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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 outpatient
visits 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 Rotarix
Manufacturer 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.
THANK YOU

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Rotavirus Vaccines: Challenges in India

  • 1. ROTAVIRUS- CHALLENGES AHEAD - Dr. Gulrukh Hashmi
  • 2. OVERVIEW  Introduction  Disease burden  Virus description  Epidemiology  Vaccine  Challenges  Conclusion
  • 3. 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
  • 4. 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
  • 5.
  • 6. ROTAVIRUS DISEASE BURDEN IN INDIA 122,000-153,000 457,000-884,000 2 million Estimated annual number and risk of death, hospitalization, and outpatient visits 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
  • 7. 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)
  • 8. 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
  • 9. MODE OF TRANSMISSION  Faeco-oral route  Direct contact  Fomites  Respiratory droplets  Incubation period - 24 to 48 hrs
  • 10. CLINICAL MANIFESTATIONS  Vomiting  Mild watery diarrhea of short duration  Severe gastroenteritis  Life-threatening dehydration secondary to gastrointestinal fluid loss
  • 11.  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.
  • 12. PREVENTIVE MEASURES  Breast-feeding  Hand washing  Improve water quality and sanitation  Oral rehydration therapy- to prevent dehydration
  • 13. 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
  • 14. 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.
  • 17.  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
  • 18. Rotavirus Vaccines RotaTeq Rotarix Manufacturer 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%
  • 19. 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
  • 20. 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
  • 21.
  • 22. 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,
  • 23.
  • 24. 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
  • 25. 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
  • 26. 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
  • 27. 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
  • 28. 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.
  • 29. 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
  • 30. 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)
  • 31. 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.
  • 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.