Abstract
Rotaviruses are the most important cause of pediatric gastroenteritis worldwide. In August 1998, a new rotavirus vaccine was licensed for general use in the United States. However, 14 months later, the vaccine was withdrawn from the market because of serious gastrointestinal side effects. This paper discusses the need for a rotavirus vaccine, the development of the first rotavirus vaccine, and the safety issues that led to the recall of that vaccine.
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References and Recommended Reading
Glass RI, Kilgore PE, Holman RC, et al.: The epidemiology of rotavirus diarrhea in the United States: surveillance and estimates of disease burden. J Infect Dis 1996, 174:S5-S11.
Huilan S, Zhen LG, Mathan MM, et al.: Etiology of acute diarrhoea among children in developing countries: a multicenter study in five countries. Bull WHO 1991, 69:549–555.
Murray CJ, Lopez AD: Global mortality, disability, and the contribution of risk factors: global burden of disease study. Lancet 1997, 349:1436–1442.
Ardern-Holmes SL, Lennon D, Pinnock R, et al.: Trends in hospitalization and mortality from rotavirus disease in New Zealand infants. Pediatr Infect Dis J 1999, 18:614–619.
Parashar UD, Holman RC, Clarke MJ, et al.: Hospitalizations associated with rotavirus diarrhea in the United States, 1993 through 1995; surveillance based on the new ICD-9-CM rotavirus-specific diagnostic code. J Infect Dis 1997, 177:13–17. This study documents the burden of rotavirus-related disease in the United States.
Smith JC, Haddix AC, Teutsch SM, Glass RI: Cost-effectiveness analysis of a rotavirus immunization program for the United States. Pediatrics 1998, 96:609–615.
Tucker AW, Haddix AC, Bresee JS, et al.: Cost-effectiveness analysis of a rotavirus immunization program for the United States. JAMA 1998, 279:1371–1376. This comprehensive analysis demonstrates the cost-effectiveness of universal rotavirus immunization in the United States.
Matson DO, Estes MK: Impact of rotavirus infection at a large pediatric hospital. J Infect Dis 1990, 162:598–604.
Carr M, McKendrick D, Spyridakis T: The clinical features of infantile gastroenteritis due to rotavirus. Scand J Infect Dis 1987, 8:241–243.
Rodriguez WJ, Kim HW, Arrobio JO, et al.: Clinical features of acute gastroenteritis associated with human reoviruslike agent in infants and young children. J Pediatr 1977, 91:188–193.
Tallett S, MacKenzie C, Middleton P, et al.: Clinical, laboratory, and epidemiologic features of a viral gastroenteritis in infants and children. Pediatrics 1977, 60:217–222.
Offit PA: Host factors associated with protection against rotavirus disease: the skies are clearing. J Infect Dis 1996, 174:S59-S64.
Ward RL, Bernstein DI: Protection against rotavirus disease after natural rotavirus infection. J Infect Dis 1994, 169:900–904.
Velazquez FR, Matson DO, Calva JJ, et al.: Rotavirus infections in infants as protection against subsequent infections. N Engl J Med 1996, 335:1022–1028.
Moulton LH, Staat MA, Santosham M, Ward RL: The protective effectiveness of natural rotavirus infection in an American Indian population. J Infect Dis 1998, 178:1562–1566.
Matson DO, O’Ryan ML, Herrera I, et al.: Fecal antibody responses to symptomatic and asymptomatic rotavirus infections. J Infect Dis 1993, 167:577–583.
Coulson BS: Typing of human rotavirus VP4 by an enzyme immunoassay using monoclonal antibodies. J Clin Microbiol 1993, 31:1–8.
Offit PA: Rotaviruses: immunologic determinants of protection against infection and disease. Adv Virus Res 1994, 44:161–202.
Moser CA, Cookinham S, Coffin SE, et al.: Relative importance of rotavirus-specific effector and memory B cells in protection against challenge. J Virol 1998, 72:1108–1114.
Estes MK: Rotaviruses and their replication. In Fields’ Virology. Edited by Fields BN, Knipe DM, Howley PM. New York: Raven Press; 1996:1329–1352.
Ramachandran M, Gentsch JR, Parashar UD, et al.: Detection and characterization of novel rotavirus strains in the United States. J Clin Microbiol 1998, 37:3223–3229.
Gentsch JR, Woods PA, Ramachandran M, et al.: Review of G and P typing results from a global collection of rotavirus strains: implications for vaccine development. J Infect Dis 1996, 174:S30-S36.
Alfieri AA, Leite JP, Nakagomi O, et al.: Characterization of human rotavirus genotype P[8]G5 from Brazil by probehybridization and sequence. Arch Virol 1996, 141:2353–2364.
