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Simplified Reverse Genetics Method to Recover Recombinant Rotaviruses Expressing Reporter Proteins
Published on: April 17, 2020
Rotavirus live, oral, pentavalent vaccine
1Department of Pharmacy Practice, Arnold & Marie Schwartz College of Pharmacy and Health Sciences, Long Island University, Brooklyn, NY 11201, USA. Catherine.Tom@liu.edu
Clinical Therapeutics
|January 19, 2008
Summary
The pentavalent rotavirus vaccine (PRV) effectively prevents rotavirus gastroenteritis (RVGE) in infants, significantly reducing hospitalizations and emergency visits. Post-marketing surveillance is ongoing to confirm safety regarding intussusception.
Area of Science:
- Pediatric infectious diseases
- Vaccinology
- Public health
Background:
- In 2006, the FDA approved a live, oral, pentavalent rotavirus vaccine (PRV) for infant immunization against rotavirus gastroenteritis (RVGE).
- Recommendations from the CDC and AAP advise routine infant vaccination with PRV at 8, 12, and 24 months of age.
Purpose of the Study:
- To review the composition, clinical efficacy, adverse events, and cost-effectiveness of the pentavalent rotavirus vaccine (PRV).
- To assess the vaccine's impact on rotavirus gastroenteritis (RVGE) prevalence and healthcare utilization in infants.
Main Methods:
- Literature search of MEDLINE and International Pharmaceutical Abstracts (1990-2007) using terms like RotaTeq, PRV, and intussusception.
- Inclusion of publications from reference lists and guidelines from CDC and AAP websites.
- Analysis of two Phase III clinical trials evaluating PRV efficacy, safety, and immunogenicity.
Main Results:
- PRV demonstrated high efficacy in preventing RVGE (74% overall, 98% severe RVGE) and significantly reduced hospitalizations (95.8%) and ED visits (93.7%).
- No confirmed cases of intussusception were linked to the vaccine in clinical trials; adverse events like fever, diarrhea, and vomiting were similar to placebo.
- PRV can be co-administered with other routine infant vaccinations; post-marketing surveillance noted 28 VAERS reports of intussusception, requiring further investigation.
Conclusions:
- Published studies indicate PRV is effective in reducing RVGE prevalence in the US.
- While large trials showed no intussusception cases, post-marketing surveillance via VAERS and CDC is crucial to confirm vaccine safety regarding this rare event.
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