Study identification

EU PAS number

EUPAS108847

Study ID

199012

Official title and acronym

Post-Authorisation Safety Study of Comirnaty Original/Omicron BA.1 and Comirnaty Original/Omicron BA.4-5 in Europe

DARWIN EU® study

No

Study countries

Italy
Netherlands
Norway
Spain
United Kingdom

Study description

This study aims to answer the research question is there an increased risk of pre-specified adverse events of special interest (AESIs) after vaccination with bivalent BA.1 or bivalent BA.4-5 compared with no vaccination against COVID-19 among individuals with comparable vaccination histories? The primary study objective is 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. A retrospective cohort design will be used to estimate the incidence of AESIs after receiving a Pfizer-BioNTech COVID-19 bivalent vaccine, and these incidences will be compared with those in a comparator group that did not receive any COVID-19 vaccine during follow-up. Exposed individuals will be matched to unexposed individuals using relevant individual characteristics. For selected AESIs a self-controlled risk interval (SCRI) study design will also be used, when appropriate. The source population will comprise all individuals registered in each of the health care data sources who are eligible to receive bivalent BA.1 or bivalent BA.4-5. The study period will start on the date of availability of the bivalent BA.1, which was the first bivalent vaccine to receive authorisation in the EU (on 01 Sep 2022), in each participating country and will end on 31 Aug 2024 or the date of the latest data availability. BA.4-5 received authorisation in the EU on 12 Sep 2022. Individuals will be evaluated for eligibility and time zero will be determined as the date of exposure (vaccination with bivalent BA.1 or bivalent BA.4-5). Matching will occur at time zero and follow-up will begin at time zero. Individuals who have received at least one dose of bivalent BA.1 or bivalent BA.4-5 will be included in the exposed cohort. Individuals who have not received a dose of any COVID-19 vaccine at time zero will be included in the unexposed cohort.

Study status

Ongoing
Research institutions and networks

Institutions

Pfizer
First published:
01/02/2024
Institution
RTI Health Solutions (RTI-HS)
France
Spain
Sweden
United Kingdom
United Kingdom (Northern Ireland)
United States
First published:
13/03/2025
Institution Not-for-profit ENCePP partner
Teamit Institute
Spain
First published:
12/03/2024
Institution Other ENCePP partner
Fondaziione Penta ONLUS

Networks

Contact details

Cynthia de Luise

Primary lead investigator

Study timelines

Date when funding contract was signed

Planned:

Study start date

Planned:
Actual:

Date of final study report

Planned:
Sources of funding
Pharmaceutical company and other private sector 

More details on funding

Pfizer
Regulatory

Was the study required by a regulatory body?

Yes

Is the study required by a Risk Management Plan (RMP)?

EU RMP category 3 (required)