2: Operation Warp Speed and COVID-19 Vaccines
- Page ID
- 121313
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\(\newcommand{\avec}{\mathbf a}\) \(\newcommand{\bvec}{\mathbf b}\) \(\newcommand{\cvec}{\mathbf c}\) \(\newcommand{\dvec}{\mathbf d}\) \(\newcommand{\dtil}{\widetilde{\mathbf d}}\) \(\newcommand{\evec}{\mathbf e}\) \(\newcommand{\fvec}{\mathbf f}\) \(\newcommand{\nvec}{\mathbf n}\) \(\newcommand{\pvec}{\mathbf p}\) \(\newcommand{\qvec}{\mathbf q}\) \(\newcommand{\svec}{\mathbf s}\) \(\newcommand{\tvec}{\mathbf t}\) \(\newcommand{\uvec}{\mathbf u}\) \(\newcommand{\vvec}{\mathbf v}\) \(\newcommand{\wvec}{\mathbf w}\) \(\newcommand{\xvec}{\mathbf x}\) \(\newcommand{\yvec}{\mathbf y}\) \(\newcommand{\zvec}{\mathbf z}\) \(\newcommand{\rvec}{\mathbf r}\) \(\newcommand{\mvec}{\mathbf m}\) \(\newcommand{\zerovec}{\mathbf 0}\) \(\newcommand{\onevec}{\mathbf 1}\) \(\newcommand{\real}{\mathbb R}\) \(\newcommand{\twovec}[2]{\left[\begin{array}{r}#1 \\ #2 \end{array}\right]}\) \(\newcommand{\ctwovec}[2]{\left[\begin{array}{c}#1 \\ #2 \end{array}\right]}\) \(\newcommand{\threevec}[3]{\left[\begin{array}{r}#1 \\ #2 \\ #3 \end{array}\right]}\) \(\newcommand{\cthreevec}[3]{\left[\begin{array}{c}#1 \\ #2 \\ #3 \end{array}\right]}\) \(\newcommand{\fourvec}[4]{\left[\begin{array}{r}#1 \\ #2 \\ #3 \\ #4 \end{array}\right]}\) \(\newcommand{\cfourvec}[4]{\left[\begin{array}{c}#1 \\ #2 \\ #3 \\ #4 \end{array}\right]}\) \(\newcommand{\fivevec}[5]{\left[\begin{array}{r}#1 \\ #2 \\ #3 \\ #4 \\ #5 \\ \end{array}\right]}\) \(\newcommand{\cfivevec}[5]{\left[\begin{array}{c}#1 \\ #2 \\ #3 \\ #4 \\ #5 \\ \end{array}\right]}\) \(\newcommand{\mattwo}[4]{\left[\begin{array}{rr}#1 \amp #2 \\ #3 \amp #4 \\ \end{array}\right]}\) \(\newcommand{\laspan}[1]{\text{Span}\{#1\}}\) \(\newcommand{\bcal}{\cal B}\) \(\newcommand{\ccal}{\cal C}\) \(\newcommand{\scal}{\cal S}\) \(\newcommand{\wcal}{\cal W}\) \(\newcommand{\ecal}{\cal E}\) \(\newcommand{\coords}[2]{\left\{#1\right\}_{#2}}\) \(\newcommand{\gray}[1]{\color{gray}{#1}}\) \(\newcommand{\lgray}[1]{\color{lightgray}{#1}}\) \(\newcommand{\rank}{\operatorname{rank}}\) \(\newcommand{\row}{\text{Row}}\) \(\newcommand{\col}{\text{Col}}\) \(\renewcommand{\row}{\text{Row}}\) \(\newcommand{\nul}{\text{Nul}}\) \(\newcommand{\var}{\text{Var}}\) \(\newcommand{\corr}{\text{corr}}\) \(\newcommand{\len}[1]{\left|#1\right|}\) \(\newcommand{\bbar}{\overline{\bvec}}\) \(\newcommand{\bhat}{\widehat{\bvec}}\) \(\newcommand{\bperp}{\bvec^\perp}\) \(\newcommand{\xhat}{\widehat{\xvec}}\) \(\newcommand{\vhat}{\widehat{\vvec}}\) \(\newcommand{\uhat}{\widehat{\uvec}}\) \(\newcommand{\what}{\widehat{\wvec}}\) \(\newcommand{\Sighat}{\widehat{\Sigma}}\) \(\newcommand{\lt}{<}\) \(\newcommand{\gt}{>}\) \(\newcommand{\amp}{&}\) \(\definecolor{fillinmathshade}{gray}{0.9}\)- 2.1: Investigational New Drug (IND) Application
- Since the Investigational New Drug Application (IND) is a project deliverable, we describe it in detail.
