Study identification

EU PAS number

EUPAS1000000712

Study ID

1000000712

Official title and acronym

Safety of mRNA COVID-19 vaccines during pregnancy

DARWIN EU® study

No

Study countries

Norway
Spain
Sweden
United Kingdom

Study description

In this study we aim to improve the understanding of complications during pregnancy, and to find out if COVID-19
vaccination during pregnancy increases the risk of these complications. To do so, we will use data from four
European countries: the United Kingdom, Spain, Norway, and Sweden.
First, we will analyse the data to find out how often complications like blood clots, strokes, or miscarriage, happen
during pregnancy. Then, we will investigate if there are differences between pregnant women who experienced
complications and those who did not.
Second, we will compare pregnant women receiving the 1st, 2nd, or booster (3rd or subsequent doses) COVID-19
vaccine doses with those eligible for the same dose, but who have not received it yet. We will compare how often
complication happened between groups to see if vaccination increased risk of complications. The study will be
restricted to COVID-19 vaccines recommended for used on pregnant women.

Study status

Ongoing
Research institutions and networks

Institutions

University of Oxford
University of Gothenburg

Contact details

Nuria Mercade-Besora 0009-0006-7948-3747

Primary lead investigator
ORCID number:
0009-0006-7948-3747

Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:
Actual:

Date of final study report

Planned:
Sources of funding
No external funding

More details on funding

NMB is funded trhough the Claredon Scholarship at the University of Oxford.
Prof. Prieto-Alhambra reported receiving grant support from Les Laboratoires Servier; that his research group has received grants and advisory or speaker fees from Amgen, Astellas, AstraZeneca,
Chesi-Taylor, Johnson and Johnson and UCD; and that Janssen, on behalf of Innovative Medicines Initiative-funded European Health Data Evidence Network and European Medical Information Framework
consortium and Synapse Management Partners, have supported training programs, open to external participants, organized by his department.
SVW reports ad hoc consulting for Exponent Inc, Cytel Inc, and MITRE a federally funded research and development center for the Centers for Medicare and Medicaid Services.
The Department of Pharmacy at the University of Oslo takes part in multinational studies conducted under VAC4EU, an initiative receiving funding from pharmaceutical companies that manufacture COVID-19
vaccines (Pfizer, Moderna).
FN has funding from SciLifeLab / the Knut and Alice Wallenberg Foundation (KAW 2021-0010/ VC2021.0018 and KAW 2020.0299/VC 2022.0008) and the Swedish Research Council (2021-05045 and
2021-05450). The overarching SCIFI-PEARL study (contributing Swedish data to the current analysis) through P.I. FN also has core funding from the Swedish state under the agreement between the Swedish
government and the county councils, the ALF-agreement (Avtal om Läkarutbildning och Forskning/Medical Training and Research Agreement), grants ALFGBG-938453, ALFGBG-971130, ALFGBG-978954, A
LFGBG-1006729, a grant from FORTE (Research Council for Health, Working Life, and Welfare), grant 2024-01711, and previously from a joint grant from FORTE and FORMAS (Research Council for Environment, Agricultural Sciences and Spatial Planning), grant 2020-02828.
FN owns some AstraZeneca shares.

Regulatory

Was the study required by a regulatory body?

No

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

Not applicable