Toward more specific and transparent research and development costs: The case of seasonal influenza vaccines

Chit, Ayman; Parker, Jayson L.; Halperin, Scott A.; Papadimitropoulos, M.; Krahn, Murray; Grootendorst, Paul

doi:10.1016/j.vaccine.2013.06.055

Cited by 17 publications

(20 citation statements)

References 17 publications

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“…The annual $200 million proposed by the Flu Vaccine Act therefore represent only a fraction of current influenza-related costs. Our estimates of the economic impact of universal vaccines therefore justify the substantial costs of developing a new vaccine (38, 39). In addition, universal vaccines would save time and money spent each year in reformulating current seasonal vaccines.…”

Section: Discussionmentioning

confidence: 97%

Future epidemiological and economic impacts of universal influenza vaccines

Sah

Alfaro-Murillo

Fitzpatrick

et al. 2019

Proc. Natl. Acad. Sci. U.S.A.

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The efficacy of influenza vaccines, currently at 44%, is limited by the rapid antigenic evolution of the virus and a manufacturing process that can lead to vaccine mismatch. The National Institute of Allergy and Infectious Diseases (NIAID) recently identified the development of a universal influenza vaccine with an efficacy of at least 75% as a high scientific priority. The US Congress approved $130 million funding for the 2019 fiscal year to support the development of a universal vaccine, and another $1 billion over 5 y has been proposed in the Flu Vaccine Act. Using a model of influenza transmission, we evaluated the population-level impacts of universal influenza vaccines distributed according to empirical age-specific coverage at multiple scales in the United States. We estimate that replacing just 10% of typical seasonal vaccines with 75% efficacious universal vaccines would avert ∼5.3 million cases, 81,000 hospitalizations, and 6,300 influenza-related deaths per year. This would prevent over $1.1 billion in direct health care costs compared to a typical season, based on average data from the 2010–11 to 2018–19 seasons. A complete replacement of seasonal vaccines with universal vaccines is projected to prevent 17 million cases, 251,000 hospitalizations, 19,500 deaths, and $3.5 billion in direct health care costs. States with high per-hospitalization medical expenses along with a large proportion of elderly residents are expected to receive the maximum economic benefit. Replacing even a fraction of seasonal vaccines with universal vaccines justifies the substantial cost of vaccine development.

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Section: Discussionmentioning

confidence: 97%

Future epidemiological and economic impacts of universal influenza vaccines

Sah

Alfaro-Murillo

Fitzpatrick

et al. 2019

Proc. Natl. Acad. Sci. U.S.A.

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“…Additionally, seven articles had no change in their comparative ranking and five changed their position by one place only. The comparative rankings of two [45,48] of the remaining 10 studies are two places lower in Chart B than in Chart A. An additional article, Jayasundara et al [40], which focuses on the differences on the R&D costs between orphan and non-orphan drugs, decreased by three places.…”

Section: Suitability Assessmentmentioning

confidence: 99%

“…Additionally, two articles reported results in non-US dollar (US$) currency. For the first article, Chit et al [45], in which results were shown in Canadian dollars (CAN$) at 2011 prices, we used the 5 July 2011 exchange rate reported by the International Monetary Fund [46] to convert their estimates into US$. For the second article, Årdal et al [47], in which the results were reported in Euros at 2015 prices, we converted their values by using the 1 July 2015 exchange rate [46].…”

Section: Systematic Literature Reviewmentioning

confidence: 99%

How Much Does It Cost to Research and Develop a New Drug? A Systematic Review and Assessment

Schlander

Hernández-Villafuerte

Cheng

et al. 2021

PharmacoEconomics

178

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Background Debate over the viability of the current commercial research and development (R&D) model is ongoing. A controversial theme is the cost of bringing a new molecular entity (NME) to market. Objective Our aim was to evaluate the range and suitability of published R&D cost estimates as to the degree to which they represent the actual costs of industry. Methods We provided a systematic literature review based on articles found in the Pubmed, Embase and EconLit electronic databases, and in a previously published review. Articles published before March 2020 that estimated the total R&D costs were included (22 articles with 45 unique cost estimates). We included only literature in which the methods used to collect the information and to estimate the R&D costs were clearly described; therefore, three reports were excluded. We extracted average pre-launch R&D costs per NME and converted the values to 2019 US dollars (US$) using the gross domestic product (GDP) price deflator. We appraised the suitability of the R&D estimated costs by using a scoring system that captures three domains: (1) how success rates and development time used for cost estimation were obtained; (2) whether the study considered potential sources contributing to the variation in R&D costs; and (3) what the components of the cost estimation were. Results Estimates of total average capitalized pre-launch R&D costs varied widely, ranging from $161 million to $4.54 billion (2019 US$). Therapeutic area-specific estimates were highest for anticancer drugs (between $944 million and $4.54 billion). Our analysis identified a trend of increasing R&D costs per NME over time but did not reveal a relation between cost estimates and study ranking when the suitability scores were assessed. We found no evidence of an increase in suitability scores over time. Conclusion There is no universally correct answer regarding how much it costs, on average, to research and develop an NME. Future studies should explicitly address previously neglected variables, which likely explain some variability in estimates, and consider the trade-off between the transparency and public accessibility of data and their specificity. Use of our proposed suitability scoring system may assist in addressing such issues.

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“…Since the viral epidemics die out within one year or two, such a process would be impossible for new viruses. Drugs are curatives; vaccines, as preventive means, have been a more attractive alternative, and development costs are relatively lower [ 8 ], but the standard practice of utilizing inactivated or attenuated viruses for the purpose has been fraught with their own problems including allergenic reactions [ 9 ].…”

Section: Interest In Peptide Vaccinesmentioning

confidence: 99%

A Brief Review of Computer-Assisted Approaches to Rational Design of Peptide Vaccines

Nandy

Basak

2016

IJMS

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The growing incidences of new viral diseases and increasingly frequent viral epidemics have strained therapeutic and preventive measures; the high mutability of viral genes puts additional strains on developmental efforts. Given the high cost and time requirements for new drugs development, vaccines remain as a viable alternative, but there too traditional techniques of live-attenuated or inactivated vaccines have the danger of allergenic reactions and others. Peptide vaccines have, over the last several years, begun to be looked on as more appropriate alternatives, which are economically affordable, require less time for development and hold the promise of multi-valent dosages. The developments in bioinformatics, proteomics, immunogenomics, structural biology and other sciences have spurred the growth of vaccinomics where computer assisted approaches serve to identify suitable peptide targets for eventual development of vaccines. In this mini-review we give a brief overview of some of the recent trends in computer assisted vaccine development with emphasis on the primary selection procedures of probable peptide candidates for vaccine development.

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Toward more specific and transparent research and development costs: The case of seasonal influenza vaccines

Cited by 17 publications

References 17 publications

Future epidemiological and economic impacts of universal influenza vaccines

Future epidemiological and economic impacts of universal influenza vaccines

How Much Does It Cost to Research and Develop a New Drug? A Systematic Review and Assessment

A Brief Review of Computer-Assisted Approaches to Rational Design of Peptide Vaccines

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