Comparing the 4 available Rotavirus vaccines in the Indian context, Rotateq (RV5), Rotavac/ Rotasure (116E), Rotarix (RV1), and Rotasiil (BRV-PV), with special reference to Rotateq.

1. Rotavirus Vaccines: What’s New?
RV5/116E/RV1/BRV-PV
Dr. Gaurav Gupta,
Charak Clinics, Mohali

2. Conflict of Interest

3. Scope
• Indian RV seroprevalence
• Indian data of vaccines
• Comparing RV vaccines
• Strengths of RV5

4. Rotavirus Serotypes
Changing Rotavirus serotype patterns.

5. RV Serotypes change as per time,
region and setting
Natural
Infection Study:
Gladstone et al1
(2002-2006)
Indian
Rotavirus Strain
Surveillance
Network2
(2005-2009)
RVGE Outpatient
Burden study3
(2011-2012)
* All values expressed as %
1. Gladstone B P et al. N Engl J Med 2011;365 (4):337-46. 2. Kang G et al. Vaccine 31 (2013) 2879-2883. 3. Gajanan S. Namjoshi et al. Rotavirus
gastroenteritis among children less than 5 years of age in private outpatient setting in urban India. Vaccines 32S (2014) A36-A44.
G1P(8), 15.9 G2P(4), 13.6
G10P(11), 8.7
Others, 61.8
G1, 25
G2, 21
G9, 13
Others, 41
G1P(8), 32.1
G2P(4), 27.5
G2P(6), 7.33
Others, 33.1

6. Rotavirus Serotype distribution in India – IRSN (2012-2014)1
Major genotypes: G1P[8] (62.7%), G2P[4] (7.6%), G9P[4] (4.2%), G12P[6] (3.7%).
Sample size:
N = 10,207.
RV positive = 4042 (39.6%)
1. CP Girish Kumar et al. Rotavirus genotypes in India. Data from Indian Rotavirus Strain Surveillance Network (2012-2014). Poster presented at ds RNA
conference in Oct 2015. (P1-40).

7. Rotavirus Vaccines in India:
RV5/RV1/116E/BRV-PV

8. Rotavirus Vaccines in India
Vaccine Valency Rotavirus
strains
Country of
Manufacture
No. of
doses
Dosing
schedule
Regulatory
approval
RotaTeq Pentavalent
vaccine
G1-G4,P8 Pennsylvania,
USA
3 6, 10, 14 weeks Yes
116E Monovalent
vaccine
G9P11 India 3 6, 10, 14 weeks Yes
BRV-PV Pentavalent
vaccine
G1-G4, G9 India 3 6, 10, 14 weeks Yes
3 Dose Rotavirus Vaccines:
2 Dose Rotavirus Vaccines:
Company Valency Rotavirus
strains
Country No. of
doses
Dosing
schedule
Regulatory
approval
RV1 Monovalent
vaccine
G1 Belgium,UK 2 10, 14 weeks Yes

