Vaccine Safety and AEFI

Surveillance - COVID-19
Vaccination during
Pregnancy
Dr M K Aggarwal
Additional Commissioner (UIP)
MoHFW, Government of India
 Safety of COVID-
19 vaccines in
Pregnant Women

• Pregnancy increases risk of severe

illness and mortality from COVID-19
disease in comparison with non-
pregnant women of reproductive age.*
• Based on current knowledge, experts
believe that COVID -19 vaccines are
unlikely to pose a risk to the pregnant
person or foetus

*Allotey J, Stallings E, Bonet M, Yap M, Chatterjee S, Kew T, et al. for PregCOV-19 Living Systematic Review
Consortium. Clinical manifestations, risk factors, and maternal and perinatal outcomes of coronavirus
disease 2019 in pregnancy: living systematic review and meta-analysis. BMJ. 2020;370:m3320. doi:
10.1136/bmj.m3320.
Safety of COVID-19 vaccines in Pregnant
Women
• Available COVID-19 vaccines are safe
• Vaccination protects pregnant women
against COVID-19 illness/disease like other
individuals
• May have mild adverse events for 1-3 days
 mild fever

 pain at injection site

 malaise

• Long-term adverse effects and safety of vaccine in pregnant

woman and foetus are not well established yet
COVID 19 vaccination in pregnant women
• Pregnant women may be exposed to COVID-19 vaccines in two ways:
 Inadvertent vaccination before the woman knows she is pregnant,

i.e., at an early gestational stage; or

 Vaccination offered to a woman with confirmed pregnancy who is at

high risk of COVID-19 exposure and infection or at risk of severe

disease should they become infected, and who choose to be
vaccinated
• Gestational age at the time of vaccination should be recorded
• Report both
 Maternal AEFIs

 AEFIs in foetus/neonate/infant born to vaccinated pregnant woman

Managing AEFIs in Pregnant Woman

• Immediate medical attention

o Refer to nearest AEFI management center/secondary or
tertiary healthcare facility
o Arrange for transport
• Report AEFI to Medical Officer/DIO
 Preparation
• Follow national AEFI surveillance operational guidelines and operational guidance for COVID-
19 vaccination of pregnant women
• SoPs of AEFI reporting, investigation & management remain same, with some additions
• Guidelines already issued to states and districts to include obstetrician & gynaecologist in
AEFI committees
• Sensitize and orient on Covid-19 vaccination of pregnant women and reporting and
investigation of AEFIs
 Members of AEFI committees including obstetrician & gynaecologist and
paediatrician/neonatologist
 Members of local chapters of FOGSI, IAP, IMA and API
 Midwives, ASHAs, AWWs, health workers, medical officers, private practitioners,
obstetricians & gynaecologists, paediatricians
• Prioritize reporting of adverse events following immunization (AEFIs) in vaccinated pregnant
women
During Vaccination
• The vaccinator should ask any
woman of childbearing age for
status of pregnancy before
vaccination
• Vaccinator will inform all female
beneficiaries who are pregnant or
might be pregnant to report any
adverse event immediately to the
vaccinator or nearest health facility
Reporting an AEFI in pregnant women
What should be reported?
An AEFI should be reported if:
• the pregnancy outcome is other than a normal delivery
• a non-pregnancy-related event occurs that the mother/primary
caregiver or the health care worker attributes to COVID-19 vaccination
• any event of concern is observed in the neonate or the mother
postpartum
• the mother/primary caregiver or the health care worker attributes any
event to COVID-19 vaccination in the mother (postpartum) or the
neonate/infant born to vaccinated pregnant women
What should be reported
• Non-obstetric events
o Allergic reactions, anaphylaxis, Guillain-Barre Syndrome,
etc. as in normal vaccinated person
• Obstetric events
o Maternal deaths, hospitalizations, thrombotic events,
hypertensive disorders of pregnancy,
miscarriage/spontaneous abortions
• Adverse birth outcomes
o Stillbirth, neonatal death, low-birth weight, preterm
delivery and birth defects
Reporting an AEFI in pregnant women
• All adverse events (minor, severe and serious) following vaccination
in pregnant women should be reported immediately into Co-WIN
• All serious and severe adverse event following vaccination of
pregnant women should be reported immediately to concerned
Medical Officer / District Immunization Officer
• The pregnancy status of women should be recorded with
information on gestation period at the time of vaccination
• Additional information may be asked for during investigation and
causality assessment
 Pregnancy related information in AEFI
formats
For women in reproductive age group (in notification form/CRF/CIF)
 
1. Status of pregnancy at the time of vaccination: Yes / No / Don’t know
2. If Yes, duration of pregnancy at the time of vaccination: 1-3 months / 4-6 months / 7-9 months

Adverse event(s) - clinical* (TICK AS MANY AS APPLICABLE): (in CRF)

Pregnancy related events

□ Maternal death □ Fetal loss (abortion) □ Premature delivery □ Still birth □ Neonatal mortality □ Congenital
anomaly in newborn

If patient is an infant or baby born to pregnant woman vaccinated during pregnancy, give birth details: (in CIF)
1. Birth Weight:
2. Duration of pregnancy □ Full term □ Pre-mature □ Postdated □ Unknown
3. Place of birth □ Home delivery □ Institutional □ Unknown
4. Delivery procedure □ Normal □ Caesarian □ Assisted with forceps/vacuum □ Unknown
5. Any antenatal / postnatal complications: Yes / No / Unknown; if yes please specify________________________________________
Investigation of cases
• Include obstetrician and paediatrician/neonatologist
• Expedite investigation
• Verify and record gestational age at the time of
vaccination
• Note the outcome of adverse event and pregnancy, record
in ANC/MCH card
• Interview the treating physician
• Collect all antenatal, post-natal and other relevant clinical
records
• Arrange histopathological examination in case of
abortion/perinatal death
 • Conduct causality assessment
within a week of receipt of
complete investigation reports
Causality and supporting documents
Assessment • Involve obstetrician,
paediatrician/neonatologist in
conducting causality
assessment of such cases
 Summary
• Benefits of vaccination in pregnant women is much more than risk of
adverse events
• Adverse events in pregnant women can be related to non-obstetric
outcomes, obstetric outcomes and fetal/neonatal/infant outcomes
• Recording status of pregnancy at the time of vaccination is important
• Reporting and investigations of serious/severe AEFI in pregnant women
will be as per national AEFI surveillance guidelines and operational
guidance for COVID-19 vaccination of pregnant women
• Involving obstetrician and neonatologist/paediatrician is important in
investigations and causality assessments
Thank You