Vaccine development costs: a review

Waye, Arianna; Jacobs, Philip; Schryvers, Anthony B.

doi:10.1586/14760584.2013.850035

Cited by 16 publications

(15 citation statements)

References 25 publications

Supporting

Mentioning

Contrasting

Unclassified

Order By: Relevance

“…For a back-of-the-envelope calculation, we assume that the cost per subject in a phase 3 vaccine efficacy trial is around US$5,000. This suggests a cost of US$150M for a study with 30,000 subjects, close to that estimated for rotavirus vaccines [54] in one of the very few studies that estimate the cost of vaccine development [55]. The figure is very high as compared to the median expense of a phase 3 trial for novel therapeutic agents, estimated to be US$19M [56].…”

Section: Efficacy Analysismentioning

confidence: 67%

A Cost/Benefit Analysis of Clinical Trial Designs for COVID-19 Vaccine Candidates

Berry

Hale

et al. 2020

Preprint

View full text Add to dashboard Cite

We compare and contrast the expected duration and number of infections and deaths averted among several designs for clinical trials of COVID-19 vaccine candidates, including traditional randomized clinical trials and adaptive and human challenge trials. Using epidemiological models calibrated to the current pandemic, we simulate the time course of each clinical trial design for 504 unique combinations of parameters, allowing us to determine which trial design is most effective for a given scenario. A human challenge trial provides maximal net benefits---averting an additional 1.1M infections and 8,000 deaths in the U.S. compared to the next best clinical trial design---if its set-up time is short or the pandemic spreads slowly. In most of the other cases, an adaptive trial provides greater net benefits.

show abstract

Section: Efficacy Analysismentioning

confidence: 67%

A Cost/Benefit Analysis of Clinical Trial Designs for COVID-19 Vaccine Candidates

Berry

Hale

et al. 2020

Preprint

View full text Add to dashboard Cite

show abstract

“…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

View full text Add to dashboard Cite

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.

show abstract

“…Conventional vaccine development takes on average 8 to 14 years and costs 0.55 to 1 billion USD, [13][14][15][16][17][18][19][20][21][22] as illustrated in Figure 1. Fast-tracked regulatory processes implemented for emergency response to pandemics can cut the duration of pre-clinical and clinical development to 0.8 to 1.5 years if patient recruitment and testing can be carried out rapidly.…”

Section: Development Timelinementioning

confidence: 99%

“…A, Pre-clinical development and clinical testing timelines, costs and success/failure rates for conventional vaccines and for vaccines produced using emerging platform technologies (eg, RNA vaccines). [13][14][15][16][17][18][19][20][21][22] Once the platform is developed and used to produce a licensed product, the costs and failure rates for developing further products using the same platform technology would drop substantially. The highest costs and longest development timelines are encountered in phase III clinical trials and the highest failure rates tend to occur in phase II clinical trials.…”

Section: Manufacturing Process and Footprintmentioning

confidence: 99%

Rapid development and deployment of high‐volume vaccines for pandemic response

Kis

Kontoravdi

Dey

et al. 2020

J Adv Manuf & Process

View full text Add to dashboard Cite

Overcoming pandemics, such as the current Covid-19 outbreak, requires the manufacture of several billion doses of vaccines within months. This is an extremely challenging task given the constraints in small-scale manufacturing for clinical trials, clinical testing timelines involving multiple phases and largescale drug substance and drug product manufacturing. To tackle these challenges, regulatory processes are fast-tracked, and rapid-response manufacturing platform technologies are used. Here, we evaluate the current progress, challenges ahead and potential solutions for providing vaccines for pandemic response at an unprecedented scale and rate. Emerging rapid-response vaccine platform technologies, especially RNA platforms, offer a high productivity estimated at over 1 billion doses per year with a small manufacturing footprint and low capital cost facilities. The self-amplifying RNA (saRNA) drug product cost is estimated at below 1 USD/dose. These manufacturing processes and facilities can be decentralized to facilitate production, distribution, but also raw material supply. The RNA platform technology can be complemented by an a priori Quality by Design analysis aided by computational modeling in order to assure product quality and further speed up the regulatory approval processes when these platforms are used for epidemic or pandemic response in the future.

show abstract

Vaccine development costs: a review

Cited by 16 publications

References 25 publications

A Cost/Benefit Analysis of Clinical Trial Designs for COVID-19 Vaccine Candidates

A Cost/Benefit Analysis of Clinical Trial Designs for COVID-19 Vaccine Candidates

Emerging Technologies for Low‐Cost, Rapid Vaccine Manufacture

Rapid development and deployment of high‐volume vaccines for pandemic response

Contact Info

Product

Resources

About