Dr. Sharda jain,Life care centre Safety of Inactivated Influenza Vaccines – WHO –SAGE position paper , The study found no evidence of increased RR or HR for Major birth defects, spontaneous abortion, or Small for gestational age infants in pregnant women vaccinated with trivalent or monovalent influenza vaccine .

1. SAFETY
OF
THE
INFLUENZA
VACCINE IN
PREGNANCY
Dr. Sharda Jain

2. Chairman & founder :-
Consultant : Max Hospital , Vashali, Founder chairman & Advisor
Former : Advisor Health National Commission for Women (2004-2007) -
Chairperson : Women Wing , IMA (2004-2007)
Member : Resources Committee NACO (2008-2011)
Dr. Sharda jain
ISO 14001:2004 (EMS)
…..Caring hearts, healing hands
ISO 9001:2008 ISO 9001:2008
Sec General :
Delhi Gynae Forum
LIFE TIME ACHIEVEMENT AWARDS
•FOGSI & ICOG(2016 )
•Delhi Gynaecologist Forum (2009)
•Lady Harding Medical Collage (2015)
•Delhi ISAR ( March 2016)
“Excellence Award in Medical Services” by
IMA 2016 .
2006 : SOUTHEAST ASIAN PARIAMENT
AWARD for outstanding work on Aneamia in
women & children
2008 : Received prestigious Lucy Omen
Award for contribution in women & girl child
health
“INDIA’S MOST EMINENT WOMEN AWARD
‘2015”
•Crusader against FEMALE FETICIDE
movement in the country by ALL INDIA
COUNCIL OF HUMAN RIGHT, LIBERTIES &
SOCIAL JUSTICE (2015 Dec.)
• Crusader against FEMALE FETICIDE , by
Gynae Endocrinology Association 2015

4. Questions
1. Do we agree that the Inactivated Influenza vaccine
is safe in pregnancy regardless of the trimester ?
2. Do we agree that Inactivated influenza vaccine
should be considered as a part of routine antenatal
care like Tetanus toxoid ?
3. Do we agree that we need to spread the awareness
regarding the need for Influenza vaccination in
Pregnancy ?
4. Is there a gap in our knowledge on Influenza
vaccination in pregnancy that we need to address –
in epidemiology , effectiveness or safety ?

5. Safety of Inactivated Influenza Vaccines –
WHO –SAGE position paper
From 1990 to 2009 the Vaccine
Adverse Event Reporting System
(VAERS) database in the United
States of America reported only
20 serious adverse events following
administration of trivalent influenza vaccine (TIV)
to an estimated 11.8 million pregnant women .

6. Safety of Inactivated Influenza Vaccines –
WHO –SAGE position paper
A recent review by Tamma et al. included TEN
observational studies and two RCTs that reported
safety outcomes for the mother and fetus. Among
over 4400 women given inactivated influenza
vaccine at all stages of pregnancy, there was no
increase in adverse birth outcomes or congenital
fetal anomalies over reported background rates.

7. Nordin et al – Maternal safety
• This study assessed the safety of TIV at 3 and 42 days
after vaccination in 75,906 vaccinated pregnant
women with
147,992 unvaccinated counterparts.
Outcomes :
• Use of trivalent influenza vaccine (TIV) even during first
trimester, did not increase vaccine related major adverse events
particularly neurological disorders such as Guillain-Barre
syndrome, optic neuritis, transverse myelitis, or Bell's palsy.
• There was no increase in allergic reactions, cellulitis , seizures
and other medically attended events .
• No association with thrombocytopenia .

8. Kharbanda et al – Maternal Safety
Kharbanda et al. Compared 74,292 vaccinated pregnant
women at 42 days after vaccination with 144,597 unvaccinated
counterparts found no increase in the risk of
1. Pregnancy-associated health problems (including
proteinuria, urinary tract infection )
2. Gestational hypertension, preeclampsia or eclampsia,
3. Chorioamnionitis
And a significant decrease in the
• risk of gestational diabetes.

9. Naleway et al – Maternal Safety

10. Naleway – Maternal safety

11. Naleway et al – Maternal safety

12. Naleway – Maternal safety

13. Naleway- Maternal Safety

14. Heinonen et al – FETAL SAFETY
Heinonen et al. reported the results of a collaborative perinatal
project conducted in 1959 through 1965 in which more than
2000 pregnant women were enrolled.
Of those women, nearly one third were vaccinated during the
first trimester.
Seven year follow-up of the offspring revealed no increased
incidences of stillbirth, congenital anomaly, malignancies, or
neurocognitive disorder

15. Chambers et al – FETAL SAFETY
Study type : Prospective Cohort study
Arms : Comparison of Trivalent or Monovalent Influenza -
vaccine-exposed Vs unexposed pregnant women followed
between October 2009 and August 2012.
Country : US and Canada
What was compared ?
Relative risks (RRs) were estimated and compared for major
birth defects and infants small for gestational age in the 2 arms.
Adjusted hazard ratios (HRs) were estimated and compared for
spontaneous abortion and preterm delivery in the 2 arms .

16. Results
Total sample= 1032 subjects
Vaccinated arm ( VA ) = 841 women, and
Non-vaccinated arm (NVA) = 191 women
BIRTH DEFECTS :
2.7% in VA versus 3.2% in NVA ( first trimester)
This shows that there was no difference in the
incidence of birth defects if Influenza vaccine was
administered in 1st trimester .

17. Results
Spontaneous abortion : Hazard ratios similar in both
arms . The risk of spontaneous abortion was not increased
with vaccination in pregnancy .

18. Results
PRETERM DELIVERY :
No significant difference in the two arms .
SMALL FOR GESTATIONAL AGE :
Adjusted RRs for small for gestational age
infants on weight and length approximated 1.0
which indicates no “evidence of risk”.

19. Conclusions
• The study found no evidence of increased
RR or HR for
• Major birth defects,
• spontaneous abortion, or
• Small for gestational age infants in
pregnant women vaccinated with trivalent
or monovalent influenza vaccine .

20. Conclusions
Taken together with the known risks
of maternal influenza infection for
both mother and infant, this study
adds to the overall reassuring body of
evidence about influenza vaccine in
pregnancy.

21. Moro et al- Maternal and Fetal safety
A major review by Moro et al. indicated that the influenza
vaccination does not affect the risks for
1. preterm delivery,
2. Caesarean section,
3. miscarriage, and
4. congenital anomaly,
Or increase the incidences of
1. preeclampsia and
2. intrauterine growth retardation.

22. Colin et al – Adverse events in Mother and
Fetus
Colin et al. examined the safety of inactivated vaccine in
• 10,376 pregnant women (4122 of whom [39.7%]
received vaccination during the first trimester) and
their newborns, and found
No vaccine-associated adverse effects

23. Sheffield et al – Safety in 1st trimester
vaccination
• This was a retrospective cohort study.
• During the 5-year study period, 10,225 women received the
seasonal influenza vaccine antepartum; 8,690 of these
delivered at the trial site , 439 in the first trimester and 8,251
in the second and third trimesters.
Outcomes:
1. Neonates born to mothers receiving the vaccine in any
trimester did not have an increase in major malformations
regardless of trimester of vaccination
2. Stillbirth (p<0.006 ) , neonatal death ( P<.01), and premature
delivery (P<.004) were significantly decreased in the vaccinated
group.

24. ISO 14001:2004 (EMS)
…..Caring hearts, healing hands
ISO 9001:2008
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