Abstract
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.
Highlights
The federal government inspects meat in the slaughterhouses more carefully than it has examined the polio vaccine
In 1954, five drug companies, Eli Lilly, Parke-Davis, Wyeth, Pitman-Moore, and Cutter Laboratories devoted their effort to producing mass lots of polio vaccine using a procedure Jonas Salk, m.d. had successfully devised through which the polio virus was killed—technically known as inactivation— with formaldehyde.[2]
From these mass lots of vaccine, “samples of the inactivated polio vaccine were sent to the National Institute of Health’s Laboratory of Biologic Control, which was responsible for certifying that the vaccines were inactivated and safe for use.”[3]. At one of the companies developing these vaccines, Cutter Laboratories of Berkeley, California, numerous samples were tested by a scientist, Dr Bernice Eddy
Summary
This article focuses on the Cutter Incident and it describes how problems in the past may illuminate contemporary and future challenges in either immunizing against or treating covid-19. A 2013 lecture on polio recorded for C-Span briefly mentions the Cutter Incident, but it does so in the context of discussing Oshinsky’s book.[14] Medical journals continue to assess polio, but primarily in terms of potential risks of a contemporary outbreak and vaccine availability.[15] As an example, a 1996 Institute of Medicine Vaccine Safety Forum workshop historical summary of polio in the United States mentioned the peak incidence of polio in 1952, when 20,000 cases of paralytic poliomyelitis occurred. The Cutter Incident is valuable to revisit, because of its significant role affecting vaccine development in the past, and because of its relevance among those demanding a covid-19 vaccine today in what is the most pressing pandemic in the first quarter of the 21st century
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