Breakthrough: WHO approves First Vaccine against Malaria, Mosquirix

Geneva: The World Health Organization, in a major breakthrough, recommended the use of the first malarial vaccine, called Mosquirix or RTS,S/AS01 (RTS,S) against Malaria, in Sub-Saharan African region and other regions having moderate to high, Plasmodium falciparum malaria transmission. It is also the first vaccine against parasitic diseases.

According to WHO, malaria is a life-threatening disease that is caused by the Plasmodium parasite and is transmitted amongst people via the infected female Anopheles mosquito bites. There were around 229 million cases of malaria in 2019 globally, with children under the age of five being the most vulnerable comprising 67% (274 000) of the deaths.

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Out of the 5 parasite species that cause malaria in human beings, P.falciparum and P.vivax are the greatest threat, with the former being more prevalent in the WHO African Region, WHO South-East Asia Region, Eastern Mediterranean, and the Western Pacific; and the latter being more prevalent in WHO Region of the Americas.

Malaria is a major cause of childhood illness and death in sub-Saharan Africa, with more than 260000 children under the age of five, dying due to it every year. 94% of the world's malaria cases and death in 2019 took place in the WHO African region. The vaccine, developed by the British drugmaker GlaxoSmithKline, is based on the results of the pilot study conducted by the WHO in Ghana, Kenya, and Malawi and it has reached more than 80,000 children since 2019. The endorsement by the WHO would further lead to a wide distribution of the vaccine in countries that are fighting against this disease.

Stating that the vaccine could save a lot of lives every year, the WHO Director-General Dr. Tedros Adhanom Ghebreyesus in a press conference that went live on social media said, "This is a historic moment. The long-awaited malaria vaccine for children is a breakthrough for science, child health, and malaria control", adding, "Using this vaccine on top of existing tools to prevent malaria could save tens of thousands of young lives each year".

The WHO further recommended that the vaccine should be given in a schedule of 4 doses to children from the time they become 5 months old for reducing the disease. The recommendation was based on the advice of WHO global advisory bodies for immunization and for malaria.

Dr. Matshidiso Moeti, WHO Regional Director for Africa said, "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. Today's recommendation offers a glimmer of hope for the continent which shoulders the heaviest burden of the disease and we expect many more African children to be protected from malaria and grow into healthy adults."

Some of the key findings from the pilot study conducted in a period of two years implemented under the leadership of the Ministries of Health of Ghana, Kenya, and Malawi are:

• Can be easily delivered with good and equitable coverage of RTS,S through a routine immunization system, even amidst the COVID pandemic
•  Increases equity and reaches those who don't have access to various preventive methods
• It has a favorable safety profile since more than 2.3 million doses of the vaccine have been given to children in the 3 African countries.
• The use of insecticide-treated nets, uptake of other childhood vaccinations, or health-seeking behavior for other fever-related illnesses has not been affected in any manner
• There is a major reduction of around 30% of deadly severe malaria, even when it is given in places that have a good system of diagnosis and treatment available.
• Vaccine is also cost-effective

The pilot study was funded in a collaborative manner by three global health funding bodies, Gavi, the Vaccine Alliance; the Global Fund to Fight AIDS, Tuberculosis, and Malaria; and Unitaid.

Talking about the progress made against malaria globally in the last 2 decades, Dr. Ghebreyesus said that malaria deaths have fallen by half and it was also completely eliminated in many parts of the world. However, he added that "globally, progress has stalled at an unacceptable high level, with more than 200 million cases and 400 thousand deaths every year. Two-thirds of those deaths are children under five in Africa."

Cautioning to not take the vaccine as the only tool, Dr. Ghebreyesus further added, "this is a powerful new tool, but like COVID19 vaccines, it's not the only tool. Vaccination against malaria does not replace or reduce the need for other measures, including bednets, or seeking care for fever".

According to a report in Economic Times, in the first year, the vaccine had an efficacy of around 50% against severe malaria, whereas it dropped around zero by the fourth year. Since the trials did not measure the vaccine's effect on preventing deaths, some experts also reportedly questioned the decision to invest in countries with countless other intractable problems. However, Dr. Mary Hamel, who leads WHO's malaria vaccine implementation program expected to see an impact since severe malaria accounts for up to half of the malaria deaths and is considered "a reliable proximal indicator of mortality". 

Future steps related to the vaccine would be based on the decisions by the global health community for a wider rollout of the vaccine and country-based choice to introduce the vaccine in their national malaria control strategies.

The Malaria Vaccine Implementation Programme is taking place under the coordination of WHO and is supported by other international partners including PATH, UNICEF, and GSK, donating around 10 million doses of vaccine for the pilot project. The vaccine was developed by GSK through a partnership with PATH, along with support from the network of African Research centers, according to the WHO news release.

Medical Dialogues had earlier also reported a study published in The New England Journal of Medicine that had found that a new combination approach of giving the world's first malaria vaccine, RTS,S/ASO1E along with antimalarial drugs before the rainy season could result in a 70% reduction in life-threatening malaria in the African Sahel, thus decreasing the child hospitalizations and death.