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
Other

Non-interventional study design, other

Self-controlled risk interval
Study drug and medical condition

Name of medicine

COMIRNATY
COMIRNATY 15/15 µG - ORIGINAL/OMICRON BA.1 (--) - DISPERSION FOR INJECTION
COMIRNATY 15/15 µG - ORIGINAL/OMICRON BA.4-5 (--) - DISPERSION FOR INJECTION
COMIRNATY 5/5 µG - ORIGINAL/OMICRON BA.4-5 (--) - CONCENTRATE FOR DISPERSION FOR INJECTION

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

COVID-19 MRNA VACCINE (NUCLEOSIDE-MODIFIED)
FAMTOZINAMERAN
RAXTOZINAMERAN
RILTOZINAMERAN
TOZINAMERAN

Anatomical Therapeutic Chemical (ATC) code

(J07BN01) covid-19, RNA-based vaccine
covid-19, RNA-based vaccine
(J07BX) Other viral vaccines
Other viral vaccines

Medical condition to be studied

Adverse event following immunisation
Population studied

Short description of the study population

The study size will be determined by the uptake of the bivalent BA.1 and bivalent BA.4-5 vaccines in the contributing data sources during the study period.

Age groups

Preterm newborn infants (0 – 27 days)
Term newborn infants (0 – 27 days)
Infants and toddlers (28 days – 23 months)
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

Immunocompromised
Pregnant women

Estimated number of subjects

1
Study design details

Main study objective

To determine whether there is an increased risk of pre-specified AESIs following the administration of bivalent BA.1 or bivalent BA.4-5 compared with not receiving any COVID-19 vaccine during follow-up.

Outcomes

Risk of pre-specified AESIs following the administration of bivalent BA.1 or bivalent BA.4-5 compared with not receiving any COVID-19 vaccine during follow-up.

Data analysis plan

Data from the matched cohort design will be analysed as follows: Conditional exchangeability: The pairs will be matched using several variables considered as potential confounders to ensure conditional exchangeability. Additional standard epidemiological methods, based on propensity scores, will be used to improve adjustment for confounding, if necessary. The effect estimates will be reported as risk ratios and risk differences (and their corresponding 95% confidence intervals) for those exposed to a Pfizer-BioNTech COVID-19 bivalent vaccine compared with those not exposed to any COVID-19 vaccine during follow-up. Appropriate data analysis models will be used to estimate the incidence rate ratios of AESIs in the risk and the control windows in the SCRI study.