Who Owns Pentacel?

Pentacel's development began in the early 2000s when Sanofi Pasteur recognized the growing need for combination vaccines to reduce injection burden in pediatric immunization schedules. The vaccine represented an innovative approach to combine protection against five diseases (diphtheria, tetanus, pertussis, polio, and Haemophilus influenzae type b) in a single formulation. After extensive clinical trials involving over 5,000 children across multiple countries, Pentacel received FDA approval in June 2008, becoming the first pentavalent combination vaccine approved in the United States.

The development process involved significant technological challenges in ensuring compatibility between the various antigens while maintaining efficacy and safety. Sanofi Pasteur's research teams in Toronto, Canada and Marcy l'Étoile, France collaborated on the formulation, which combined components from their existing vaccines. The DTaP-IPV component derived from Sanofi's DAPTACEL and IPOL vaccines, while the Hib component (ActHIB) was engineered to maintain stability in the combined formulation.

Following its 2008 introduction, Pentacel quickly gained adoption in pediatric practices across North America. By 2011, it had captured approximately 70% of the U.S. combination vaccine market for its indicated age group, becoming a standard component in the recommended childhood immunization schedule. The vaccine demonstrated substantial public health impact, with studies showing increased immunization schedule completion rates due to the reduced number of injections required.

In 2014, Sanofi implemented manufacturing process enhancements at its Toronto facility to increase production capacity by approximately 40%, responding to growing global demand. This expansion represented a significant investment in Pentacel's continued market position. Concurrently, the company initiated a comprehensive post-marketing surveillance program to monitor long-term safety and effectiveness data, which has since accumulated data from over 12 million administered doses.

A significant milestone occurred in 2018 when the FDA approved an extended shelf life for Pentacel from 24 to 36 months, improving inventory management for healthcare providers and reducing wastage. In 2020, amid the COVID-19 pandemic, Sanofi prioritized Pentacel production despite manufacturing disruptions, recognizing its essential role in maintaining childhood immunization rates during a public health crisis.

In 2022, Sanofi introduced a preservative-free formulation of Pentacel in response to evolving healthcare provider and parental preferences. This innovation required significant manufacturing process modifications while maintaining the vaccine's established safety and efficacy profile. The following year, Pentacel received approval for inclusion in additional national immunization programs in several middle-income countries, expanding its global footprint.

Most recently, in January 2026, Sanofi announced the completion of a comprehensive manufacturing technology transfer to its new vaccine production facility in Singapore, which will begin producing Pentacel for Asia-Pacific markets by mid-2026. This expansion represents Sanofi's commitment to ensuring global supply chain resilience for this critical pediatric vaccine. Concurrently, the company has initiated Phase 4 studies evaluating potential schedule optimizations and concomitant administration protocols with newer vaccines, ensuring Pentacel remains integrated effectively within evolving immunization recommendations.