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. 2025 Feb 26;2(2):CD015785.
doi: 10.1002/14651858.CD015785.

Efficacy and safety of SARS-CoV-2 vaccination in pregnancy to prevent COVID-19 in mothers and early infancy

Odette de Bruin  1   2 , Emily Wem Phijffer  3 , Fariba Ahmadizar  2 , Nicoline At Van der Maas  4 , Joanne G Wildenbeest  3 , Miriam Cjm Sturkenboom  2 , Louis J Bont  3 , Carlos E Durán  2   5 , Kitty Wm Bloemenkamp  1
Affiliations

Efficacy and safety of SARS-CoV-2 vaccination in pregnancy to prevent COVID-19 in mothers and early infancy

Odette de Bruin et al. Cochrane Database Syst Rev. .

Abstract

This is a protocol for a Cochrane Review (intervention). The objectives are as follows: To assess the effects of SARS-CoV-2 vaccination during pregnancy, versus placebo or no vaccination during pregnancy, for preventing COVID-19 disease in mothers and infants.

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Conflict of interest statement

Odette de Bruin has no conflicts of interest to declare.

Emily Phijffer has no conflicts of interest to declare. Emily works as an MD in paediatrics.

Fariba Ahmadizar has not received personal fees or any other personal benefits. She is an associate editor of Frontiers journal and actively working on vaccine safety and effectiveness/efficacy studies, specifically COVID‐19 vaccine.

Nicoline van der Maas has no conflicts of interest to declare. Nicoline is a medical advisor on vaccinations and screening programs at the National Institute for Health and the Environment, the Netherlands.

Joanne Wildenbeest has not received personal fees or other personal benefits. She has been an investigator for clinical trials funded by pharmaceutical companies, including AstraZeneca, Merck, Pfizer, Sanofi, and Janssen. All funds have been paid to University Medical Center Utrech (UMCU). JGW participated in advisory boards of Janssen and Sanofi and was a speaker at a Sanofi‐sponsored symposium with honoraria paid to UMCU.

Miriam Sturkenboom has not received personal fees or other personal benefits. University Medical Center Utrecht has received major funding (> EUR 100,000 per industrial partner) for investigator‐initiated studies from AstraZeneca, Janssen Global Services, and Pfizer laboratories.

Louis Bont has regular interaction with pharmaceutical and other industrial partners. He has not received personal fees or other personal benefits. University Medical Center Utrecht (UMCU) has received major funding (> EUR 100,000 per industrial partner) for investigator‐initiated studies from AbbVie, MedImmune, AstraZeneca, Sanofi, Janssen, Pfizer, MSD, and MeMed Diagnostics, Bill and Melinda Gates Foundation. UMCU has received major funding as part of the public private partnership IMI‐funded RESCEU and PROMISE projects with partners GSK, Novavax, Janssen, AstraZeneca, Pfizer, and Sanofi. UMCU has received major funding by Julius Clinical for participating in clinical studies sponsored by MedImmune and Pfizer. UMCU has received minor funding (EUR 1000 to 25,000 per industrial partner) for consultation and invited lectures by AbbVie, MedImmune, Ablynx, Bavaria Nordic, mAbxience, GSK, Novavax, Pfizer, Moderna, AstraZeneca, MSD, Sanofi, Genzyme, and Janssen.

Kitty Bloemenkamp has not received personal fees or any other personal benefits. During the COVID‐19 pandemic, she advised on Covid maternal vaccination in pregnancy and the postpartum period and appeared on television and interviews for public newspapers. She is chair of INOSS (International Obstetric Survey System), and performed a meta‐analysis on Covid and pregnancy. University Medical Center Utrecht has received minor funding (EUR 1000 to 25,000 per industrial partner) for the Consign study from EMA to support the monitoring of the efficacy and safety of COVID‐19 treatments and vaccines when used in day‐to‐day clinical practice. This is underpinned by three contracts for observational research that EMA has signed with academic and private partners over recent months, to be ready to effectively monitor vaccines in the real world as soon as they are authorised, and support the safe and effective use of COVID‐19 vaccines and medicines.

Carlos E Durán has worked as PI and co‐PI of two COVID‐19 vaccine‐related safety studies funded by the European Medicines Agency (CVM study: EUPAS42467 and SAFETY‐VAC study: EUPAS1000000193). He has no other conflicts to declare. He will not be involved in study selection, data abstraction, RoB or GRADE assessments for any study on which he is an author.

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