Manufacturing DTaP-based combination vaccines: industrial challenges around essential public health tools

Vidor, Emmanuel; Soubeyrand, B.

doi:10.1080/14760584.2016.1205492

Cited by 27 publications

(19 citation statements)

References 39 publications

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“…Despite several challenges (e.g. antigen compatibility, complex manufacturing and quality control processes), multivalent vaccines are of great public health and economic value, as they improve vaccine coverage, reduce costs and potential outbreaks, and allow incorporation of new antigens without increasing the number of injections [1, 2].…”

Section: Introductionmentioning

confidence: 99%

DTaP-IPV-HepB-Hib Vaccine (Hexyon®): An Updated Review of its Use in Primary and Booster Vaccination

Syed

2019

Pediatr Drugs

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Hexyon ® is a fully-liquid, ready-to-use, hexavalent vaccine approved in the EU since 2013 for primary and booster vaccination in infants and toddlers from age 6 weeks against diphtheria, tetanus, pertussis, hepatitis B (HB), poliomyelitis, and invasive diseases caused by Haemophilus influenzae type b (Hib). While the source of HB antigen in Hexyon ® is different from other vaccines, the rest of its valences have been extensively used in other approved vaccines. Hexyon ® is highly immunogenic for all its component toxoids/antigens when used as primary and booster vaccine in infants and toddlers, irrespective of vaccination schedule. It provides durable protection against hepatitis B. Hexyon ® can be used for a mixed primary series of hexavalent-pentavalent-hexavalent vaccines or as a booster in infants primed with Infanrix hexa™ or pentavalent (whole-cell or acellular pertussis) vaccines. Coadministration of Hexyon ® with other common childhood vaccines did not affect immune response to any vaccines. Hexyon ® has a good reactogenicity/safety profile. The immunogenicity and safety profile of Hexyon ® was similar to that of several approved vaccines, including Infanrix hexa™. However, Hexyon ® offers the convenience of full-liquid, ready-to-use formulation, which may minimize vaccination errors and preparation time. Thus, Hexyon ® is a convenient, useful option for vaccination against childhood diseases caused by six major pathogens.

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Section: Introductionmentioning

confidence: 99%

DTaP-IPV-HepB-Hib Vaccine (Hexyon®): An Updated Review of its Use in Primary and Booster Vaccination

Syed

2019

Pediatr Drugs

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“…Further, the in vitro analytics required to release the product may not detect a change in process and a clinical trial may be needed to validate a new process and to maintain licensure of a product. This compounded risk of biological and physical variability makes vaccine manufacturing more challenging than typical small molecule pharmaceuticals and is a primary root cause of the high proportion of vaccine manufacturing failures and supply shortages [7] , [8] . This is also the main reason why the number of vaccine manufacturers that succeed and thrive remains low despite unmet demand for many vaccines globally.…”

Section: Vaccine Manufacturing Overviewmentioning

confidence: 99%

The complexity and cost of vaccine manufacturing – An overview

Plotkin

Robinson

Cunningham

et al. 2017

Vaccine

338

281

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As companies, countries, and governments consider investments in vaccine production for routine immunization and outbreak response, understanding the complexity and cost drivers associated with vaccine production will help to inform business decisions. Leading multinational corporations have good understanding of the complex manufacturing processes, high technological and R&D barriers to entry, and the costs associated with vaccine production. However, decision makers in developing countries, donors and investors may not be aware of the factors that continue to limit the number of new manufacturers and have caused attrition and consolidation among existing manufacturers. This paper describes the processes and cost drivers in acquiring and maintaining licensure of childhood vaccines. In addition, when export is the goal, we describe the requirements to supply those vaccines at affordable prices to low-resource markets, including the process of World Health Organization (WHO) prequalification and supporting policy recommendation. By providing a generalized and consolidated view of these requirements we seek to build awareness in the global community of the benefits and costs associated with vaccine manufacturing and the challenges associated with maintaining consistent supply. We show that while vaccine manufacture may prima facie seem an economic growth opportunity, the complexity and high fixed costs of vaccine manufacturing limit potential profit. Further, for most lower and middle income countries a large majority of the equipment, personnel and consumables will need to be imported for years, further limiting benefits to the local economy.

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“…Developing a vaccine from concept to market costs $200‐$500 million, and takes 5–18 years . Additionally, it costs an estimated $50‐$700 million to construct, equip, and commission a vaccine manufacturing facility, taking on average 7 years, while the lead time to manufacture a vaccine ranges between 0.5‐3 years …”

Section: Introductionmentioning

confidence: 99%

Emerging Technologies for Low‐Cost, Rapid Vaccine Manufacture

Kis

Shattock

Shah

et al. 2018

Biotechnology Journal

117

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To stop the spread of future epidemics and meet infant vaccination demands in low‐ and middle‐income countries, flexible, rapid and low‐cost vaccine development and manufacturing technologies are required. Vaccine development platform technologies that can produce a wide range of vaccines are emerging, including: a) humanized, high‐yield yeast recombinant protein vaccines; b) insect cell‐baculovirus ADDomer vaccines; c) Generalized Modules for Membrane Antigens (GMMA) vaccines; d) RNA vaccines. Herein, existing and future platforms are assessed in terms of addressing challenges of scale, cost, and responsiveness. To assess the risk and feasibility of the four emerging platforms, the following six metrics are applied: 1) technology readiness; 2) technological complexity; 3) ease of scale‐up; 4) flexibility for the manufacturing of a wide range of vaccines; 5) thermostability of the vaccine product at tropical ambient temperatures; and 6) speed of response from threat identification to vaccine deployment. The assessment indicated that technologies in the order of increasing feasibility and decreasing risk are the yeast platform, ADDomer platform, followed by RNA and GMMA platforms. The comparative strengths and weaknesses of each technology are discussed in detail, illustrating the associated development and manufacturing needs and priorities.

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Manufacturing DTaP-based combination vaccines: industrial challenges around essential public health tools

Cited by 27 publications

References 39 publications

DTaP-IPV-HepB-Hib Vaccine (Hexyon®): An Updated Review of its Use in Primary and Booster Vaccination

DTaP-IPV-HepB-Hib Vaccine (Hexyon®): An Updated Review of its Use in Primary and Booster Vaccination

The complexity and cost of vaccine manufacturing – An overview

Emerging Technologies for Low‐Cost, Rapid Vaccine Manufacture

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