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 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.
"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 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."