Study type

Study topic

Human medicinal product

Study type

Non-interventional study

Scope of the study

Safety study (incl. comparative)

Data collection methods

No individual level data collected for the purpose of the study
Non-interventional study

Non-interventional study design

Cohort
Study drug and medical condition

Medicinal product name

SPIKEVAX

Medicinal product name, other

​​mRNA-1273.222 or mRNA-1273.815​
Population studied

Short description of the study population

​​Pregnancies among women aged 12-50 years​

Special population of interest

Pregnant women
Study design details

Study design

​​Retrospective cohort study design​

Main study objective

​​1: To assess whether exposure to Spikevax during pregnancy is associated with an increased rate of the following pregnancy complications:
a. Gestational hypertensive disorders;
b. Gestational hypertension;
c. Pre-eclampsia;
d. Eclampsia o Gestational diabetes.
2: To assess whether exposure to Spikevax during pregnancy is associated with an increased rate of the following pregnancy outcomes: a. Medically-attended spontaneous abortion; b. Stillbirth; c. Preterm birth.
3. To assess whether exposure to Spikevax during pregnancy is associated with an increased prevalence of infant major congenital malformation (MCM)​

Data analysis plan

​​This study will be conducted using a sequential cohort design that aligns cohort entry at gestational week of vaccination. Spikevax-exposed pregnancies will be matched in a 1:4 ratio to unexposed pregnancies based on gestational week, age, calendar time at cohort entry, and propensity score. We will estimate prevalence ratios using robust Poisson regression models and hazard ratios using Cox proportional hazards models.​