Literature DB >> 28486524

Rotavirus vaccine will have an impact in Asia.

Carl D Kirkwood1, A Duncan Steele1.   

Abstract

Carl Kirkwood and Duncan Steele discuss the evidence supporting rotavirus vaccine deployment in Asian countries.

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Year:  2017        PMID: 28486524      PMCID: PMC5423548          DOI: 10.1371/journal.pmed.1002298

Source DB:  PubMed          Journal:  PLoS Med        ISSN: 1549-1277            Impact factor:   11.069


Diarrhea remains the second leading infectious cause of death among children under five years of age, with more than half a million deaths each year. Rotavirus disease accounts for 25%–30% of all severe diarrhea cases [1]. While every child is at risk of rotavirus infection, the vast majority of rotavirus deaths occur in low- and middle-income countries, particularly in sub-Saharan Africa and South Asia, where access to treatment for severe rotavirus-related diarrhea may be limited or absent. Rotavirus immunization is well recognized as the best approach to protect children from mortality and morbidity caused by severe rotavirus disease. In 2009, the World Health Organization (WHO) recommended that all countries should include rotavirus vaccines in their national immunization programs, particularly those with high child mortality due to diarrhea [2]. Currently, 84 countries have introduced rotavirus vaccines into their national immunization programs, including 41 Gavi-eligible countries with financial support for vaccine procurement. The uptake of rotavirus vaccines in sub-Saharan Africa and the Americas has been excellent; however, progress in Asia has been insignificant, with a notable lack of introductions into national immunization programs despite the well-characterized burden of rotavirus disease [3,4]. Rotavirus disease and hospitalization have been significantly reduced in high- and middle-income countries, with multiple vaccine-effectiveness studies documenting their powerful impact [5]. Moreover, recent vaccine-effectiveness studies in low-middle–and low-income countries in Latin America and Africa have shown dramatic reductions in rotavirus-associated morbidity and mortality [6-8]. Thus, the large infant population at risk in Asia is a priority for future rotavirus introduction efforts. The reasons for delayed vaccine introduction likely vary by country, with multiple stages along the pathway to implementation posing hurdles, including evidence gathering, decision-making, planning, and introduction. The driver for introduction may also differ; for example, perceived health benefits may be the primary reason in one area, and economic benefits may be more important in another. However, the limited data from low-resource populations across Asia, which are needed to provide evidence of the clinical protection that rotavirus vaccination provides against severe diarrhea, have also likely stalled the uptake of rotavirus vaccines within these regions. In a recent study in PLOS Medicine, John Victor and colleagues describe effectiveness of the human monovalent rotavirus vaccine, (Rotarix) in Bangladesh [9], providing evidence that should help to change the status quo in the region. Victor and colleagues’ study is the first to evaluate protection in infants in a low-resource population in Asia, using the WHO-recommended schedule at 6 and 10 weeks of age (i.e., the visits corresponding to the first and second dose of diphtheria–pertussis–tetanus-containing vaccine [DPT 1 and DPT 2]). The trial used a cluster-randomized village approach, comparing Rotarix vaccination integrated into the routine childhood immunization program in Bangladesh to the standard childhood immunizations without rotavirus vaccine but still utilizing oral rehydration salt (ORS) and other routine standard of care. The vaccine reduced severe acute rotavirus diarrhea by 41.4% (95% CI 23.2–55.2) among vaccinees. However, vaccine-induced protection appeared to wane from 45.2% in the first year of life to 28.9% during the second year, with the latter estimate not reaching statistical significance. Also, this study did not identify any measurable indirect protective effects despite being designed to capture the full effects of a rotavirus vaccination program. Interestingly, these effectiveness rates generated through the programmatic implementation of the vaccine are consistent with the Phase III efficacy results for another rotavirus vaccine, RotaTeq, in Bangladesh, which demonstrated 42.7% (95% CI 10.4–63.9) efficacy against moderate-to-severe rotavirus diarrhea [10]. The results also align with the Phase III efficacy data for Rotarix in Malawi: 49.4% (95% CI 19.2–68.3) [11]; waning protection was also noted in this clinical trial setting in the second year of life [12]. Finally, an indigenous Indian vaccine (Rotavac) recently demonstrated 53.6% efficacy (95% CI 35.0–66.9) against moderate-to-severe rotavirus diarrhea in India [13]. Thus, rotavirus vaccines implemented in Asia are likely to have a similar impact to that observed in Bangladesh in Victor and colleagues’ study and in Gavi-eligible countries previously. Concerns about the costs associated with rotavirus vaccines showing limited efficacy have been raised. A recent examination of the cost effectiveness of rotavirus immunization in Bangladesh highlighted that the vaccine is cost effective, even in the scenario of no Gavi financing support (personal communication, C. Pecenka to C. Kirkwood). Similar health economic analyses consistently indicate that rotavirus vaccines are very cost-effective interventions for low- and middle-income countries with a high diarrhea burden [14]. With increasing regional evidence of the benefits of vaccination, the introduction of rotavirus vaccines in national immunization programs should be a priority for countries in the Asian region. In recent progress, India commenced introduction of locally manufactured vaccine (Rotavac), using a staged rollout that commenced in March, 2016. The first four states introduced the rotavirus vaccine into the state-based immunization program and included active monitoring for programmatic and safety concerns as the vaccine was rolled out. Vaccine effectiveness is also being assessed. During 2017–2018, the government plans to roll out the vaccine into an additional five states, reaching approximately 50% of the Indian birth cohort. Another large country, Pakistan, commenced routine rotavirus immunization, with Gavi support, in January 2017 and plans to expand immunization over the coming months. Finally, Gavi recently approved support for Bangladesh to introduce rotavirus vaccine, which is anticipated to launch in 2018. Therefore, the report by Victor and colleagues is timely and provides excellent evidence for the health benefits of rotavirus vaccines within a low-resource setting in Asia. The vaccine-effectiveness data highlight that introduction in settings of high rotavirus disease burden will result in a large public health benefit through a significant reduction in morbidity and mortality associated with rotavirus infection. As India, Pakistan, Bangladesh, and other countries in the region scale up the programmatic use of rotavirus vaccines, we should see dramatic reductions in childhood mortality due to diarrheal disease. Furthermore, as many countries transition from Gavi support and subsequently have to pay the full vaccine costs, we will see the advent of new safe, efficacious, and lower-cost rotavirus vaccines from manufacturers in India and elsewhere in the region, which will support the long-term sustainability of national immunization programs.
  14 in total

