2. A bit about diarrhea & ORS
Epidemiology & disease burden of Rotavirus
Efficacy of Rotavirus vaccine incl differences
between Rotarix v/s Rotateq
Special issues with RV vaccines
CME
3. A bit about diarrhea & ORS
Epidemiology & disease burden of Rotavirus
Efficacy of Rotavirus vaccine incl differences
between Rotarix v/s Rotateq
Special issues with RV vaccines
CME
4.
5.
6.
7. A bit about diarrhea & ORS
Epidemiology & disease burden of Rotavirus
Efficacy of Rotavirus vaccine incl differences
between Rotarix v/s Rotateq
Special issues with RV vaccines
CME
8.
9. Almost every child infected by 2 years
irrespective of Socio Economic Class
Rotavirus is:
Highly Contagious: Person to person, feco-oral,
respiratory droplets
Resistant to inactivation: Most soaps and disinfectants
not effective
Highly Stable: Retains infectivity for several weeks
10.
11. Number of deaths due to
rotavirus disease (and
percentage of the global
total) in 10 countries with
the greatest number of
deaths due to rotavirus
disease.
23% of all deaths due to rotavirus disease occurred in India
Adapted from: Umesh Parashar, Global Mortality Associated with Rotavirus among Children • JID 2009:200 (Suppl 1) • S9-15
12.
13. Other
G9P[6]
7%
G9P[8] 1%
3%
G4P[8]
9%
G3P[8]
3%
G2P[4]
12% G1P[8]
65%
Other=untypeable and rare G-P combinations.
1. Santos N, Hoshino Y. Rev Med Virol. 2005;15:29–56. Reproduced by permission of John Wiley & Sons Limited.
14. IRSN Data
G12 P[4][6][8],
6.5%
G9 P[8], 8.5%
G2 P[4], 25.7%
G1 P[8], 22.1%
Unique features: Diversity of rotavirus strains & mixed infections. Need for vaccines formulated
against a broad range of strains.2
It is found that the predominant Rota Virus strain (type) in cities varied from year to year and
from city to city. 3
1. The Journal of Infectious Diseases 2009; 200:S147–53. 2. Indian J. Med Res 118, Aug 2003, Pg 59-67 3. Journal of Clinical Microbiology. Oct 2001, Pg 3524-3529.
15.
16.
17. RISK EVENTS
1 in every 177-196 children 122,000-153,000
Deaths
1 in every 31-59 children 457,000-884,000
Hospitalizations
1 in every 13 children 2 million
Outpatient Visits
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
18.
19. A bit about diarrhea & ORS
Epidemiology & disease burden of Rotavirus
Efficacy of Rotavirus vaccine incl differences
between Rotarix v/s Rotateq
Special issues with RV vaccines
CME
22. Vaccines should mimic the natural infection
Predominance of individual serotypes
pattern can vary
from A multivalent vaccine is by geographic region.1
year to year and expected to give more
Primary infections are usually associated with
diverse protection against multiple serotypes
with the 1st dose
more severe disease than subsequent
infections.2 are expected to give good protection
2 doses
against moderate to severe diarrheas
Protection against disease is thought to
increase with each subsequent protection 2
3 doses are expected to give good infection.
against mild diarrheas as well
Immunity following primary infection is
thought to be predominantly serotype specific.2
1. Santos N et al. Rev Med Virol. 2005;15:29–56. 2. Velázquez FR et al. N Engl J Med. 1996;335:1022–1028.
23. SEROTYPE-SPECIFIC
(HOMOTYPIC)
Immune Response
First infection elicited a HOMOTYPIC
protective response
Second & subsequent“CROSS-PROTECTIVE”
infections
(HETEROTYPIC)
elicited a HETEROTYPIC protective
response
1 2 3
Number of Infections
(Graph for illustrative purposes only)
• After primary infection, antibody response appears to be predominantly serotype specific (homotypic).1,2
• After subsequent infections, a broadened, cross-reactive (heterotypic) antibody response can occur.1,2
1. Cortese MM et al. MMWR Morb Mort Wkly Rep. 2009;58(RR02):1–25. 2. Jiang B et al. Clin Infect Dis. 2002;34:1351–1361.
24.
25.
26.
27.
28.
29.
30.
31. A bit about diarrhea & ORS
Epidemiology & disease burden of Rotavirus
Efficacy of Rotavirus vaccine incl differences
between Rotarix v/s Rotateq
Special issues with RV vaccines
CME
32.
33.
34.
35.
36.
37.
38. A bit about diarrhea & ORS
Epidemiology & disease burden of Rotavirus
Efficacy of Rotavirus vaccine incl differences
between Rotarix v/s Rotateq
Special issues with RV vaccines
CME
39. A 10-week-old boy born HIV positive
A 16-week-old adopted girl from unknown
parentage
A 12-week-old premature stable boy in the
neonatal intensive care unit
A 13-week-old girl who is breastfeeding
40. A 10-week-old boy born HIV positive
A 16-week-old adopted girl from unknown
parentage
A 12-week-old premature stable boy in the
neonatal intensive care unit
A 13-week-old girl who is breastfeeding
41.
