Biotech Revolution

Polio, Pertussis and Influenza Vaccine
by Food and Drug Administration (FDA)

(Page 2 of 4)

The War on Polio

Infantile paralysis, or polio, was a much-feared disease. Highly contagious, it paralyzed or killed its victims, and children were especially vulnerable.

"When I was 10 years old in 1936, there was a big epidemic of polio in the country and I remember my parents and I lived in an apartment house right across the street from the park," Ruth Kirschstein, M.D., former acting director of the NIH recalled in a 2002 CBER publication, Science and the Regulation of Biologics. "And they would take me to the park every day in the summer and sit me 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 and having their children end up in iron lungs."

Former President Franklin D. Roosevelt, who was crippled by the disease, began a "War on Polio" in 1938 with the creation of the National Foundation for Infantile Paralysis, now the March of Dimes. The foundation raised funds for scientists to conduct research on the cause and prevention of polio.

One of these scientists was Jonas Salk, whose polio vaccine gave the country hope for preventing the dread disease. Salk's inactivated, or killed, polio vaccine had to be tested in human trials before the government could license it. By 1954, in one of the largest clinical tests of a drug or vaccine in medical history, 1.8 million children had been inoculated with the vaccine, which was determined to be safe and effective. But later, polio started appearing in vaccinated people. The infection was traced to live polio virus that had survived the inactivation process in two batches of vaccine produced by Cutter Laboratories of Berkeley, Calif. More than 250 cases of polio were attributed to the Cutter vaccine.

In 1955, the U.S. Surgeon General recommended that all polio vaccinations be suspended until the Laboratory of Biologics Control, a CBER predecessor, had thoroughly inspected each manufacturing facility and reviewed the procedures for testing vaccine safety. After more precise testing and stricter standards were employed to ensure the complete inactivation of polio virus, manufacturing resumed.

Pertussis Vaccine

Whooping cough (pertussis) is a highly contagious and potentially deadly respiratory infection. Although the pertussis vaccine had been available since 1915, there were many concerns about its potency. In 1944, Dr. Margaret Pittman, a researcher in the Laboratory of Biologics Control, developed a method to determine vaccine potency. The method became the industry standard, and manufacturers were then able to make and sell whooping cough vaccine based on potency as well as safety and sterility.

Improvements to the pertussis vaccine continue. In 1996, the CBER licensed the first acellular pertussis vaccine for use in infants and children for the primary series of immunizations. Containing only the parts of the pertussis bacterium thought to be important for immunity, the vaccine protects children against whooping cough while causing fewer side effects than the previously used whole-cell pertussis vaccines. In 2005, the CBER approved a new vaccine for adolescents and adults that provides a single booster immunization against pertussis in combination with tetanus and diphtheria.

German Measles Vaccine

In 1964, a global epidemic of German measles spread to the United States, infecting about 12.5 million people that year. Rubella is a usually mild viral disease that most often affects children and young adults, but it is a very dangerous disease for pregnant women. The virus can be transmitted to the unborn child, resulting in conditions such as blindness, deafness, heart defects, and mental retardation.

In 1966, former CBER Directors Paul D. Parkman, M.D., and Harry M. Meyer Jr., M.D., then working as scientists in the NIH's Division of Biologics Standards, reported that they had developed the first effective experimental vaccine for rubella.

Parkman and Meyer 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. "The experimental vaccine we made was shown not to be communicable," Parkman said in Science and the Regulation of Biologics. "In the middle of all of this, the U.S. had the biggest rubella epidemic ever, and there were maybe 20,000 babies with birth defects across the country that resulted from rubella in that epidemic."

Based on the success of the Parkman and Meyer vaccine, the first rubella vaccines were licensed in 1969. These vaccines, and the current vaccine that was approved a decade later, have been strikingly successful in controlling rubella. By 1988, there were only 225 reported cases of rubella in the United States.

Influenza Vaccine

The influenza (flu) pandemic of 1918 caused an estimated 20 million deaths worldwide and killed more Americans than all the wars of the 20th century. Early flu vaccines were not always effective because no accurate test was available to measure their potency. In the 1940s, Bernice Eddy, Ph.D., a scientist in the Division of Biological Control, as the CBER was called then, concentrated on developing the first reliable potency test for flu vaccine so that manufacturers could make a uniform product with the desired effectiveness. The first flu vaccine was licensed in 1945.

The CBER plays a vital role in ensuring that new vaccines can be produced in time to respond to each flu season and for future pandemics. "Influenza vaccine is unique because its active ingredients - the virus strains used to develop the vaccine - change almost every year," says Goodman. "Each year, FDA begins working with manufacturers at the earliest stages of vaccine development, and we continue to assist them throughout the production phase."

About the Author

www.fda.gov
FDA is A United States government body that oversees medical devices, including contact lenses, intraocular lenses, excimer lasers and eyedrops. In the US, these products must be approved by the FDA before they can be marketed.