9. Rotavirus Vaccines: RV5/RV1/116E/BRV-PV
• Indian Immunogenicity Data

10. Rotavirus Vaccines: Indian Immunogenicity Data* (*Not head to Head comparisons)
Vaccine Design Schedule Results
RV12
(n = 363)
V-182/P-181
MONOVALENT
VACCINE
• Immunogenicity & Safety
• Routine pediatric vaccines
including OPV restricted to 14 days
prior to each dose of RV1.
• 56 out of 182 infants (31%) in the
vaccine group received OPV
through the Pulse Polio Program
within 14 days of vaccine.
• 2 dose schedule.
• Starting at 8 - 10
weeks.
• 2nd dose 1 month post
dose 1.
• Overall seroconversion* – 58.3%
post dose 2.
* Seropositivity defined as anti-
rotavirus IgA concentration ≥ 20 U/ml.
1. Lokeshwar et al. Immunogenicity and safety of the pentavalent human-bovine (WC3) reassortant rotavirus vaccine (PRV) in Indian infants. Human Vaccines & Immunotherapeutics 9:1, 178–182; January 2013; c 2013.
2. Narang et al. Immunogenicity, reactogenicity and safety of human rotavirus vaccine (RIX4414) in Indian infants. Human Vaccines 5:6, 414-419; June 2009.
3. Vipin Vashistha et al. Indian Academy of Pediatrics (IAP) Recommended Immunization Schedule for Children Aged 0 through 18 years – India, 2016 and Updates on Immunization. Indian Pediatrics. Aug 26 2016 [E-pub. Ahead of
print]. P. 35.
4. Bhandari N et al. Efficacy of a Monovalent Human-Bovine (116E) Rotavirus Vaccine in Indian Infants: A Randomized Double Blind Placebo Controlled Trial. Lancet. 2014; 383 (9935): 2136–43.
Vaccine Design Schedule Results
RV51
(n = 110)
V-110
PENTAVALENT
VACCINE
(MERCK)
• Immunogenicity & Safety
• With concomitant administration
of OPV (no restrictions on
additional doses that may have
been administered during the Pulse
Polio Program).
• No restrictions on breast feeding &
other routine pediatric vaccines.
• 3 dose schedule.
• Starting at 6 weeks
• Overall seroconversion* - 83% post
dose 3.
• G1 - 77.3%,G2 - 71.4%
• G3 - 55.6%,G4 - 93.3%,P1 - 90.0%
* Seropositivity defined as anti-rotavirus
IgA concentration ≥ 20 IU/ml.
• As per IAP 2016 recommendations, RV1 administered at 6 & 10 weeks is less immunogenic than RV1 given at 10 & 14 weeks3.
• Hence, IAP-ACVIP recommends RV1 at 10 & 14 weeks in order to achieve a better immune response3.
Vaccine Design Schedule Results
116 E4
(Phase 3
trial)
(n = 6799)
V-4532/P- 2267
MONOVALENT
VACCINE
• Efficacy, Immunogenicity & Safety.
• With Concomitant OPV, DTPw, Hib,
Hep B.
• No restriction on breast feeding.
• Storage of vaccine (-20 degrees C)
& administration of citrate
bicarbonate buffer 5-10 mins prior
to vaccine.
• 3 dose schedule
(1x105FFU).
• 6-10-14 weeks.
• Overall seroconversion* - 39.9%
post dose 3.
* Seroconversion defined as a 4-fold rise
in titre from paired serum samples.

11. Rotavirus Vaccines: Indian Immunogenicity Data (Contd.):
Pentavalent RV Vaccines
(Not head to head comparison trials)
1. Lokeshwar et al. Immunogenicity and safety of the pentavalent human-bovine (WC3) reassortant rotavirus vaccine (PRV) in Indian infants. Human
Vaccines & Immunotherapeutics 9:1, 178–182; January 2013; c 2013.
2. Prasad Kulkarni et al. A randomized Phase III clinical trial to assess the efficacy of a bovine human reassortant pentavalent rotavirus vaccine in Indian
infants. Vaccine (2017). https://doi.org/10.1016/j.vaccine.2017.09.014.
Vaccine Design Schedule Results
RV51
(n = 110)
V-110
PENTAVALENT
VACCINE
(MERCK)
• Immunogenicity & Safety
• With concomitant administration
of OPV (no restrictions on
additional doses that may have
been administered during the Pulse
Polio Program).
• No restrictions on breast feeding &
other routine pediatric vaccines.
• 3 dose schedule.
• Starting at 6 weeks
• Overall seroconversion* - 83% post
dose 3.
• G1 - 77.3%,G2 - 71.4%
• G3 - 55.6%,G4 - 93.3%,P1 - 90.0%
* Seropositivity defined as anti-rotavirus
IgA concentration ≥ 20 IU/ml.
Vaccine Design Schedule Results
BRV-PV2
(n = 219)
V-116/P-103
PENTAVALENT
VACCINE
• Efficacy, Safety & Immunogenicity
& With concomitant
administration of routine DTP-HB-
Hib & OPV.
• No restrictions on breast feeding.
• 3 dose schedule.
• 6-10-14 weeks
schedule.
• Overall seroconversion* - 33.6%
post dose 3.
* Seroresponse defined as ≥ 3 fold rise of
anti-rotavirus IgA at Day 28 (+/- 7 Days)
post-dose 3 when compared to baseline
titres.

