WOMEN
AND
IMMUNISATIONDR. SHARDA JAIN
PROMOTING ADOLESCENT / ADULT
WOMEN IMMUNIZATION

WHO

WHO COMMISSIONED GLOBAL
REVIEW PUBLISHED IN 1993
S. Sridhar et al. A systematic literature review of missed opportunities
for immunization in low- and middle-income countries, Vaccine 32
(2014)
MISSED
OPPORTUNITIES
to vaccinate an
estimated 30% of
children and women

TODAY’S SCENARIO FOR VACCINATING WOMEN is
GLOOMY ………..
WHAT SHOULD BE OUREMPHASIS
 Health worker knowledge
 Access and vaccine service availability;
 Cost and service quality; and
Use of all opportunities;

 All women of childbearing age should be
evaluated for the possibility of pregnancy before
immunisation2
 Immunisation history should be taken at first
antenatal visit
 LIVE VIRAL VACCINES are contraindicated
during pregnancy, but risk is largely theoretical2
2. Guidelines for Vaccinating Pregnant Women, Recommendations of the Advisory
Committee on Immunization Practices (ACIP) December 2012
GUIDELINES

 WOMEN WHO HAVE INADVERTENTLY RECEIVED LIVE
VACCINE DURING PREGNANCY SHOULD NOT BE
COUNSELED TO TERMINATE THE PREGNANCY FOR
TERATOGENIC RISK3
 Non pregnant women should delay pregnancy
for at least 4 week
 Inactivated viral vaccines, bacterial vaccines and
toxoids are safe in pregnancy
Immunization in Pregnancy and Breast-Feeding, Part 3
Recommended Immunization, Canadian Immunization Guide
GUIDELINES

 Breast feeding women can be
immunised safely
 Pregnant women should be offered the
influenza vaccine during the season
Immunization in Pregnancy and Breast-Feeding, Part 3
Recommended Immunization, Canadian Immunization Guide
GUIDELINES

Vaccines help keep a woman and her growing family
healthy! Maternal Vaccination – CDC, September, 2016
Available from https://www.cdc.gov/vaccines/pregnancy/downloads/immunizations-preg-chart.pdf; accessed on 26-12-2016

Chickenpox Vaccination
for Women

PREGNANCY AND CHICKENPOX
Varicella infection
during the 1st & 2nd
trimester may
increase the risk for
congenital varicella
syndrome.5
1st & 2nd
Trimester
Varicella infection
during the 3rd trimester
may lead to maternal
pneumonia.5
3rd
Trimester
Newborns whose
mothers develop
chickenpox from 5
days before to 2 days
after delivery are at
risk of chickenpox
shortly after birth5
Perinatal
Varicella
5. Ronald F Lamont et al. BJOG 2011;118:1155–1162

CONGENITAL VARICELLA
SYNDROME
 Varicella infection in the first or early second trimester of
pregnancy could lead to “Congenital Varicella Syndrome" in the
fetus5.
 Primary VZV infection during pregnancy may result in:
 intrauterine infection in about 25% of the cases5
 congenital anomalies can be expected in approximately 12% of
infected fetuses5Clinical features
Reports6
Sauerbrei and Wutzler [3] % Enders and Miller [6] %
Skin lesions 73 72
Neurologic defects or diseases 62 48
Eye diseases 52 44
Limb hypoplasia 46 72
Intrauterine retardation 23
Muscle hypoplasia 20 24
Gastrointestinal abnormalitiesa 19 20
Genitourinary abnormalities 12 -
Affections of internal organs 13 -
Developmental delay 12 -
Defects of cardiovascular
system 8 -
Defects of other organs 7 -
5. Ronald F Lamont et al. BJOG 2011;118:1155–1162 6. Michael Paul Tan et al. Reproductive Toxicology 21 (2006) 410–420

1. Classic cicatricial scarring is visualized in an infant
with congenital varicella syndrome7.
2. The right lower leg has significant bone and muscle
hypoplasia. The classic cicatricial scarring is also visualized7.
3. Infant aged 14 months with herpes zoster in the
classic dermatomal pattern. There was a maternal
history of varicella at 28 weeks of pregnancy7.
4. Newborn with varicella acquired from the mother in
the perinatal period7.
7. Candice K. Smith at al. Fetal & Neonatal Medicine 14 (2009) 209–217

