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To Boldly Remember Where We Have Already Been
Revisiting the Cutter Polio Vaccine Incident during Operation Warp Speed
https://brill.com/view/journals/joah/2/1-2/article-p17_2.xml?language=en
Abstract
This article revisits the Cutter Incident in the United States in April 1955 when mass-produced doses of polio vaccine containing insufficiently inactivated (killed) live polio virus were released to the U.S. public. The Cutter Incident also affected subsequent vaccine development and these lessons remain relevant in the international quest to create a rapidly developed vaccine for COVID-19. The Cutter Incident shows how things can go wrong when a vaccine is manufactured in haste and without adequate safety precautions during mass-production. In the article’s later section, liability without fault, among other consequences resulting from the incident, are also assessed in the context of current vaccine development through Operation Warp Speed, the public-private partnership funded by the U.S. government to develop a remedy for COVID-19.
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The U.S. government’s program, “Operation Warp Speed,” the private-public partnership to create a vaccine for the SARs-CoV-2 virus and the COVID-19 disease it causes, is widely regarded, and even relied upon, as a solution with global consequences.11 Yet, Operation Warp Speed is also a program with limitations and these may be better understood with historical contextualization stemming from the Cutter Incident in 1955.
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Vaccines have prevented disabling and deadly diseases in the United States for decades. Despite the alarm that the Cutter Incident created, vaccines have also proven to be historically low-cost and represent, according to a 2003 Institute of Medicine report, “one of the outstanding bargains in health care.”59 Despite these factors, according to the same report, the vaccine industry was “surprisingly fragile” in 2003 and this weakness—which has grown over the last seventeen years—now necessitates the large-scale and significant financial outlays to effectively “catch-up” through creating and funding Operation Warp Speed to remedy COVID-19’s extensive reach.60 Through the CARES Act, the U.S. government has allocated almost $ 10 billion to Operation Warp Speed and the program is multi-faceted.61 The primary concern this paper seeks to raise, as the Cutter Incident demonstrated, is that the urgency to create a solution is not only driven by medical necessity. Solutions are also driven by political concerns that may create unexpected and deleterious outcomes with long-term consequences with significant financial cost and social disruption. Science, however, should never become politics’ handmaiden, even when immense political pressure is applied to create a solution. Before 2020, the Cutter Incident contributed to the fragility of the vaccine industry. Yet, can Operation Warp Speed safely push vaccine development into the future to address COVID-19? Operation Warp Speed reveals problems that are not always strictly scientific in nature.