Celebrating prequalification—a major milestone in typhoid prevention efforts

This week, our team is celebrating a big milestone: the news that the World Health Organization (WHO) prequalified Typbar-TCV®, a vaccine manufactured by Bharat Biotech. This is the first typhoid conjugate vaccine (TCV) to achieve prequalification and a major advance for efforts to prevent typhoid and, ultimately, save children’s lives.

Achieving prequalification is a gateway to access for those who most need this vaccine. This designation indicates that Typbar-TCV meets international standards and WHO’s stringent criteria regarding safety, efficacy, and quality. It also allows organizations like WHO, UNICEF, other United Nations procurement agencies, and Gavi, the Vaccine Alliance to purchase the vaccine for use in low- and middle-income countries (LMICs). Without prequalification, this vaccine could remain out of reach for countries unable to finance the vaccine on their own.

This exciting news follows two other important global recommendations and decisions. The WHO Strategic Advisory Group of Experts (SAGE) on Immunization recently reviewed the evidence on TCVs and recommended their use as a single dose for infants and children six months of age and older in typhoid-endemic countries. Following these recommendations, Gavi approved $US85 million to support the introduction of TCVs in Gavi-eligible countries and will begin accepting applications for support in 2018, with introductions in 2019-2020. Prequalification of a TCV, SAGE recommendations, and Gavi financing are all critical pieces of the puzzle that together will facilitate access to TCVs in LMICs.

Typhoid continues to cause more than 128,000 deaths each year, with children disproportionately impacted. I am thrilled that, with prequalification, we’ve cleared one of the last hurdles at the global level before TCVs can be used where the need is greatest. TCVs offer several advantages over the other globally available vaccines, including longer-lasting protection, suitability for young infants under two years old, and fewer doses. Typbar-TCV is currently licensed in India and Nepal as a single intramuscular dose for children as young as six months, protecting them earlier and allowing for inclusion in routine childhood immunization programs, facilitating their delivery. Previous studies have shown that Typbar-TCV elicits a strong immune response in infants, and additional studies are underway that will provide further data on the vaccine’s effectiveness.

TCVs have the potential to be a powerful new tool for countries to employ as part of an integrated strategy with water, sanitation, and hygiene improvements to prevent typhoid and save lives, particularly among young children. Prequalification of Typbar-TCV is an achievement to celebrate, but in order to accelerate access to the vaccine for who need it most, there is still more work to do. We now need to work together to ensure that countries have the information they need to make decisions on TCV introduction.

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Photo Credit: Bill & Melinda Gates Foundation

Kathleen Neuzil is the Project Director of the Typhoid Vaccine Acceleration Consortium (TyVAC) and the Director of the Center for Vaccine Development at the University of Maryland School of Medicine.