MATERNAL PNEUMONIA
 Maternal pneumonia is a complication in about 10–20%
of cases of Varicella infection during 3rd trimester of
pregnancy, resulting in a higher mortality and morbidity
than in non pregnant adults
 Pregnant women with VZV pneumonia should be
hospitalized for monitoring and administered antiviral
therapy, because up to 40% of women may need
mechanical ventilation
 Mortality in severe cases is estimated to be 3–14%
 The risk for pneumonia also increases with increasing
gestational age
3rd Trimester
Ronald F Lamont et al. BJOG 2011;118:1155–1162

 Newborns whose mothers develop chickenpox
rash from 5 days before to 2 days after delivery
are at risk for chickenpox shortly after birth, with
the chance of death as high as 30%8
8. http://www.cdc.gov/chickenpox/hcp/high-
PRENATAL VARICELLA

PREVENTION OF VARICELLA INFECTION
Woman of
childbearing
age9
The best way to
protect against
chickenpox is
to get the
chickenpox
vaccine.
(1-3 months
prior
pregnancy)9
Pregnant woman
who is not
protected against
chickenpox9
Vaccination of
close contacts
is the most
effective way to
protect a
pregnant woman
against
chickenpox9.
Postpartum
As soon as a
pregnant woman
delivers her baby,
she should be
vaccinated against
chickenpox with 1st
dose and the
second dose at the
6-8-week post-
partum visit9
9. http://www.cdc.gov/pregnancy/infections-chickenpox.html

Seroprevalence of antibodies
against varicella increased with
age1
0
10
20
30
40
50
60
70
80
90
100
1–5 6–10 11–15 16–20 21–30 31–40
%seroprevalence
Age group (years)
Varicella is most common in adolescents
and adults in tropical regions4
Reports from South India showed that nearly
30% of adolescents >15 years of age may be
susceptible to varicella5
Studies conducted in the Uttar
Pradesh region:2,3
• 4.4–15.8% of patients hospitalised
with acute viral encephalitis had
anti-VZV antibodies
Study conducted across four sites across
India (Kolkata, Lucknow, Mumbai,
Bangalore):1
• Overall anti-VZV seroprevalence:
68.22%
• Seroprevalence increased with age,
with a significant proportion of
adolescents susceptible to infection
Owing to the high disease burden in India,it’s important
to protect against Varicella
VZV, varicella zoster virus
1. Lokeshwar MR et al. Indian Pediatr 2000; 37: 714–9; 2. Beig FK et al. Int J Infect Dis 2010; 14: e141–6; 3. Jain P et al. Jpn J Infect Dis 2014; 67: 197–203;
4. World Health Organization. Wkly Epidemiol Rec 2014; 89: 265–87; 5. Verma R et al. Hum Vaccin 2011; 7: 874–7.

VARICELLA VACCINATION
 100% sero-conversion with 2 doses of VarilrixTM in
healthy adults10
 1 dose: 85% seroconversion
 2 doses: 100% seroconversion and 4 fold rise in GMTs
 Proven Safety and efficacy in 53 clinical trials in
>10000 individuals10
10. H W Kreth et al. Biodrugs 2008; 22 (6): 387-402
VarilrixTM (Varicella Vaccine Live)

Recommendations for Chickenpox Vaccination
 2 doses for all older than 12
months recommended by:
 Indian Academy of Pediatrics#
 Advisory Committee on Immunization
Practices/Centre for Disease Control & Prevention
*
 American Academy of Pediatrics^
# IAP Guidebook
* MMWR, June 22, 2007; 56(RR-4):1-40
^ Prevention of Varicella: Recommendations for Use of Varicella Vaccines in Children, Including a Recommendation for a Routine 2-Dose
Varicella Immunization Schedule Committee on Infectious Diseases Pediatrics 2007;120;221

MMR VACCINATION
FOR WOMEN

Measles, Mumps and Rubella
 Measles illness during pregnancy leads to
increased rates of premature labor,
spontaneous abortion, and low birth weight
among affected infants and also birth defects11
 Mumps developed in women during the first
trimester of pregnancy, leads to an increased
risk for fetal death11
 Rubella developed in women during
preganancy may lead to Congential Rubella
syndrome11
11. CDC MMWR1998 ; 47: 2-6

