Established and new rotavirus vaccines: a comprehensive review for healthcare professionals

ABSTRACT

Robust scientific evidence related to two rotavirus (RV) vaccines available worldwide demonstrates their significant impact on RV disease burden. Improving RV vaccination coverage may result in better RV disease control. To make RV vaccination accessible to all eligible children worldwide and improve vaccine effectiveness in high-mortality settings, research into new RV vaccines continues. Although current and in-development RV vaccines differ in vaccine design, their common goal is the reduction of RV disease risk in children <5 years old for whom disease burden is the most significant. Given the range of RV vaccines available, informed decision-making is essential regarding the choice of vaccine for immunization. This review aims to describe the landscape of current and new RV vaccines, providing context for the assessment of their similarities and differences. As data for new vaccines are limited, future investigations will be required to evaluate their performance/added value in a real-world setting.

PLAIN LANGUAGE SUMMARY

The disease

• Rotaviruses are a leading cause of acute diarrhea, also called gastroenterities, among young children. They can lead to servere dehydration, hospitilization, and even death.

• Several vaccines against rotavirus disease have been developed. Their design is based on:

• weakened human rotavirus that mimic natural infection without causing disease, such as Rotarix, Rotavin-M1, Rotavac and RV3-BB (not yet marketed)

• non-infective animal viruses such as RotaTeq, Rotasiil or LLR.

• new concepts, such as inactivated vaccines

What is new?

We reviewed the current, recently launched and soon-to-be-launched rotavirus vaccines and found that:

• Rotarix and RotaTeq have been used globally for more than a decade with demonstrated impact and favourable safety profile

• Limited data on the impact and safety profile are available to date for:

• Rotavin-M1 and LLR vaccines, locally marketed in Vietnam and China, respectively

• Rotavac and Rotasiil, licensed in india

• New vaccine concepts have been mainly investigated animal models with encouraging results

What is the impact?

• Despite their different designs, the current rotavirus vaccines demonstrate effectiveness in protecting against rotairus gastroenterits.

• Data for most recent vacciness are currently limited, for which additional data are needed to demonstrate how they will perform on a larger scale, their added value in a real setting and ther safety profile.

KEYWORDS:

• Rotavirus vaccines
• rotavirus vaccine design
• coverage
• impact

Acknowledgments

The authors thank the Modis platform (Modis, Wavre, Belgium c/o GSK) for providing medical writing services and Emmanuelle Ghys, PhD (Modis, Wavre, Belgium c/o GSK) for editorial support and publication management.

Contributorship

All authors participated in the preparation of the article and have approved the final version of the manuscript.

Disclosure of potential conflicts of interest

Bernd Benninghoff, Serge Debrus, Priya Pereira and Volker Vetter are employed by and hold shares in the GSK group of companies. Robert C. Gardner was employed by the GSK group of companies during the conduct of this study and has no non-financial interest to declare.

Trademark statements

Rotarix is a trademark owned by or licensed to the GSK group of companies. RotaTeq is a trademark of Merck & Co., Inc. Rotavac is a trademark of Bharat Biotech. Rotavin-M1 is a trademark of Polyvac. Lanzhou lamb rotavirus vaccine is a trademark of Lanzhou Institute of Biomedical Products. Rotasiil is a trademark of Serum Institute of India. Rotashield is a trademark of Wyeth.

Additional information

Funding

This publication was sponsored by GlaxoSmithKline Biologicals SA.