Stockpiling safety?

On 12 December 1997, the FDA's Vaccine and Related Biologicals Products Advisory Committee unanimously concluded that RotaShield, the first vaccine for rotavirus-a highly contagious disease that causes life-threatening diarrhea in young children-is safe and effective, and recommended licensing. In the United States alone, rotavirus causes 3 million cases of childhood diarrhea, resulting in 500,000 doctor visits, 100,000 hospitalizations, and up to 100 deaths annually. Direct costs of the disease run to as much as $400 million and indirect costs (such as lost work time for parents) total $1.4 billion. Worldwide, rotavirus kills 873,000 children each year, largely in underdeveloped countries. The vaccine is intended to be administered in three doses at 2, 4, and 6 months of age when children receive their polio vaccine. The RotaShield vaccine was created and patented by virologist and physician Albert Kapikian and his colleagues at the National Institute ofAllergy and Infectious Diseases in Bethesda, Maryland. Kapikian, head of the epidemiology section of the Laboratory of Infectious Diseases, has devoted nearly 25 years to studying rotavirus. "It's exciting and gratifying as a physician to see that most babies can be protected from severe diarrhea with a product developed in our laboratory," he says. Australian virologists discovered rotavirus in 1973. Later, several epidemiological studies proved that rotavirus was the most important agent involved in infantile diarrhea worldwide. Kapikian's ingenuity and perseverance helped overcome obstacles in creating the vaccine. For instance, human rotavirus resisted growth in cell cultures, whereas simian rotavirus grew well. The researchers worked to determine whether an animal rotavirus could protect humans, much in the same way that Edward Jenner determined 200 years ago that vaccinating people with cowpox could prevent smallpox. The final vaccine contains a weakened form of rotavirus obtained from rhesus monkeys, bioengineered with three genes from human rotavirus. This combination proved most effective at protecting people against the four most prevalent clinical strains of rotavirus. The vaccine was tested successfully in numerous clinical trials. Among 2,000 infants in Venezuela, the vaccine reduced severe diarrheal illness by 88% and dehydration by 75%, and decreased hospitalizations Last of a dying breed? A new vaccine expected to be approved by the FDA may mean the end of rotavirus outbreaks. by 70%. This study, reported in the 23 October 1997 issue of the New England Journal ofMedicine, was the largest and most successful trial of the vaccine in a developing country. A multi-center trial …