Sector News

Pilot launch complete: GlaxoSmithKline’s malaria shot scores WHO backing for wider rollout in Africa

October 10, 2021
Life sciences

GlaxoSmithKline has spent many years developing and testing its world-first malaria vaccine, but even after a positive recommendation from European regulators in 2015, the shot still isn’t widely deployed. That’s set to change with the World Health Organization’s (WHO’s) blessing for the vaccine.

Wednesday, the WHO recommended a wider use of the shot—known as RTS,S—in children in sub-Saharan Africa and other areas with moderate to high levels of malaria transmission. Specifically, WHO recommends a four-dose course of the vaccine starting at five months of age to help protect against Plasmodium falciparum malaria and to lower the overall disease burden.

GSK’s vaccine, also known as Mosquirix, won a recommendation from the European Medicines Agency back in the summer of 2015. Shortly after, the WHO called for pilot projects to test its efficacy rather than wide rollouts. The pilot projects were designed to test the vaccine in the real world rather than in carefully controlled clinical trials.

Now, it seems the WHO has seen enough. The agency said it’s recommending the shot based on a pilot program in Ghana, Kenya and Malawi that reached 800,000 children in recent years.

In anticipation of the WHO recommendation, GSK has been gearing up to support a wide rollout, the company said in a statement. The pharma giant pledged to donate 10 million doses for the pilot programs and will supply up to 15 million doses annually at “no more than 5% above cost of production.”

GSK also started a product transfer process with India’s Bharat Biotech to further bolster supply, the company said.

The WHO recommendation marks the second win for the vaccine program in recent months. Back in August, researchers reported that after three years, the combination of the vaccine and seasonal antimalarial drugs lowered the number of clinical episodes of malaria, hospital admissions from malaria and deaths from malaria by about 70% compared with the seasonal drugs alone. The data from more than 6,000 children showed that the shot could be introduced on top of existing antimalarial measures to further fight the disease, GSK said.

The shot is the result of more than 30 years of research by GlaxoSmithKline, global nonprofit PATH and other partners.

Malaria is a leading cause of illness and death among children in sub-Saharan Africa. The disease kills more than 260,000 children under the age of five in Africa each year.

by Eric Sagonowsky

Source: fiercepharma.com

comments closed

Related News

January 23, 2022

UCB to acquire Zogenix

Life sciences

UCB (Euronext: UCB) and Zogenix (NASDAQ: ZGNX) announced that the companies have entered into a definitive agreement under which UCB would acquire Zogenix, Inc., a global biopharmaceutical company commercializing and developing therapies for rare diseases.

January 23, 2022

argenx announces VYVGART™ approval in Japan for the treatment of generalized myasthenia gravis

Life sciences

argenx SE, a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases, announced that Japan’s Ministry of Health, Labour and Welfare (MHLW) has approved VYVGART™ (efgartigimod alfa) intravenous infusion for the treatment of adult patients with generalized myasthenia gravis (gMG) who do not have sufficient response to steroids or non-steroidal immunosuppressive therapies (ISTs).

January 23, 2022

GlaxoSmithKline rejects Unilever’s $68B consumer health buyout offer, but a bigger bid is brewing

Life sciences

GSK has rejected three offers from Unilever to buy GSK’s consumer health unit, the company said Saturday. The latest offer from the fellow U.K. consumer goods giant, received Dec. 20 for a total value of 50 billion pounds ($68 billion), “fundamentally undervalued” the business and its prospects, GSK said.

Send this to a friend