ROTAVIRUS- CHALLENGES AHEAD

- Dr. Gulrukh Hashmi

OVERVIEW

Introduction

Disease burden

Virus description

Epidemiology

Vaccine

Challenges

Conclusion

INTRODUCTION

Diarrhea remains one of the commonest illnesses of

childhood.

In developing countries it is 3rd most common cause of

deaths

20 different pathogens cause diarrhea.

Rotavirus causes 25-55% hospital admissions for

diarrhea

DISEASE BURDEN

Rotavirus is the most common cause of severe diarrhea

in infants and young children worldwide.

Globally it is responsible for 611,000 childhood deaths

More than 80% deaths occur in low-income countries

and India records the highest mortality

ROTAVIRUS DISEASE BURDEN IN INDIA

122,000-153,000

457,000-884,000

2 million

Estimated annual number and risk of death, hospitalization, and outpatientvisits due to rotavirus diarrhea in children <5 years of age in India.

Adapted from: J. E. Tate et al. Disease and economic burden of rotavirus diarrhea in India/Vaccine 27 S (2009) F18–F24

EVENTSRISK

1 in every 177-196 children

1 in every 31-59 children

1 in every 13 children

Deaths

Hospitalizations

Outpatient Visits

FINANCIAL BURDEN

It is estimated that India spends approximately Rs 1.8–3.2 billion

(US$ 37.4 to 66.8 million) in direct medical costs annually

Rs 107–176 million (US$ 2.2–3.7 million) in non-medical costs

for the treatment of rotavirus diarrhea in children <5 years of age

With a total burden of Rs 2.0–3.4 billion (US$ 41–72 million)

VIROLOGY

Rotaviruses are double stranded RNA viruses

Belongs to the family Reoviridae

Scientists have described 7 groups(A-G)

Only A,B,C infect humans

of which A is commonest.

A is further divided in G and

P serotypes

MODE OF TRANSMISSION

Faeco-oral route

Direct contact

Fomites

Respiratory droplets

Incubation period - 24 to 48 hrs

CLINICAL MANIFESTATIONS

Vomiting

Mild watery diarrhea of short duration

Severe gastroenteritis

Life-threatening dehydration secondary to

gastrointestinal fluid loss

Majority of children become infected with rotavirus

within the first three years of life

With a peak incidence of rotavirus diarrhea between six

to 24 months of age

Initial infection after 3months of age is most likely to

cause severe diarrhea and dehydration.

PREVENTIVE MEASURES

Breast-feeding

Hand washing

Improve water quality and sanitation

Oral rehydration therapy- to prevent

dehydration

IMPROVEMENT IN HYGIENE AND SANITATION DOES NOT SIGNIFICANTLY REDUCE ROTAVIRUS INFECTION

Almost every child infected by 2 year irrespective of socio economic class

Rotavirus is highly contagious

Resistant to inactivation

Highly Stable

ROTAVIRUS DIARRHEA AND ORT

Oral rehydration therapy reduces mortality but does not

decrease the episode duration or their consequences such

as malnutrition.

Adherence to ORT is poor.

Leads to use of antibiotics or other treatment of no

proven value.

Resistance to disinfectants

Ineffectiveness to ORS

Need for effective vaccine

VACCINES

RotaShield

Rotarix

RotaTeq

Rotavac

Two oral, live, attenuated rotavirus vaccines

Rotarix (GlaxoSmithKline Biologicals,Rixensart,

Belgium)

RotaTeq (Merck & Co. Inc., West Point, PA, USA)

Available internationally

Both vaccines are considered safe and effective

WHO now recommends that infants worldwide be

vaccinated against Rotavirus

Rotavirus Vaccines

RotaTeq RotarixManufacturer Merk & Co. GSK

Genetic framework

Bovine Rotavirus – WC3

Human Rotavirus-89-12

Composition 5 Human, Bovine reassortant

Single Human rotavirus

Genotypes G1, 2, 3, 4 and [P8] G1 [P8]

Dosage Schedule 3 doses at 2, 4 and 6 months

2 doses at 2 and 4 months

Route oral oral

Presentation liquid Lysophilized-reconstituted

Efficacy against severe disease

85% 95%

Virus shedding Up to 13 % 17 % - 27%

ROTARIX™ VACCINE

Administered orally

A two-dose schedule

Infants approximately 2 and 4 months of age

The first dose can be administered at the age of 6 weeks and must

be given no later than the age of 12 weeks.

