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WHO Grants Prequalification to GSK’s Mosquirix – the First and Only Approved Malaria Vaccine

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WHO Grants Prequalification to GSK’s Mosquirix – the First and Only Approved Malaria Vaccine | Pharmtech Focus

GSK plc (LSE/NYSE: GSK) announced today that the World Health Organization (WHO) has awarded prequalification to Mosquirix (also known as RTS,S/AS01), GSK’s groundbreaking malaria vaccine. This is the first prequalification for a malaria vaccine and is an important step in rolling out the vaccine in countries with moderate to high P. falciparum malaria transmission.

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.

Thomas Breuer, Chief Global Health Officer, GSK, said: “WHO prequalification of Mosquirix is a key step in reaching children with the first and only approved malaria vaccine. Malaria remains a significant cause of illness and death for children in many parts of the world, and it is a significant driver of inequality. So far, over 1 million children in Ghana, Kenya and Malawi have had at least one dose of Mosquirix, donated by GSK, through the Malaria Vaccine Implementation Programme, and WHO’s prequalification paves the way for more children to benefit from the vaccine.”

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