12. Rotavirus Efficacy and Safety Trial
(REST)1
• Multicentre, in 11 countries on 3 continents
(Europe, US, Latin America/Caribbean), from
2001 to 2004
• Randomised, double-blind controlled,
RotaTeq vs placebo
• 70,301 infants enrolled/68,038 received
at least 1 dose of RotaTeq or placebo
• Age at enrollment: children 6 to 12 weeks
• Oral, 3-dose regimen, every 4–10 weeks
1. Vesikari T, et al. N Engl J Med. 2006;354:23–33.

13. RotaTeq® Proven Efficacy &
Effectiveness Across Serotypes
1. Vesikari T et al. Safety and Efficacy of a Pentavalent Human– Bovine (WC3) Reassortant Rotavirus VaccineN Engl J Med. 2006;354:23–33.
2. Payne DC et al. Clin Infect Dis. 2013;57:13–20
Rest trial: Efficacy of RotaTeq on reduction of
hospitalizations and emergency visits due to
different serotypes (N=68,038: RotaTeq=34,035;
placebo=34,003)1
G1 G2 G3 G4 G9
95% 88% 93% 89% 100%
(92-97) (0<99) NS (49-99) (52-98) (67-100)
Effectiveness of RotaTeq by Genotype Among
Children <5 Years of Age: New Vaccine Surveillance
Network, US : 2010-20112
89% 87% 87% 83%
G1P[8] G2P[4] G3P[8] G12P[8]
VaccineEffectiveness(%)
100%
90%
80%
70%
60%
50%
40%
30%
20%
10%
0%
0%
20%
40%
60%
80%
100%

14. Rotavirus Vaccine 116E

15. 116E Vaccine: Indian Immunogenicity
Data
Vaccine Setting Results
116 E1
n=
1 X 104 FFU*
93(V) & 94 (P)
1 X 105 FFU*
92(V) & 90 (P)
Phase 1b/IIa: Safety and Immunogenicity, Dose Escalation
study (3 dose schedule)
Vaccine or placebo received at 8-12-16 weeks.
Limitations:
• Risk of intussusception would become evident only during
larger trials or PM surveillance.
• No concomitant administration of other childhood vaccines,
including OPV.
• Breast feeding was restricted 30 mins prior to & post dosing.
• Stringent exclusion criteria.
• Storage of vaccine (-70 degrees C) & administration of
citrate bicarbonate buffer prior to vaccine.
Seroconversion 2 doses
(% of infants with
>=4 fold increase
in IgA titres)
3 doses
(% of infants
with >=4 fold
increase in IgA
titres)
1 X 104 FFU* 116E 62.9% 62.1%
1 X 105 FFU* 116E
*FFU=Focus
forming Units.
67.7% 89.7%
Safety No significant difference in clinical
adverse events or lab toxicity
between vaccine & placebo
recipients
116 E2
n=
4532(V) & 2267(P)
116 E3
n= 4532(V) &
2267(P)
Phase III study: Efficacy (3 dose schedule/1x105FFU)
• Vaccine or placebo received at 6-10-14 weeks.
• Concomitant OPV, DTPw, Hib, Hep B.
Cases of intussusception: 6/4532 (V) & 2/2267 (P)
• A thorough evaluation of risk of intussusception will await
phase IV surveillance studies.
Extension of Phase III study: Efficacy & Additional Safety upto
2 years of age.
39.9% Seroconversion in the vaccine & 18.4% in the placebo
groups.
Reasons cited for decreased immunogenicity:
• Study cohort healthier.
• No concomitant administration of OPV.
• Age of 1st dose earlier (6 vs 8 wks)-Possible interference
by maternal anti RV IgG.
• Possible Breast feeding interference with “TAKE” of RV
vaccine (controlled in 1b/IIa).
• Variability in Anti RV IgA response in different populations
Bhandari N et al. A Dose-Escalation Safety and Immunogenicity Study of Live Attenuated Oral Rotavirus Vaccine 116E in Infants: A Randomized, Double-Blind, Placebo-Controlled Trial. The Journal of Infectious
Diseases 2009; 200:421–9.
Bhandari N et al. Efficacy of a Monovalent Human-Bovine (116E) Rotavirus Vaccine in Indian Infants: A Randomized Double Blind Placebo Controlled Trial. Lancet. 2014; 383 (9935): 2136–43.
Bhandari N et al. Efficacy of a monovalent human-bovine (116E) rotavirus vaccine in Indian children in the second year of life . Vaccines 32S (2014) A110-A116.

