• Agustín Ciapponi, Ariel Bardach, Agustina Mazzoni, Tomás Alconada, Steven A Anderson, Fernando J Argento, Jamile Ballivian, Karin Bok, Daniel Comandé, Emily Erbelding, Erin Goucher, Beate Kampmann, Ruth Karron, Flor M Munoz, María Carolina Palermo, ParkerEdward P KEPKThe Vaccine Centre, London School of Hygiene and Tropical Medicine, London WC1E 7HT, UK. Electronic address: Edward.Parker@lshtm.ac.uk., Rodriguez CairoliFedericoFInstituto de Efectividad Clínica y Sanitaria (IECS-CONICET), Buenos Aires, Dr. Emilio Ravignani 2024 C1014CPV, Argentina. Electronic address: fcairoli@iecs.org.ar., Victoria Santa María, Andy S Stergachis, Gerald Voss, Xu Xiong, Natalia Zamora, Sabra Zaraa, Mabel Berrueta, and Pierre M Buekens.
• Instituto de Efectividad Clínica y Sanitaria (IECS-CONICET), Buenos Aires, Dr. Emilio Ravignani 2024 C1014CPV, Argentina. Electronic address: aciapponi@iecs.org.ar.
• Vaccine. 2021 Sep 24; 39 (40): 5891-5908.

BackgroundRapid assessment of COVID-19 vaccine safety during pregnancy is urgently needed.MethodsWe conducted a rapid systematic review, to evaluate the safety of COVID-19 vaccines selected by the COVID-19 Vaccines Global Access-Maternal Immunization Working Group in August 2020, including their components and their technological platforms used in other vaccines for pregnant persons. We searched literature databases, COVID-19 vaccine pregnancy registries, and explored reference lists from the inception date to February 2021 without language restriction. Pairs of reviewers independently selected studies through COVIDENCE, and performed the data extraction and the risk of bias assessment. Discrepancies were resolved by consensus. Registered on PROSPERO (CRD42021234185).ResultsWe retrieved 6757 records and 12 COVID-19 pregnancy registries from the search strategy; 38 clinical and non-clinical studies (involving 2,398,855 pregnant persons and 56 pregnant animals) were included. Most studies (89%) were conducted in high-income countries and were cohort studies (57%). Most studies (76%) compared vaccine exposures with no exposure during the three trimesters of pregnancy. The most frequent exposure was to AS03 adjuvant, in the context of A/H1N1 pandemic influenza vaccines, (n = 24) and aluminum-based adjuvants (n = 11). Only one study reported exposure to messenger RNA in lipid nanoparticles COVID-19 vaccines. Except for one preliminary report about A/H1N1 influenza vaccination (adjuvant AS03), corrected by the authors in a more thorough analysis, all studies concluded that there were no safety concerns.ConclusionThis rapid review found no evidence of pregnancy-associated safety concerns of COVID-19 vaccines or of their components or platforms when used in other vaccines. However, the need for further data on several vaccine platforms and components is warranted, given their novelty. Our findings support current WHO guidelines recommending that pregnant persons may consider receiving COVID-19 vaccines, particularly if they are at high risk of exposure or have comorbidities that enhance the risk of severe disease.Copyright © 2021. Published by Elsevier Ltd.

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