Public Release: 

First typhoid conjugate vaccine achieves WHO prequalification, a key step in protecting children and reducing the burden of typhoid

Sabin Vaccine Institute

Geneva, Switzerland - January 3, 2018 - A typhoid conjugate vaccine has been prequalified by the World Health Organization (WHO), bringing the vaccine one step closer to reaching millions more people at risk of typhoid.

Typbar-TCV, a Vi-tetanus toxoid conjugate vaccine manufactured by Indian company Bharat Biotech, is the first typhoid conjugate vaccine to achieve WHO prequalification. The vaccine, which is currently licensed in India and Nepal as a single, intramuscular dose, has been shown to elicit a robust immune response in infants as young as six months of age. Typbar-TCV offers advantages over currently available typhoid vaccines, including the ability to provide longer-lasting protection, require fewer doses, and be administered to children younger than two years of age, making it the first-ever to be approved for this age group. These advantages will allow for delivery through routine childhood immunization programs and better protection for younger children.

"The prequalification of the first typhoid conjugate vaccine is a major advancement for child health," said Dr. Kathy Neuzil, director of the Center for Vaccine Development at the University of Maryland School of Medicine. "Typbar-TCV can be incorporated into routine vaccination schedules, giving us the best chance to reach children most at risk for this devastating disease."

WHO prequalification is a critical step in expanding access to this lifesaving vaccine. This designation allows WHO, UNICEF, and other United Nations procurement agencies to purchase Typbar-TCV, and also serves as an endorsement of quality, efficacy, and safety for countries interested in adopting the vaccine. It also enables eligible countries to apply for funding assistance from Gavi, the Vaccine Alliance, which recently approved $85 million to support the introduction of typhoid conjugate vaccines, including Typbar-TCV, between 2019 and 2020. Today's announcement comes shortly after the WHO Strategic Advisory Group of Experts on Immunization recommended typhoid conjugate vaccines be introduced in endemic countries to all children over six months of age.

"Today's announcement is an important step toward our goal of addressing the high burden of typhoid in children. For too long, this disease, which invariably affects the world's poorest people, has been neglected in efforts to improve global health," said Dr. Anita Zaidi, director of the Vaccine Development, Surveillance, and Enteric and Diarrheal Diseases teams at the Bill & Melinda Gates Foundation, which supported efforts that helped generate data for prequalification. "With this new vaccine - the first-ever to be safe for infants - countries will finally be able to protect millions of children who are most vulnerable to this deadly disease."

Typhoid results in nearly 12 million cases and more than 128,000 deaths globally each year, mostly among children and young adults in Asia and sub-Saharan Africa. Research shows that the impact of typhoid in developing communities goes beyond physical illness and death.

Typhoid disproportionately impacts children and adolescents, disrupting a child's education and affecting families' and communities' economic development and potential. Typhoid vaccines - alongside safe water, sanitation, and hygiene interventions - are a critical component to reducing the disease's burden in high-risk, endemic areas.

"Today's prequalification means that this lifesaving typhoid vaccine will soon start making its way to the people who need it most," said Dr. Bruce Gellin, president of Global Immunization at the Sabin Vaccine Institute. "For communities where typhoid is common and drug-resistant strains of typhoid are increasing, this presents an opportunity to protect children and adults, save lives and curb dangerous antimicrobial resistance."

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About the Sabin Vaccine Institute

The Sabin Vaccine Institute, which serves as the secretariat of the Coalition against Typhoid, is a leading advocate for expanding vaccine access and uptake globally, advancing vaccine research and development, and amplifying vaccine knowledge and innovation. Unlocking the potential of vaccines through partnership, Sabin has built a robust ecosystem of funders, innovators, implementers, practitioners, policy makers and public stakeholders to advance its vision of a future free from preventable diseases. As a non-profit with more than two decades of experience, Sabin is committed to finding solutions that last and extending the full benefits of vaccines to all people, regardless of who they are or where they live. At Sabin, we believe in the power of vaccines to change the world. For more information, visit http://www.sabin.org and follow us on Twitter, @SabinVaccine.

The Sabin Vaccine Institute's Coalition against Typhoid has led efforts to prevent typhoid and other invasive salmonelloses through research, education, and advocacy. In October 2017, the Coalition joined forces with the Typhoid Vaccine Acceleration Consortium (TyVAC) to take on typhoid. Together, the Coalition and TyVAC are working to focus attention on typhoid and the need for typhoid conjugate vaccines, and improved water, sanitation, and hygiene interventions to reduce the burden and impact of typhoid fever. Additional data on typhoid conjugate vaccine effectiveness will be generated by TyVAC studies underway in Bangladesh, Nepal, and Malawi.

About the Typhoid Vaccine Acceleration Consortium

The Typhoid Vaccine Acceleration Consortium (TyVAC) is a partnership between the Center for Vaccine Development (CVD) at the University of Maryland School of Medicine, the Oxford Vaccine Group at the University of Oxford, and PATH, an international nonprofit organization. TyVAC aims to accelerate the introduction of new typhoid conjugate vaccines (TCVs) as part of an integrated approach to reduce the burden of typhoid in countries eligible for support from Gavi, the Vaccine Alliance.

TyVAC employs a multidisciplinary approach, working with global and local partners to accelerate the introduction of TCVs in low-income countries and facilitate access to typhoid vaccines as part of an integrated prevention plan that also includes improved water, sanitation, and hygiene. We work to ensure that typhoid prevention and control are global health priorities and that stakeholders and decision-makers have the data and tools they need to make evidence-based decisions for TCV introduction.

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