Congenital Rubella Syndrome
 Congenital Rubella Syndrome is the most
serious feature of rubella
 It arises when pregnant women become
infected with the rubella virus in the early
stages of pregnancy
 Infection of the foetus occurs when the rubella
virus spreads from the placenta and enters the
foetal circulation
CDC pink book (http://www.cdc.gov/vaccines/pubs/pinkbook/index.html)

Incidence of Congenital Rubella
Syndrome (CRS)
 CRS is estimated to affect up to 85% of infants
born to women infected with rubella during the
first trimester of pregnancy
 Over 100,000 cases per year of CRS occur in the
developing world alone#
 Congenital Rubella Syndrome is associated with
spontaneous abortion, premature delivery and
stillbirth4
4. http://www.cdc.gov/vaccines/pubs/pinkbook/rubella.html
# IAP Guidebook
40k.cases CRS…occur in
INDIA

CONGENITAL RUBELLA SYNDROME-
MANIFESTATIONS
Consequence of CRS12 Incidence (%)
Hearing Impairment 60
Heart Defect 45
Microcephaly 27
Cataracts 25
Low Birth Weight
(<2500g)
23
Mental Retardation 13
12. Scott R Lambert, Br J Ophthalmol 2007;91:1418–1419

A. A child with expanded or acute congenital rubella
syndrome who had hepatosplenomegaly,
thrombocytopenia, cataracts, deafness, Congenital
heart disease and mental retardation. Also Cutis
marmorata, a peculiar mottling common in infants and
young children with congenital rubella syndrome13
B. CRS patient showing cataracts13
13. MA South et al. Teratology 31:297-307 (1985)

Rubella in Delhi: In-utero Infection and Congenital
Rubella Syndrome
 A section of women (5-10%) unexposed to
natural or vaccinated rubella virus remain
susceptible and add the burden of CRS in
society by contracting rubella infection
during pregnancy as can be seen from the
significant correlation between the in-utero
infection cases and CRS in new-borns
1) I. Gandhoke, et al.; Indian Journal of Medical Microbiology; Vol. 26, Issue 4; 2008
RUBELLA INFECTION IS THE
MAJOR CAUSE OF BIRTH OF
DEFORMED BABY

Rubella Vaccine or combined MMR vaccine?
 CDC EMPHASIZES on the use of
Combined MMR vaccine for any
indication
 CDC: Potential additional benefit of
protection against measles and mumps
1CDC MMRW 1998 ; 47: 2-6

MMR Vaccination
 The MMR vaccine prevents measles, mumps
and rubella**
 MMR Vaccine [PriorixTM - Measles, Mumps
and Rubella vaccine (live)] is highly
immunogenic after one dose, with reported
seroconversion rates of:
 98.7% for measles14
 95.5% for mumps14
 99.5% for rubella14
14. Priorix Prescribing information
** http://www.cdc.gov/vaccines/vpd-vac/measles/faqs-dis-vac-risks.htm

MMR Vaccination
Recommendations
2 doses for all older than 12 months
recommended by…
 Indian Academy of Pediatrics#
 Advisory Committee on Immunization
Practices/Centre for Disease Control &
Prevention**
 American Academy of Pediatrics^^
** http://www.cdc.gov/vaccines/vpd-vac/measles/faqs-dis-vac-risks.htm
# IAP Guidebook, Committee on Infectious Diseases
^^Age for Routine Administration of the Second Dose of Measles-Mumps-Rubella Vaccine Committee on Infectious Diseases Pediatrics

Cervarix® 2-dose schedule
(9-14 years)

PUBLIC HEALTH RATIONALE FOR
2-DOSE DEVELOPMENT
 Delivering a 3-dose schedule to adolescents has proven challenging
 The most important challenges are related to:
 Implementation
 Affordability™®
Cervarix 2-dose for 9-14
years old girls.
HPV, human papillomavirus
Unmet need in Private Market
There is an unmet need for an easier-to-implement and
more affordable HPV vaccine schedule to improve
convenience and compliance.

