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Vaccination during
Pregnancy &
its Importance
Dr. Sharda Jain
gsk.com
gsk.com
Maternal immunisation has a long history1
2015
2014‒ 15
2014
2012
2011
2009
1996
1995
1990s
1990
1980s
1977
1970/90
1960s
1950/60s
1930/40s
1879
Vaccine against
smallpox
WHO
recommends
influenza MI
UK Tdap MI
safety and
efficacy
ACIP
recommends
Tdap MI
Pandemic
H1N1 MI
safety and
efficacy
Tetanus MI
safety and
efficacy
Maternal tetanus
vaccination
WHO MNTE
initiative
ACIP general influenza
MI recommendation
Over 13 Crore women vaccinated in MNTE programme*
1. Sobanjo-Ter Meulen A et al. Clin Infect Dis 2016;63:S123–S133; 2. Centers for Disease Control and Prevention, 2016. Guidelines for Vaccinating Pregnant Women.
https://www.cdc.gov/vaccines/pregnancy/hcp-toolkit/guidelines.html (accessed August 2020).
, maternal immunisation; MNTE, Maternal and Neonatal Tetanus Elimination; WHO, World Health Organization;
ACIP, Advisory Committee on Immunization Practices; GBS, Group B streptococcus; RSV, respiratory syncytial virus
Several non-live vaccines have been found to be generally well tolerated and immunogenic
in pregnant women and their neonates2
Pregnant women and infants are particularly vulnerable to
some infections1,2
Pregnancy is a period of
immunological
and physiological change1,3
Increased susceptibility to and severity of certain diseases1–3
Early infancy is a period of immune
system development2
Immune system modification1,3
Non-immune physiological changes may impair
pathogen clearance1,3
Immune system immaturity and no prior
exposure to pathogens2
Too young to receive some vaccines4
Lingering maternal immunity –
protective and inhibitory effects2
1. Kourtis AP et al. N Engl J Med 2014;370:2211–2218; 2. Demirjian A, Levy O. Eur J Immunol 2009;39:36–46;
3. Robinson DP, Klein SL. Horm Behav 2012;62:263–271; 4. CDC. CDC Recommended Immunization Schedule for Children and Adolescents Aged 18 Years or Younger,
United States, 2017. https://www.cdc.gov/vaccines/schedules/downloads/child/0-18yrs-child-combined-schedule.pdf (accessed Jan 2023).
In maternal immunisation, antibodies are transferred across the
placenta, providing passive immunity to the newborn child1,2
Active transport
begins after Week 322
Majority of IgG is acquired
in the last 4 weeks of
pregnancy1
Exceed maternal
levels by 20–30% at
full term1
Starts to increase at
Week 131
5–10% of maternal
levels at Weeks 17–
221
50% of maternal
levels at
Weeks 28–321
None when
first pregnant
Placental transfer of IgG is generally linear, with the largest amount transferred in the third
trimester1
1. Palmeira P, et al. Clin Dev Immunol 2012;2012:985646; 2. Chu HY, Englund JA. Clin Infect Dis 2014;59:560–568.
Summary of Maternal Immunization Recommendations
1. Faucette AN, Pawlitz MD, Pei B, Yao F, Chen K. Immunization of pregnant women: Future of early infant protection. Hum Vaccin Immunother. 2015;11(11):2549-2555.
2. MOHFW. Operational Guidance for COVID-19 Vaccination of Pregnant Women. Accessed 13 May 2022. https://www.mohfw.gov.in/pdf/OperationalGuidanceforCOVID19vaccinationofPregnantWoman.pdf.
3. Erie County Department of Health. Immunizations During Pregnancy; Vaccines Help Keep, Mom, Baby and Family Healthy. Accessed 13 May 2022. https://www2.erie.gov/health/index.php?q=immunizations-during-pregnancy-vaccines-help-keep-mom-baby-and-family-healthy.
COVID-19, coronavirus disease; DTaP, diphtheria, tetanus, and pertussis; Mo, month; Tri, trimester
Vaccine
Before Pregnancy Pregnancy Postpartum &
Breastfeeding
>1 Mo 1 Mo 1st Tri 2nd Tri 3rd Tri
Influenza1
COVID-192
DTaP1,3
Hepatitis A1,3
Hepatitis B1,3
Meningococcal conjugate &
serogroup B1,3
Pneumococcal1,3
MMR1,3
Varicella1,3
Recommended
Not Recommended, unless high
risk for exposure. Must consult a
health care provider before
proceeding.
Not Recommended
8
Vaccination during pregnancy is recommended by
Global and National Expert Health authorities
Vaccine
HealthCare
Organization
Recommendations
Tetanus,
Diphtheria,
Pertussis
ACOG1
• Obstetric care providers should administer the tetanus toxoid, reduced diphtheria toxoid,
and acellular pertussis (Tdap) vaccine to all pregnant patients during each pregnancy, as
early in the 27-36-weeks-of-gestation window as possible
FOGSI2,3
• 2 doses of TD at least 28 days apart commencing from 2nd trimester
• Tdap vaccination can be considered instead of the 2nd dose of TD
• Tdap should be administered during pregnancy in order to provide optimal
protection to the baby during its first months of life. (Strength of recommendation:
A; quality of evidence IV)
Influenza
ACOG⁴
• All women who are or might be pregnant or post-partum during influenza season should
receive an influenza vaccination.
• Any of the licensed, recommended, age appropriate, inactivated influenza vaccine can be
given at any time during pregnancy
FOGSI⁵
• Influenza vaccine is recommended to all pregnant women from 26 weeks
onwards
(Strength of recommendation: A; quality of evidence III)
• In case of a pandemic the influenza vaccine can be given earlier to
protect the mother
Reference: 1. ACOG Committee Opinion, Sept 2017 https://www.acog.org/clinical/clinical-guidance/committee-opinion/articles/2017/09/update-on-immunization-and-pregnancy-tetanus-diphtheria-and-pertussis-vaccination (accessed Oct 2020) 2. FOGSI: Vaccination in Women:
https://www.fogsi.org/wp-content/uploads/2015/11/vaccination_women.pdf (accessed Oct 2020) 3. FOGSI-Good Clinical Practice Recommendations on PRECONCEPTION CARE: : https://www.fogsi.org/gcpr-preconception-care/ (accessed Oct 2020) 4. ACOG COMMITTEE OPINION.
Influenza Vaccination During Pregnancy. Obstetrics and Gynecology. Vol. 131, No. 4, April 2018 (Accessed Oct 2020). 5. FOGSI. Consensus- Good Clinical Practice Recommendations on Preconception Care-India. FOGSI 2018. Available at https://www.fogsi.org/gcpr-preconception-care
(Accessed Jan 2023).
TD vaccination during pregnancy to
prevent Maternal Tetanus /Diptheria
&Neonatal Tetanus
TT vaccination during pregnancy to
prevent Maternal Tetanus /Diptheria
&Neonatal Tetanus 1930 ,90 WHO
MNTE 2 DOSES
Tdap vaccination is NEW Initiative
during pregnancy to prevent Neonatal
Pertussis
Pertussis disease– Key facts
• Pertussis is more commonly known as ‘whooping cough’1
• Pertussis is a highly contagious respiratory infection caused by
the Gram-negative bacterium Bordetella pertussis1,2
• Pertussis transmission: airborne droplets or direct contact with
nasopharyngeal discharges from an infected person1,3
• In an immune-naïve population, 1 primary case of pertussis can
cause ~12-17 new cases4,5
• Pertussis affects people of all ages3
Source: 1. CDC.Pink Book. Available at https://www.cdc.gov/vaccines/pubs/pinkbook/pert.html (accessed on 2 Aug
2018); 2. Grant C. In: Oxford Textbook of Medicine. 2010:Section 7.6.14; 3. WHO. Wkly Epidemiol Rec 2010;85:385–
400. 4. Schellekens J et al. Pediatr Infect Dis J. 2005;24:S19–S24; 5. Fine PE: Epidemiol Rev 1993;15:265–302
IAP
Vaccine Schedule1
Birth
Primary immunization 1st
Booster
2nd
Booster
6 wk 10 wk 14 wk 15m – 18m 4-6 Yr
DTP vaccine
Dose 1 Dose 2 Dose 3 Dose 4 Dose 5
1. Kasi SG, Indian Pediatr. 2021 Jan 15;58(1):44-53.; 1068 2.ACOG Committee Opinion. Update on Immunization and Pregnancy: tetanus, diphtheria, and pertussis vaccination. Number 718, September
2017. Available at: https://www.acog.org/Clinical-Guidance-and-Publications/Committee-Opinions/Committee-on-Obstetric-Practice/Update-on-Immunization-and-Pregnancy-Tetanus-Diphtheria-and-Pertussis-
Vaccination. Accessed 12 Nov 2019.3 Best Practice&ResearchClinicalObstetricsandGynaecology76(2021)23e40
Immunity Gap
1st dose of DTP vaccine is not recommended until 6–8 weeks of age
Infants are not protected during the
first 2 months of life2
Rationale for pertussis vaccination during pregnancy
Vaccination for neonatal protection should ideally occur between 30 and 32 weeks to
maximize placental antibody transfer.
