and the timely use of malaria testing and treatment.

Image Credits: WHO.

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