Study identification

PURI

https://redirect.ema.europa.eu/resource/1000000337

EU PAS number

EUPAS1000000337

Study ID

1000000337

Official title and acronym

VAC4EU Postauthorisation Effectiveness Study of BIMERVAX® Vaccine in Europe

DARWIN EU® study

No

Study countries

Spain

Study description

The coronavirus disease 2019 (COVID 19) HIPRA vaccine BIMERVAX® is a recombinant protein-based bivalent variant vaccine intended for use as a booster in individuals 16 years of age and older who have previously received a messenger RNA (mRNA) COVID 19 vaccine. In March 2023, the European Commission granted marketing authorisation of BIMERVAX® vaccine for use in the European Union. Marketing authorisation applications of BIMERVAX vaccine formulations adapted to other subsequent SARS-CoV-2 variants were submitted to the European Medicines Agencies (EMA) for approval. As of September 2024, approval is pending for the adapted vaccine containing the monovalent JN.1 lineage as the antigen. This study will evaluate the effectiveness of BIMERVAX® as a booster vaccine compared with non-BIMERVAX® booster vaccines using real-world data from European countries.

Study status

Planned
Research institutions and networks

Institutions

RTI Health Solutions (RTI-HS)
France
Spain
Sweden
United Kingdom
United Kingdom (Northern Ireland)
United States
First published:
13/03/2025
InstitutionNot-for-profitENCePP partner

Networks

Contact details

J. Bradley Layton

Primary lead investigator
ORCID number:
0000-0003-0994-5820
Study timelines

Date when funding contract was signed

Planned:

Study start date

Planned:

Data analysis start date

Planned:

Date of interim report, if expected

Planned:

Date of final study report

Planned:
Sources of funding
Pharmaceutical company and other private sector 

More details on funding

HIPRA Human Health S.L.U.
Study protocol
Initial protocol

Protocol_PAES_6578_HIPRA_BIMERVAX_v1.1_19Feb2024_Redacted.pdf

English (1.71 MB - PDF)View document
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)