Pertussis in young infants
>90% of infants under 2 months of age with pertussis require hospitalization1
Pertussis complications in infants <2 months of age1
Complication Rate%
Pneumonia 15–25
Seizures 2–4
Encephalopathy 0.5–1
~75% of pertussis-related deaths occur in infants under 2 months of age2
1. Hong. Korean J Pediatr 2010;53(5):629–633. 2.Healy CM. Hum Vaccin Immunothe.
2016;12(8):1972-1981
Mothers are the most common source of pertussis infection for
newborns1
Percentage
of
total
source
contacts
with
pertussis
1.Data derived from Wiley KE et al. Vaccine 2013;31:618–625
Pooled data from a maximum of 7 studies which included case infants less than 6 months old
0
5
10
15
20
25
30
35
40
Mother Father Sibling Grandparent Other
37.3
17.6
26.8
14.9
Maternal immunisation2
Maternal immunisation is most effective strategy in
protecting young infants from Pertussis
4.2
Boostrix has shown high effectiveness in preventing pertussis
disease in infants < 3 months of age
1. Amirthalingam G, et al. Clin Infect Dis 2016:63 (Suppl 4); 2. Bellido-Blasco J, et al. Euro Surveill 2017;22:pii=30545; 3. Saul N, et al. Vaccine 2018;36(14):1887–1892.
Country Surveillance period
Time vaccine given during
pregnancy
Adjusted VE
UK1
July 2014-August 2015
(Boostrix-IPV) Between 27 and 36 weeks
VE in infant <3 months
88% (95% CI: 79–93)
against pertussis disease
Spain:
Valencia2
March 2015- February 2016
(Boostrix)
Between 27 and 36 weeks
Infants <3 months of age:
91% against disease
(95% CI: 56.6–98.1)
Australia3 August 2015- August 2016
(Boostrix)
Between 27 and 36 weeks
VE in infant <3 months
69% (95% CI 13% – 89%)
against pertussis disease
Disclaimer: The flags in this material is for generalized illustration. All efforts have been made to ensure the accuracy of the national flags of the respective countries depicted in this however GSK and its directors do not own
any for the correctness or authenticity of the same.
1.. Hong. Korean J Pediatr 2010;53(5):629–633. 2. Healy CM. Hum Vaccin Immunothe. 2016;12(8):1972-1981 3. Wiley KE et al. Vaccine 2013;31:618–625
4. Amirthalingam G, et al. Clin Infect Dis 2016:63 (Suppl 4); 5. Bellido-Blasco J, et al. Euro Surveill 2017;22:pii=30545; 6. Saul N, et al. Vaccine 2018;36(14):1887–1892.
Summary
>90% of infants under 2 months of age with pertussis require hospitalization1
~75% of pertussis-related deaths occur in infants under 2 months of age2
Mothers are the most common source of pertussis infection for newborns3
Boostrix has shown high effectiveness in preventing pertussis disease in
infants < 3 months of age4,5,6
HUSBAND – is given vac at
delivery in hospital itself in
USA
Influenza
during
Pregnancy
Influenza during pregnancy
& its prevention
Global and National expert health authorities recommend
maternal immunization
Reference: 1. WHO Wkly Epidemiol Rec 2014;89(21):221–236 2. ACOG Committee Opinion, Sept 2017 https://www.acog.org/clinical/clinical-guidance/committee-opinion/articles/2017/09/update-on-immunization-and-
pregnancy-tetanus-diphtheria-and-pertussis-vaccination accessed June 2021 3. RCOGhttps://www.rcog.org.uk/en/news/rcog-statement-pertussis-whooping-cough-vaccination-now-offered-from-20-weeks-of-pregnancy/
accessed June 2021 4. FOGSI-Good Clinical Practice Recommendations on PRECONCEPTION CARE: : https://www.fogsi.org/gcpr-preconception-care/ accessed June 2021 5. Kasi et al. Indian Pediatr. 2021 6. Summary of
Recommendations (cdc.gov).7. FIGO Statement: Vaccination in pregnancy - Nassar - 2021 - International Journal of Gynecology & Obstetrics - Wiley Online Library
Influenza vaccines are recommended during Pregnancy 1-7
since many years
WHO ACOG FOGSI ACIP IAP
WHO: World health organization ACOG: American college of obstetric and gynecology, RCOG: Royal College of Obstetricians & Gynaecologists FOGSI: The federation of obstetrics and gynaecological societies of
India IAP: Indian academy of pediatrics
RCOG FIGO
Global recommendations for Influenza Vaccination in pregnancy
WHO World health organization. CDC Centre for disease control and prevention ACIP Advisory committee on immunization practices, ACOG American College of obstetrics and gynecologists,
1. WHO. SAGE meeting April 2012. Statement on influenza immunization. 2012. Available at: www.who.int/influenza/vaccines/SAGE_information/en (Accessed June 2021)
2. ACOG COMMITTEE OPINION. Influenza Vaccination During Pregnancy. Obstetrics and Gynecology. Vol. 131, No. 4, April 2018 (Accessed June 2021)
• Pregnant women should be vaccinated with influenza vaccine at any stage of
pregnancy.
• Seasonal influenza vaccine is safe and effective in preventing influenza in the
women as well as in their young infants
•WHO (SAGE) 20121
• All women who are or might be pregnant or post-partum during influenza season
should receive an influenza vaccination.
• Any of the licensed, recommended, age appropriate, inactivated influenza vaccine
can be given at any time during pregnancy
ACOG 20192
Indian recommendations for Influenza Vaccination in pregnancy
FOGSI Federation of obstetrics and gynecological societies of India, IAP Indian academy of paediatrics.
1. FOGSI. Consensus- Good Clinical Practice Recommendations on Preconception Care-India. FOGSI 2016. Available at https://www.fogsi.org/gcpr-preconception-care (Accessed June 2021).
2. IAP Guidebook on Immunization 2018-2019 3rd Edition, Jaypee Brothers
• Influenza vaccine is recommended to all pregnant women from 26 wks. onwards
• In case of a pandemic the influenza vaccine can be given earlier to protect the
mother
FOGSI 20181
• Pregnant women can be immunized against influenza at any time during their
pregnancy.
• Vaccine is safe and effective in preventing influenza in the women as well as in
their young infants, in whom the disease burden is high.
