Abstract
Coronavirus 2019 (COVID-19) has created a global pandemic that is devastating human lives, public healthcare systems, and global economies. Multiple effective and safe COVID-19 vaccines have been developed at an unprecedented speed due to the efforts of the scientific community, and collaboration between the federal government and pharmaceutical companies. However, the continued exclusion of pregnant and lactating women from the COVID anti-viral and vaccine trials has created the paradox of a lack of empirical evidence in a high-risk population. Based on the experience of similar prior vaccines, animal developmental and reproductive toxicology studies, and preliminary findings from human studies, various healthcare professional advisory committees (Advisory Committee on Immunization Practices, American College of Obstetricians and Gynecologists, Society for Maternal-Fetal Medicine, and Academy of Breastfeeding Medicine) have issued guidance supporting COVID-19 vaccination in pregnant and lactating women. In this article, we summarize the available data on the efficacy and safety profile of COVID-19 vaccination in pregnant and lactating women, review the challenges of vaccine hesitancy, and include recommendations for healthcare providers.
Highlights
These can be divided into three different types based on their mechanism of action: messenger RNA (BNT162b2 Pfizer BioNTech (Pfizer, Inc., Philadelphia, PA, USA) and mRNA-1273 Moderna vaccines (ModernaTX, Inc., Cambridge, MA, USA)), viral vector (AstraZeneca, Janssen Ad26.COV2.S) (Janssen Biotech, Inc, Johnson & Johnson, New Brunswick, NJ, USA), and recombinant antigen proteins manufactured in a baculovirus (DNA virus that infects insect cells) system (Novavax (Novavax, Inc., Gaithersburg, MD, USA) and GSK-Sanofi (Sanofi Inc., Bridgewater, NJ, USA; GlaxoSmithKline Inc., Philadelphia, PA, USA)
A combination of (i) strong advocacy groups providing regulatory framework and guidelines for inclusion of pregnant and lactating women in COVID-19 vaccine clinical trials, and (ii) leveraging data collected developmental and reproductive toxicology studies (DART) studies, accidental pregnancies during clinical trials, and various safety profile registries can help bridge the gap between evidencebased recommendations and expert opinion on COVID-19 vaccination in pregnant and lactation women [69,70,71]
Approval of vaccine use intended for pregnant or breastfeeding women rely on a critical review of observational studies, clinical case reports, registries, and clinical trials to ascertain if the vaccine is: (i) safe—no adverse pregnancy outcomes or potential harm to mother and/or fetus, (ii) efficacious—reduce morbidity in the pregnant woman and/or fetus [72,73,74,75,76,77,78,79,80,81]
Summary
Publisher’s Note: MDPI stays neutral with regard to jurisdictional claims in published maps and institutional affiliations. Vaccination and public health measures, including wearing facemasks, social distancing, and personal hygiene, remain the most promising means of controlling this global pandemic. With this hope, multiple COVID-19 vaccines are being developed, approved, and manufactured for global use while still upholding rigorous regulatory processes [3,4,5]. Millions of women have become pregnant, given birth, and initiated breastfeeding since the start of the COVID-19 pandemic This has created an ethical and clinical conundrum on protecting our vulnerable pregnant and lactating population while lacking empirical evidence. The purpose of this article is to provide an overview of the efficacy and safety of COVID-19 vaccination in pregnant and lactating women, with a review of limited data and theoretical considerations and review-recommended guidelines for clinical use
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