Safety and effectiveness of COVID-19 maternal immunisation: An update of available evidence

Study type

• Study topic:
  Disease /health condition
• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness

  Effectiveness study (incl. comparative)

  Safety study (incl. comparative)
• Data collection methods:
  Secondary data collection

Non-interventional study

• Non-interventional study design:
  Systematic review and meta-analysis

Study drug and medical condition

• Medical condition to be studied:
  Abortion spontaneous

  Postpartum haemorrhage

  Stillbirth

  Small for dates baby

  COVID-19
• Additional medical condition(s):
  Caesarean delivery, Pregnancy related hypertensive disorders, Preterm birth, Neonatal Intensive Care Unit (NICU) admission, Congenital anomalies, Low birth weight, Neonatal hospitalisation, COVID-19-related hospitalization, COVID-19-related severe illness

Population studied

• Short description of the study population:
  The study focused on effect of covid-19 vaccines on pregnant women and their neonates identified from the Embase and PubMed databases between January 1, 2021, to June 7, 2022.
• Age groups:
  Preterm newborn infants (0 – 27 days)

  Infants and toddlers (28 days – 23 months)

  Adults (18 to < 46 years)
• Special population of interest:
  Pregnant women
• Estimated number of subjects:
  290000

Study design details

• Main study objective:
  The objective of this scoping literature review was to identify and compile the most recent evidence on the safety and effectiveness of COVID-19 vaccination during pregnancy and breastfeeding.
• Outcomes:
  Pregnancy and delivery outcomes Neonatal outcomes Vaccine effectiveness against SARS-CoV-2 infection COVID-19-related hospitalisation and severe illness
• Data analysis plan:
  A literature search was conducted to include studies published between January 1, 2021, through June 7, 2022. The information sources were EMBASE and PubMed database. The search key terms included: pregnancy, maternal, fetal, birth, perinatal, neonatal, newborn, infant, breastfeeding, lactation AND covid-19 vaccine, covid-19 vaccination, SARS-CoV-2 vaccine. Studies were included if they presented a comparison group (e.g. unvaccinated women) or used background rates, and if they addressed at least one of the following topics: (1) Safety of COVID-19 vaccines during pregnancy with pregnancy, delivery, or neonatal outcomes, or (2) effectiveness of COVID-19 vaccines against SARS-CoV-2 infection, severe COVID-19 illness, or COVID-19-related complications or death, in pregnant women or their infants. Additionally, we included studies looking at the potential protective effect of COVID-19 vaccination during breastfeeding of infants.

Documents

Study results

Report_COVID-19 maternal immunisation review_20220610