SWITZERLAND – The World Health Organization (WHO) has awarded prequalification to GSK’s malaria vaccine, Mosquirix (also known as RTS,S/AS01), GSK notified recently via a statement.

The statement noted that the WHO prequalification decision is a mandatory prerequisite for the United Nations (UN) agencies, such as UNICEF, to procure the vaccine in partnership with Gavi, the Vaccine Alliance, and eligible countries.

Pre-qualification for Mosquirix is the result of a rigorous regulatory process with the assessment of clinical, safety, and technical data ensuring that the vaccine meets standards of quality, safety, and efficacy, and is suitable for the target population.

Working in collaboration with PATH and other partners, GSK developed Mosquirix, the first vaccine to help protect children against the deadliest form of malaria, Plasmodium falciparum, the statement added.

In 2021, WHO recommended broader use of GSK’s Mosquirix to reduce childhood illness and deaths from malaria in children living in sub-Saharan Africa and other regions with moderate-to-high transmission as defined by WHO.

However, research has found that the effectiveness of GSK’s Mosquirix vaccine is about 60 percent, and significantly wanes over time even with a booster dose.

GSK is currently working with partners to accelerate a product transfer for long-term antigen production, including technology transfer, to Bharat Biotech.

This partnership is expected to enable more efficient production at higher volumes over time, the statement concluded.

In 2021, WHO recommended broader use of GSK’s Mosquirix to reduce childhood illness and deaths from malaria in children living in sub-Saharan Africa and other regions with moderate-to-high transmission as defined by WHO.

Meanwhile, Mosquirix maker GSK has committed to producing up to 15 million doses of the vaccine every year through 2028, well under the 100 million doses of the four-dose vaccine.

The WHO believes the vaccine is needed in long term to cover around 25 million children.

GSK expects more international donations in order to expand the production of the essential vaccine.

In a separate development, A malaria shot developed by researchers at the University of Oxford has shown that its strong protection can hold up a year after a booster, bolstering the case for a second vaccine to be used to protect children and infants in Africa from the deadly disease.

The vaccine, known as R21, was shown to have efficacy as high as 80% one year after a fourth dose was administered to some 400 infants aged 5 to 17 months in an African region with a seasonal circulation of the disease, according to a study published by the peer-reviewed medical journal Lancet Infectious Diseases.

Oxford’s R21/Matrix-M vaccine meanwhile has been found to be 77 percent effective at preventing malaria– the first time the WHO’s roadmap goal of 75 percent had been met.

Oxford vaccinologist and study co-author Adrian Hill said the vaccine meant, “we really could be looking at a very substantial reduction in that horrendous burden of malaria, deaths, and disease in the coming years, certainly by 2030”.

A 70 percent reduction in deaths from malaria could be feasible in that time, he said, partly because of the vast number of vaccine doses that could be quickly produced.

Oxford has partnered with the world’s largest vaccine manufacturer, the Serum Institute of India.

The institute is “willing and able to manufacture 200 million doses a year starting next year,” Hill said.

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