16. First1 and Second2 Year Safety data –
116E
1.Bhandari N et al. Efficacy of a Monovalent Human-Bovine (116E) Rotavirus Vaccine in Indian Infants: A Randomized Double Blind Placebo Controlled Trial. Lancet.
2014; 383 (9935): 2136–43.
2. Bhandari N et al. Efficacy of a monovalent human-bovine (116E) rotavirus vaccinei n Indian children in the second year of life . Vaccines 32S (2014) A110-A116.
Year Adverse Events Intussusception Remarks
1st year Safety data1 • 20.3% (V)
• n=925
• 22% (P)
n=499
• 6/4532 (V)
• 2/2267 (P
* A thorough evaluation of risk of
intussusception will await phase IV
surveillance studies.
2nd year Safety data2 • 20.9% (V) n=947
• 22.7% (P) n=515
• 8/4532 (V)
• 3/2267 (P)
None occurred within 30 days of a vaccine
dose and all were reported only after the
third dose. The intussuception events
following the third dose occurred between
112 and 587 days post vaccination in the
vaccine group and between 36 and 605 days
in the placebo group.
20 cases of G9P[11] GE seen after dose 1 & 2 cases post dose 2 of II6E RV vaccine. All
cases were mild or moderate by VS1

17. Rotavirus Vaccine BRV-PV

18. Formulations : BRV-PV & RotaTeq
BRV-PV RotaTeq
Lyophilized.
Reconstitution
required.
Ready to use liquid
formulation in a latex
– free dosing tube
stable at 2-8
degrees1
1. RotaTeq PI. MSDIN 11/16.

19. BRV-PV Thermostability Facts: (Data from Naik et al 20171)
Vaccine is stable for1 (2017 paper)
• < 250C for 36 months.
• 18 months at 37◦C, and 40◦C,
• 55+/- 20C for 72 hrs.
• -200 C for 48 hrs & 42+/-20 C (Stable even
after 2 freeze thaw cycles)
Summary:
• Heat stable vaccine which can be stored
below 250C & does not need refrigeration.
• Was developed to reduce cold storage
space for RV vaccines supplied for NIPs2.
Reconstituted vaccine must be used
immediately. If not used
immediately, it can be held for a
period of maximum 6 hours
provided a syringe is used to cap the
opening of the vial adapter & the
entire assembly is stored at 2-80 C 2.
Important if Multi dose (5 ml) packs
are supplied.
1. Sameer P. Naik et al. Stability of heat stable, live attenuated Rotavirus vaccine (ROTASIIL). Vaccine 35
(2017) 2962-2969.
2. Rotasiil PI Multidose pack. 20014546/1.
3. RotaTeq PI. MSDIN 11/16.
RotaTeq storage conditions (from PI) 3
• To be stored & transported at 2-80C.
• When out of refrigeration or <= 250 C, administration may be delayed for up to 48 hours.

20. BRV-PV Phase 3 Efficacy & Safety Trial in India1
Phase 3 Efficacy data-India1 (Kulkarni et al_2017)1:
* Vaccine transported & stored at 2-80C**.
BRV-PV Phase 3 study in India.
Total 7500 infants (V=3749 & P=3751).
No restrictions on OPV, DTP-HB-Hib, Breastfeeding.
Vaccine Efficacy- Pr. Analysis (PPP): Min. no. of cases needed for analysis.
VSRVGE = 60.5% (VS>16).
SRVGE = 36% (VS>11).
Vaccine Efficacy- Sec. Analysis (PPP): End of 2 years.
VSRVGE = 54.7% (VS>16).
SRVGE = 39.5% (VS>11).
IgA seroresponse (>= 3 fold rise): 33.6% (BRV-PV group).
Safety Profile:
Similar in both vaccine & placebo groups.
SAE: 12 cases of GE 7 days post vaccination (V=7, P=5). Only 1 tested positive for RV
antigen in stool by ELISA. Genotype did not reveal any vaccine strain.
Authors’ note (Verbatim):
“Since this was a pivotal trial to
support licensure, the study vaccine
was transported & stored at 2-80C
out of caution”.
1. Kulkarni et al. A randomized Phase III clinical trial to assess the efficacy of a bovine human reassortant pentavalent rotavirus vaccine in Indian infants. Vaccine (2017).
https://doi.org/10.1016/j.vaccine.2017.09.014.

