Biologics Regulation : Polio Vaccine, Measles Vaccine

by Food and Drug Administration (FDA)

Around the turn of the last century, diphtheria patients were routinely treated with antitoxin derived from the blood of horses. There were no central or uniform controls in place and the antitoxin was often manufactured in local plants. In St. Louis, that combination had tragic consequences. Thirteen children died of tetanus in 1901 after being treated with diphtheria antitoxin made from the blood of a tetanus-infected milk wagon horse named Jim.

Soon after this and a similar tragedy in Camden, N.J., involving deaths and injuries related to a tainted biological product, Congress enacted the Biologics Control Act. July 1, 2002, marks the 100th anniversary of the law, which gives the Food and Drug Administration's Center for Biologics Evaluation and Research (CBER) authority to regulate biological products and ensure their safety.

Biologics are medical products derived from living sources. They include vaccines, blood and blood derivatives, allergenic patch tests and extracts, tests to detect HIV and hepatitis, gene therapy products, cells and tissues for transplantation, and new treatments for cancers, arthritis, and other serious diseases.

Here are some key research contributions in biologics over the last century.

Polio Vaccine

In the early 1900s, Americans were frightened of polio for good reason. Polio is a highly contagious disease that paralyzes or kills its victims, and children are especially vulnerable.

In 1908, Austrian biomedical researcher Karl Landsteiner determined that polio is caused by a virus rather than bacteria. Eight years later, thousands of New York City residents fled their homes to avoid a polio epidemic that hit the area in 1916.

Ruth Kirschstein, M.D., deputy director at the National Institutes of Health, remembers living with her parents near a park when she was 10 years old and the country was in the midst of another polio epidemic in 1936.

"They would take me to the park every day in the summer and sit down and say, 'don't talk to anybody, don't go near anybody, don't do anything because you might get polio.' That was the thing people were most scared about-having their children end up in iron lungs. We've gotten rid of that, and it's just absolutely marvelous."

During the early 1950s, researcher Jonas Salk developed a killed virus polio vaccine. Salk tried the vaccine on volunteers, as well as himself, his wife and children. All those who received the vaccine developed antibodies to polio and no one got sick. In 1954, nationwide testing of Salk's vaccine began with mass inoculations of school children. A million children participated in the tests, making it the largest clinical test of a drug or vaccine in medical history. The Salk vaccine was found to be safe and effective. However, the tests came to a halt after more than 200 cases of polio caused by the vaccine suddenly occurred. It was determined that two batches of the vaccine produced by Cutter Labs contained live poliovirus and were responsible for the outbreak. Eleven people died as a result.

In 1955, the U.S. Surgeon General recommended that all polio vaccinations be suspended until a thorough inspection of each manufacturing facility and review of the procedure for testing vaccine safety had been completed. Manufacturing resumed after stricter standards were adopted, and more than 4 million doses of the Salk vaccine were distributed by August of that year.

In the late 1950's, Albert Sabin theorized that a weakened, live-virus polio vaccine would provide longer-lasting immunity. The Sabin vaccine, which was inexpensive and administered orally, became the primary weapon for polio prevention in the United States by the end of the 1960s. Ironically, because the vaccine contains weakened live forms of the virus that can mutate, some people develop polio after taking this vaccine.

Now, with polio on the brink of eradication throughout the world, the Salk inactivated vaccine is the only product recommended for routine childhood vaccination in the United States.

Measles Vaccine

In 1964, a global epidemic of rubella, also known as German measles, spread to the United States. About 12.5 million cases were reported that year, and 20,000 infants were born with birth defects as a result.

In 1966, former CBER directors Paul D. Parkman, M.D., and Harry M. Meyer, Jr., M.D., reported that they had developed the first effective experimental vaccine for rubella. The researchers prepared a weakened, live vaccine for human testing and inoculated 34 children. None of the children developed rubella, nor did they transmit the disease to their unvaccinated playmates. By 1988, only 225 cases of rubella were reported in the United States.

About the Author

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