Dataset Information

Probability of Success and Timelines for the Development of Vaccines for Emerging and Reemerged Viral Infectious Diseases.

ABSTRACT:

Background

Anticipated success rates and timelines for COVID-19 vaccine development vary. Recent experience with developing and testing viral vaccine candidates can inform expectations regarding the development of safe and effective vaccines.

Objective

To estimate timelines and probabilities of success for recent vaccine candidates.

Design

ClinicalTrials.gov was searched to identify trials testing viral vaccines that had not advanced to phase 2 before 2005, and the progress of each vaccine from phase 1 through to U.S. Food and Drug Administration (FDA) licensure was tracked. Trial characteristics were double-coded. (Registration: Open Science Framework [https://osf.io/dmuzx/]).

Setting

Trials launched between January 2005 and March 2020.

Participants

Preventive viral vaccine candidates for 23 emerging or reemerged viral infectious diseases.

Measurements

The primary end point was the probability of vaccines advancing from launch of phase 2 to FDA licensure within 10 years.

Results

In total, 606 clinical trials forming 220 distinct development trajectories (267 343 enrolled participants) were identified. The probability of vaccines progressing from phase 2 to licensure within 10 years was 10.0% (95% CI, 2.6% to 16.9%), with most approvals representing H1N1 or H5N1 vaccines. The average timeline from phase 2 to approval was 4.4 years (range, 6.4 weeks to 13.9 years). The probabilities of advancing from phase 1 to 2, phase 2 to 3, and phase 3 to licensure within the total available follow-up time were 38.2% (CI, 30.7% to 45.0%), 38.3% (CI, 23.1% to 50.5%), and 61.1% (CI, 3.7% to 84.3%), respectively.

Limitations

The study did not account for preclinical development and relied primarily on ClinicalTrials.gov and FDA resources. Success probabilities do not capture the varied reasons why vaccines fail to advance to regulatory approval.

Conclusion

Success probabilities and timelines varied widely across different vaccine types and diseases. If a SARS-CoV-2 vaccine is licensed within 18 months of the start of the pandemic, it will mark an unprecedented achievement for noninfluenza viral vaccine development.

Primary funding source

McGill Interdisciplinary Initiative in Infection and Immunity (MI4) Emergency COVID-19 Research Funding program.

SUBMITTER: MacPherson A

PROVIDER: S-EPMC7707230 | biostudies-literature | 2021 Mar

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Probability of Success and Timelines for the Development of Vaccines for Emerging and Reemerged Viral Infectious Diseases.

MacPherson Amanda A Hutchinson Nora N Schneider Oliver O Oliviero Elisabeth E Feldhake Emma E Ouimet Charlotte C Sheng Jacky J Awan Fareed F Wang Catherine C Papenburg Jesse J Basta Nicole E NE Kimmelman Jonathan J

Annals of internal medicine 20201124 3

<h4>Background</h4>Anticipated success rates and timelines for COVID-19 vaccine development vary. Recent experience with developing and testing viral vaccine candidates can inform expectations regarding the development of safe and effective vaccines.<h4>Objective</h4>To estimate timelines and probabilities of success for recent vaccine candidates.<h4>Design</h4>ClinicalTrials.gov was searched to identify trials testing viral vaccines that had not advanced to phase 2 before 2005, and the progress ...[more]

PMID: 33226855

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Dataset Information

Probability of Success and Timelines for the Development of Vaccines for Emerging and Reemerged Viral Infectious Diseases.

Background

Objective

Design

Setting

Participants

Measurements

Results

Limitations

Conclusion

Primary funding source

Publications

Probability of Success and Timelines for the Development of Vaccines for Emerging and Reemerged Viral Infectious Diseases.

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