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

Name of medicine

SPIKEVAX

Study drug International non-proprietary name (INN) or common name

ELASOMERAN

Anatomical Therapeutic Chemical (ATC) code

(J07BN01) covid-19, RNA-based vaccine
covid-19, RNA-based vaccine
Population studied

Short description of the study population

The source population for this study consists of women of childbearing age in the HealthCare Integrated Research Database (HIRD) with pharmacy and medical benefits, from 01 December 2019 to 01 January 2023.

Special population of interest

Pregnant women
Study design details

Study design

This is a claims-based retrospective cohort study comparing adverse pregnancy and neonatal outcomes among pregnant women exposed to Spikevax with three reference populations.

Main study objective

This study aims to assess whether there is an increased risk of pregnancy complications, adverse pregnancy outcomes, or adverse neonatal outcomes in pregnancies exposed to Spikevax compared with pregnancies unexposed to Spikevax.

Setting

The source population for this study includes women of childbearing age in the HIRD from 01 December 2019 to 01 Jan 2023. It will include the following groups:
(a) pregnant women exposed to Spikevax (primary exposure) from last menstrual period (LMP) through the exposure ascertainment period of the outcome of interest.
(b) pregnant women not exposed to Spikevax or any other COVID-19 vaccine at any time within 60 days prior to LMP or from LMP through the exposure ascertainment period of the outcome of interest.
(c) pregnant women who were exposed to Spikevax at least 60 days prior to the LMP but not from the LMP to exposure ascertainment period of the outcome of interest.
(d) Pregnant women not exposed to Spikevax or any other COVID-19 vaccine within 60 days prior to LMP with medically attended COVID-19 infection at least once from LMP through the exposure ascertainment period of the outcome of interest.

Outcomes

Outcomes of interest in infants include prevalence of major congenital malformations (MCMs), neonatal encephalopathy, small-for-gestational-age, respiratory distress in the newborn, and hospitalization due to infections (including COVID-19).
Outcomes in pregnant women include prevalence of hypertensive disorders (including preeclampsia, eclampsia, and gestational hypertension), gestational diabetes, post-partum hemorrhage, stillbirth, preterm birth, and medically attended spontaneous abortion.

Data analysis plan

Descriptive analyses will characterize pregnant women in the exposed and comparator groups regarding their demographics and health-related characteristics. The frequency of the outcomes of interest for pregnant women exposed to Spikevax will also be described.
Comparative analyses will be performed separately for each outcome and contrast of interest, estimating birth prevalence ratios for outcomes measured as birth prevalence (e.g., MCM), prevalence ratios for outcomes measured as a prevalence (e.g., preeclampsia), or hazard ratios for outcomes measured based on incidence (e.g., infant hospitalizations in the first year of life) both unadjusted and adjusted for confounding via propensity score weighting.