- 2.2: Introduction
- In this chapter we will cover: the organization of Operation Warp Speed and the scope of its activities, traditional pharmaceutical development cycles, what mRNA vaccines are, project management considerations (including schedule acceleration techniques), and legal considerations, including looking at emergency powers and contracts between the US government at pharmaceutical companies.
- 2.3: Operation Warp Speed
- This section describes the mission of Operation Warp Speed, its leadership, its funding, its constituency, and oversight of COVID-19 vaccine development and distribution.
- 2.4: COVID-19 Vaccine Development
- This section looks at the traditional vaccine development timeline in contracts with the timelines under Operation Warp Speed. Operation Warp Speed hedged its bets and funded multiple platforms. We discuss the major Operation Warp Speed vaccine platforms and the specific adaptations to traditional processes that were made to accelerate timelines.
- 2.5: Drug Development for Traditional Drugs and Biologics
- This section summarizes the normal development cycle for traditional drugs and biologics, including vaccines as governed in the United Stated by the Food and Drug Administration (FDA). It summarizes Discovery and Development, Preclinical work, Clinical work (Phase 1, Phase 2, Phase 3, and Phase 4) and interactions with the FDA.
- 2.6: Immune System and Vaccines
- This section provides a summary of the human immune system and how vaccines work to provide immunity to pathogens.
- 2.7: Project Management Considerations
- This section and accompanying subsections address the project management considerations associated with Operation Warp Speed and the pharmaceutical companies developing and manufacturing COVID-19 vaccines. It includes a discussion of the project management triangle, preparing a schedule, and ways to accelerate vaccine development projects in emergency situations.
- 2.8: Introduction to Pharmacology
- The page provides an overview of pharmacology, emphasizing the effects and actions of drugs on the body (pharmacodynamics) and the body's processing of drugs (pharmacokinetics). It discusses drug distribution methods, absorption, metabolism, and excretion. The document describes various targets for drug action, including water, hydrogen ions, metal ions, and enzymes.
- 2.9: FDA Vaccine Development 101
- This section describes the vaccine development cycle using material from the Food and Drug Administration.
- 2.10: mRNA Vaccines
- This section provides a brief summary of how mRNA vaccines (like the Moderna and Pfizer vaccines) work.
- 2.11: Biologics License Application (BLA)
- Since the Biologics License Application (BLA) is a project deliverable in vaccine development, we describe it in detail.
- 2.12: Emergency Use Authorization (EUA)
- Since an Emergency Use Authorization (EUA) was required to ship COVID-19 vaccines, we use material from the Food and Drug Administration to describe what it is and how it is used.
- 2.13: Current Good Manufacturing Practice (CGMP)
- This section describes Current Good Manufacturing Practice regulations for pharmaceuticals that are enforced by the FDA, using material from the FDA.
- 2.14: CDC Advisory Committee on Immunization Practices (ACIP)
- This section describes the role of the Advisory Committee on Immunization Practices (ACIP), a federal advisory committee that develops recommendations on the use of vaccines in the civilian population of the United States.
- 2.15: Legal Considerations
- We cover the following topics: The legal underpinning for declaring National Emergencies (National Emergencies Act); President Trump's invocation for the COVID-19 emergency; contracts in general (contract types and when to use them); BARDA contracts for COVID-19 (contracts between the United Stated government and vaccine developers and for procuring vaccine vials); handling potential liability issues.
- 2.16: Glossary
- This section provides a lexicon or glossary defining technology specific vocabulary used in this chapter.
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