The rotavirus vaccine development pipeline

Abstract

Rotavirus disease is a leading global cause of mortality and morbidity in children under 5years of age. The effectiveness of the two globally used oral rotavirus vaccines quickly became apparent when introduced into both developed and developing countries, with significant reductions in rotavirus-associated mortality and hospitalizations. However, the effectiveness and impact of the vaccines is reduced in developing country settings, where the burden and mortality is highest. New rotavirus vaccines, including live oral rotavirus candidates and non-replicating approaches continue to be developed, with the major aim to improve the global supply of rotavirus vaccines and for local implementation, and to improve vaccine effectiveness in developing settings. This review provides an overview of the new rotavirus vaccines in development by developing country manufacturers and provides a rationale why newer candidates continue to be explored. It describes the new live oral rotavirus vaccine candidates as well as the non-replicating rotavirus vaccines that are furthest along in development.

Molecular epidemiology of group A rotavirus in outpatient diarrhea infants and children in Chongqing, China, 2011‐2015

“…There is no specific drug for the rotavirus diarrhea, but safe, effective, and affordable vaccination is an effective means to prevent and control rotavirus infection . There are four vaccines licensed for global use (Rotarix‐GSK, RotaTeq‐Merck, ROTAVAC, and ROTASIIL), others for national use (eg in Vietnam, China, and India) and several others in the pipeline, including neonatal and non‐replicating injectable vaccines …”

Global rotavirus vaccine introductions and coverage: 2006 – 2016

“…In March 2016, India launched a phased introduction of its indigenous vaccine ROTAVAC™ (Bharat Biotech, Hyderabad). 19 Pakistan began a phased rotavirus vaccine introduction in early 2017 20 and Nigeria's introduction is scheduled for 2018. 21 The Democratic Republic of Congo has made plans to introduce rotavirus vaccine with Gavi NVI support.…”

“…Lanzhou Institute is in late stage development of a new trivalent vaccine and the Wuhan Institute of Biological Products, in collaboration with PATH, is developing a hexavalent vaccine. 19 …”

“…2 Serum Institute of India is also seeking WHO pre-qualification for ROTASIIL™. Indonesia's national vaccine manufacturer, PT Biofarma, Bandung, is developing a rotavirus vaccine in collaboration with the Murdoch Children's Research Institute, Melbourne 19 but whether Indonesia would consider other WHO pre-qualified rotavirus vaccines in the interim for universal use is uncertain. None of the 13 Gavi-eligible countries in WHO's Southeast Asia and Western Pacific regions had introduced rotavirus vaccine by December 2016.…”

Rational design of heat stable lyophilized rotavirus vaccine formulations

“…1 Vaccination by rotavirus vaccines (RVVs) remains the most effective way to address the disease, 2 consequently World Health Organization (WHO) recommends introducing RVVs worldwide to reduce the heavy burden of RV caused under-5 years diarrheal mortality. 1 Although few RVVs are licensed for local use, as of this writing three RVVs were licensed globally; two monovalent vaccines Rotarix®, and Rotavac® and a pentavalent vaccine RotaTeq.® 3 These vaccines have been proven safe and efficacious, however, they require cold-chain storage at or below 2 o to 8 o C before use. 4-5 The need for introduction of RVVs by many low-income countries is high, but several limitations such as price, adequate supply as well as insufficient cold-chain capacity at distant delivery points, have slowed their introduction.…”