Proceedings of the SAGE Working
Group on Rubella Vaccines
Susan E. Reef, MD
Global Measles and Rubella Management
Meeting
March 15, 2011
Outline
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•
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Background
Terms of Reference
Opportunities to align with measles strategies
Recommendations from the WG
– Phases of rubella control and CRS prevention (Goals)
– Strategies
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Paradoxical Effect
Minimum Coverage for Rubella Vaccine introduction
Recommendation from the WG on minimum threshold
Summary
Background
• Current WHO rubella vaccine position paper
was published in 2000
– Since the publication, there have been several
areas that have changed
• Additional countries using vaccine,
• 2 regions with elimination goals and one with
accelerated rubella control and CRS prevention
• Additional information on vaccine safety (e.g., pregnant
women)
• Additional information duration of immunity
• Additional formulations of vaccine
Terms of Reference
SAGE Working Group on Rubella
• Review and propose necessary updates to the WHO rubella vaccine
position paper of 2000.
• Identify the information gaps, guide the work required to address the
information gaps, and prepare for a SAGE review of the updated
vaccination strategies.
• The specific questions to be addressed:
– What are the possible goals for rubella/CRS prevention and rubella/CRS
elimination (country, regional or global)?
– With the goals mentioned in question 1, what are the most appropriate
vaccination strategies to achieve these goals?
– What is the minimum required routine immunization coverage that should
be achieved and maintained to ensure that the introduction of rubellacontaining vaccine does not increase the risk of CRS?
Opportunities
• In 2000 PP
– Countries undertaking measles elimination should
consider taking the opportunity to eliminate rubella as
well, through use of MR or MMR vaccine in their
childhood immunization programmes, and also in
measles campaigns
• Several potential areas of integration of measles
and rubella
– Combined vaccine (MR, MMR, MMRV)
– Combined surveillance
• Measles/rubella surveillance
• Vaccine coverage monitoring
• Adverse events monitoring
Phases of Rubella Control and CRS
TABLEPrevention
of the phases
No goal
No rubella
CRS
vaccine use
Prevention
Only
CRS
Prevention
Only
Target
adolescent girls
and/or women
of childbearing
age for
immunization
either through
routine services
or mass
campaigns
CONTROL
Introduce
rubellacontaining
vaccine into EPI
schedule,
follow-up
campaigns plus
adolescent/
adult females
ACCELERATED
CONTROL
Mass
vaccination
campaigns
with MR
vaccine
targeting
children plus
control
strategies
ELIMINATION
Mass
vaccination
campaigns
targeting all
adults : men and
women – plus
accelerated
control
strategies
Strategies
• For each phase of rubella control and CRS
prevention
– Vaccination strategies
– Surveillance recommendations
• Integrated measles/rubella surveillance
• CRS surveillance
• Monitoring vaccine coverage
Strategies
Vaccination Strategy
Goal
No introduction
Not applicable
Surveillance Strategy
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Detection of rubella cases
through measles case-based
surveillance
During outbreaks
o Investigation of all rash
illness (suspected
rubella) in pregnant
women including
laboratory testing
o Conduct laboratory
testing of at least first
5-10 rash illnesses per
month to confirm
rubella as cause of
outbreaks
o Investigate outbreaks
o Conduct active CRS
surveillance
Collection of specimens for
molecular epidemiology
(may want to include earlier)
Sentinel case-based CRS
surveillance in infants 0-11
months
Goals
CRS prevention only
Rubella control and CRS
Prevention
Vaccination Strategy
Surveillance Strategie
Strategies,
con’t
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Target adolescent girls and/or
women of childbearing age for
immunization either through
routine services or mass
campaigns
Including strategy above and
Introduction of RCV into the
routine childhood program –
preferable to be introduced
combined with both MCV1 and
MCV2.
