Operation Warp Speed 2.0 White Paper

OPERATIONWARP SPEED

# SOONER

ACCELERATING THE NEXT GENERATION OF COVID VACCINES AND TREATMENTS

# About 1Day Sooner

1Day Sooner was founded in response to the COvID-19 pandemic in order to represent volunteers for COvID-19 challenge trials who wanted to rapidly accelerate the deployment of the most effective COvID-19 vaccines possible. Since then, 1Day Sooner continues to represent volunteers for high impact medical studies, while also advocating for other approaches to accelerate the arrival of medical countermeasures.

# Warp Speed 2.0 Campaign

Operation Warp Speed was the US government effort to concentrate funding and regulatory support on the development of the COVID-19 vaccines. With OWS, the world saw successful, cutting-edge mRNA vaccines deployed in record time—not even a year after the pandemic was declared. 1Day Sooner advocates for the adoption of the Operation Warp Speed model for other diseases, especially ones we know have high pandemic-causing potential.

For more information, please visit 1daysooner.org

# CONTENTS

Executive Summary .. . . . . 3

Summary of Recommendations . . . . . . . . . ..4

1. Introduction . . .. 5

2. The Warp Speed Model . . . .. .10

3. Project NextGen . . . . . ..14

4. Warp Speed for NextGen . . . . . ..16

5. Contributors .. . . . .23


# EXECUTIVE SUMMARY

Operation Warp Speed revolutionized vaccine development. In the spring of 2020, President Trump announced the $$ 18$ billion public-private partnership to accelerate the development and subsequent production of vaccines against COVID-19. On December 11, less than 8 months after the program's announcement, the first vaccine was authorized by the U.S. Food and Drug Administration (FDA). Prior to Operation Warp Speed, the fastest vaccine to have ever been developed took four years.

The public health and economic benefits of the Operation Warp Speed vaccines are indisputable. Within just 6 months of their authorization, it has been estimated that the Operation Warp Speed vaccines saved nearly 140,ooo American lives. The magnitude of the benefits were so great that it's estimated that Operation Warp Speed would still have paid for itself if it had cut the duration of the pandemic by merely 12 hours.

Despite the incredible achievement of these vaccines, COvID-19 continues to pose a substantial problem three years later with the continuing threat of emerging variants. Furthermore, experts warn of the increasing likelihood of new pandemics, with estimates that the annual probability of an extreme epidemic could increase threefold in the coming decades.

The Biden Administration's Project NextGen—a $$ 5$ billion initiative to accelerate next generation COVID-19 vaccines and treatments—is a great leap forward toward quashing COVID-19 and protecting America against future pandemics. Applying lessons learned from Operation Warp Speed will be key to the successful execution of Project NextGen's goals.

In this white paper we establish the "Warp Speed mode

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