1.  Childhood diarrhea deaths after rotavirus vaccination in Mexico.

Authors:  Vesta Richardson; Umesh Parashar; Manish Patel
Journal:  N Engl J Med       Date:  2011-08-25       Impact factor: 91.245

2.  Meeting of the Strategic Advisory Group of Experts on immunization, October 2009 - conclusions and recommendations.

Authors: 
Journal:  Wkly Epidemiol Rec       Date:  2009-12-11

3.  Estimated impact and cost-effectiveness of rotavirus vaccination in India: effects of geographic and economic disparities.

Authors:  Richard Rheingans; John D Anderson; Benjamin Anderson; Poulomy Chakraborty; Deborah Atherly; Deepa Pindolia
Journal:  Vaccine       Date:  2014-08-11       Impact factor: 3.641

Review 4.  Rotavirus vaccines: a story of success.

Authors:  H Kollaritsch; M Kundi; C Giaquinto; M Paulke-Korinek
Journal:  Clin Microbiol Infect       Date:  2015-02-11       Impact factor: 8.067

5.  Efficacy of pentavalent rotavirus vaccine against severe rotavirus gastroenteritis in infants in developing countries in Asia: a randomised, double-blind, placebo-controlled trial.

Authors:  K Zaman; Duc Anh Dang; John C Victor; Sunheang Shin; Md Yunus; Michael J Dallas; Goutam Podder; Dinh Thiem Vu; Thi Phuong Mai Le; Stephen P Luby; Huu Tho Le; Michele L Coia; Kristen Lewis; Stephen B Rivers; David A Sack; Florian Schödel; A Duncan Steele; Kathleen M Neuzil; Max Ciarlet
Journal:  Lancet       Date:  2010-08-06       Impact factor: 79.321

6.  Surveillance of rotavirus in a rural diarrhoea treatment centre in Bangladesh, 2000-2006.

Authors:  K Zaman; Md Yunus; A S G Faruque; Shams El Arifeen; Ilias Hossain; Tasnim Azim; Mustafizur Rahman; G Podder; Eliza Roy; S Luby; David A Sack
Journal:  Vaccine       Date:  2009-11-20       Impact factor: 3.641

7.  Efficacy of a monovalent human-bovine (116E) rotavirus vaccine in Indian infants: a randomised, double-blind, placebo-controlled trial.

