Transcript Rotavirus vaccination

Rotavirus: advocacy slides
These slides are intended to support your advocacy efforts.
Please incorporate those that may be useful to you in your
presentations.
For questions, please contact [email protected].
Special thanks to the ROTA Council’s Partners: Johns Hopkins
University, PATH, US Centers for Disease Control and
Prevention and Bill & Melinda Gates Foundation for their
technical guidance and expertise in developing these slides.
Rotavirus Vaccines
Rotavirus vaccines: provide best protection
benefits
saves
lives
improves
health
cost
effective
A comprehensive approach to fighting diarrhea, including rotavirus vaccines
and other proven preventions and treatments,
can significantly reduce child illnesses and deaths.
Two vaccines licensed for global use
Shown to be safe and effective in large-scale clinical studies and real-world use
RotaTeq (Merck)
Rotarix (GSK)
Formulation
Pentavalent, bovine-human
reassortant
Monovalent, human
Orally administered, doses
3
2
Safety: clinical trials
(intussusception risk)
No difference1
No difference1
Safety: post-introduction
(intussusception risk)
Low-level risk in some countries,
not others2,4,5,6
Low-level risk in some
countries, not others2,3
Efficacy: against severe rotavirus 98%7
diarrhea in children < 1
(developed countries)
85%-96%8,9
Efficacy: against severe rotavirus 51%-64%10,11
diarrhea in children < 1
(developing countries)
59%13
1Soares-Weiser, Cochrane
2Buttery, PID,
2011
NEJM, 2011
4Shui, JAMA, 2012
5Cortese, PID, 2010
6Haber, Pediatrics, 2008
3Patel,
Review, 2012
7Vesikari,
NEJM, 2006
8Ruiz-Palacios, NEJM, 2006
9Vesikari, Lancet, 2007
10Armah,
Lancet, 2010
Lancet, 2010
13Mahdi and Cunliffe, NEJM,
2010
11Zaman,
5
Rotavirus vaccines: recommended by WHO
 WHO recommends rotavirus vaccines
in all national immunization programs
(NIPs), particularly in south and southeastern Asia and sub-Saharan Africa
 Should be part of a comprehensive
approach to control diarrhea
 Vaccination age restriction may be
relaxed in countries where delays in
immunizations and deaths from
rotavirus are common
WHO. Rotavirus vaccines: WHO position paper – January 2013
NIP status as of August 2013
47 countries have introduced
rotavirus vaccines into their NIPs
Rotavirus vaccine: introduction status
47 countries have introduced rotavirus vaccines into their
national immunization programs as of August 2013
Africa
Botswana, Ghana, Malawi, Rwanda, South Africa, Tanzania, The Gambia
Americas
Bolivia, Brazil, Cayman Islands, Colombia, Dominican Republic, Ecuador, El
Salvador, Guatemala, Guyana, Haiti, Honduras, Mexico, Nicaragua, Panama,
Paraguay, Peru, USA, Venezuela
Eastern
Mediterranean
Bahrain, Iraq, Morocco, Qatar, Saudi Arabia, Sudan, Yemen
Europe
Armenia, Austria, Belgium, Finland, Georgia, Israel, Luxembourg, Moldova,
United Kingdom
Southeast Asia
Philippines
Western Pacific Australia, Fiji, Marshall Islands, Micronesia, Palau
*Canada, Thailand, United Arab Emirates, Zambia have introduced regionally
WHO, 2013
Diarrhea: comprehensive approach
Rotavirus vaccines are key to a comprehensive approach to fighting diarrheal disease
Prevent
•
•
Rotavirus vaccines
Improved drinking
water, hygiene,
sanitation
Treat
Protect
•
•
Exclusive
Breastfeeding
Appropriate
complementary
feeding
•
•
Rehydration therapy
(oral rehydration
solution [ORS], home
available or IV fluids)
Zinc supplementation
Impact: reductions in hospitalizations
Major reductions in
hospitalizations for children
under 5 observed within 2 years
of rotavirus vaccine introduction
 Hospital admissions for
rotavirus reduced by half or
more (49-89%)
 Significant declines (17- 55%)
in hospitalizations for all
causes of diarrhea
Patel, Lancet, 2012
Impact: reduction in rotavirus hospitalizations
Hospitalizations: documented reductions of 50% or more
Country
(Nationwide)
Vaccine Used
Age Group Eligible to
Receive Vaccine
Yearly Reductions in
Hospitalizations
(Across Studies and Age
Groups)
Australia
RotaTeq & Rotarix
0-1 years old
87%
Austria
RotaTeq & Rotarix
0-2 years old
74-79%
Belgium
RotaTeq & Rotarix
0-2 years old
50-77%
Bolivia
Rotarix
0-1 years old
~70%
US
RotaTeq
0-2 years old
66-86%
Note: table derived from Table 2 from: Patel MM, Glass R, Desai R, Tate JE, Parashar UD. Fulfilling the
Promise of Rotavirus Vaccines: How Far Have We Come Since Licensure? The Lancet Infectious
Diseases. 2012;12(7):561-570.
