Monitoring safety of Spikevax in pregnancy: an observational study using routinely collected health data in five European countries (COVID-19)

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness

  Drug utilisation

Non-interventional study

• Non-interventional study design:
  Cohort

  Cross-sectional

Study drug and medical condition

• Name of medicine:
  Spikevax
• Study drug International non-proprietary name (INN) or common name:
  COVID-19 MRNA VACCINE (NUCLEOSIDE-MODIFIED)

Population studied

• Age groups:
  Preterm newborn infants (0 – 27 days)

  Term newborn infants (0 – 27 days)

  Infants and toddlers (28 days – 23 months)
• Special population of interest:
  Pregnant women
• Estimated number of subjects:
  300000

Study design details

• Main study objective:
  8.1. Primary objectives: To determine whether exposure to the Spikevax during pregnancy is associated with an increased risk of: a. Pregnancy complications b. Adverse pregnancy outcomes c. Major congenital malformations in the offspring (overall and organ-specific if feasible) d. Adverse neonatal outcomes
• Outcomes:
  a. Pregnancy complications b. Adverse pregnancy outcomes c. Major congenital malformations in the offspring (overall and organ-specific if feasible) d. Adverse neonatal outcomes, Utilization of Spikevax in pregnancy
• Data analysis plan:
  Counts and percentages will be presented for categorical variables (age at conception in categories, sex). Means, standard errors, medians and ranges will be presented for continuous variables (age at conception). The proportion of missing data will be described when appropriate. For maternal outcomes, pregnancy will be the unit of observation, for neonatal outcomes, a newborn will be the unit of observation. For the outcomes of congenital malformations and stillbirth the number at risk will be the total number of live or stillborn children. Prevalence of each outcome will be computed as number of observations with a given outcome divided by the total number of study population members. For neonatal death, a 28-day mortality risk will be the measure of occurrence among live-born infants. Prevalence/risks will be compared according to predefined exposure categories and using, whenever necessary, plausible exposure risk windows.