IAP 20182
Pertussis
Influenza
Tetanus/ diphtheria
Hepatitis B
Risk of Severe Disease 1,2
In pregnant women/
foetus
In new-borns/ infants
HIGH
LOW
LOW
LOW
HIGH
HIGH
HIGH
HIGH
1. Swamy GK & Beigi RH. Vaccine 2015;33:6436–6440; 2. Kourtis AP et al. N Engl J Med 2014;370:2211–2218
Pregnancy-related adaptations of the immune and the cardiovascular systems promotes a
prolonged inflammatory phenotype, increasing disease severity, and causing maternal and fetal
health problems
Indian data on impact of Influenza in Pregnancy ¹
Review of 8 Indian studies with ~12000 subjects (South-5, West-2, North-1)
Influenza imposes high burden of maternal & fetal complications in pregnancy
• Maternal mortality
• Fetal loss
• Premature delivery
• ICU admissions & prolonged hospitalization
• Complications including renal failure, mechanical ventilation
Findings
1.Bhalerao-Gandhi et al. Influenza and Pregnancy: A Review of the Literature from India. Infectious Diseases in Obstetrics and Gynecology Volume 2015, Article ID 867587, 1-8,
http://dx.doi.org/10.1155/2015/867587
I1. nfluenza and Pregnancy: A Review of the Literature from India Ashwini Bhalerao-Gandhi,1 Pankdeep Chhabra,2 Saurabh
Arya,2 and James Mark Simmerman3
0.0%
10.0%
20.0%
30.0%
40.0%
50.0%
60.0%
70.0%
80.0%
90.0%
Mathur et
al
2013(n=37
)
Mehta et al
2013(n= 6)
Ramkrishn
a et al
2012(n=19
)
Gunasekar
an et al
2012(n=
126)
Praminick
et al 2012
(n=79)
Puvanaling
am et al
2011(n=12
)
Chudasam
a et al
2010
(n=15)
prevalence of influenza 23.40% 5.20% 73% 32.50% 25% 90%
ICU admission and complications 29.60% 40% 75% 73.30%
Maternal mortality 70% 33% 52.60% 25% 25%
Influenza in pregnancy is associated with adverse outcomes like ICU admission & associated
complications and Maternal Mortality1
• Influenza-related maternal mortality ranged from 25% to 70% among pregnant women; higher than that reported in
other countries.
• Pregnant women have been observed to be at a 18-fold higher risk of hospitalization as compared to healthy
nonpregnant women, and the risk is greatest among women in later stages of pregnancy
27
23 March 2024
PERINATAL OUTCOMES
Maternal and Perinatal Outcomes of Influenza in Pregnancy after Treatment with Oseltamivir1
Prospective observational cohort study conducted in a tertiary hospital in Vellore; Patients with ILI – 73.2% (476/650)
Lab confirmed cases = 36.5% (174/476)
Significantly higher proportion of women
in Cohort 1 had severe illness requiring
inpatient and ICU care compared to
PCR-negative women (36.2% vs. 6.3%, P
< 0.001).
Abraham K, et al. J Glob Infect Dis. 2021 Jan 29;13(1):20-26
Influenza contributed to 36%
of the acute respiratory
infections in the observed
pregnant women.
↑ preterm births in the
infected women (RR – 2.75)
requiring prolonged NICU
care.
The expenditure toward treatment,
₹15,432 (~$ 216) for an average of 5
days, was three times higher for
women with severe illness
compared to women who had
outpatient-based care.
Benefits to the newborn2,3
Prevention is better than cure
• Robust immune response
• Prevention of influenza complications
• ↓ need for hospitalization
• ↓ adverse pregnancy and perinatal outcomes
• ↓ preterm and low birth weight babies
• Transplacental transfer of antibodies to
fetus
• Fills the gap till infant immunization can
begin
Benefits to the mother2,3
1. Influenza Antiviral Medications: Summary for Clinicians./CDC/Available at https://www.cdc.gov/flu/professionals/antivirals/summary-clinicians.htm#dosage (assessed on jan 2022)
2. Background paper on Influenza Vaccines and Immunization, SAGE Working group, April 2012. Available at https://www.who.int/immunization/sage/meetings/2012/april/1_Background_Paper_Mar26_v13_cleaned.pdf?ua=1 (accessed jan 2023)
3. Buchy P et al. Vaccinating pregnant women against influenza needs to be a priority for all countries: An expert commentary. International Journal of Infectious Diseases. 2020; 92: 1-12
“An Influenza Vaccine is the best protection against Influenza in Pregnancy” – CDC1
Safety of Influenza Vaccines in Pregnancy
1. Moro P L et al, Adverse events in pregnant women following administration of trivalent inactivated influenza vaccine and live attenuated influenza vaccine in the Vaccine
Adverse Event Reporting System, 1990-2009. Am J Obstet Gynecol 2011;204:146.e1-7. https://doi.org/10.1016/j.ajog.2010.08.050 2. Tamma P.D et al. Safety of influenza
vaccination during pregnancy. Am J Obstet Gynecol 2009;201 (6):547-552. doi: 10.1016/j.ajog.2009.09.034. 3. Safety of immunization during Pregnancy-A review of the
evidence. Available at https://www.who.int/vaccine_safety/publications/safety_pregnancy_nov2014.pdf (Accessed Aug 2020)
No safety concerns in >5 Lac pregnant women in Europe and >1 Lac
pregnant women in Canada after influenza vaccination¹
Safety literature review data from 7000+ pregnant women from different
countries²
• No increased risk of untoward maternal or fetal outcomes reported
WHO: Global Advisory Committee on Vaccine Safety³
• Excellent and robust safety profile of multiple inactivated influenza vaccines
over many decades
1. Swamy GK & Beigi RH. Vaccine 2015;33:6436–6440; 2. Kourtis AP et al. N Engl J Med 2014;370:2211–2218 3.Bhalerao-Gandhi et al. Influenza and Pregnancy: A Review of the Literature from India. Infectious
Diseases in Obstetrics and Gynecology Volume 2015, Article ID 867587, 1-8, http://dx.doi.org/10.1155/2015/867587 4. Background paper on Influenza Vaccines and Immunization, SAGE Working group, April 2012.
Available at https://www.who.int/immunization/sage/meetings/2012/april/1_Background_Paper_Mar26_v13_cleaned.pdf?ua=1 (accessed jan 2023)
5.Buchy P et al. Vaccinating pregnant women against influenza needs to be a priority for all countries: An expert commentary. International Journal of Infectious Diseases. 2020; 92: 1-12
Summary
Risk of disease is high in both mothers as well as newborns/ infants1,2
Benefits to mother: ↓ need for hospitalization & ↓ adverse pregnancy and perinatal outcomes4,5
Benefits to newborns: ↓ preterm and low birth weight babies4,5
Influenza imposes high burden of maternal & fetal complications in pregnancy3
Recent literature
highlighting need for
Maternal Imm
Topic 3
Influenza
Shaikh et al. Safety and Protective Effects of Influenza Vaccination in Pregnant Women on Pregnancy and Birth Outcomes in Pune, India: A Cross-Sectional Study.
Vaccines 2023, 11, 1034.
Safety and Protective Effects of Influenza Vaccination in Pregnant Women on
Pregnancy and Birth Outcomes in Pune, India: A Cross-Sectional Study
• Cross sectional observation study in a tertiary care centre in Pune in women;
N=558
STUDY DESIGN
• Pregnancy related adverse events/complications: PIH,GDM, Pre
eclampsia, PROM, Spontaneous abortion, Preterm birth.
• Birth outcomes: Congenital anomalies, LBM,VLBW, NICU or neonatal care
hospitalization, RDS & mechanical ventilatuion, Apgar score at 5mins.
Outcome Variables
• Overall Vaccination uptake- 47.5%(265/558)
• First trimester- 1.9%
• Second trimester- 40.4%
• Third trimester- 57.7%
Findings
PIH: pregnancy-induced hypertension, GDM: gestational diabetes mellitus,
Flu vaccination is SAFE in pregnancy with no increased risk of adverse birth
outcomes, regardless of the trimester in which vaccination was performed
Pregnancy outcome Fetal Outcome
No association between influenza vaccines and
PROM, Preterm birth & gestational hypertension
There was no association between maternal influenza
vaccination and adverse neonatal outcomes
Higher risk of VLBW in unvaccinated pregnant
women (AOR 2.29, 95% CI; 1.03 to 5.58, p = 0.03)
Apgar scores at 5 min (adjusted odds ratio [AOR]
0.92, 95% CI 0.23 to 3.78)
neonatal care unit (NICU) hospitalization (AOR
0.87, 95% CI, 0.29 to 2.85)
mechanical ventilation (AOR 0.72, 95% CI, 0.21 to
4.00)
respiratory distress syndrome (AOR 1.1, 95% CI,
0.35 to 3.95).