Kapikian AZ, Hoshino Y, Chanock RM, Perez-Schael I: Jennerian and modified Jennerian approach to vaccination against rotavirus diarrhea using a quadrivalent rhesus rotavirus (RRV) and human-RRV reassortant vaccine. Arch Virol Suppl 1996, 12:163–175.
Rennels MB, Losonsky GA, Young AE, et al.: An efficacy trial of the rhesus rotavirus vaccine in Maryland. Am J Dis Child 1990, 144:601–604.
Santosham M, Letson GW, Wolff M, et al.: A field study of the safety and efficacy of two candidate rotavirus vaccines in a Native American population. J Infect Dis 1991, 163:483–487.
Bernstein DI, Glass RI, Rodgers G, et al.: Evaluation of rhesus rotavirus monovalent and tetravalent reassortant vaccines in US children. JAMA 1995, 273:1191–1196.
Rennels MB, Glass RI, Dennehy PH, et al.: Safety and efficacy of high-dose rhesus-human reassortant rotavirus vaccines—report of the National Multicenter Trial. United States Rotavirus Vaccine Efficacy Group. Pediatrics 1996, 97:7–13.
Takala AK, Koskenniemi E, Joensuu J, et al.: Economic evaluation of rotavirus vaccinations in Finland: randomized, double-blind, placebo-controlled trial of tetravalent rhesus rotavirus vaccine. Clin Infect Dis 1998, 27:272–282.
Joensuu J, Koskenniemi E, Vesikari T: Symptoms associated with rhesus-human reassortant rotavirus vaccine in infants. Pediatr Infect Dis J 1998, 17:334–340.
Intussusception among recipients of rotavirus vaccine — United States, 1998–1999. MMWR Morb Mortal Wkly Rep 1999, 48:577–581. This is the original report of the possible association between rotavirus vaccine and intussusception.
American Academy of Pediatrics: AAP Issues Public Health Advisory. Chicago: AAP; 1999.
Rennels MB, Parashar UD, Holman RC, et al.: Lack of an apparent association between intussusception and wild or vaccine rotavirus infection. Pediatr Infect Dis J 1998, 17:924–925. This prelicensure study examined the possible association between intussusception and natural or vaccine-strain rotavirus infection.
Pokorny WJ: Intussusception. In Principles and Practice of Pediatrics. Edited by Oski FA. Philadelphia: JB Lippincott; 1990:1695–1697.
Rosenthal C, Chen R: The reporting sensitivities of two passive surveillance systems for vaccine adverse events. Am J Public Health 1995, 85:1706–1709.
ACIP revokes recommendation for rotavirus vaccine use. In Advisory Committee on Immunization Practices. Atlanta; 1999.
Perez-Schael I, Guntinas MJ, Perez M, et al.: Efficacy of the rhesus rotavirus-based quadrivalent vaccine in infants and young children in Venezuela. N Engl J Med 1997, 337:1181–1187.
Ward RL, Dinsmore A, Goldberg G, et al.: Shedding of rotavirus after administration of the tetravalent rhesus rotavirus vaccine. Pediatr Infect Dis J 1998, 17:386–390.
Mulcahy DL, Kamath KR, de Silva LM, et al.: A two-part study of the aetiological role of rotavirus in intussusception. J Med Virol 1982, 9:51–55.
Nicolas JC, Ingrand D, Fortier B, Bricout F: A one-year virological survey of acute intussusception in childhood. J Med Virol 1982, 9:267–271.
Konno T, Suzuki H, Kutsuzawa T, et al.: Human rotavirus and intussusception. N Engl J Med 1977, 297:945.
Konno T, Suzuki H, Kutsuzawa T, et al.: Human rotavirus infection in infants and young children with intussusception. J Med Virol 1978, 2:265–269.
Clark HF, Offit PA, Ellis RW, et al.: The development of a multivalent bovine rotavirus (WC3) reassortant vaccine for infants. J Infect Dis 1996, 174:S73-S80.
Hoshino Y, Jones RW, Chanock RM, Kapikian AZ: Construction of four double gene substitution human x bovine rotavirus reassortant vaccine candidates. J Med Virol 1997, 51:319–325.
Barnes GL, Lund JS, Adams L, et al.: Phase I trial of a candidate rotavirus vaccine (RV3) derived from a human neonate. J Paediatr Child Health 1997, 33:300–304.
Bernstein DI, Sack DA, Rothstein E, et al.: Efficacy of live, attenuated, human rotavirus vaccine 89-12 in infants: a randomised placebo-controlled trial. Lancet 1999, 354:287–290.
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Coffin, S.E. Rotavirus vaccines: Current controversies and future directions. Curr Infect Dis Rep 2, 68–72 (2000). https://doi.org/10.1007/s11908-000-0090-0
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DOI: https://doi.org/10.1007/s11908-000-0090-0