Patel, British Medical Journal, 2013.
Impact: reduction in rotavirus hospitalizations
Hospitalizations: documented reductions of 50% or more in
children 0-2 years old following rotavirus vaccination
Belgium
50-77%
RotaTeq & Rotarix
US
66-86%
RotaTeq
Bolivia
70%
Rotarix
Austria
74-79%
RotaTeq & Rotarix
Australia
87%
RotaTeq & Rotarix
Note: data derived from Table 2 from: Patel MM, Glass R, Desai R, Tate JE, Parashar UD. Fulfilling
the Promise of Rotavirus Vaccines: How Far Have We Come Since Licensure? The Lancet Infectious
Diseases. 2012;12(7):561-570.
Impact: reduction in all causes of
diarrhea hospitalizations
Hospitalizations: documented reductions of nearly 20% or more
Country
(Nationwide)
Vaccine Used
Age Group Eligible Yearly Reductions in
to Receive Vaccine Hospitalizations
(Across Studies and Age
Groups)
Mexico
Rotarix
0-2 years old
40%
Belgium
RotaTeq & Rotarix
0-2 years old
33%
USA
RotaTeq
0-2 years old
29-52%
El Salvador
Rotarix
0-2 years old
28-37%
Brazil
Rotarix
0-2 years old
17-48%
Note: table derived from Table 2 from: Patel MM, Glass R, Desai R, Tate JE, Parashar UD. Fulfilling
the Promise of Rotavirus Vaccines: How Far Have We Come Since Licensure? The Lancet Infectious
Diseases. 2012;12(7):561-570.
Impact: reduction in all causes of
diarrhea hospitalizations
Hospitalizations: documented reductions of nearly 20% or
more in children 0-2 years old following rotavirus vaccination
El Salvador
28-37%
Brazil
17-48%
Rotarix
USA
29-52%
Rotarix
Belgium
33%
RotaTeq
Mexico
40%
RotaTeq & Rotarix
Rotarix
Note: data derived from Table 2 from: Patel MM, Glass R, Desai R, Tate JE, Parashar UD.
Fulfilling the Promise of Rotavirus Vaccines: How Far Have We Come Since Licensure?
The Lancet Infectious Diseases. 2012;12(7):561-570.
Patel, British Medical Journal, 2013.
Impact: herd immunity/indirect benefits
of vaccination
Significant reductions in hospitalization observed for non-vaccinated children
Rotavirus related hospitalizations reduced
Country
(nationwide)
Children age-eligible for
vaccine
Children NOT age-eligible
for vaccine
El Salvador
79-86%
41-81%
Austria
76-79%
35%
USA
74-85%
41-80%
Belgium
65-80%
20-64%
Sao Paulo, Brazil
56-69%
24%
Queensland, Australia
50-70%
30-70%
Country (regional)
Note: table derived from Table 2 from: Patel MM, Glass R, Desai R, Tate JE, Parashar UD. Fulfilling
the Promise of Rotavirus Vaccines: How Far Have We Come Since Licensure? The Lancet Infectious
Diseases. 2012;12(7):561-570.
Impact: herd immunity/indirect
benefits of vaccination
Hospitalizations: documented
reductions of more than 50% in children
eligible for vaccination
Belgium
65-80%
USA
74-85%
Austria
76-79%
Hospitalizations: documented
reductions of more than 20% in children
NOT eligible for vaccination
USA
41-80%
Belgium
20-64%
El Salvador
79-86%
Note: data derived from Table 2 from: Patel MM, Glass R, Desai R, Tate
JE, Parashar UD. Fulfilling the Promise of Rotavirus Vaccines: How Far
Have We Come Since Licensure? The Lancet Infectious Diseases.