21. BRV-PV & 116E Phase 3 Efficacy, Immunogenicity & Safety Trials [Snapshot]
(Not head to head comparison trials)
1. Isanka et al. Efficacy of a Low-Cost, Heat-Stable Oral Rotavirus Vaccine in Niger. N Engl J Med 2017;376:1121-30.
2. Kulkarni et al. A randomized Phase III clinical trial to assess the efficacy of a bovine human reassortant pentavalent rotavirus vaccine in Indian infants. Vaccine (2017). https://doi.org/10.1016/j.vaccine.2017.09.014.
3. Zade et al. Bovine Rotavirus Pentavalent Vaccine Development in India. Vaccine 32S (2014) A124-A128.
4. Bhandari N et al. A Dose-Escalation Safety and Immunogenicity Study of Live Attenuated Oral Rotavirus Vaccine 116E in Infants: A Randomized, Double-Blind, Placebo-Controlled Trial. The Journal of Infectious Diseases 2009; 200:421–9.
5. Bhandari N et al. Efficacy of a Monovalent Human-Bovine (116E) Rotavirus Vaccine in Indian Infants: A Randomized Double Blind Placebo Controlled Trial. Lancet. 2014; 383 (9935): 2136–43.
6. Lokeshwar et al. Immunogenicity and safety of the pentavalent human-bovine (WC3) reassortant rotavirus vaccine (PRV) in Indian infants. Human Vaccines & Immunotherapeutics 9:1, 178–182; January 2013; c 2013.
7. Narang et al. Immunogenicity, reactogenicity and safety of human rotavirus vaccine (RIX4414) in Indian infants. Human Vaccines 5:6, 414-419; June 2009
8. Bhandari N et al. Efficacy of a monovalent human-bovine (116E) rotavirus vaccine in Indian children in the second year of life . Vaccines 32S (2014) A110-A116.
BRV-PV
(Niger data)
BRV-PV
(India data)
116E
(India data)
RV5
(India data)
RV1
(India data)
Efficacy
(< 2 years)
SRVGE
(VS>11)
66.7% [PPP]1 1 year Efficacy data
not published
56.4% [PPP] 5 No study in
India
No study in
India
VSRVGE
(VS>15)
78.8% [PPP] 1 1 year Efficacy data
not published
49.8% [PPP] 5
Efficacy
(at 2 years)
SRVGE
(VS>11)
Not published 39.5% [PPP] 2 55.1% [PPP] 8 No study in
India
No study in
India
VSRVGE
(VS>16)
Not published 54.7% [PPP] 2 57.2% [PPP] 8
Immunogeni
city
Not published 60% - Phase 2b3
33.6% - Phase 32
89.7% - Phase 2a4
39.9% - Phase 35
83% [India] 6 58% [India] 7
Serotype
specific
Efficacy
Not published Overall efficacy
against
G1,G2,G3,G9,G12 =
38.9%1
[ -ve CI G3,G9,G12]
Negative CI values for
G1P[8], G12P[8] &
G9P[4] 5,8
55.6-93.3%
[G1,G2,G3,G
4,P[1] 6
Safety Tolerable safety
profile1
12 cases of GE 7 days
post vaccination (V=7,
P=5) 2
20 cases of G9P[11] GE seen
after dose 1 & 2 cases post dose
2 of II6E RV vaccine. All cases
were mild or moderate by VS5
Tolerable
safety profile6
Tolerable safety
profile7

