Pfizer-BioNTech COVID-19 Vaccine Exposure during Pregnancy: A Non-Interventional Post-Approval Safety Study of Pregnancy and Infant Outcomes in the Organization of Teratology Information Specialists (OTIS)/MotherToBaby Pregnancy Registry

Study type

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

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Anatomical Therapeutic Chemical (ATC) code:
  (J07BX03) covid-19 vaccines

  covid-19 vaccines
• Medical condition to be studied:
  COVID-19 immunisation

Population studied

• Age groups:
  Children (2 to < 12 years)

  Adolescents (12 to < 18 years)

  Adults (18 to < 46 years)

  Adults (46 to < 65 years)

  Adults (65 to < 75 years)

  Adults (75 to < 85 years)

  Adults (85 years and over)
• Special population of interest:
  Pregnant women
• Estimated number of subjects:
  2000

Study design details

• Main study objective:
  To assess whether pregnant women who received the Pfizer-BioNTech COVID-19 vaccine during pregnancy experienced increased risk of pregnancy and infant safety outcomes relative to pregnant women who received no COVID-19 vaccines during pregnancy.
• Outcomes:
  Pregnancy outcomes of interest include major congenital malformations, spontaneous abortion, elective termination/abortion for any reason, stillbirth, preterm delivery, and small for gestational age. The infant outcome of interest is small for age postnatal growth of live born infants at one year of age.
• Data analysis plan:
  The distributions of demographic and baseline characteristics will be summarized within the exposure and comparator cohort. The following measures will be calculated for the pregnancy and infant outcomes: birth prevalence of major congenital malformations, incidence rates of spontaneous abortion, elective termination/abortion, stillbirth, and preterm delivery, and incidence proportions of small for gestational age and small for age postnatal growth at one year of age. For each outcome, risk estimates will be described separately for the Pfizer-BioNTech COVID-19 vaccine exposure cohort and the comparator cohort. The outcomes will be compared between the Pfizer-BioNTech COVID-19 vaccine-exposed and vaccine-unexposed cohorts. Where feasible, comparisons will also be made using methods to control potential confounding and to evaluate outcomes following receipt of specific doses (i.e. 1st, 2nd, 3rd, booster) in pregnancy.