Study identification

PURI

https://redirect.ema.europa.eu/resource/1000000321

EU PAS number

EUPAS1000000321

Study ID

1000000321

Official title and acronym

VAC4EU Postauthorisation Safety 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 is a post-authorisation safety study (PASS) to be conducted within the Vaccine Monitoring Collaboration for Europe (VAC4EU) study network. This PASS will evaluate the risk of safety concerns and AESIs, as defined in the approved EU RMP, following immunisation in the real-world setting. The PASS has 2 components—a vaccine utilisation study and a comparative safety study—that will be conducted in a staggered-phase approach. The vaccine utilisation study will characterise individuals receiving BIMERVAX® vaccine. The comparative safety study will comprise 2 sub-studies: a cohort study and a self-controlled risk interval (SCRI) study (a subtype of the self-controlled case series design). The cohort study will evaluate the risk of adverse events due to use of BIMERVAX® vaccine booster compared with that of other COVID-19 vaccines with the same indication, whereas the SCRI study will evaluate the risk of adverse events following receipt of a BIMERVAX® vaccine booster compared with the risk of AESIs in a later period not preceded by any COVID-19 vaccination booster.

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

Xabier García de Albéniz

Primary lead investigator
ORCID number:
0000-0002-9814-2343
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_PASS_6578_HIPRA_BIMERVAX_Final_V1.1_12Jan2024_clean_Redacted.pdf

English (2.62 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)