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.

Background/Objectives: Vancomycin dosing in neonates is challenging due to high pharmacokinetic variability and immature renal function. This study evaluated current therapeutic drug monitoring (TDM) practices, the association between vancomycin concentration and clinical outcomes, and the predictive performance of a locally developed population pharmacokinetic (popPK) model compared to the published models. Methods: This was a retrospective cohort study of neonates admitted to a tertiary neonatal intensive care unit (NICU). We assessed the persistent positive culture, infection recurrence, mortality and acute kidney injury (AKI) stratified by initial vancomycin trough concentrations (15 mg/L). The locally developed popPK model was externally validated and compared with 32 other published neonatal vancomycin popPK models (with a total of 33 models evaluated). Results: A total of 366 neonates were included (mean postmenstrual age of 28.9 ± 3.81 weeks; 191 received at least 5 days of vancomycin). Only 28% of neonates achieved initial vancomycin trough concentrations within the 10–15 mg/L using standard vancomycin dosing. Higher vancomycin trough concentrations (>15 mg/L) were not associated with improved efficacy but were significantly associated with a higher incidence of AKI. The locally derived popPK model demonstrated superior predictive accuracy, meeting all predefined performance criteria, whereas none of the 32 other published models met all the criteria. Conclusions: Current vancomycin dosing strategies often result in suboptimal exposure and increased nephrotoxicity without added efficacy. Model-informed precision dosing using the locally developed popPK model may offer a safer, more effective approach for neonatal vancomycin therapy.

Background: The evaluation of suspected late-onset sepsis in neonates and infants ≤6 months includes obtaining a sterile urine sample. Two techniques are used interchangeably in clinical practice to detect the presence of microorganisms: suprapubic aspiration (SPA) and urethral catheterization (UC). At present, it is unclear which method causes more pain. The primary objective of this systematic review and meta-analysis is to determine which technique is more painful. Methods: Electronic databases were searched for relevant randomized and quasi-randomized trials in September 2023. The literature search was updated in June 2025 and no additional eligible articles were identified for inclusion. Title and abstract screening, followed by data extraction, were performed in duplicate. The risk of bias was assessed using Cochrane’s risk of bias (RoB) 2.0 tool. The critically important outcome was pain measured using validated tools including unidimensional (behavioural) and multidimensional (combination of behavioural and physiological components) tools. Secondary outcomes included procedure success, procedure duration, and adverse events. Pooled effects estimates were standardized mean difference (SMD), mean difference (MD), and relative risk (RR) with 95% confidence intervals (CI) from random effects meta-analyses. Certainty assessment was completed using Grading of Recommendations, Assessment, Development and Evaluation (GRADE) methodology. Results: Of the seven included studies, five studies reported pain scores among 378 infants. Clinical heterogeneity was noted across the studies specifically differences in postnatal age, procedure details (e.g., operator skillset, use of anesthetic and analgesic, ultrasound guidance), and pain assessment tools (unidimensional vs. multidimensional pain scores). There was no difference in pain score for overall procedure for SPA versus UC (SMD 0.25 [95% CI –0.63, 1.14], I2 = 84%; n = 330) and duration of cry (MD 5.26 [95% CI –43.72, 54.23], I2 = 97%; n = 245). The quality of evidence was low for these outcomes. There was a statistically significant difference in procedure duration when SPA was compared to UC (MD –62.62 [95% CI –112.96, –12.27], I2 = 96%; n = 299) with SPA being the procedure of shorter duration. The quality of evidence for this outcome was moderate. None of the studies reported any serious adverse events. Discussion: There is insufficient evidence to recommend one technique over the other for reducing pain in infants ≤6 months. Healthcare professionals can select SPA or UC based on the unit preference, skillset, and available resources. Future research is required to inform clinical practice.

Background: Lumbar puncture (LP) is a painful procedure performed in infants. Both national and international organizations recommend the use of local anesthetics for LP pain management. However, recommendations are not based on systematic review of the literature. The primary objective of this systematic review and meta-analysis was to synthesize the literature on local anesthetics and opioids for pain management in infants undergoing LP. Methods: Databases were searched for randomized trials from inception to March 2024. The literature search was updated in June 2025 and no additional eligible articles were identified for inclusion. Title and abstract screening, full-text screening and data extraction were performed in duplicate. Risk of bias was assessed using Cochrane’s risk of bias (RoB) 2.0 tool. The critically important outcome was pain measured using validated tools including unidimensional behaviour and multidimensional (comprising combinations of contextual, behavioural and/or physiological components) tools. Secondary outcomes included procedure success and adverse events. Pooled effect estimates were standardized mean difference (SMD) and relative risk (RR) with 95% confidence intervals (CI) using random effects models. A GRADE assessment of the overall certainty of the evidence for each outcome was completed. Results: Five studies with 292 infants were included. The interventions evaluated include local anesthetics (subcutaneous injection of lidocaine, needle-free jet injection of lidocaine using J-Tip and topical administration of lidocaine-prilocaine) and opioids (intravenous fentanyl). Local anesthetics were effective in reducing acute pain compared to placebo/control (SMD −0.70 [95% CI −0.89, −0.51]; I2 = 0, n = 215). Fentanyl was effective in reducing acute pain compared to placebo (SMD −1.93 [95% CI −2.64, −1.21]). Across all comparisons, there was no difference in procedure success and number of attempts in studies including local anesthetics. No serious adverse events were attributed to local anesthetics or opioids. There was moderate to low certainty of evidence for all critical and important outcomes. Discussion: Both local anesthetics and opioids are effective in reducing pain associated with LP based on limited evidence and can be incorporated in clinical practice. Future studies should evaluate the effectiveness and safety of combined analgesia and alternative routes of administration for opioids.