Authors:  Nita Bhandari; Temsunaro Rongsen-Chandola; Ashish Bavdekar; Jacob John; Kalpana Antony; Sunita Taneja; Nidhi Goyal; Anand Kawade; Gagandeep Kang; Sudeep Singh Rathore; Sanjay Juvekar; Jayaprakash Muliyil; Alok Arya; Hanif Shaikh; Vinod Abraham; Sudhanshu Vrati; Michael Proschan; Robert Kohberger; Georges Thiry; Roger Glass; Harry B Greenberg; George Curlin; Krishna Mohan; G V J A Harshavardhan; Sai Prasad; T S Rao; John Boslego; Maharaj Kishan Bhan
Journal:  Lancet       Date:  2014-03-12       Impact factor: 79.321

8.  Effect of human rotavirus vaccine on severe diarrhea in African infants.

Authors:  Shabir A Madhi; Nigel A Cunliffe; Duncan Steele; Desirée Witte; Mari Kirsten; Cheryl Louw; Bagrey Ngwira; John C Victor; Paul H Gillard; Brigitte B Cheuvart; Htay H Han; Kathleen M Neuzil
Journal:  N Engl J Med       Date:  2010-01-28       Impact factor: 91.245

9.  Effectiveness of Pentavalent Rotavirus Vaccine Under Conditions of Routine Use in Rwanda.

Authors:  Jacqueline E Tate; Fidele Ngabo; Philippe Donnen; Maurice Gatera; Jeannine Uwimana; Celse Rugambwa; Jason M Mwenda; Umesh D Parashar
Journal:  Clin Infect Dis       Date:  2016-05-01       Impact factor: 9.079

10.  Effectiveness of a live oral human rotavirus vaccine after programmatic introduction in Bangladesh: A cluster-randomized trial.

Authors:  K Zaman; David A Sack; Kathleen M Neuzil; Mohammad Yunus; Lawrence H Moulton; Jonathan D Sugimoto; Jessica A Fleming; Ilias Hossain; Shams El Arifeen; Tasnim Azim; Mustafizur Rahman; Kristen D C Lewis; Andrea J Feller; Firdausi Qadri; M Elizabeth Halloran; Alejandro Cravioto; John C Victor
Journal:  PLoS Med       Date:  2017-04-18       Impact factor: 11.069

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  7 in total

1.  Rotavirus Vaccine will Improve Child Survival by More than Just Preventing Diarrhea: Evidence from Bangladesh.

Authors:  Senjuti Saha; Mathuram Santosham; Manzoor Hussain; Robert E Black; Samir K Saha
Journal:  Am J Trop Med Hyg       Date:  2017-11-30       Impact factor: 2.345

2.  The Efficacy of Bifidobacterium longum BORI and Lactobacillus acidophilus AD031 Probiotic Treatment in Infants with Rotavirus Infection.

Authors:  Myeong Soo Park; Bin Kwon; Seockmo Ku; Geun Eog Ji
Journal:  Nutrients       Date:  2017-08-16       Impact factor: 5.717

Review 3.  Improving rotavirus vaccine coverage: Can newer-generation and locally produced vaccines help?

Authors:  Jacqueline Deen; Anna Lena Lopez; Suman Kanungo; Xuan-Yi Wang; Dang Duc Anh; Milagritos Tapia; Rebecca F Grais
Journal:  Hum Vaccin Immunother       Date:  2017-12-21       Impact factor: 3.452

Review 4.  Accounting for equity considerations in cost-effectiveness analysis: a systematic review of rotavirus vaccine in low- and middle-income countries.

Authors:  Marie-Anne Boujaoude; Andrew J Mirelman; Kim Dalziel; Natalie Carvalho
Journal:  Cost Eff Resour Alloc       Date:  2018-05-18

Review 5.  Experiences with rotavirus vaccines: can we improve rotavirus vaccine impact in developing countries?

Authors:  A D Steele; J C Victor; M E Carey; J E Tate; D E Atherly; C Pecenka; Z Diaz; U D Parashar; C D Kirkwood
Journal:  Hum Vaccin Immunother       Date:  2019-02-08       Impact factor: 3.452

6.  A Real-Time RT-PCR Assay for Genotyping of Rotavirus

Authors:  Seyed Dawood Mousavi-Nasab; Farzaneh Sabahi; Hooman Kaghazian; Mahdi Paryan; Siamak Mirab Samiee; Mostafa Ghaderi; Fatemeh Zali; Manoochehr Makvandi
Journal:  Iran Biomed J       Date:  2020-06-13

7.  Diarrheal Etiology and Impact of Coinfections on Rotavirus Vaccine Efficacy Estimates in a Clinical Trial of a Monovalent Human-Bovine (116E) Oral Rotavirus Vaccine, Rotavac, India.

Authors:  Ira Praharaj; James A Platts-Mills; Sunita Taneja; Kalpana Antony; Krista Yuhas; Jorge Flores; Iksung Cho; Nita Bhandari; R Revathy; Ashish Bavdekar; Temsunaro Rongsen-Chandola; Timothy McMurry; Eric R Houpt; Gagandeep Kang
Journal:  Clin Infect Dis       Date:  2019-07-02       Impact factor: 9.079

  7 in total

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