This principle is independent of dosing schedule (2 or 3)
9-14 years
Cannot be
assessed
Not ethical in <15
years;
challenging feasibility
Assessed
Immune response 2x
higher than older age
group
Efficacy Inferred
9-14 years
Assessed
Immune response not
inferior to older age
group
Efficacy
Inferred
15-25 years
Efficacy
Immunogenicity
Assessed
CIN2+, CIN3+, 6 & 12M
persistent infection
Assessed
3-dose 3-dose 2-dose
Development
BACKGROUND: EFFICACY AND
IMMUNOBRIDGING
Cannot be
assessed
Not ethical in <15
years;
challenging feasibility

CONGRATULATIONS
to
D.G.F. & FOGSI
HPV VACCINATION
DELHI PUNJAB

2-dose for girls aged 9-14 years old demonstrated
non-inferior immune response to HPV-16 and 18 compared
with 3-dose 15-25 years old.
Natural infection = subjects who had cleared infection had GMTs of 29.8 (HPV-16) and 22.6 EL.U/mL (HPV-18) in Study HPV-008 [Paavonen J et al. Lancet 2007;369:2161–70]. Plateau
= GMTs at the plateau level in Study HPV-007 (Month 45–50 time point, females aged 15–25 years) were 397.8 (HPV-16) and 297.3 EL.U/mL (HPV-18) [HPV-007 Study Group et al.
Lancet 2009;374:1975–85].
ATP, according-to-protocol; CI, confidence interval; ELISA, enzyme-linked immunosorbent assay; GMT, geometric mean titres; HPV, human papillomavirus
1.Romanowski B, et al.. Hum Vaccin Immunother. 2015;12:1,20-29
• Antibody kinetics similar in both groups (ELISA, 9-14 vears & 15-25 years)
• GMTs above plateau level seen in subjects with sustained protection (HPV-001/007)
• GMTs above levels elicited after natural infection (control arm HPV-008)
• All subjects seropositive from Month 7 to 60
HPV-16 HPV-18

HPV-070: Safety profile with 2-dose
and 3-dose
 Incidence of local solicited symptoms and
general solicited symptoms (per subject)
during the 7-day post-vaccination period
(TVC)
3
4
HPV, human papillomavirus; TVC, total vaccination cohort
Puthanakit et al JID 2016:214:525-36
Reactogenicity & safety for 2-dose compared 3-dose were
assessed up to M13
All groups showed clinically acceptable safety profile

Clinical Summary on 2 Dose Development
= Immunogenicity
(4 yr follow up)
(Vaccine and non vaccine type)
=Safety
= Duration of protection
(21 years at least)
= Efficacy (93.2% in naieve
girls)
(Inferred by Immunobridging)
3 Dose in 15-25 years old 2 Dose in 9-14 years old=
New Indicated age group of Cervarix® : 9-45 years old.
1.Romanowski B, et al.. Hum Vaccin Immunother. 2015;12:1,20-29 2. Puthanakit et al JID 2016:214:525-36. Cervarix PI"

Cervarix® 2D demonstrated superior immune response as compared
to a 2 D or 3D of q-HPV in 9-14 years old.
2.5 times
3 times
3 times
5.5 times
2 Dose 3 Dose
• HPV 16
•HPV 18
2 Dose
HEAD TO HEAD COMPARISON of Two vaccine
IMMUNE RESPONSE
ATP, according to protocol; ED, mean effective dose; GMT, geometric mean titre; HPV, human papillomavirus; PBNA,
pseudovirion-based neutralisation assay - Leung et al. Hum Vaccin Immunother. 2015 Jul3;11(7):1689-702

• 2-dose development of Cervarix® consistently
demonstrates high immunogenicity versus a 3-dose
schedule1-2
– Non-inferiority of the antibody response against HPV-16 and -18 up to 5
years
– Comparable antibody responses to non-vaccine types 31 and 45 up to at
least 48 months
– Comparable T- and B-cell responses induced by the 2-dose schedule and
the 3-dose schedule
• Modeling predicts this immunity will last at least 21 years1
• The safety profile of the 2-dose schedule remains similar 1-2-3
• The immune response elicited by Cervarix® In a 2-dose schedule is superior
to that of Gardasil in 2-dose and 3-dose schedule in 9-14 year-old girls3
CONCLUSIONS
HPV, human papillomavirus; PBNA, pseudovirion-based neutralisation assay
1.Romanowski B, et al.. Hum Vaccin Immunother. 2015;12:1,20-29; 2. Puthanakit et al JID 2016:214:525-36.
3.Leung et al. Hum Vaccin Immunother. 2015 Jul 3;11(7):1689-702

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