~2 increased risk of VLBW for non-vaccinated pregnant women (p=0.03)
Shaikh et al. Safety and Protective Effects of Influenza Vaccination in Pregnant Women on Pregnancy and Birth Outcomes in Pune, India: A Cross-Sectional Study.
Vaccines 2023, 11, 1034.
Pertussis
Hospital Based Multicentric Study - India
To estimate burden due to pertussis among infants ≤6 months of age, hospitalized with acute respiratory
infections (ARIs)
Kolkata
 Chennai
Delhi
Pune
Singh V, S B, Lalwani S, Singh R, Singh P, Datta K, Mohanty N, Poddar S, Sodani R, Saha M, Mitra M. Evaluation of Pertussis Disease in Young Infants in India: A Hospital-
Based Multicentric Observational Study. Indian J Pediatr. 2023 Jun 28. doi: 10.1007/s12098-023-04700-y.
Active surveillance study
(Jan 2020 -April 2022 @ 7 tertiary care centers)
Infants screened [hospitalized with ARIs]
1102
Excluded (not satisfying CDC 2020
clinical case definition of pertussis)
702
Enrolled infants (CDC 2020 clinical case definition of pertussis)
400
Collection of nasopharyngeal swabs
RT-PCR to test for the presence of Bordetella pertussis
and other respiratory pathogens
0-3 month [248/400 (62%)]
4-6 month [152/400 (38%)]
Participants with LCP: 34/400 (8.5 %)
0-3 months: 21/248
(8.47 %)
4-6 months: 13/152
(8.55 %)
Participants with PP: 46/400 (11.5%)
0-3 months: 30/248
(12. %)
4-6 months: 16/152
(10.53 %)
Mothers of only 2 infants (aged 0-3 months) had received the Tdap vaccine during
pregnancy
Clinical features included in CDC-2020
guidelines
Clinical
Features
Total,
N =400
LCP
N=34
PP
N=46
Paroxysms of
coughing
312
(78%)
26
(76.47%)
35
(76.09%)
Posttussive
vomiting
128
(32%)
8
(23.53%)
19
(41.30%)
Apnea 55
(13.75%)
8
(23.53%)
10
(21.74%)
Inspiratory
whoop
45
(11.25%)
5
(14.71%)
4
(8.70%)
Participants with LCP: 34/400 (8.5 %)
0-3 months: 21/248
(8.47 %)
4-6 months: 13/152
(8.55 %)
Participants with PP: 46/400 (11.5%)
0-3 months: 30/248
(12. %)
4-6 months: 16/152
(10.53 %)
Respiratory pathogens isolated from nasopharyngeal
swabs of ‘clinically suspected’ pertussis
 Rhinovirus/ Enterovirus 23 (5.75)
 Respiratory Syncytial Virus A 21 (5.25)
Coronavirus 229E 20 (5)
 Bocavirus Type 1 12 (3)
 Coronavirus HKU1/ NL63 7 (1.75)
 Human Metapneumovirus 6 (1.5)
Singh V, S B, Lalwani S, Singh R, Singh P, Datta K, Mohanty N, Poddar S, Sodani R, Saha M, Mitra M. Evaluation of Pertussis Disease in Young
Infants in India: A Hospital-Based Multicentric Observational Study. Indian J Pediatr. 2023 Jun 28. doi: 10.1007/s12098-023-04700-y.
Indian data on Neonatal Pertussis reported from many centers
2021 Multicentric Surveillance Data 1
(Pune, Kolkata, Chennai, Ludhiana)
~5% infants had laboratory-confirmed
Pertussis (n=32) with 3.6 months
median age
Apnoea was significantly more
associated with Pertussis
Post tussive emesis observed in 50%
and pneumonia in 34% cases.
.1. Apte A et al, Multicentric Hospital-Based Surveillance of Pertussis Amongst Infants Admitted in Tertiary Care Facilities in India; INDIAN PEDIATRICS; VOLUME 58, AUGUST 15, 2021
2. Kavitha T K, Clinical Profile of Critical Pertussis in Children at a Pediatric Intensive Care Unit in Northern India; INDIAN PEDIATRICS, VOLUME 57, MARCH 15, 2020
2020 Clinical Profile of Critical
Pertussis at a PICU 2
(PGI, Chandigarh)
• 86% cases of Pertussis were Infants
(~28% <6wks of age) (n=36)
• Mechanical ventilation required in
over 30% cases
• Exchange transfusion required in
over 8% cases
Regan AK, Moore HC, Binks MJ, McHugh L, Blyth CC, Pereira G, Lust K, Sarna M, Andrews R, Foo D, Effler PV. Maternal pertussis
vaccination, infant immunization, and risk of pertussis. Pediatrics. 2023 Nov 1;152(5).
Effectiveness of pertussis vaccination during pregnancy
First 3 years of maternal pertussis immunization programs from Australia
52% of pregnant individuals received acellular pertussis vaccine and vaccine
was associated with ~66% overall decrease in neonatal pertussis infection
among <2 months old infants
My Clinical Experience
Boostrix Safety Profile
1. Boostrix_BTX_PI_IN_2022_02 dated 27 Jul 2022; 2. Petousis-Harris H et al. BMJ Open 2016;6(4):e010911.
I STRONGLY ADVOCATE BOOSTERIX FOR ALL IN PREGNANCY , USING FROM
THE DAY IT IS INTRODUCED IN INDIA
Adverse Events in adults1
Very common: injection site redness/
swelling, pain, malaise, fatigue,
headache
Common: Fever >37.5 C, dizziness,
nausea, Injection site mass/sterile
abscess
Uncommon: URTI, diarrhea, vomiting,
lymphadenopathy, rash, pruritic,
arthralgia, myalgia
Adverse Events during pregnancy2*
In clinical trials
• Mild and moderate pain (79%)
• Injection site induration (12%)
-Swelling (7.6%)
-Redness (5.8%)
• Severe pain (2.6%), fever (2.1%)
• Others : headache, nausea/vomiting,
fatigue, myalgia/ arthralgia
SAFE IN ADULTS
SAFE IN PREGNANCY
MUST FOR ALL
INFUENJA VACCINATION
Fluarix Tetra safety information
Adapted from . Menveo Product Information (India) {Version: MNV/PI/IN/2019/03 dated 21 August 2019
Summary from clinical trials:
Post-marketing data:
Most frequently
reported general
adverse
reactions after
vaccination
All age groups 18 years and
above
6 to 17 years 3 to 5 years 6 months to 3
years
Injection site pain
(15.6% to 40.9%)
Fatigue (11.1%),
headache (9.2%)
and myalgia
(11.8%)
Fatigue (12.6%),
myalgia (10.9%)
and headache
(8.0%)
Drowsiness (9.8%)
and irritability
(11.3%)
Irritability/
fussiness (14.9%)
and loss of
appetite (12.9%)
Rare events
General
disorders and
administration
site conditions
Skin and
subcutaneous
tissue disorders
Immune system
disorders
Nervous system
disorders
Blood and
lymphatic system
disorders
Influenza-like
illness, malaise
Urticaria, pruritus,
erythema,
angioedema
Allergic reactions
(including
anaphylactic
reactions)
Neuritis, acute
disseminated
encephalomyelitis,
Guillain-Barré
syndrome
Transient
lymphadenopathy
Fluarix Tetra Product Information. Available at https://india-pharma.gsk.com/media/850622/fluarix-tetra.pdf
44
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Vaccination during Pregnancy & its Importance : Dr Sharda Jain

  • 1. Vaccination during Pregnancy & its Importance Dr. Sharda Jain
  • 4. Maternal immunisation has a long history1 2015 2014‒ 15 2014 2012 2011 2009 1996 1995 1990s 1990 1980s 1977 1970/90 1960s 1950/60s 1930/40s 1879 Vaccine against smallpox WHO recommends influenza MI UK Tdap MI safety and efficacy ACIP recommends Tdap MI Pandemic H1N1 MI safety and efficacy Tetanus MI safety and efficacy Maternal tetanus vaccination WHO MNTE initiative ACIP general influenza MI recommendation Over 13 Crore women vaccinated in MNTE programme* 1. Sobanjo-Ter Meulen A et al. Clin Infect Dis 2016;63:S123–S133; 2. Centers for Disease Control and Prevention, 2016. Guidelines for Vaccinating Pregnant Women. https://www.cdc.gov/vaccines/pregnancy/hcp-toolkit/guidelines.html (accessed August 2020). , maternal immunisation; MNTE, Maternal and Neonatal Tetanus Elimination; WHO, World Health Organization; ACIP, Advisory Committee on Immunization Practices; GBS, Group B streptococcus; RSV, respiratory syncytial virus Several non-live vaccines have been found to be generally well tolerated and immunogenic in pregnant women and their neonates2
  • 5. Pregnant women and infants are particularly vulnerable to some infections1,2 Pregnancy is a period of immunological and physiological change1,3 Increased susceptibility to and severity of certain diseases1–3 Early infancy is a period of immune system development2 Immune system modification1,3 Non-immune physiological changes may impair pathogen clearance1,3 Immune system immaturity and no prior exposure to pathogens2 Too young to receive some vaccines4 Lingering maternal immunity – protective and inhibitory effects2 1. Kourtis AP et al. N Engl J Med 2014;370:2211–2218; 2. Demirjian A, Levy O. Eur J Immunol 2009;39:36–46; 3. Robinson DP, Klein SL. Horm Behav 2012;62:263–271; 4. CDC. CDC Recommended Immunization Schedule for Children and Adolescents Aged 18 Years or Younger, United States, 2017. https://www.cdc.gov/vaccines/schedules/downloads/child/0-18yrs-child-combined-schedule.pdf (accessed Jan 2023).
