WHO grants prequalification to GSK's Mosquirix - the first and only approved malaria vaccine

GlaxoSmithKlineGSK plc (LSE/NYSE: GSK) announced 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."

About Mosquirix

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.

About GSK

GSK is a global biopharma company with a purpose to unite science, technology, and talent to get ahead of disease together.

Most Popular Now

Xenpozyme™ (olipudase alfa-rpcp) approved by FDA a…

The U.S. Food and Drug Administration (FDA) has approved Xenpozyme™ (olipudase alfa-rpcp) for the treatment of non-central nervous system (non-CNS) manifestations of acid...

FDA grants Breakthrough Therapy Designation to Pfi…

Pfizer Inc. (NYSE:PFE) today announced that its investigational Group B Streptococcus (GBS) vaccine candidate, GBS6 or PF-06760805, received Breakthrough Therapy Designat...

Malaria booster vaccine shows durable high efficac…

Researchers from the University of Oxford and their partners have today reported new findings from their Phase 2b trial following the administration of a booster dose of ...

Research reveals widespread use of ineffective COV…

Monoclonal antibodies are laboratory-designed treatments tailor-made to fight specific infections. In early 2021, the U.S. Food & Drug Administration issued emergency use...

Strict COVID lockdowns in France improved cardiova…

A new paper in European Heart Journal - Digital Health, published by Oxford University Press, indicates that social-distancing measures like total lockdown have a measura...

Efficacy, cash and more will increase booster shot…

The more effective the COVID-19 booster, the more likely people are to get it, according to new Cornell research. And they are more likely to accept the booster shot with...

U.S. clinical trial evaluating antiviral for monke…

A Phase 3 clinical trial evaluating the antiviral tecovirimat, also known as TPOXX, is now enrolling adults and children with monkeypox infection in the United States. St...

Stem cell-gene therapy shows promise in ALS safety…

Cedars-Sinai investigators have developed an investigational therapy using support cells and a protective protein that can be delivered past the blood-brain barrier. This...

Novartis invests in early technical development ca…

Novartis today announced it is investing in next-generation biotherapeutics with the creation of a fully integrated, dedicated USD 300m scientific environment that will b...

Drug turns cancer gene into "eat me" fla…

Tumor cells are notoriously good at evading the human immune system; they put up physical walls, wear disguises and handcuff the immune system with molecular tricks. Now...

Mucosal antibodies in the airways protect against …

High levels of mucosal antibodies in the airways reduce the risk of being infected by omicron, but many do not receive detectable antibodies in the airways despite three ...

Pfizer and BioNTech receive positive CHMP opinion …

Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) announced a 30-µg booster dose of their Omicron BA.4/BA.5 bivalent-adapted COVID-19 vaccine (COMIRNATY® Original/Om...