Development and introduction of a ready-to-use pediatric pentavalent vaccine to meet and sustain the needs of developing countries – Quinvaxem®: The first 5 years

Quinvaxem® injection (DTwP–HepB–Hib fully-liquid combined vaccine) is a ready-to-use, preservative-free, fully-liquid combined vaccine containing diphtheria and tetanus toxoids, Bordetella pertussis inactivated cellular suspension, hepatitis B surface antigen (HBsAg), and Haemophilus influenzae type b conjugated oligosaccharide. The vaccine was the first ready-to-use, fully-liquid pentavalent vaccine to gain WHO pre-qualification status in 2006. The immunogenicity and safety of Quinvaxem® was assessed in four clinical trials and a large post-marketing surveillance study. Quinvaxem® was found to be highly immunogenic in each of the primary vaccination studies and was also shown to be suitable as a booster with the advantage that it could be given concomitantly with measles vaccine. Quinvaxem® has become a cornerstone in EPI vaccination programs. To further support the needs of EPI vaccination processes and developing countries, a simple, all-in-one, compact, prefilled, auto-disabled Uniject® injection system has been chosen and optimized as a potential new presentation for Quinvaxem®. Hopefully, Quinvaxem® in the Uniject® presentation will help vaccination programs in developing countries to achieve more.

► We review immunogenicity and safety data of Quinvaxem®.
► We present data from four clinical trials and a post-marketing surveillance study.
► The key role of Quinvaxem® in EPI vaccination programs is discussed.
► We present Uniject®, a simplified, prefilled injection system.
► Quinvaxem® in Uniject® presentation should aid vaccination programs achieve more.