The previous year, in August 1954, Dr. Bernice Eddy had been testing a batch of polio vaccines from Cutter Laboratories and she noticed that the vaccine had given polio to a test monkey. She found that three of the six samples had paralyzed test monkeys. She knew something was wrong and brought it to the attention of her supervisor, Dr. William Workman. Because of the previous polio epidemics and the race to create a vaccine, Dr. Eddy and her team had been working around the clock testing the Salk vaccine. Amidst the scientific and bureaucratic chaos, Workman never told the licensing committee, and the Cutter vaccine was approved and shipped out. Dr. Eddy was relieved of her polio control testing duties in 1955 but continued to work in biologics.

Not coincidentally, the Laboratory of Control Activities was formed—along with the NIH Division of Biologics Standards (DBS) itself—in the wake of the Cutter polio vaccine incident in 1955. The organizational response to that (biologics regulation existing independently within NIH as DBS) . This was likely related to the change in regulations regarding polio vaccine production as well. It was one structural way that the NIH recognized its biologics function should get more attention from the agency.

In the years following the Cutter Incident, Dr. Ruth Kirschstein’s polio investigations paved the way for safer vaccines, both the killed vaccine and live, attenuated oral polio vaccine.  She and her colleagues shed light on the pathogenesis of the polio virus and developed a standardized test involving precise, experimental inoculation of vaccine matter. It served as the basis for the testing DBS conducted on every lot of polio vaccine produced and the laboratory instructed vaccine producers and others that needed to know the procedure from around the world.