Inclusion of children and pregnant women in COVID-19 intervention trials

Malhotra, Atul; Kumar, Arunaz; Roehr, Charles Christoph; Boer, M. den

doi:10.1038/s41390-020-1067-3

Cited by 11 publications

(10 citation statements)

References 7 publications

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“…Several efforts have been made over the years to address the exclusion of pregnant women from clinical trials of new medications and vaccines, including [56,57], for example, the National Institute of Allergy and Infectious Diseases has developed guidelines for protocol design and safety assessment for clinical trials conducted in pregnant persons. In 2018, the FDA provided a framework for the inclusion of pregnant persons in clinical trials [58].…”

Section: Clinical Trials Of Covid-19 Vaccine In Pregnant and Lactating Womenmentioning

confidence: 99%

COVID-19 Vaccine in Pregnant and Lactating Women: A Review of Existing Evidence and Practice Guidelines

Garg

Shekhar

Sheikh

et al. 2021

Infectious Disease Reports

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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.

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Section: Clinical Trials Of Covid-19 Vaccine In Pregnant and Lactating Womenmentioning

confidence: 99%

COVID-19 Vaccine in Pregnant and Lactating Women: A Review of Existing Evidence and Practice Guidelines

Garg

Shekhar

Sheikh

et al. 2021

Infectious Disease Reports

View full text Add to dashboard Cite

show abstract

“… 14 A better understanding of age-group-specific disease pathomechanisms, treatment options including effect of infant/child vaccinations, long-term outcomes and prevention of viral spread is urgently needed and should be the topics of future research. 144 , 145 The overall low morbidity of SARS-CoV-2 infection in neonates as compared to adults is striking, as well as the low susceptibility to SARS-CoV-2 compared to bacterial or other severe viral infections. The relatively low incidence among children, and especially neonates, necessitate multi-national collaborations 128 to address these questions in adequately sized studies.…”

Section: Future Directions/present and Future Research Needsmentioning

confidence: 99%

Neonates and COVID-19: state of the art

et al. 2021

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The SARS-CoV-2 pandemic has had a significant impact worldwide, particularly in middle- and low-income countries. While this impact has been well-recognized in certain age groups, the effects, both direct and indirect, on the neonatal population remain largely unknown. There are placental changes associated, though the contributions to maternal and fetal illness have not been fully determined. The rate of premature delivery has increased and SARS-CoV-2 infection is proportionately higher in premature neonates, which appears to be related to premature delivery for maternal reasons rather than an increase in spontaneous preterm labor. There is much room for expansion, including long-term data on outcomes for affected babies. Though uncommon, there has been evidence of adverse events in neonates, including Multisystem Inflammatory Syndrome in Children, associated with COVID-19 (MIS-C). There are recommendations for reduction of viral transmission to neonates, though more research is required to determine the role of passive immunization of the fetus via maternal vaccination. There is now considerable evidence suggesting that the severe visitation restrictions implemented early in the pandemic have negatively impacted the care of the neonate and the experiences of both parents and healthcare professionals alike. Ongoing collaboration is required to determine the full impact, and guidelines for future management. Impact Comprehensive review of current available evidence related to impact of the COVID-19 pandemic on neonates, effects on their health, impact on their quality of care and indirect influences on their clinical course, including comparisons with other age groups. Reference to current evidence for maternal experience of infection and how it impacts the fetus and then neonate. Outline of the need for ongoing research, including specific areas in which there are significant gaps in knowledge.

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“…Based on urgent ethical and clinical concerns in vaccinating this population, numerous health organiza-tions have called for the inclusion of pregnant and lactating women in clinical trials. [3][4][5][6][7][8][9][10][11] The theoretical risk of current COVID-19 vaccines adversely impacting lactation or breastfed children is quite low. However, breastfeeding mothers and their clinicians have minimal objective data to guide decisions on vaccine safety.…”

Section: Introductionmentioning

confidence: 99%

Maternal and Child Symptoms Following COVID-19 Vaccination Among Breastfeeding Mothers

McLaurin‐Jiang

Garner

Krutsch

et al. 2021

Breastfeeding Medicine

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Background: The impact of COVID-19 vaccination on breastfeeding is unknown. The primary aim of this study was to determine whether vaccine-related side effects following COVID-19 vaccination were associated with an adverse impact on breastfeeding. Secondarily, we sought to determine perceived symptoms in breastfed children and maternal opinion about COVID-19 vaccination. Materials and Methods: We conducted a cross-sectional survey of breastfeeding mothers who underwent COVID-19 vaccination >2 days before the survey. Subjects were recruited through social media and websites. Data included sociodemographic information, vaccine history, maternal and child symptoms, and impact on lactation/breastfeeding. Bivariate statistics (chi-square, Wilcoxon rank sum, and t tests) and multivariable logistic regression models examined the association of vaccine side effects with lactation, symptoms in breastfed children, and maternal opinion on vaccination. Results: Analysis included 4,455 breastfeeding mothers. Maternal postvaccination symptoms were more common after the second dose ( p < 0.001). Overall, 77 (1.7%) respondents reported a negative impact on breastfeeding postvaccination, and these mothers were more likely to have experienced fatigue, headache, muscle pain, injection site pain, chills, fever, or allergic reactions. After adjusting for confounding variables, higher odds of an adverse impact on lactation were associated with lower breastfeeding intensity, dose of vaccine, and child symptoms. Even among mothers who reported an adverse impact on breastfeeding, maternal opinion about vaccination and confidence in their decision to receive the COVID-19 vaccine were high. Conclusions: COVID-19 vaccination among breastfeeding mothers resulted in minimal disruption of lactation or adverse impact on the breastfed child. These findings may be considered in vaccination decision-making.

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Inclusion of children and pregnant women in COVID-19 intervention trials

Cited by 11 publications

References 7 publications

COVID-19 Vaccine in Pregnant and Lactating Women: A Review of Existing Evidence and Practice Guidelines

COVID-19 Vaccine in Pregnant and Lactating Women: A Review of Existing Evidence and Practice Guidelines

Neonates and COVID-19: state of the art

Maternal and Child Symptoms Following COVID-19 Vaccination Among Breastfeeding Mothers

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