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

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/47698
• EU PAS number:
  EUPAS47697
• Study ID:
  47698
• Official title and acronym:
  Safety and effectiveness of COVID-19 maternal immunisation: An update of available evidence
• DARWIN EU® study:
  No
• Study countries:
  Brazil

  Canada

  Israel

  Norway

  Qatar

  Romania

  Sweden

  United Kingdom

  United States
• Study description:
  There are still relatively limited data on the safety and effectiveness of COVID-19 vaccines during pregnancy. Even scarcer are data on how vaccination during pregnancy or lactation protects the infant during the first months of life. We presented an updated overview of the evidence on COVID-19 maternal immunisation including studies published between January 1, 2021, through June 7, 2022. We identified 29 studies, of which 21 reported results on vaccine safety and 12 reported results on vaccine effectiveness (VE) during pregnancy. None of the studies reported on the potential protective effect of maternal immunisation during lactation of breastfed infants. Findings from included studies suggest that mRNA COVID-19 vaccines are not associated with an increased risk of adverse outcomes in pregnant women and their neonates and are effective in reducing the incidence of SARS-CoV-2 infection in both mothers and infants. The low incidence of maternal COVID-19-related hospitalisation and severe disease precluded the studies from providing precise VE estimates for these outcomes. Despite the number of published studies, there remain major gaps in our knowledge of how COVID-19 vaccines impact pregnancy and newborns. Strong evidence is needed based on large population-based studies that use rigorous methods and include diverse populations that could confirm these initial findings. Evidence is still scarce on ideal timing of immunisation and number of doses to provide protection to the pregnant women and their infants, vaccine safety during the first trimester of pregnancy, vaccine effectiveness of boosters and against emerging SARS-CoV-2 variants as well as evidence on safety and effectiveness of viral vector vaccines or inactivated vaccines. Additionally, whether COVID-19 vaccine-derived antibodies transferred from the mothers to their infants during breastfeeding provide protection against SARS-CoV-2 infection or health complications remains to be elucidated.
• Study status:
  Finalised

Research institution and networks

Institutions

European Medicines Agency (EMA)

Study timelines

Date when funding contract was signed

Planned: 21/03/2022

Actual: 21/03/2022

Study start date

Planned: 11/04/2022

Actual: 11/04/2022

Date of final study report

Planned: 13/06/2022

Actual: 13/06/2022

Sources of funding

EMA

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable