Mosquiorix becomes first malaria vaccine to receive WHO prequalification
22 September, 2022
In a historic development, World Health Organization (WHO) has granted prequalification to malaria vaccine developed by Glaxo SmithKline (GSK). The vaccine is available across the globe by the brand name Mosquiorix (also known as RTS,S/AS01). With this development, Mosquiorix becomes first malaria vaccine to receive WHO prequalification. This is an important step in rolling out the vaccine in countries with moderate to high P. falciparum malaria transmission.
Sharing this historic development, WHO Director-General Dr Tedros Adhanom Ghebreyesus said “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.”
Next steps for the WHO-recommended malaria vaccine will include funding decisions from the global health community for broader rollout, and country decision-making on whether to adopt the vaccine as part of national malaria control strategies.
The WHO prequalification decision is a mandatory prerequisite for 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, P. falciparum.
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. GSK is currently working with partners to accelerate a product transfer for long-term antigen production, including technology transfer, to Bharat Biotech of India. This partnership is expected to enable more efficient production at higher volumes over time.
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