Pregnant and postpartum individuals are known to have an elevated risk of severe COVID‐19 compared with their non‐pregnant counterparts. Vaccination is the most important intervention to protect these populations from COVID‐19‐related morbidity and mortality. An added benefit of maternal COVID‐19 vaccination is transfer of maternal immunity to newborns and infants, for whom a vaccine is not (yet) approved. Severe acute respiratory syndrome coronavirus 2 (SARS‐CoV‐2)‐specific binding and neutralizing antibodies are present in infant cord blood and breast milk following natural maternal infection and transfer of maternal immunity following COVID‐19 vaccination is an area of active research. In this review, we synthesize the available research, discuss knowledge gaps, and outline factors that should be evaluated and reported when studying the transfer of maternal immunity following COVID‐19 vaccination. The data reviewed herein suggest that maternal SARS‐CoV‐2‐specific binding antibodies are efficiently transferred via the placenta and breast milk following maternal mRNA COVID‐19 vaccination. Moreover, antibodies retain strong neutralizing capacity. Antibody concentrations appear to be at least as high in infant cord blood as in the maternal serum, but lower in breast milk. Breast milk IgA rises rapidly following maternal vaccination, whereas IgG rises later but may persist longer. At least two COVID‐19 vaccine doses appear to be required to reach maximal antibody concentrations in cord blood and breast milk. There is no indication that infants consuming breast milk from vaccinated mothers experience serious adverse effects, although follow‐up is limited. No clear pattern has emerged regarding changes in milk supply following maternal vaccination. The heterogeneity in important methodological aspects of reviewed studies underscores the need to establish standard best practices related to research on the transfer of maternal COVID‐19 vaccine‐induced immunity.

Pregnant people have an elevated risk of severe COVID-19-related complications compared to their non-pregnant counterparts, underscoring the need for safe and effective therapies. In this review, we summarize published data on COVID-19 therapeutics in pregnancy and lactation to help inform clinical decision-making about their use in this population. Although no serious safety signals have been raised for many agents, data clearly have serious limitations and there are many important knowledge gaps about the safety and efficacy of key therapeutics used for COVID-19. Moving forward, diligent follow-up and documentation of outcomes in pregnant people treated with these agents will be essential to advance our understanding. Greater regulatory push and incentives are needed to ensure studies to obtain pregnancy data are expedited.

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To describe the eligibility and enrollment of pregnant and breastfeeding women in psychiatry randomized controlled trials (RCTs). We screened citations published 2017–2019 in the three highest impact psychiatry and five highest impact general medicine journals. We excluded male, pediatric, geriatric, and postmenopausal-focused RCTs and publications reporting subgroup, pooled, or secondary analyses of RCTs. We reviewed appendices, protocols, and registries for additional data. In total 108 RCTs were included. Three (2.8%) permitted enrollment of pregnant women; 59/108 (55%) and 46/108 (43%) explicitly excluded pregnant women or did not report pregnancy inclusion criteria, respectively. All RCTs including pregnant women evaluated non-pharmacological interventions for depression during pregnancy or postpartum. Among RCTs excluding pregnant women, 5/59 (8.5%) provided a rationale for exclusion. Contraception and/or negative pregnancy testing were required for women with reproductive capacity in 31/59 (53%). Three (2.8%) RCTs permitted enrollment of breastfeeding women and 3/41 (7.3%) RCTs excluding breastfeeding women provided a rationale for exclusion. This study demonstrates a major gap in psychiatry research involving pregnant and breastfeeding women. A shift from exclusion by default to inclusion and integration of this population into the clinical research agenda is needed to ensure they receive evidence-based care for mental illness. Supplementary Information The online version contains supplementary material available at 10.1007/s00737-023-01319-y.