“Follow-up” MR or MMR
campaigns targeting preschoolaged children (aged 1 to 4 years)
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Including strategies above and
Rubella vaccination coverage
monitoring
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Including strategies above and
Detection of rubella cases
through measles case-based
surveillance –transition to
integrated measles-rubella
case-based surveillance
Enhance investigation of
outbreaks with laboratory
testing of suspected cases
Including strategies above and
Enhancing integrated measlesrubella case-based surveillance
– start to investigate every
suspected case
Including strategies above and
Strengthening integrated
measles-rubella or febrile rash
illness surveillance – testing
and investigating all suspected
cases
Seroprevalence studies in
WCBA?, as appropriate

Accelerated Rubella Control and
CRS Prevention
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Including strategies above and
“Catch-up” MR or MMR
campaigns targeting children
aged less than 15 years.
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Rubella/CRS Elimination
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Including strategies above and
“Speed-up” campaigns
targeting adolescents and
adults, men and women.
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◦
Paradoxical Effect
• Possibility that introduction of universal childhood
vaccination with inadequate coverage may lead to
an increase in CRS
• Low coverage  reduced transmission, increase in
average age of infection of remaining susceptible
• Children miss natural disease and vaccination and
may enter reproductive age susceptible to rubella
• WHO policy (2000) – > 80% MCV1 coverage to the
national routine (childhood) program
Minimum Coverage
• WHO policy (2000) – > 80% MCV1 coverage to
the national routine (childhood) program
• Re-evaluate the 80% MCV1 cut-off in
relationship to the accumulated experiences
in countries and regions
Dynamics of ρ (short term)
Changes in ratio of CRS cases fo
R0=10, and 40 births per 1000
per year (i.e., as in AFRO region
Routine + 4 yr SIA + starting
campaign 1-14 yr olds
CRS incidence/100,000 livebirths
Cumulative CRS incidence
ratio
Bangladesh (low-medium birth rate, medium transmission)
500
2.0
1.8
1.6
1.4
1.2
1.0
0.8
0.6
0.4
0.2
0.0
400
300
200
100
0
2005 2010 2015 2020 2025 2030 2035 2040 2045 2050
2005 2010 2015 2020 2025 2030 2035 2040 2045 2050
Pakistan (medium birth rate, medium transmission)
200
2.0
1.8
1.6
1.4
1.2
1.0
0.8
0.6
0.4
0.2
0.0
150
100
50
0
2005 2010 2015 2020 2025 2030 2035 2040 2045 2050
500
2005 2010 2015 2020 2025 2030 2035 2040 2045 2050
Zambia(high birth rate, low-medium transmission)
2.0
1.8
1.6
1.4
1.2
1.0
0.8
0.6
0.4
0.2
0.0
400
300
200
100
0
2005 2010 2015 2020 2025 2030 2035 2040 2045 2050
100
2005 2010 2015 2020 2025 2030 2035 2040 2045 2050
Ethiopia (high birth rate, high transmission)
80
60
40
20
500
400
300
200
100
0
0
2005
2010
2015
2020
2025
2030
2035
2040
2045
2050
2005 2010 2015 2020 2025 2030 2035 2040 2045 2050
Vaccination coverage (%)
0%
60%
70%
75%
80%
85%
2.0
1.8
1.6
1.4
1.2
1.0
0.8
0.6
0.4
0.2
0.0
2005 2010 2015 2020 2025 2030 2035 2040 2045 2050
Year
Draft Recommendations for minimum
coverage threshold
• For countries that want to introduce
– Must have a well functioning program that is
committed to sustaining rubella vaccination program
long term
– Well functioning programs should achieve MCV1
coverage 80% using WHO/UNICEF estimates either
through routine or campaign or, if program doesn’t
have 80%, be committed to improve immunization
program.
– Point out it is OK to give at 9 months – same as the
previous position paper
Summary
• Since the 2000 PP, several changes have occurred
prompting an updating of the PP.
• WG was established in 2010
• Using the experiences from the regions and
countries, several different phases (Goals) and
corresponding strategies were developed
• With the re-evaluation of the minimum coverage
threshold, countries may introduce RCV into
routine childhood program if they can achieve an
80% MCV1 threshold either through routine or
SIA