2012;12(7):561-570.
Austria
35%
El Salvador
41-81%
Rotavirus vaccines: cross-strain protection
Rotavirus vaccines provide broad protection
against rotavirus–even against strains of the
virus not included in the vaccine.
Rotarix Efficacy Against Vaccine and Non-Vaccine Type Rotavirus
Vaccine Type
Efficacy
Non-Vaccine Type
Efficacy
G1
64.1%
G12
55.5%
G8
64.6%
P[4]
70.9%
P[6]
55.2%
P8
Steele, BMCID, 2012
59.1%
Real world impact: Mexico and Brazil
Post-introduction impact in Mexico and Brazil comparable to
phase 3 clinical trial efficacy data
Mexico
Brazil
• Widespread introduction in 2007
• Widespread introduction in 2006
• In 2008, diarrhea deaths declined by 35%1
• In 2007, diarrhea deaths declined by 30%3
• In 2009, diarrhea deaths declined by more
than 65%
• In 2008, diarrhea deaths declined by 39%3
• Sustained reduction of 22% over 3 years
(2007-2009)4
Hospitalizations for rotavirus and all-cause diarrhea decline
1Richardson
V, et al.
IJID, 2011
4Carmo, PLOS, 2011
3Lanzieri,
Impact: Mexico
 Reduction in deaths of more than 50% realized and sustained (2009-2011) across all
regions1
 Reduction in deaths of 35% seen in just the first year.2
1Gastañaduy,
2Richardson,
Pediatrics, 2013
NEJM, 2010
Impact: Bolivia
 Bolivia, first high-mortality country to introduce Rotarix® in 2008,
with GAVI support
 Study found vaccinated children 70% less likely to be hospitalized for
rotavirus compared to unvaccinated children
 Protection sustained through first 2 years of a child’s life, when risk of
infection is greatest
 Vaccination protected against wide variety of rotavirus strains,
including those not found in the vaccine
 Findings applicable to many other GAVI-eligible countries in Africa
and Asia, especially those using Rotarix
BMJ, 2013
Rotavirus vaccines: cost effective
Prevent an estimated
180,000 deaths
annually
If used in all GAVIeligible countries,
rotavirus vaccines
could…
Avert 6 million clinic
and hospital visits
annually
Save US $68 million
annually
Atherly, Vaccine, 2012
Cost-effectiveness: GAVI countries
Cost per DALY averted, 2011-2030
Compared to GDP per capita
(Very cost effective when cost per DALY averted < 1x GDP)
Slide from Debbie Atherly
Source: GAVI Investment Case
Rotavirus vaccines: cost effective
Cost effectiveness is about more
than the price of the vaccine.
We must also consider:
 Hospitalizations
 Loss of income/productivity
when taking care of a sick
child
 Child suffering
Patel, Santosham, & Tate, Medscape, 2012.
Rotavirus vaccination: benefits outweigh risks
Benefits of rotavirus vaccination are substantial and
include prevention of hospitalization and death
Benefits far outweigh possible low-level risk of
intussusception associated with the vaccine
Rotavirus vaccines: benefits outweigh risks
If introduced into all national immunization programs at the same coverage levels
of other routine vaccines administered by 15 weeks of age
Benefit:
156,000 deaths
related to
rotavirus
averted
WHO, 2012
Risk: 288 potential deaths from
vaccine-associated intussusception,
an intestinal obstruction
Real world observations:
intussusception risk
Post-licensure Studies
Australia
Brazil
Mexico
US
• Low-level risk
• 5-6 excess cases of
intussusception/100,000
children vaccinated
• Low-level risk
• 1st dose: no excess risk
observed so far
• 2nd dose: 1-2 excess cases
of intussusception/
100,000 children
vaccinated
• Low-level risk
• 1st dose: 2 excess cases of
intussusception/100,000
children vaccinated
• 2nd dose: no excess risk
observed so far
• Low-level risk
• 1-5 excess cases of
intussusception/100,000
children vaccinated
Benefits outweigh risk, but surveillance remains essential
Buttery, Vaccine, 2011
Patel, NEJM, 2011
CDC, 2013
FDA, 2013
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