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New Delhi: Scientific efforts that spanned three decades came to fruition Wednesday when the World Health Organisation (WHO) gave its nod to the world’s first vaccine against any parasitic disease.

RTS,S (trade name Mosquirix), which has been developed by GlaxoSmithKline (GSK), significantly reduces the risk of severe disease in malaria-infected children. 

For India, this is good news on two counts — the country’s own significant malaria burden; and the fact that by 2029, Indian firm Bharat Biotech is slated to be the sole global manufacturer of the vaccine.

In January this year, PATH, an international non-profit that works with countries and institutions on health problems, GSK, and Bharat Biotech India Ltd (BBIL) announced the signing of a product transfer agreement for the malaria vaccine.

The vaccine though needs to be used in conjunction with existing mosquito control measures such as nets, repellants etc — much like use of masks in Covid vaccinated individuals.

It has been in use as part of a pilot project since 2019 in Malawi, Kenya and Ghana where over 800,000 children have already received it.

While WHO has recommended its use among children in sub-Saharan Africa, where malaria caused by the parasite Plasmodium falciparum is rampant, India too has a significant malaria burden. International malaria reports have often hinted that India’s actual official malaria figures reflect just the tip of an iceberg. 

This year, a total of 64,520 malaria cases were reported in India until July, of which 44,391 were Plasmodium falciparum cases. A total of 35 deaths were reported in this period because of the disease.

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About the vaccine

The vaccine has been developed with financial support from three global funding organisations — Gavi, the Vaccine Alliance; the Global Fund to Fight AIDS, Tuberculosis and Malaria; and Unitaid.

According to information provided by PATH’s Malaria Vaccine Initiative (MVI), RTS,S was created in 1987 by scientists working in GSK laboratories.

“…(it) aims to trigger the immune system to defend against the first stages of malaria when the Plasmodium falciparum parasite enters the human host’s bloodstream through a mosquito bite and infects liver cells. The vaccine is designed to prevent the parasite from infecting the liver, where it can mature, multiply, re enter the bloodstream, and infect red blood cells, which can lead to disease symptoms,” it said.

Trial results indicate that the vaccine can cause a 30 per cent reduction in the incidence of severe malaria when introduced in areas where access to medical facilities is good and people normally use insecticide treated mosquito nets.

What the WHO recommends

Countries will need to take individual decisions on whether to introduce the vaccine or not and also work out funding arrangements on their own.

The WHO recommends the use of RTS,S for the prevention of Plasmodium falciparum malaria in children living in regions with moderate to high transmission as defined by the global health body.

“RTS,S/AS01 malaria vaccine should be provided in a schedule of 4 doses in children from 5 months of age for the reduction of malaria disease and burden,” the WHO said.

According to its estimates, more than 260,000 African children under the age of five die from malaria annually. That is why WHO Director General Tedros Adhanom Ghebreyesus described the approval of the vaccine as a “historic” development. 

“This is a historic moment. The long-awaited malaria vaccine for children is a breakthrough for science, child health and malaria control. Using this vaccine on top of existing  tools to prevent malaria could save tens of thousands of young lives each year,” he said in a statement.

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The India connection

Earlier this year, Bharat Biotech, which is also the manufacturer of the indigenous Covid vaccine Covaxin, signed an agreement with GSK and PATH under which it will produce the antigen for RTS,S as a part of GSK’s commitment to provide 15 million vaccine doses annually once it is recommended for wider use.

“This agreement with BBIL is the result of efforts by GSK, PATH, and WHO to help ensure long-term sustainable vaccine supply, in the event of a WHO policy recommendation for broader use and a commitment of sustained funding,” the MVI said in a statement before the WHO nod.

“This builds on existing GSK commitments to donate up to 10 million RTS,S/AS01E doses for use in the pilot, and to supply up to 15 million doses annually until 2028 if the product is recommended for wider use by WHO. It is expected that by 2029, at the latest, BBIL will be the sole supplier of the vaccine, with GSK supplying the adjuvant AS01E to them,” it added.

India’s malaria problem ‘tip of the iceberg’

India has contended with malaria for centuries now — during the British Raj, it was one of the biggest fears for East India Company/British government officials headed to these shores.

In 2017, the World Malaria Report had claimed that India detects only 8 per cent of its malaria cases.

However, the World Malaria Report (WMR) 2020 said India is the only high endemic country that reported a decline of 17.6 per cent in 2019 as compared to 2018. 

The Annual Parasitic Incidence (API) reduced by 27.6 per cent in 2018 compared to 2017, and by 18.4 per cent in 2019 as compared to 2018. India has sustained API less than one since 2012.

“India has also contributed to the largest drop in cases region-wide, from approximately 20 million to about 6 million. The percentage drop in the malaria cases was 71.8% and deaths was 73.9% between 2000 to 2019,” a Press Information Bureau (PIB) statement on the report said.

“India achieved a reduction of 83.34% in malaria morbidity and 92% in malaria mortality between the year 2000 (20,31,790 cases, 932 deaths) and 2019 (3,38,494 cases, 77 deaths), thereby achieving Goal 6 of the Millennium Development Goals (50-75% decrease in case incidence between 2000 and 2019),” the PIB statement added.

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