Gsk: “Historic WHO ok to anti-malaria vaccine, commitment to supply 15 million doses per year”

“A long-awaited historic decision” that “may reinvigorate the fight against malaria” in sub-Saharan Africa and other regions with moderate to high transmission “at a time when progress in” disease control “is underway. stall”. These are the words with which Thomas Breuer, Chief Global Health Officer of GSK accepted the recommendation of the World Health Organization (WHO) for the widespread use of the anti-malaria vaccine (RTS, S), produced by the company, in children who they live in these areas where there is an intense transmission of the disease. GSK will now work closely with partners, financiers and governments to support the additional supply of the vaccine and has pledged to make 15 million doses available annually at no more than 5% more than the cost of production. The recommendation, Gsk explains, comes after new data showed that the vaccine, in combination with seasonal administration of antimalarials, reduces clinical episodes of malaria, hospitalizations with severe malaria and deaths by about 70%. A significant impact is therefore expected. This shield product is “the first and only vaccine against malaria with which a significant reduction of malaria in children has been demonstrated in important long-term clinical studies”, is highlighted in the note. GSK, says Breuer, “is proud that the innovative RTS vaccine, S, developed over decades by our teams and partners, can now be made available to children in sub-Saharan Africa and other regions with moderate to malaria transmission. Both real-world evidence and clinical trial data show that RTS, S, along with other malaria prevention measures, has the potential to save hundreds of thousands of lives. ” Pilot vaccination programs in Ghana, Kenya and Malawi have shown a strong impact in real-life childhood vaccination settings, strong community demand, and it also emerges that the RTS, S vaccine can be effectively delivered through childhood vaccination programs. GSK, as the company explains in the note, “is working with partners to develop solutions to ensure equitable and long-term access to the vaccine for people who need it”, in anticipation of an extension of use beyond the pilot programs. The company has pledged to donate up to 10 million doses for use in pilot projects and provide up to 15 million doses per year, following a recommendation and funding for wider use. A product transfer, including technology transfer for long-term antigen production, is also underway with India’s Bharat Biotech. The WHO recommendation is defined by GSK as “a second key milestone” for the RTS, S malaria vaccine in recent weeks. In August, data from a study of 6,000 children from the London School Hygiene and Tropical Medicine, published in the ‘New England Journal of Medicine’, showed that after 3 years the combination of seasonal antimalarial administration (known as Seasonal Malaria Chemoprevention or Smc ) and RTS vaccination, S reduced clinical episodes of malaria, hospital admissions with severe malaria defined by the WHO and deaths from malaria by about 70% compared to SCM alone. “These data indicate that the impact of vaccination can be increased to further reduce mortality, especially when combined with other malaria control interventions recommended in a seasonal context,” the company stressed, pointing out that defeating malaria is a “responsibility. shared “and requires more tools: from accessible tests and care to preventive measures such as a vaccine, supplemented by mosquito nets and sanitary facilities trained to support prevention and treatment in the community. Since the launch of the pilot malaria programs in 2019, more than 800,000 children with at least 1 serving. More than 2.3 million doses have been administered to date.