The interval between the two doses should be at least 4 weeks.

The two-dose schedule should be completed by age 16 weeks and

not later than 24 weeks of age

ROTATEQ™ VACCINE

Three oral doses at ages 2, 4, and 6months.

The first dose should be administered between ages 6 – 12

weeks and subsequent doses at intervals of 4 – 10 weeks.

Vaccination should not be initiated for infants aged > 12

weeks.

All three doses should be administered before the age of 32

weeks

BENEFITS OF VACCINATION

A universal rotavirus immunization program in

Asia has the potential to avert

109,000 deaths

1.4 million hospitalizations

7.7 million outpatient visits, and US $ 139

million in healthcare costs each year, for

children < 5 years of age,

ROTAVAC

Developed by Govt of India

and Bharat biotech

Oral vaccine to be given in 3 doses at 6,10 and 14

weeks.

More affordable than the other two vaccines

Needs to be licensed and sanctioned by WHO before it

can be sold in India and distributed globally

ROTAVAC

The efficacy of vaccine in study was 50 to 58% while

that of Rotarix vaccine in West is 90%.

The trials for vaccine enrolled only 6,779 infants.

Impossible to compare the side effects of this vaccine

with the previously available ones

CHALLENGES FOR IMPLEMENTATION

Monitoring impact of rotavirus vaccines on diarrheal

disease burden in resource-limited settings

Improving rotavirus vaccine performance in developing

countries.

Monitoring the safety of rotavirus vaccines & further

understanding the relationship between rotavirus

vaccines and intussusceptions

CHALLENGES

Monitoring rotavirus vaccine impact on circulating

rotavirus strains

Overcoming programmatic challenges

Accurate information on vaccine risk and benefits to

maintain public trust in rotavirus immunization

Ensuring adequate vaccine supply and competition

CONCLUSION

Rotavirus diarrhea is a significant public health problem

in India

Rotavirus accounts for more severe dehydrating diarrhea

in children.

In view of continuing high morbidity and mortality from

rotavirus diarrhea and enormous economic consequences

thereof, there is a strong case for immunization against

rotavirus infection in India.

CONCLUSION

Availability of current rotavirus vaccines and continued

development of new rotavirus vaccines

Introduction of the vaccine in routine immunisation

schedule

Progress needed in different areas.

Decline in morbidity and mortality

REFERENCES

WHO AFMC’s Textbook of Public health and community medicine

Shaun K Morris, Shally Awasthi,Ajay Khera,Diego G Basani. Rotavirus mortality in India: estimates based on a nationally representative survey of diarrheal deaths ; Bull Word Health Organisation 2012,90:720-727.

Penelope H Dennehy. Rotavirus Vaccine : an overview Clinical Microbiology Reviews,Jan 2008,198-208 Vol 21,No.1

J.E.Tate,Manish m Patel, Global impact of rotavirus vaccines expert review Vaccines 9 (4), 395-40407(2010)

REFERENCES

Dheeraj shah, panna choudhary, piyush Gupta Promoting appropriate management of diarrhea: a systematic review of literature for advocacy and action: Unicef-PhFI series on newborn and child health,India Indian Pediatrics Journal Vol 49-August 16,2012627-650.

Rakesh Lodha and Dheeraj Shah. Prevention of Rotavirus Diarrhea in India: Is Vaccination the Only Strategy?. Indian Pediatr 2012;49: 441-443

Paramita Sengupta. Rotavirus: The Challenges Ahead . Glass RI, Parashar VD, Bresee JS, Turcios R, Fischer TK,

Widowson MA, et al. Rotavirus vaccines: current prospects and future challenges. Lancet.2006;368:323–32.

REFERENCES

 Naik TN. Commentary. Rapid diagnosis of rotavirus infection: prevent unnecessary use of antibiotics for treatment of children Diarrhea. Indian J Med Res.2004;119:5–7

WHO. World Health Org Report of the meeting on future directions for rotavirus vaccine research in developing countries. Geneva: 2000. Feb, Report no. WHO/VandB/00.23.

Pratibha Masand. Propaganda by consumer goods companies to curb rotavirus infection.

Consensus recommendation on immunization and IAP Immunization time table 2012. Indian academy of Paediatrics Committee on Immunization. Indian paediatrics, July 2012;vol. 49.pp 549-564.

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