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Vaccines were the first biologic drugs to be developed and regulated by the FDA (Table 3.4). National and global viral pandemics have continued to push research scientists to develop new vaccines throughout the 1900s

Table 3.4 A history of vaccine development and regulation in the United States.

Source: Bren.¹²

Polio vaccine

In 1938, former US President Franklin D. Roosevelt began a “War on Polio” with the creation of the National Foundation for Infantile Paralysis. In 1954, Jonas Salk's inactivated polio vaccine was tested in 1.8 million children. In 1955, all polio vaccinations were suspended due to ineffective batches of the vaccine circulating in the market and would not resume until all manufacturing facilities were inspected and reviewed to ensure procedures for safety testing were in place.

German measles vaccine

A global epidemic of German measles (rubella) spread to the United States in 1964, infecting about 12.5 million people that year. Rubella is typically a mild virus affecting children and young adults, but it can also pass to an unborn child if pregnant women are infected, resulting in conditions such as mental retardation, blindness, deafness, and heart defects. In 1966, two former Center for Biologics Evaluation and Research (CBER) directors developed the first experimental vaccine, and in 1969, the first vaccines were marketed. By 1988, there were only 225 reported cases of rubella in the United States.

Influenza vaccine

It is estimated that the influenza pandemic of 1918 caused 20 million deaths worldwide. In the 1940s, scientists at the Division of Biological Control – a CBER predecessor – developed the first reliable potency test for flu vaccine so that manufacturers could produce uniform products with desired effectiveness. In 1945, the first flu vaccine was developed, and today CBER works with manufacturers on an annual basis to assist in development and production of annual updated vaccines to keep responding to the ever‐evolving influenza virus.