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Vaccine Safety and AEFI Surveillance - COVID-19 Vaccination During Pregnancy
Vaccine Safety and AEFI Surveillance - COVID-19 Vaccination During Pregnancy
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
*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
malaise
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