Journal Article

The Pentavalent Rotavirus Vaccine: Discovery to Licensure and Beyond

Penny M. Heaton and Max Ciarlet

in Clinical Infectious Diseases

Published on behalf of Infectious Diseases Society of America

Volume 45, issue 12, pages 1618-1624
Published in print December 2007 | ISSN: 1058-4838
Published online December 2007 | e-ISSN: 1537-6591 | DOI: http://dx.doi.org/10.1086/522997
The Pentavalent Rotavirus Vaccine: Discovery to Licensure and Beyond

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Twenty-five years passed between the discovery of the parent strain (WC3) of the pentavalent human-bovine reassortant rotavirus vaccine (PRV) in 1981 and the licensure of PRV in 2006. This orally administered liquid vaccine, which is given as a 3-dose series, is indicated for the prevention of rotavirus gastroenteritis, caused by the G serotypes contained in the vaccine, in infants and children. PRV is recommended by the Advisory Committee on Immunization Practices and the American Academy of Pediatrics for administration to all infants in the United States. These recommendations are supported by the results of the phase III studies, which demonstrated that PRV is well tolerated and efficacious. PRV reduced rotavirus-related hospitalizations by 96% and was not associated with an increased incidence of serious adverse events, including intussusception. This report focuses on the safety and efficacy data from the late-phase studies of PRV and discusses plans for providing this vaccine to the developing world.

Journal Article.  4617 words.  Illustrated.

Subjects: Infectious Diseases ; Immunology ; Public Health and Epidemiology ; Microbiology

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