On Aug. 31, 1998, Rotashield (Wyeth Laboratories, Marietta, Pennsylvania) was licensed by the U.S. Food and Drug Administration (FDA) for oral administration to infants at two, four and six months of age in the U.S. This product was a live, attenuated rhesus rotavirus based tetravalent vaccine (RRV-TV).

Each dose of vaccine contains 1×10⁵ 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) 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 American Academy of Pediatrics also recommended RRV-TV for use in infants two, four and six months of age for prevention of rotavirus disease. However, it stated that “routine implementation of this recommendation will require reconciliation of related economic issues.