22. Introduction of RotaTeq in GAVI-Eligible
CountriesRwanda
May 2012
Nicaragua
Oct 2006
The Gambia
Aug 2013
Burkina Faso
Oct 2013
Mali
Jan 2014
Cote d’Ivoire
Sao Tome
2016
• In same year as US licensure (2006)
Merck-Nicaragua MoH partnership
implemented
• 1.3 million doses donated over 3 yrs
• 3 dose vaccine effectiveness after 2
years of follow-up (2007-9) against
severe rota (≥11) was 85% (66,93) in
those <1 year
• Hospitalizations for diarrhea in <1 year
olds decreased by 51% in 2014
• Diarrhea hospitalizations declined
among older children not vaccinated,
suggesting indirect protection
Lancet Global
Health 2016
PIDJ 2011
• 3 dose vaccine effectiveness in
those < 2 years (2007-8)
46% (18,64) against rota –
related hospitalization and IV
fluid
58% (30,74) against severe
rota disease (≥11)
77% (39,92) against very
severe rota disease ( ≥15)
JAMA
2009

23. RotaTeq in NIP in Rwanda (Effectiveness of RV5)_20161
1. Jacqueline E. Tate, Fidele Ngabo et al. Effectiveness of Pentavalent Rotavirus Vaccine Under Conditions of Routine Use in Rwanda. Clinical Infectious Diseases® 2016;62(S2):S208–12.
Overall VE = 75%

24. RotaTeq: – Data on G9 & G12
(Ref: RotaTeq Product Insert MSDIN 11/16)

25. RotaTeq Updated PI (Information on G9) – [G1-G4 & G9 Efficacy at 1 year-REST]1
1. RotaTeq PI. MSDIN 11/16.
• The vaccine was specifically designed to prevent rotavirus gastroenteritis caused by the
individual G-serotypes included in the vaccine (G1, G2, G3, and G4);
• P1A[8] was included in the vaccine to potentially provide cross-protection against
nonvaccine G-serotypes that may contain P1A[8].
• Based on limited data, the efficacy against any severity of gastroenteritis caused by the
non-vaccine G serotype (G9) was 74.1%.

26. RotaTeq Updated PI (Information on G12)
[Effectiveness against G12 & protection until 7th year of Life]1
1. RotaTeq PI. MSDIN 11/16

27. ACIP – Grading for RV5

28. ACIP: Moving from Evidence to
Recommendation
Pentavalent Rotavirus Vaccine gets Category A recommendation
Overall evidence type
Overall evidence type across all critical
outcomes
1
Values and preferences (assume a set of values for each outcome considered)
OUTCOME VALUES AND PREFERENCES
Rotavirus diarrhea Relatively lower value
Severe rotavirus diarrhea High value
Hospitalization for rotavirus diarrhea High value
Intussusception High value
Other serious adverse events High value
Cost effectiveness Relatively lower value
Draft recommendation
We recommend vaccination of infants with three doses of rotavirus vaccine.
Recommendation category Category A
Ahmed F. U.S. Advisory Committee on Immunization Practices Handbook for Developing Evidence-based Recommendations. Version 1.2. Atlanta, GA: Centers for
Disease Control and Prevention (CDC); 2013. Available from http://www.cdc.gov/vaccines/acip/recs/GRADE/about-grade.html#resources
RotaTeq:
Type 1 GRADE A recommendation

29. WHO – Grading of Scientific
Evidence

30. WHO Grading of Scientific Evidence:
Higher score for RV5 in preventing severe rotavirus
diarhhoea in High Mortality Countries
What is the effect of
RV1 compared to
placebo for preventing
severe rotavirus
diarrhoea in high-
mortality countries?
What is the effect of
RV5 compared to
placebo for preventing
severe rotavirus
diarrhoea in high-
mortality countries?
What is the effect of
RV1 compared to
placebo for preventing
severe all cause
diarrhoea in high-
mortality countries?
What is the effect of
RV5 compared to
placebo for preventing
severe all cause
diarrhoea in high-
mortality countries?
Final numerical rating of
quality of evidence
3* 4 3* 4
Statement on quality of
evidence
Further research is likely
to change the estimate
of effect
Further research is very
unlikely to change our
confidence in the
estimate of effect
Further research is likely
to change the estimate
of effect.
Further research is very
unlikely to change our
confidence in the
estimate of effect
Conclusion We are moderately
confident that use of
RV1 in high mortality
countries reduces the
rate of severe rotavirus
diarrhoea
We are confident that
use of RV5 in high
mortality countries
reduces the rate of
severe rotavirus
diarrhoea
We are moderately
confident that use of
RV1 in high mortality
countries reduces the
rate of severe all-cause
diarrhoea
We are confident that
use of RV5 in high
mortality countries
reduces the rate of
severe all-cause
diarrhoea
* Downgraded due to indirectness as trials were conducted in Malawi and South Africa: generalization to high--‐mortality countries is difficult.
http://www.who.int/immunization/documents/positionpapers/en/ . Accessed 7th Jan 2018.

