Drug intelligence / Profile preview

Rotamune

Development stage
Discontinued
Lead developer
Pfizer
Modality
Vaccines & Immunotherapeutics
Administration
Oral
01

Overview

**Rotamune** is the non-US trade name associated with **RotaShield**, a live, oral, tetravalent rhesus-human reassortant rotavirus vaccine developed from National Institutes of Health technology and licensed to Wyeth. It contains a rhesus rotavirus serotype G3 strain plus three rhesus-human reassortant strains expressing human rotavirus VP7 serotypes G1, G2, and G4, designed to induce protective immunity against severe group A rotavirus gastroenteritis in infants. RotaShield was licensed in the United States in 1998 and authorized in the European Union in 1999, but distribution and use were stopped after post-marketing evidence established an increased risk of intussusception; its EU marketing authorization was subsequently withdrawn. ([ema.europa.eu](https://www.ema.europa.eu/en/medicines/human/EPAR/rotashield))

Brand names
RotamuneRotaShield
Other names
rhesus-human reassortant tetravalent rotavirus vaccinerotavirus vaccine, live, oral, tetravalentRRV-TV
02

Targets

RVA (Rotavirus A)

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