Abstract
Vaccines have been developed at “warp speed” to combat the COVID-19 pandemic caused by the SARS-CoV-2 coronavirus. Although they are considered the best approach for preventing mortality, when assessing the safety of these vaccines, pregnant women have not been included in clinical trials. Thus, vaccine safety for this demographic, as well as for the developing fetus and neonate, remains to be determined. A global effort has been underway to encourage pregnant women to get vaccinated despite the uncertain risk posed to them and their offspring. Given this, post-hoc data collection, potentially for years, will be required to determine the outcomes of COVID-19 and vaccination on the next generation. Most COVID-19 vaccine reactions include injection site erythema, pain, swelling, fatigue, headache, fever and lymphadenopathy, which may be sufficient to affect fetal/neonatal development. In this review, we have explored components of the first-generation viral vector and mRNA COVID-19 vaccines that are believed to contribute to adverse reactions and which may negatively impact fetal and neonatal development. We have followed this with a discussion of the potential for using an ovine model to explore the long-term outcomes of COVID-19 vaccination during the prenatal and neonatal periods.
Highlights
Vaccines are a key strategy for preventing and controlling endemic and emerging diseases of both humans and livestock
A widely cited preliminary study of the V-safe and Vaccine Adverse Event Reporting System (VAERS) data suggested that COVID-19 mRNA vaccines were safe for pregnant women [9]; errors were found in their analysis [10], and a follow-up re-analysis of the data revealed a cumulative incidence of spontaneous abortion of 7–8 times higher than the original author’s calculations, which was statistically higher than the typical average for pregnancy loss during the equivalent time period [11]
While this post-hoc data analysis of extreme outcomes will be very important for assessing vaccine safety during pregnancy, it does not include more subtle multi-organ developmental changes that would be expected to occur in the fetus during an adverse vaccine reactions (AVR), and these could lead to an increased risk of disease according to the Developmental Origins of Health and Disease (DOHaD) Hypothesis [12]
Summary
Vaccines are a key strategy for preventing and controlling endemic and emerging diseases of both humans and livestock. A widely cited preliminary study of the V-safe and Vaccine Adverse Event Reporting System (VAERS) data suggested that COVID-19 mRNA vaccines were safe for pregnant women [9]; errors were found in their analysis [10], and a follow-up re-analysis of the data revealed a cumulative incidence of spontaneous abortion of 7–8 times higher than the original author’s calculations, which was statistically higher than the typical average for pregnancy loss during the equivalent time period [11] While this post-hoc data analysis of extreme outcomes will be very important for assessing vaccine safety during pregnancy, it does not include more subtle multi-organ developmental changes that would be expected to occur in the fetus during an AVR, and these could lead to an increased risk of disease according to the Developmental Origins of Health and Disease (DOHaD) Hypothesis [12]. While anaphylaxis during pregnancy is typically a rare event, a recent study has reported severe outcomes for infants from mothers with anaphylaxis [30], which should alert us to potential fetal/neonatal outcomes resulting from vaccine-induced maternal anaphylaxis
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