WHO grants prequalification to GSK’s malaria vaccine

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, P 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. 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.