  • 6. In maternal immunisation, antibodies are transferred across the placenta, providing passive immunity to the newborn child1,2 Active transport begins after Week 322 Majority of IgG is acquired in the last 4 weeks of pregnancy1 Exceed maternal levels by 20–30% at full term1 Starts to increase at Week 131 5–10% of maternal levels at Weeks 17– 221 50% of maternal levels at Weeks 28–321 None when first pregnant Placental transfer of IgG is generally linear, with the largest amount transferred in the third trimester1 1. Palmeira P, et al. Clin Dev Immunol 2012;2012:985646; 2. Chu HY, Englund JA. Clin Infect Dis 2014;59:560–568.
  • 7. Summary of Maternal Immunization Recommendations 1. Faucette AN, Pawlitz MD, Pei B, Yao F, Chen K. Immunization of pregnant women: Future of early infant protection. Hum Vaccin Immunother. 2015;11(11):2549-2555. 2. MOHFW. Operational Guidance for COVID-19 Vaccination of Pregnant Women. Accessed 13 May 2022. https://www.mohfw.gov.in/pdf/OperationalGuidanceforCOVID19vaccinationofPregnantWoman.pdf. 3. Erie County Department of Health. Immunizations During Pregnancy; Vaccines Help Keep, Mom, Baby and Family Healthy. Accessed 13 May 2022. https://www2.erie.gov/health/index.php?q=immunizations-during-pregnancy-vaccines-help-keep-mom-baby-and-family-healthy. COVID-19, coronavirus disease; DTaP, diphtheria, tetanus, and pertussis; Mo, month; Tri, trimester Vaccine Before Pregnancy Pregnancy Postpartum & Breastfeeding >1 Mo 1 Mo 1st Tri 2nd Tri 3rd Tri Influenza1 COVID-192 DTaP1,3 Hepatitis A1,3 Hepatitis B1,3 Meningococcal conjugate & serogroup B1,3 Pneumococcal1,3 MMR1,3 Varicella1,3 Recommended Not Recommended, unless high risk for exposure. Must consult a health care provider before proceeding. Not Recommended
  • 8. 8 Vaccination during pregnancy is recommended by Global and National Expert Health authorities Vaccine HealthCare Organization Recommendations Tetanus, Diphtheria, Pertussis ACOG1 • Obstetric care providers should administer the tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis (Tdap) vaccine to all pregnant patients during each pregnancy, as early in the 27-36-weeks-of-gestation window as possible FOGSI2,3 • 2 doses of TD at least 28 days apart commencing from 2nd trimester • Tdap vaccination can be considered instead of the 2nd dose of TD • Tdap should be administered during pregnancy in order to provide optimal protection to the baby during its first months of life. (Strength of recommendation: A; quality of evidence IV) Influenza ACOG⁴ • All women who are or might be pregnant or post-partum during influenza season should receive an influenza vaccination. • Any of the licensed, recommended, age appropriate, inactivated influenza vaccine can be given at any time during pregnancy FOGSI⁵ • Influenza vaccine is recommended to all pregnant women from 26 weeks onwards (Strength of recommendation: A; quality of evidence III) • In case of a pandemic the influenza vaccine can be given earlier to protect the mother Reference: 1. ACOG Committee Opinion, Sept 2017 https://www.acog.org/clinical/clinical-guidance/committee-opinion/articles/2017/09/update-on-immunization-and-pregnancy-tetanus-diphtheria-and-pertussis-vaccination (accessed Oct 2020) 2. FOGSI: Vaccination in Women: https://www.fogsi.org/wp-content/uploads/2015/11/vaccination_women.pdf (accessed Oct 2020) 3. FOGSI-Good Clinical Practice Recommendations on PRECONCEPTION CARE: : https://www.fogsi.org/gcpr-preconception-care/ (accessed Oct 2020) 4. ACOG COMMITTEE OPINION. Influenza Vaccination During Pregnancy. Obstetrics and Gynecology. Vol. 131, No. 4, April 2018 (Accessed Oct 2020). 5. FOGSI. Consensus- Good Clinical Practice Recommendations on Preconception Care-India. FOGSI 2018. Available at https://www.fogsi.org/gcpr-preconception-care (Accessed Jan 2023).
  • 9. TD vaccination during pregnancy to prevent Maternal Tetanus /Diptheria &Neonatal Tetanus
  • 10. TT vaccination during pregnancy to prevent Maternal Tetanus /Diptheria &Neonatal Tetanus 1930 ,90 WHO MNTE 2 DOSES
  • 11. Tdap vaccination is NEW Initiative during pregnancy to prevent Neonatal Pertussis
  • 12. Pertussis disease– Key facts • Pertussis is more commonly known as ‘whooping cough’1 • Pertussis is a highly contagious respiratory infection caused by the Gram-negative bacterium Bordetella pertussis1,2 • Pertussis transmission: airborne droplets or direct contact with nasopharyngeal discharges from an infected person1,3 • In an immune-naïve population, 1 primary case of pertussis can cause ~12-17 new cases4,5 • Pertussis affects people of all ages3 Source: 1. CDC.Pink Book. Available at https://www.cdc.gov/vaccines/pubs/pinkbook/pert.html (accessed on 2 Aug 2018); 2. Grant C. In: Oxford Textbook of Medicine. 2010:Section 7.6.14; 3. WHO. Wkly Epidemiol Rec 2010;85:385– 400. 4. Schellekens J et al. Pediatr Infect Dis J. 2005;24:S19–S24; 5. Fine PE: Epidemiol Rev 1993;15:265–302
  • 13. IAP Vaccine Schedule1 Birth Primary immunization 1st Booster 2nd Booster 6 wk 10 wk 14 wk 15m – 18m 4-6 Yr DTP vaccine Dose 1 Dose 2 Dose 3 Dose 4 Dose 5 1. Kasi SG, Indian Pediatr. 2021 Jan 15;58(1):44-53.; 1068 2.ACOG Committee Opinion. Update on Immunization and Pregnancy: tetanus, diphtheria, and pertussis vaccination. Number 718, September 2017. Available at: https://www.acog.org/Clinical-Guidance-and-Publications/Committee-Opinions/Committee-on-Obstetric-Practice/Update-on-Immunization-and-Pregnancy-Tetanus-Diphtheria-and-Pertussis- Vaccination. Accessed 12 Nov 2019.3 Best Practice&ResearchClinicalObstetricsandGynaecology76(2021)23e40 Immunity Gap 1st dose of DTP vaccine is not recommended until 6–8 weeks of age Infants are not protected during the first 2 months of life2 Rationale for pertussis vaccination during pregnancy Vaccination for neonatal protection should ideally occur between 30 and 32 weeks to maximize placental antibody transfer.
