Rotavirus Vaccine Withdrawal in the United States: The Role of Postmarketing Surveillance

On August 31, 1998, Rotashield (Wyeth Laboratories, Marietta, Pennsylvania) was licensed by the United States Food and Drug Administration for oral administration to infants at two, four and six months of age in the United States. This product is a live, attenuated rhesus rotavirusbased tetravalent vaccine (RRV-TV). Each dose of vaccine contains 1×10 plaque forming units of each of four strains: one is a rhesus rotavirus strain with human serotype 3 specificity, and the three other strains are single gene human-rhesus reassortants that contain the human gene for serotype 1, 2 and 4 antigens, respectively, along with other genes from the parent rhesus rotavirus strain. Shortly following licensure of the vaccine in the United States, the Advisory Committee on Immunization Practices (ACIP) (1) recommended routine immunization with three oral doses of RRV-TV for infants at age two, four and six months of age for the prevention of rotavirus disease in the United States. The rationale for recommending use of the vaccine was the following.