TARGET-EU: Effectiveness of BNT162b2 mRNA COVID-19 vaccine in healthy individuals or with stable pre-existing medical conditions against SARS-CoV-2 infection

12/05/2026
12/05/2026
EU PAS number:
EUPAS1000000995
Study
Ongoing
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Study summary
No information provided.
Study identification

EU PAS number

EUPAS1000000995

Study ID

1000000995

Official title and acronym

TARGET-EU: Effectiveness of BNT162b2 mRNA COVID-19 vaccine in healthy individuals or with stable pre-existing medical conditions against SARS-CoV-2 infection

DARWIN EU® study

No

Study countries

Netherlands
Spain
United Kingdom

Study description

This case study is part of the broader TARGET EU project (EUPAS1000000539), which aims to advance the regulatory use of real-world data through the application of target trial emulation and estimand methodologies.

Objectives: To estimate the effectiveness of BNT162b2, an mRNA-based COVID-19 vaccine by Pfizer/BioNTech, in preventing SARS-CoV-2 infection among individuals ≥16 years, including those with stable pre-existing conditions, accounting for deviations from standard dosing schedules.
Methods: A matched cohort study using routinely collected healthcare data from the CPRD and VID databases (December 2020 – April 2022). Eligible participants were ≥16 years with ≥6 months of continuous registration. Individuals with prior non-BNT162b2 vaccines, prophylactic COVID-19 treatments, or immunocompromised status were excluded. Vaccinated individuals were matched 1:1 with unvaccinated comparators on age, sex, location, calendar time, and key risk factors. Follow-up began at first dose (or matched date) and continued up to 90 days or until SARS-CoV-2 infection, death, deregistration, or end of data availability. The primary outcome was laboratory-confirmed SARS-CoV-2 infection.
The study follows the target trial emulation and ICH E9(R1) estimand frameworks. Intercurrent events (IEs) include: missing or ineligibility for a second dose; early BNT162b2 booster receipt; non-BNT162b2 booster; non-COVID-19 vaccine post-completion; prophylactic COVID-19 treatment; and death. In the primary estimand, a treatment policy strategy applies to missing a second dose, early boosting, and non-COVID-19 vaccination; a hypothetical strategy applies to non-BNT162b2 boosters and preventive COVID-19 treatments; death is handled via a composite strategy. A supplementary estimand uses a principal stratum strategy for missing a second dose and a while-alive strategy for death.

Study status

Ongoing
Research institutions and networks

Institutions

Teamit Institute
Spain
First published:
12/03/2024
Institution Other ENCePP partner

Networks

Contact details

Constanza Andaur Navarro 0000-0002-7745-2887

Primary lead investigator
ORCID number:
0000-0002-7745-2887

Study timelines

Date when funding contract was signed

Planned:

Study start date

Planned:
Actual:

Date of final study report

Planned:
Sources of funding
EMA
Regulatory

Was the study required by a regulatory body?

No

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

Not applicable