  • 14. Pertussis in young infants >90% of infants under 2 months of age with pertussis require hospitalization1 Pertussis complications in infants <2 months of age1 Complication Rate% Pneumonia 15–25 Seizures 2–4 Encephalopathy 0.5–1 ~75% of pertussis-related deaths occur in infants under 2 months of age2 1. Hong. Korean J Pediatr 2010;53(5):629–633. 2.Healy CM. Hum Vaccin Immunothe. 2016;12(8):1972-1981
  • 15. Mothers are the most common source of pertussis infection for newborns1 Percentage of total source contacts with pertussis 1.Data derived from Wiley KE et al. Vaccine 2013;31:618–625 Pooled data from a maximum of 7 studies which included case infants less than 6 months old 0 5 10 15 20 25 30 35 40 Mother Father Sibling Grandparent Other 37.3 17.6 26.8 14.9 Maternal immunisation2 Maternal immunisation is most effective strategy in protecting young infants from Pertussis 4.2
  • 16. Boostrix has shown high effectiveness in preventing pertussis disease in infants < 3 months of age 1. Amirthalingam G, et al. Clin Infect Dis 2016:63 (Suppl 4); 2. Bellido-Blasco J, et al. Euro Surveill 2017;22:pii=30545; 3. Saul N, et al. Vaccine 2018;36(14):1887–1892. Country Surveillance period Time vaccine given during pregnancy Adjusted VE UK1 July 2014-August 2015 (Boostrix-IPV) Between 27 and 36 weeks VE in infant <3 months 88% (95% CI: 79–93) against pertussis disease Spain: Valencia2 March 2015- February 2016 (Boostrix) Between 27 and 36 weeks Infants <3 months of age: 91% against disease (95% CI: 56.6–98.1) Australia3 August 2015- August 2016 (Boostrix) Between 27 and 36 weeks VE in infant <3 months 69% (95% CI 13% – 89%) against pertussis disease Disclaimer: The flags in this material is for generalized illustration. All efforts have been made to ensure the accuracy of the national flags of the respective countries depicted in this however GSK and its directors do not own any for the correctness or authenticity of the same.
  • 17. 1.. Hong. Korean J Pediatr 2010;53(5):629–633. 2. Healy CM. Hum Vaccin Immunothe. 2016;12(8):1972-1981 3. Wiley KE et al. Vaccine 2013;31:618–625 4. Amirthalingam G, et al. Clin Infect Dis 2016:63 (Suppl 4); 5. Bellido-Blasco J, et al. Euro Surveill 2017;22:pii=30545; 6. Saul N, et al. Vaccine 2018;36(14):1887–1892. Summary >90% of infants under 2 months of age with pertussis require hospitalization1 ~75% of pertussis-related deaths occur in infants under 2 months of age2 Mothers are the most common source of pertussis infection for newborns3 Boostrix has shown high effectiveness in preventing pertussis disease in infants < 3 months of age4,5,6
  • 18. HUSBAND – is given vac at delivery in hospital itself in USA
  • 21. Global and National expert health authorities recommend maternal immunization Reference: 1. WHO Wkly Epidemiol Rec 2014;89(21):221–236 2. ACOG Committee Opinion, Sept 2017 https://www.acog.org/clinical/clinical-guidance/committee-opinion/articles/2017/09/update-on-immunization-and- pregnancy-tetanus-diphtheria-and-pertussis-vaccination accessed June 2021 3. RCOGhttps://www.rcog.org.uk/en/news/rcog-statement-pertussis-whooping-cough-vaccination-now-offered-from-20-weeks-of-pregnancy/ accessed June 2021 4. FOGSI-Good Clinical Practice Recommendations on PRECONCEPTION CARE: : https://www.fogsi.org/gcpr-preconception-care/ accessed June 2021 5. Kasi et al. Indian Pediatr. 2021 6. Summary of Recommendations (cdc.gov).7. FIGO Statement: Vaccination in pregnancy - Nassar - 2021 - International Journal of Gynecology & Obstetrics - Wiley Online Library Influenza vaccines are recommended during Pregnancy 1-7 since many years WHO ACOG FOGSI ACIP IAP WHO: World health organization ACOG: American college of obstetric and gynecology, RCOG: Royal College of Obstetricians & Gynaecologists FOGSI: The federation of obstetrics and gynaecological societies of India IAP: Indian academy of pediatrics RCOG FIGO
  • 22. Global recommendations for Influenza Vaccination in pregnancy WHO World health organization. CDC Centre for disease control and prevention ACIP Advisory committee on immunization practices, ACOG American College of obstetrics and gynecologists, 1. WHO. SAGE meeting April 2012. Statement on influenza immunization. 2012. Available at: www.who.int/influenza/vaccines/SAGE_information/en (Accessed June 2021) 2. ACOG COMMITTEE OPINION. Influenza Vaccination During Pregnancy. Obstetrics and Gynecology. Vol. 131, No. 4, April 2018 (Accessed June 2021) • Pregnant women should be vaccinated with influenza vaccine at any stage of pregnancy. • Seasonal influenza vaccine is safe and effective in preventing influenza in the women as well as in their young infants •WHO (SAGE) 20121 • All women who are or might be pregnant or post-partum during influenza season should receive an influenza vaccination. • Any of the licensed, recommended, age appropriate, inactivated influenza vaccine can be given at any time during pregnancy ACOG 20192
  • 23. Indian recommendations for Influenza Vaccination in pregnancy FOGSI Federation of obstetrics and gynecological societies of India, IAP Indian academy of paediatrics. 1. FOGSI. Consensus- Good Clinical Practice Recommendations on Preconception Care-India. FOGSI 2016. Available at https://www.fogsi.org/gcpr-preconception-care (Accessed June 2021). 2. IAP Guidebook on Immunization 2018-2019 3rd Edition, Jaypee Brothers • Influenza vaccine is recommended to all pregnant women from 26 wks. onwards • In case of a pandemic the influenza vaccine can be given earlier to protect the mother FOGSI 20181 • Pregnant women can be immunized against influenza at any time during their pregnancy. • Vaccine is safe and effective in preventing influenza in the women as well as in their young infants, in whom the disease burden is high. IAP 20182
  • 24. Pertussis Influenza Tetanus/ diphtheria Hepatitis B Risk of Severe Disease 1,2 In pregnant women/ foetus In new-borns/ infants HIGH LOW LOW LOW HIGH HIGH HIGH HIGH 1. Swamy GK & Beigi RH. Vaccine 2015;33:6436–6440; 2. Kourtis AP et al. N Engl J Med 2014;370:2211–2218 Pregnancy-related adaptations of the immune and the cardiovascular systems promotes a prolonged inflammatory phenotype, increasing disease severity, and causing maternal and fetal health problems
  • 25. Indian data on impact of Influenza in Pregnancy ¹ Review of 8 Indian studies with ~12000 subjects (South-5, West-2, North-1) Influenza imposes high burden of maternal & fetal complications in pregnancy • Maternal mortality • Fetal loss • Premature delivery • ICU admissions & prolonged hospitalization • Complications including renal failure, mechanical ventilation Findings 1.Bhalerao-Gandhi et al. Influenza and Pregnancy: A Review of the Literature from India. Infectious Diseases in Obstetrics and Gynecology Volume 2015, Article ID 867587, 1-8, http://dx.doi.org/10.1155/2015/867587
  • 26. I1. nfluenza and Pregnancy: A Review of the Literature from India Ashwini Bhalerao-Gandhi,1 Pankdeep Chhabra,2 Saurabh Arya,2 and James Mark Simmerman3 0.0% 10.0% 20.0% 30.0% 40.0% 50.0% 60.0% 70.0% 80.0% 90.0% Mathur et al 2013(n=37 ) Mehta et al 2013(n= 6) Ramkrishn a et al 2012(n=19 ) Gunasekar an et al 2012(n= 126) Praminick et al 2012 (n=79) Puvanaling am et al 2011(n=12 ) Chudasam a et al 2010 (n=15) prevalence of influenza 23.40% 5.20% 73% 32.50% 25% 90% ICU admission and complications 29.60% 40% 75% 73.30% Maternal mortality 70% 33% 52.60% 25% 25% Influenza in pregnancy is associated with adverse outcomes like ICU admission & associated complications and Maternal Mortality1 • Influenza-related maternal mortality ranged from 25% to 70% among pregnant women; higher than that reported in other countries. • Pregnant women have been observed to be at a 18-fold higher risk of hospitalization as compared to healthy nonpregnant women, and the risk is greatest among women in later stages of pregnancy
  • 27. 27 23 March 2024 PERINATAL OUTCOMES Maternal and Perinatal Outcomes of Influenza in Pregnancy after Treatment with Oseltamivir1 Prospective observational cohort study conducted in a tertiary hospital in Vellore; Patients with ILI – 73.2% (476/650) Lab confirmed cases = 36.5% (174/476) Significantly higher proportion of women in Cohort 1 had severe illness requiring inpatient and ICU care compared to PCR-negative women (36.2% vs. 6.3%, P < 0.001). Abraham K, et al. J Glob Infect Dis. 2021 Jan 29;13(1):20-26 Influenza contributed to 36% of the acute respiratory infections in the observed pregnant women. ↑ preterm births in the infected women (RR – 2.75) requiring prolonged NICU care. The expenditure toward treatment, ₹15,432 (~$ 216) for an average of 5 days, was three times higher for women with severe illness compared to women who had outpatient-based care.
