Summary: Pursuant to a congressional request, GAO reviewed: (1) actions the federal government took to improve the safety of the oral polio vaccine (OPV); (2) the basis for recommending the use of a live polio vaccine for routine childhood immunization; and (3) the steps required to initiate an inactivated polio vaccine (IPV) for childhood immunization.
GAO found that: (1) federal research efforts to improve the safety of live polio vaccines were adequate; (2) FDA proposed changes to its OPV regulations and manufacturing requirements for future OPV licensed in the United States; and (3) the Immunization Practices Advisory Committee recommended the use of OPV because it could immunize unvaccinated people through contact and provide a higher level of intestinal immunity than IPV. GAO also found that the federal government would have to initiate several actions to recommend IPV for childhood immunization, specifically: (1) licensing a more potent IPV for marketing in the United States; (2) demonstrating the efficacy and safety of a more potent IPV; and (3) reducing the importation of polio viruses into the United States.
