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Methodology Page

This dashboard relies on information reported in Operation Warp Speed: Accelerated COVID-19 Vaccine Development Status and Efforts to Address Manufacturing Challenges, among other reports (see the full list of sources below).

As a part of that report, in order to understand each vaccine candidate’s characteristics and development status, we developed a questionnaire that reflected HHS’s integrated technology readiness levels (TRLs) and sent the questionnaires to all six COVID-19 vaccine companies.

We also collected supporting documentation and conducted follow-up interviews with companies to clarify and gather additional support to their responses to the questionnaire. We used the company responses on the progress and activities conducted for each candidate, and reviewed the relevant supporting information, such as clinical trial documents and safety and immunogenicity data evaluations conducted by research and development scientists, to verify information reported by each vaccine company.

To assign TRLs for each vaccine, we relied on peer-reviewed or other public information to validate company responses to the greatest extent possible. When feasible, we used company documents that were created for FDA, such as components from the Investigational New Drug application. If we did not receive sufficient documentation to support the answers provided by the companies, we assigned a TRL with a caveat (asterisk), and noted that testimonial evidence was used to support the TRL designation.

To determine how each vaccine company adapted their developmental processes to meet the timelines set by OWS and the continued Department of Defense (DOD) and Department of Health and Human Services (HHS) partnership, we reviewed the supporting documents we collected and compared them against the partnership timelines.

To identify key challenges in scaling up manufacturing for COVID-19 vaccines and the steps DOD and HHS partnership developers and manufacturers have taken to address them, we conducted a literature review and reviewed reports and journal articles about vaccine manufacturing. We interviewed or received written responses from HHS and DOD officials, including those working within the partnership. We also interviewed representatives from industry groups and representatives from DOD and HHS partnership vaccine companies for additional perspectives on vaccine and therapeutic development and manufacturing activities.

We also reviewed information on the number of completed and projected vaccine dose productions from each of the six DOD and HHS partnership vaccine developers.

This dashboard relies on information that was gathered from related GAO products, including:

  • COVID-19: Efforts to Increase Vaccine Availability and Perspectives on Initial Implementation. GAO-21-443. Washington, D.C.: April 14, 2021.
  • COVID-19: Critical Vaccine Distribution, Supply Chain, Program Integrity, and Other Challenges Require Focused Federal Attention. GAO-21-265. Washington, D.C.: January 28, 2021.
  • COVID-19: Urgent Actions Needed to Better Ensure an Effective Federal Response. GAO-21-191. Washington, D.C.: November 30, 2020.
  • COVID19: Federal Efforts Accelerate Vaccine and Therapeutic Development, but more Transparency Needed on Emergency Use Authorizations. GAO-21-207. Washington, D.C.: November 17, 2020.
  • COVID-19: Federal Efforts Could Be Strengthened by Timely and Concerted Actions. GAO-20-701. Washington, D.C.: September 21, 2020.
  • COVID-19: Brief Update on Initial Federal Response to the Pandemic. GAO-20-708. Washington, D.C.: August 31, 2020.
  • COVID-19 Contracting: Observations on Federal Contracting in Response to the Pandemic. GAO-20-632. Washington, D.C.: July 29, 2020.
  • COVID-19: Opportunities to Improve Federal Response and Recovery Efforts. GAO-20- 625. Washington, D.C.: June 25, 2020.
  • Defense Acquisitions: DOD’s Use of Other Transactions for Prototype Projects Has Increased. GAO-20-84. Washington, D.C.: November 22, 2019.
  • Federal Acquisitions: Use of ‘Other Transaction’ Agreements Limited and Mostly for Research and Development Activities. GAO-16-209. Washington, D.C.: January 7, 2016.
  • Influenza Pandemic: Lessons from the H1N1 Pandemic Should Be Incorporated into Future Planning. GAO-11-632. Washington, D.C.: June 27, 2011

This dashboard includes publically available information from https://www.clinicaltrials.gov.