The need for inclusion of pregnant women in COVID-19 vaccine trials

Beigi, Richard H.; Krubiner, Carleigh; Jamieson, Denise J.; Lyerly, Anne Drapkin; Hughes, Brenna L.; Riley, Laura E.; Faden, Ruth R.; Karron, Ruth A.

doi:10.1016/j.vaccine.2020.12.074

Cited by 77 publications

(60 citation statements)

References 7 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…Pregnant and lactating women are usually not included in the vaccine research, primarily because of safety and liability concerns, not only for the mother but also the baby [50][51][52][53][54]. However, systemic exclusion of this vulnerable population from clinical trials, including from SARS-CoV-2 vaccine trials, also means limited available data on vaccine safety and efficacy in pregnant and lactating women.…”

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

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.

show abstract

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

“…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

View full text Add to dashboard Cite

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.

show abstract

“…There is a critical need for the inclusion of pregnant women in vaccine trials, given the vulnerability of this population to developing severe illness with COVID-19. Vaccination of pregnant women can also decrease household transmission of COVID-19 among children too young to receive the vaccine (8). Greater evidence on vaccine safety amongst pregnant women can increase vaccine confidence and trust in both pregnant women and their obstetrics providers.…”

Section: "In This Cross-sectional Sample Of Patients Pregnant Patients Who Discussed the Covid-19 Vaccine With A Healthcare Provider Werementioning

confidence: 99%

COVID-19 Vaccine Acceptance In Pregnancy

et al. 2021

View full text Add to dashboard Cite

Background: Early in the COVID-19 pandemic, limited data existed regarding the safety and efficacy of the COVID-19 vaccine in pregnant women. As such, many pregnant women have reservations about receiving the COVID-19 vaccine. However, pregnant women are of particular concern as they are considered a vulnerable population due to the increased risk of severe complications from COVID-19. This study investigates the willingness of pregnant patients to receive the vaccine before and after discussion with a health care provider. Methods: 124 pregnant women were surveyed from February to March of 2021 at a perinatal center. Patients were queried about their willingness to receive the COVID-19 vaccine before and after reading a fact sheet and discussing the vaccine's safety with a provider. Results: There was a statistically significant effect of discussing the vaccine with a physician regarding patients' willingness to receive the COVID-19 vaccine. Additionally, patients who received the annual influenza vaccine were significantly more likely to get the COVID-19 vaccine. Conclusion: Pregnant women were more willing to receive the COVID-19 vaccine after discussion with a health care provider. The importance and impact of health education should be given special consideration in medical offices.

show abstract

The need for inclusion of pregnant women in COVID-19 vaccine trials

Cited by 77 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

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

COVID-19 Vaccine Acceptance In Pregnancy

Contact Info

Product

Resources

About