  • 28. Benefits to the newborn2,3 Prevention is better than cure • Robust immune response • Prevention of influenza complications • ↓ need for hospitalization • ↓ adverse pregnancy and perinatal outcomes • ↓ preterm and low birth weight babies • Transplacental transfer of antibodies to fetus • Fills the gap till infant immunization can begin Benefits to the mother2,3 1. Influenza Antiviral Medications: Summary for Clinicians./CDC/Available at https://www.cdc.gov/flu/professionals/antivirals/summary-clinicians.htm#dosage (assessed on jan 2022) 2. Background paper on Influenza Vaccines and Immunization, SAGE Working group, April 2012. Available at https://www.who.int/immunization/sage/meetings/2012/april/1_Background_Paper_Mar26_v13_cleaned.pdf?ua=1 (accessed jan 2023) 3. Buchy P et al. Vaccinating pregnant women against influenza needs to be a priority for all countries: An expert commentary. International Journal of Infectious Diseases. 2020; 92: 1-12 “An Influenza Vaccine is the best protection against Influenza in Pregnancy” – CDC1
  • 29. Safety of Influenza Vaccines in Pregnancy 1. Moro P L et al, Adverse events in pregnant women following administration of trivalent inactivated influenza vaccine and live attenuated influenza vaccine in the Vaccine Adverse Event Reporting System, 1990-2009. Am J Obstet Gynecol 2011;204:146.e1-7. https://doi.org/10.1016/j.ajog.2010.08.050 2. Tamma P.D et al. Safety of influenza vaccination during pregnancy. Am J Obstet Gynecol 2009;201 (6):547-552. doi: 10.1016/j.ajog.2009.09.034. 3. Safety of immunization during Pregnancy-A review of the evidence. Available at https://www.who.int/vaccine_safety/publications/safety_pregnancy_nov2014.pdf (Accessed Aug 2020) No safety concerns in >5 Lac pregnant women in Europe and >1 Lac pregnant women in Canada after influenza vaccination¹ Safety literature review data from 7000+ pregnant women from different countries² • No increased risk of untoward maternal or fetal outcomes reported WHO: Global Advisory Committee on Vaccine Safety³ • Excellent and robust safety profile of multiple inactivated influenza vaccines over many decades
  • 30. 1. Swamy GK & Beigi RH. Vaccine 2015;33:6436–6440; 2. Kourtis AP et al. N Engl J Med 2014;370:2211–2218 3.Bhalerao-Gandhi et al. Influenza and Pregnancy: A Review of the Literature from India. Infectious Diseases in Obstetrics and Gynecology Volume 2015, Article ID 867587, 1-8, http://dx.doi.org/10.1155/2015/867587 4. Background paper on Influenza Vaccines and Immunization, SAGE Working group, April 2012. Available at https://www.who.int/immunization/sage/meetings/2012/april/1_Background_Paper_Mar26_v13_cleaned.pdf?ua=1 (accessed jan 2023) 5.Buchy P et al. Vaccinating pregnant women against influenza needs to be a priority for all countries: An expert commentary. International Journal of Infectious Diseases. 2020; 92: 1-12 Summary Risk of disease is high in both mothers as well as newborns/ infants1,2 Benefits to mother: ↓ need for hospitalization & ↓ adverse pregnancy and perinatal outcomes4,5 Benefits to newborns: ↓ preterm and low birth weight babies4,5 Influenza imposes high burden of maternal & fetal complications in pregnancy3
  • 31. Recent literature highlighting need for Maternal Imm Topic 3
  • 33. Shaikh et al. Safety and Protective Effects of Influenza Vaccination in Pregnant Women on Pregnancy and Birth Outcomes in Pune, India: A Cross-Sectional Study. Vaccines 2023, 11, 1034. Safety and Protective Effects of Influenza Vaccination in Pregnant Women on Pregnancy and Birth Outcomes in Pune, India: A Cross-Sectional Study • Cross sectional observation study in a tertiary care centre in Pune in women; N=558 STUDY DESIGN • Pregnancy related adverse events/complications: PIH,GDM, Pre eclampsia, PROM, Spontaneous abortion, Preterm birth. • Birth outcomes: Congenital anomalies, LBM,VLBW, NICU or neonatal care hospitalization, RDS & mechanical ventilatuion, Apgar score at 5mins. Outcome Variables • Overall Vaccination uptake- 47.5%(265/558) • First trimester- 1.9% • Second trimester- 40.4% • Third trimester- 57.7% Findings PIH: pregnancy-induced hypertension, GDM: gestational diabetes mellitus,
  • 34. Flu vaccination is SAFE in pregnancy with no increased risk of adverse birth outcomes, regardless of the trimester in which vaccination was performed Pregnancy outcome Fetal Outcome No association between influenza vaccines and PROM, Preterm birth & gestational hypertension There was no association between maternal influenza vaccination and adverse neonatal outcomes Higher risk of VLBW in unvaccinated pregnant women (AOR 2.29, 95% CI; 1.03 to 5.58, p = 0.03) Apgar scores at 5 min (adjusted odds ratio [AOR] 0.92, 95% CI 0.23 to 3.78) neonatal care unit (NICU) hospitalization (AOR 0.87, 95% CI, 0.29 to 2.85) mechanical ventilation (AOR 0.72, 95% CI, 0.21 to 4.00) respiratory distress syndrome (AOR 1.1, 95% CI, 0.35 to 3.95). ~2 increased risk of VLBW for non-vaccinated pregnant women (p=0.03) Shaikh et al. Safety and Protective Effects of Influenza Vaccination in Pregnant Women on Pregnancy and Birth Outcomes in Pune, India: A Cross-Sectional Study. Vaccines 2023, 11, 1034.
