title: Value of Post-Licensure Data on Benefits and Risks of Vaccination to Inform Vaccine Policy: The Example of Rotavirus Vaccines.
abstract: In 1999, the first rhesus-human reassortant rotavirus vaccine licensed in the U.S. was withdrawn within a year of its introduction after it was linked with intussusception at a rate of ~1 excess case per 10,000 vaccinated infants. While clinical trials of 60,000-70,000 infants of each of the two current live oral rotavirus vaccines, RotaTeq (RV5) and Rotarix (RV1), did not find an association with intussusception, post-licensure studies have documented a risk in several high and middle income countries, at a rate of ~1-6 excess cases per 100,000 vaccinated infants. However, considering this low risk against the large health benefits of vaccination that have been observed in many countries, including in countries with a documented vaccine-associated intussusception risk, policy makers and health organizations around the world continue to support the routine use of RV1 and RV5 in national infant immunization programs. Because the risk and benefit data from affluent settings may not be directly applicable to developing countries, further characterization of any associated intussusception risk following rotavirus vaccination as well as the health benefits of vaccination is desirable for low income settings.
authors.affiliation: U.S. Centers for Disease Control and Prevention, 1600 Clifton Road, MS A34, Atlanta, GA 30333, United States. Electronic address: uap2@cdc.gov.
authors.forename: Umesh D
authors.initials: UD
authors.lastname: Parashar
authors.affiliation: U.S. Centers for Disease Control and Prevention, 1600 Clifton Road, MS A34, Atlanta, GA 30333, United States.
authors.forename: Margaret M
authors.initials: MM
authors.lastname: Cortese
authors.affiliation: U.S. Centers for Disease Control and Prevention, 1600 Clifton Road, MS A34, Atlanta, GA 30333, United States.
authors.forename: Daniel C
authors.initials: DC
authors.lastname: Payne
authors.affiliation: U.S. Centers for Disease Control and Prevention, 1600 Clifton Road, MS A34, Atlanta, GA 30333, United States.
authors.forename: Benjamin
authors.initials: B
authors.lastname: Lopman
authors.affiliation: U.S. Centers for Disease Control and Prevention, 1600 Clifton Road, MS A34, Atlanta, GA 30333, United States.
authors.forename: Catherine
authors.initials: C
authors.lastname: Yen
authors.affiliation: U.S. Centers for Disease Control and Prevention, 1600 Clifton Road, MS A34, Atlanta, GA 30333, United States.
authors.forename: Jacqueline E
authors.initials: JE
authors.lastname: Tate
mesh_terms: D002986:Clinical Trials as Topic; D007443:Intussusception / Q000139:chemically induced*; D057766:Policy; D011358:Product Surveillance, Postmarketing / Q000379:methods*; D018570:Risk Assessment; D012400:Rotavirus Infections / Q000517:prevention & control*; D022243:Rotavirus Vaccines / Q000008:administration & dosage* / Q000009:adverse effects*; D014481:United States; D014613:Vaccines, Attenuated / Q000008:administration & dosage
chemical_list: C492457:RIX4414 vaccine; C492535:RotaTeq; D022243:Rotavirus Vaccines; D014613:Vaccines, Attenuated