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Gavi Board commits US$ 85 million for TCV introduction
Gavi, the Vaccine Alliance approved an $85 million funding window to support the introduction of typhoid conjugate vaccines (TCVs). The announcement came following a Gavi Board meeting on November 29-30 in Laos. The committed funds will enable the bulk-buying of TCVs. Countries are expected to begin applying for Gavi support in 2018 for vaccine introduction in 2019 and 2020. This important decision will help countries gain access to the TCV, including Bharat Biotech’s Typbar-TCV® which is currently under review for prequalification by the World Health Organization (WHO). An additional five manufacturers are in the process of developing TCVs that are expected to become available between 2018 and 2022.
An estimated 90 percent of typhoid deaths occur in Asia, though recent data from sub-Saharan Africa suggest that the typhoid burden may be greater than previously known. Children and adolescents younger than 15 years of age are disproportionately impacted by the disease. Gavi’s funding commitment will help TCVs reach countries most at risk of typhoid that are unable to afford the vaccine on the open market and protect millions of children from this deadly disease.
SAGE issues recommendations for TCV use
At the October meeting of the WHO Strategic Advisory Group of Experts (SAGE) on Immunization, the scientific and medical evidence regarding TCV was reviewed. SAGE re-emphasized the importance of using typhoid vaccines to control endemic and epidemic disease. Notably, SAGE recommended that typhoid-endemic countries introduce TCVs as a single dose for infants and children over the age of six months, accompanied by catch-up vaccination campaigns for children up to 15 years of age, where feasible. Additionally, SAGE recommended prioritizing TCV introduction in countries with the highest burden of disease and/or growing burden of drug-resistant typhoid. TCVs were also recommended in response to confirmed outbreaks of typhoid fever and in specific groups of people at high risk or with high transmission potential.
This recommendation, recently published in the December Weekly Epidemiological Report, is a key step forward in the goal to have TCVs accessible and available in low-income countries where the burden of typhoid is greatest. WHO will incorporate SAGE’s recommendations into a revised position paper on typhoid vaccines, which is scheduled to be published in April 2018.
Typbar-TCV undergoing WHO prequalification
Bharat Biotech has submitted an application for WHO prequalification for Typbar-TCV. Prequalification for this Vi-tetanus toxoid conjugate vaccine could occur by the end of the year–a decision that would make it the first TCV to achieve WHO prequalification and mark significant progress in expanding access to this vaccine. Typbar-TCV is currently licensed in India and Nepal as a single intramuscular dose for children six months of age and older. In India, it has been shown to elicit a robust immune response in infants as young as six months of age. Additionally, Typbar-TCV was recently found to be safe, more immunogenic than current typhoid vaccines, and prevent infections as effectively as current typhoid vaccines by a new challenge study led by the University of Oxford and published in The Lancet. Additional data on vaccine effectiveness will be generated by TyVAC studies underway in Bangladesh, Nepal, and Malawi. In addition, a separately funded study will evaluate effectiveness of TCV for public-sector implementation in Navi Mumbai, India.
Prequalification indicates that a vaccine meets international standards and serves as an endorsement of quality, efficacy, and safety. With prequalification, Typbar-TCV would be able to be purchased by WHO, UNICEF, and other United Nations procurement agencies as well as included in Gavi’s portfolio, which has $85 million earmarked to help finance and increase access to TCVs in low-resource countries.