Malaria Vaccine Awarded WHO Prequalification Status

England-based GSK plc announced today that the World Health Organization (WHO) had awarded prequalification to the malaria vaccine Mosquirix (RTS,S/AS01).

This is the first WHO prequalification for a malaria vaccine and is an essential step in rolling out the vaccine in countries with moderate to high P. falciparum malaria transmission.

Pre-qualification for Mosquirix results from 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.

The WHO prequalification decision is a mandatory prerequisite for United Nations agencies to procure Mosquirix in partnership with Gavi, the Vaccine Alliance, and eligible countries.

Thomas Breuer, Chief Global Health Officer, GSK, commented in a press release on September 6, 2022, "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 one million children in Ghana, Kenya, and Malawi have had at least one dose of Mosquirix, donated by GSK, through the Malaria Vaccine Implementation Programme."

"The WHO's prequalification paves the way for more children to benefit from the vaccine."

In 2021, the 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.

GSK secured its first commercial supply contract for its malaria vaccine, courtesy of the United Nations Children's Fund (UNICEF), in August 2022.

UNICEF will pay up to $170 million to access 18 million doses of Mosquirix over the next three years.

As of September 6, 2022, the U.S. FDA has not authorized the Mosquirix vaccine.

About 2,000 cases of malaria are diagnosed in the USA annually, mostly in returned travelers.

In May 2022, the FDA approved artesunate for injection to treat severe malaria in adult and pediatric patients.

The FDA says that treating severe malaria with intravenous artesunate should always be followed by a complete treatment course of an appropriate oral antimalarial regimen.

However, because malaria prevention recommendations and the availability of antimalarial drugs vary, travelers should consult healthcare providers in their respective countries, says the U.S. CDC.

Note: This information was manually translated and curated for mobile readership.