42. An infant with short bowel syndrome
An infant with HIV
An infant with severe combined
immunodeficiency disease
An infant with spina bifida
43. An infant with short bowel syndrome
An infant with HIV
An infant with severe combined
immunodeficiency disease
An infant with spina bifida
46. A full-term 5-week-old infant
A full-term 33-week-old infant
A full-term 16-week-old infant
A preterm 8-week-old infant
47. A full-term 5-week-old infant
A full-term 33-week-old infant
A full-term 16-week-old infant
A preterm 8-week-old infant
48. Hirschspung disease
HIV
Malabsorption syndrome
Severe combined immunodeficiency syndrome
49. Hirschspung disease
HIV
Malabsorption syndrome
Severe combined immunodeficiency syndrome
50. Intermittent fever, diarrhea, and abdominal
pain
Low-grade fever, vomiting, and
copious, watery diarrhea
Projectile vomiting, abdominal pain, and
watery diarrhea
Vomiting, fever greater than 102°F, and
intermittent diarrhea
51. Intermittent fever, diarrhea, and abdominal
pain
Low-grade fever, vomiting, and
copious, watery diarrhea
Projectile vomiting, abdominal pain, and
watery diarrhea
Vomiting, fever greater than 102°F, and
intermittent diarrhea
52. Between 8 weeks and 32 weeks
Between 6 weeks and 14 weeks, 6 days
Between 12 weeks and 24 weeks
Between 4 weeks and 14 weeks, 6 days
53. Between 8 weeks and 32 weeks
Between 6 weeks and 14 weeks, 6 days
Between 12 weeks and 24 weeks
Between 4 weeks and 14 weeks, 6 days
54. The ACIP, AAP & IAP recommend Rotarix®
because it can be administered in a 2-dose
series
The ACIP, AAP & IAP recommend RotaTeq®
because it is more effective in preventing
severe rotavirus disease
The ACIP, AAP & IAP recommend Rotarix ®
when initiation of the vaccine series is delayed
The ACIP, AAP & IAP do not recommend one
vaccine over the other
55. The ACIP, AAP & IAP recommend Rotarix®
because it can be administered in a 2-dose
series
The ACIP, AAP & IAP recommend RotaTeq®
because it is more effective in preventing
severe rotavirus disease
The ACIP, AAP & IAP recommend Rotarix ®
when initiation of the vaccine series is delayed
The ACIP, AAP & IAP do not recommend one
vaccine over the other
56. The benefit of preventing severe rotavirus
gastroenteritis outweighs the small potential
risk for intussusception
There is no risk for intussusception from
rotavirus vaccination
No association between RV vaccines and
intussusception has been observed in either
pre- or postlicensure studies
RotaShield® was taken off the market, but not
because of an association with intussusception
57. The benefit of preventing severe rotavirus
gastroenteritis outweighs the small potential
risk for intussusception
There is no risk for intussusception from
rotavirus vaccination
No association between RV vaccines and
intussusception has been observed in either
pre- or postlicensure studies
RotaShield® was taken off the market, but not
because of an association with intussusception
58. Concerns regarding RV burden in India?
Concerns regarding RV vaccine efficacy?
Concerns regarding LM / admission with AGE
after RV vaccine?
Cost of vaccine
Side-effects of vaccine
Short window period for vaccination
Lack of patient awareness/ unable to convinve
parents ?
Notes de l'éditeur
This is a common misunderstanding. Parents cannot prevent their children from getting a rotavirus infection. The primary mode of rotavirus transmission is fecal to oral. Rotavirus is highly communicable and transmissible. Close person-to-person contact and environmental surfaces are common vectors of transmission. It is impossible to keep contaminated fingers and objects from going into children's mouths. Even if a child is not cared for in a daycare setting, he or she is likely to have contact with other children or objects that other children have touched. Rotavirus is an extremely hardy pathogen. The incubation period is 1-3 days and large quantities of virus are shed in stool from just prior to onset of symptoms until about 10 days after onset.[1] Rotavirus is highly transmissible. Under experimental conditions, almost 50% of rotavirus remains viable on contaminated hands for 60 minutes.[1]
Rotavirus has a worldwide distribution, and is found in both developed and developing countries. Prevalence varies by geographic region.[15] The greatest burden of diseases is in Africa, India, and south Asia.
Recent information about the risk for intussusception comes from studies conducted in Mexico[28] and Brazil.[29] In Mexico there was a > fivefold increased risk within the first 7 days after the first vaccine dose, equating to an intussusception rate of 1 in 51,000 vaccinated infants.[28] In Brazil, there was an approximate twofold increased risk within 7 days of the second dose, equating to an intussusception rate of 1 in 68,000 vaccinated infants.[29] Although 2 additional deaths would be expected to occur as a result of intussusception in Mexico, 663 childhood deaths and 11,551 hospitalizations would be prevented.[28] In Brazil, 5 additional deaths would be expected, but 1300 childhood deaths and 80,000 hospitalizations would be prevented.[29] Data from Australia also suggest an increased risk for intussusception in the immediate window after the first dose for both RotaTeq and Rotarix, but no increase in the overall risk.[30]
Some clinicians are hesitant to administer rotavirus vaccines to infants or children with certain preexisting conditions, but there are only a few true contraindications. * Infants with severe latex allergy may receive RotaTeq.[21,22]
Recommendations for routine vaccination have not been made for children with these conditions. The potential risks and benefits of vaccine administration should be weighed for each patient, and consultation with an infectious disease specialist or immunologist should be considered. Some experts recommend that children at risk for a latex allergy developing (eg, children with spina bifida)* should preferably receive RotaTeq to minimize latex exposure. If RotaTeq is unavailable, Rotarix should be administered because the benefit of vaccination is considered greater than the risk for sensitization.[21,22] Caution should also be exercised when considering administration of the rotavirus vaccine to an infant residing in a household or in close contact with a person with known severe compromised immune function. It has been argued that the risk for transmission of a vaccine strain with associated clinical symptoms is much lower than the risk for wild-type rotavirus disease from an unvaccinated child.[7] *If RotaTeq is unavailable, Rotarix should be administered because the benefit of vaccination is considered greater than the risk for sensitization.[21,22]