  • 36. Hospital Based Multicentric Study - India To estimate burden due to pertussis among infants ≤6 months of age, hospitalized with acute respiratory infections (ARIs) Kolkata  Chennai Delhi Pune Singh V, S B, Lalwani S, Singh R, Singh P, Datta K, Mohanty N, Poddar S, Sodani R, Saha M, Mitra M. Evaluation of Pertussis Disease in Young Infants in India: A Hospital- Based Multicentric Observational Study. Indian J Pediatr. 2023 Jun 28. doi: 10.1007/s12098-023-04700-y. Active surveillance study (Jan 2020 -April 2022 @ 7 tertiary care centers) Infants screened [hospitalized with ARIs] 1102 Excluded (not satisfying CDC 2020 clinical case definition of pertussis) 702 Enrolled infants (CDC 2020 clinical case definition of pertussis) 400 Collection of nasopharyngeal swabs RT-PCR to test for the presence of Bordetella pertussis and other respiratory pathogens 0-3 month [248/400 (62%)] 4-6 month [152/400 (38%)]
  • 37. Participants with LCP: 34/400 (8.5 %) 0-3 months: 21/248 (8.47 %) 4-6 months: 13/152 (8.55 %) Participants with PP: 46/400 (11.5%) 0-3 months: 30/248 (12. %) 4-6 months: 16/152 (10.53 %) Mothers of only 2 infants (aged 0-3 months) had received the Tdap vaccine during pregnancy Clinical features included in CDC-2020 guidelines Clinical Features Total, N =400 LCP N=34 PP N=46 Paroxysms of coughing 312 (78%) 26 (76.47%) 35 (76.09%) Posttussive vomiting 128 (32%) 8 (23.53%) 19 (41.30%) Apnea 55 (13.75%) 8 (23.53%) 10 (21.74%) Inspiratory whoop 45 (11.25%) 5 (14.71%) 4 (8.70%) Participants with LCP: 34/400 (8.5 %) 0-3 months: 21/248 (8.47 %) 4-6 months: 13/152 (8.55 %) Participants with PP: 46/400 (11.5%) 0-3 months: 30/248 (12. %) 4-6 months: 16/152 (10.53 %) Respiratory pathogens isolated from nasopharyngeal swabs of ‘clinically suspected’ pertussis  Rhinovirus/ Enterovirus 23 (5.75)  Respiratory Syncytial Virus A 21 (5.25) Coronavirus 229E 20 (5)  Bocavirus Type 1 12 (3)  Coronavirus HKU1/ NL63 7 (1.75)  Human Metapneumovirus 6 (1.5) Singh V, S B, Lalwani S, Singh R, Singh P, Datta K, Mohanty N, Poddar S, Sodani R, Saha M, Mitra M. Evaluation of Pertussis Disease in Young Infants in India: A Hospital-Based Multicentric Observational Study. Indian J Pediatr. 2023 Jun 28. doi: 10.1007/s12098-023-04700-y.
  • 38. Indian data on Neonatal Pertussis reported from many centers 2021 Multicentric Surveillance Data 1 (Pune, Kolkata, Chennai, Ludhiana) ~5% infants had laboratory-confirmed Pertussis (n=32) with 3.6 months median age Apnoea was significantly more associated with Pertussis Post tussive emesis observed in 50% and pneumonia in 34% cases. .1. Apte A et al, Multicentric Hospital-Based Surveillance of Pertussis Amongst Infants Admitted in Tertiary Care Facilities in India; INDIAN PEDIATRICS; VOLUME 58, AUGUST 15, 2021 2. Kavitha T K, Clinical Profile of Critical Pertussis in Children at a Pediatric Intensive Care Unit in Northern India; INDIAN PEDIATRICS, VOLUME 57, MARCH 15, 2020 2020 Clinical Profile of Critical Pertussis at a PICU 2 (PGI, Chandigarh) • 86% cases of Pertussis were Infants (~28% <6wks of age) (n=36) • Mechanical ventilation required in over 30% cases • Exchange transfusion required in over 8% cases
  • 39. Regan AK, Moore HC, Binks MJ, McHugh L, Blyth CC, Pereira G, Lust K, Sarna M, Andrews R, Foo D, Effler PV. Maternal pertussis vaccination, infant immunization, and risk of pertussis. Pediatrics. 2023 Nov 1;152(5). Effectiveness of pertussis vaccination during pregnancy First 3 years of maternal pertussis immunization programs from Australia 52% of pregnant individuals received acellular pertussis vaccine and vaccine was associated with ~66% overall decrease in neonatal pertussis infection among <2 months old infants
  • 41. Boostrix Safety Profile 1. Boostrix_BTX_PI_IN_2022_02 dated 27 Jul 2022; 2. Petousis-Harris H et al. BMJ Open 2016;6(4):e010911. I STRONGLY ADVOCATE BOOSTERIX FOR ALL IN PREGNANCY , USING FROM THE DAY IT IS INTRODUCED IN INDIA Adverse Events in adults1 Very common: injection site redness/ swelling, pain, malaise, fatigue, headache Common: Fever >37.5 C, dizziness, nausea, Injection site mass/sterile abscess Uncommon: URTI, diarrhea, vomiting, lymphadenopathy, rash, pruritic, arthralgia, myalgia Adverse Events during pregnancy2* In clinical trials • Mild and moderate pain (79%) • Injection site induration (12%) -Swelling (7.6%) -Redness (5.8%) • Severe pain (2.6%), fever (2.1%) • Others : headache, nausea/vomiting, fatigue, myalgia/ arthralgia
  • 42. SAFE IN ADULTS SAFE IN PREGNANCY MUST FOR ALL INFUENJA VACCINATION
  • 43. Fluarix Tetra safety information Adapted from . Menveo Product Information (India) {Version: MNV/PI/IN/2019/03 dated 21 August 2019 Summary from clinical trials: Post-marketing data: Most frequently reported general adverse reactions after vaccination All age groups 18 years and above 6 to 17 years 3 to 5 years 6 months to 3 years Injection site pain (15.6% to 40.9%) Fatigue (11.1%), headache (9.2%) and myalgia (11.8%) Fatigue (12.6%), myalgia (10.9%) and headache (8.0%) Drowsiness (9.8%) and irritability (11.3%) Irritability/ fussiness (14.9%) and loss of appetite (12.9%) Rare events General disorders and administration site conditions Skin and subcutaneous tissue disorders Immune system disorders Nervous system disorders Blood and lymphatic system disorders Influenza-like illness, malaise Urticaria, pruritus, erythema, angioedema Allergic reactions (including anaphylactic reactions) Neuritis, acute disseminated encephalomyelitis, Guillain-Barré syndrome Transient lymphadenopathy Fluarix Tetra Product Information. Available at https://india-pharma.gsk.com/media/850622/fluarix-tetra.pdf

Editor's Notes

  1. WHO SAGE 2012 Pregnant women should be vaccinated with influenza vaccine at any stage of pregnancy…. seasonal influenza vaccine is safe throughout pregnancy and effective in preventing influenza in the women as well as in their young infants CDC (ACIP) 2019 all women who are pregnant or who might be pregnant during the influenza season receive influenza vaccine can be administered at any time during pregnancy FOGSI 2014 : Influenza vaccination is recommended for mothers from 26 weeks onwards 2016 : Influenza vaccine is recommended for women who would be pregnant in the influenza season especially in those who are at high risk of influenza related complications. All influenza vaccines available are recommended with the exception of the live intranasal vaccine. (Strength of recommendation: A; quality of evidence III) 2018 : FOGSI recommends immunization against tetanus, diphtheria, pertussis and influenza during pregnancy IAP Pregnant women who are immunized against influenza at any time during their pregnancy can provide protection for infants during their first 6 months of life
  2. WHO SAGE 2012 Pregnant women should be vaccinated with influenza vaccine at any stage of pregnancy…. seasonal influenza vaccine is safe throughout pregnancy and effective in preventing influenza in the women as well as in their young infants CDC (ACIP) 2019 all women who are pregnant or who might be pregnant during the influenza season receive influenza vaccine can be administered at any time during pregnancy FOGSI 2014 : Influenza vaccination is recommended for mothers from 26 weeks onwards 2016 : Influenza vaccine is recommended for women who would be pregnant in the influenza season especially in those who are at high risk of influenza related complications. All influenza vaccines available are recommended with the exception of the live intranasal vaccine. (Strength of recommendation: A; quality of evidence III) 2018 : FOGSI recommends immunization against tetanus, diphtheria, pertussis and influenza during pregnancy IAP Pregnant women who are immunized against influenza at any time during their pregnancy can provide protection for infants during their first 6 months of life
  3. Pregnant women are at increased risk for severe illness from influenza virus infection. Cardiopulmonary adaptive changes occurring during pregnancy, such as increased heart rate and stroke volume and reduced pulmonary residual capacity, may increase the risk of hypoxemia and contribute to the increased severity. 
  4. Manuscript accepted in Indian pediatrics