31. RotaTeq Product Strengths

32. Product Highlights - RotaTeq
Regulatory attributes:
• More than 10 years post US licensure1 .
• 222 million doses distributed worldwide1 .
• Registered in approximately 120 countries1 .
• Extensive drug discovery & development process spanning 13 years1 .
Quality attributes:
• Highest grading by the Advisory Committee on Immunization Practices to CDC, USA for quality of
evidence across major clinical outcomes for Rotavirus diarrhea (graded as a Type 1 GRADE A product) 2.
• Higher rating compared to RV1 for quality of evidence by World Health Organization for preventing
severe Rotavirus diarrhea in high mortality countries3.
Scientific attributes:
• Only formulation with 5 Rotavirus strains which account for 88% of infections worldwide4.
• Proven real world effectiveness of 70-95% in approximately 3 lakh subjects across the globe5-8.
• Large scale safety data in 70,000 subjects spanning 11 countries across 3 continents with no increased
risk of intussusception in vaccine vs. placebo9.
• High & consistent efficacy with 3 doses across all vaccine serotypes – 94% reduction up to 3.1 years in
the combined incidence of hospitalizations/Emergency Department visits for RGE9,10.
Commercial formulation attributes:
• Ready to use liquid formulation stable at 2-8 degrees11.
( as on Q4 2017)

33. Awards - RotaTeq
RotaTeq has been recognized externally12:
• The Lancet Paper of the Year - (2006).
• Vaccine Industry Excellence Award for Best Prophylactic Vaccine -
(2009).
• Prix Galien – (US, 2010).
References: RotaTeq Product highlights.
1. MSD data on file. Internal global communication dated 3rd Feb 2016 & 2nd Feb 2018.
2. Ahmed F. U.S. Advisory Committee on Immunization Practices Handbook for Developing Evidence-based Recommendations. Version 1.2. Atlanta, GA:
Centers for Disease Control and Prevention (CDC); 2013. Available from http://www.cdc.gov/vaccines/acip/recs/GRADE/about-grade.html#resources
3. http://www.who.int/immunization/documents/positionpapers/en/. Accessed 7th Jan 2016.
4. Santos et al. Global distribution of rotavirus serotypes/ genotypes and its implication for the development and implementation of an effective rotavirus
vaccine. Rev. Med. Virol. 2005; 15: 29–56.
5. Patel M et al. Duration of protection of Pentavalent Rotavirus vaccination in Nicaragua. Pediatrics 2012;130:e365–e372.
6. Clark MF et al. Direct & Indirect impact on RV positive & all cause GE hospitalizations in South Australian children following the impact of RV vaccination.
Vaccine 29 (2011) 4663-4667.
7. Vesikari, Uhari et al. Impact & Effectiveness of Rotateq vaccine based on 3 yrs surveillance following introduction of a Rotavirus Immunization Programme in
Finland. Pediatr Infect Dis J 2013;32:1365–1373.
8. Wan-Chi Chang et al. Effectiveness of 2 Rotavirus vaccines against Rotavirus disease in Taiwanese infants. Pediatr Infect Dis J 2014;33:e81–e86.
9. Vesikari T, et al. N Engl J Med. 2006;354:23–33.
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34. THANK YOU!!
Contact me for any queries / suggestions at docgaurav@gmail.com
Acknowledgements:
Dr Puneet Kalra, Medical Advisor, MSD