The Food and Drug Administration (FDA) has announced the licensing of a new vaccine against a disease responsible for tens of thousands of hospitalizations in the United States and hundreds of thousands of deaths around the world each year.
The vaccine, developed by Merck & Co., Inc., will be sold as ROTATEQ. and will protect infants against rotavirus infection. Rotavirus is a highly contagious virus that is the most common cause of severe dehydrating diarrhea in infants and young children.
The early research that underpins the new vaccine was conducted by three scientists at The Wistar Institute and The Children's Hospital of Philadelphia (CHOP) between 1980 and 1991, at which time Merck took on the task of developing the vaccine for the clinic. The scientists are H. Fred Clark, D.V.M., Ph.D., Paul A. Offit, M.D., and Stanley A. Plotkin, M.D. Clark and Offit are currently on faculty at CHOP, where Clark is a research professor of pediatrics and Offit is chief of infectious diseases and the Maurice R. Hilleman Endowed Chair in Vaccinology; both are adjunct professors at Wistar. Plotkin, an emeritus professor at Wistar, was the developer of a number of vaccines, including the rubella vaccine responsible for eradicating that disease in the United States, according to the Centers for Disease Control.
"This new vaccine against an important disease of childhood is the result of two leading academic research institutions and a major pharmaceutical company working together toward a common goal for roughly 25 years," says Russel E. Kaufman, M.D., president and CEO of The Wistar Institute. "It has been a long road, and we are very proud of the role our scientists played in the success of this important medical advance."
Plotkin and Clark began work on rotavirus in 1980. In 1981, Clark, a veterinarian, isolated from a calf the strain of rotavirus - dubbed the Wistar Calf-3, or WC3, strain - that would provide the foundation for the new vaccine. That same year, Offit joined Plotkin and Clark in the effort to develop a vaccine against rotavirus. As a senior resident at a hospital in Pittsburgh in 1979, Offit had witnessed the death of a nine-month-old boy from rotavirus infection, and he welcomed the opportunity to work on a vaccine to combat the disease.
Early studies with the WC3 strain indicated that while it was safe for use as a vaccine, it did not provide sufficiently effective protection against rotavirus infection. During the 1980s, the team turned to the idea of reassortants, taking advantage of the fact that viruses have the ability to borrow genetic material from each other to "reassort" themselves into new strains.