Coronavirus disease 2019 vaccines in pregnancy

Craig, Amanda M.; Hughes, Brenna L.; Swamy, Geeta K.

doi:10.1016/j.ajogmf.2020.100295

Cited by 59 publications

(59 citation statements)

References 22 publications

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“…Our results provide information needed to inform the care of lactating individuals and their infants 12 . Although there is expert consensus of minimal or no potential risk for the infant from maternal anti-COVID-19 vaccination 13,14 , no previous studies have demonstrated specific benefits during lactation. Our results now provide such evidence.…”

Section: Discussionmentioning

confidence: 99%

COVID-19 mRNA Vaccination in Lactation: Assessment of adverse events and vaccine related antibodies in mother-infant dyads

Golan

Prahl

Cassidy

et al. 2021

Preprint

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Importance: Data regarding efficacy and safety of anti-COVID-19 mRNA vaccines during lactation is needed to address vaccination guidelines, ease vaccine hesitancy concerns, and inform public health strategies for this population. Objective: To determine whether anti-COVID-19 mRNA-based vaccines administered during lactation illicit an immune response or the transfer of anti-SARS-CoV2 antibodies into human milk. Design: Plasma and milk samples were collected from a prospective cohort of lactating individuals who received the mRNA-based vaccines for COVID-19 and from individuals who recovered from COVID-19 infection. Setting: Ambulatory or during postpartum hospitalization. Participants: We report results from lactating participants who received the mRNA-1273 (Moderna, n=9) or the BNT162b2 (Pfizer, n=14) vaccine or recovered from natural SARS-CoV-2 infection (n=3). Interventions and Exposures: Anti-COVID-19 mRNA vaccination (BNT-162b2 and mRNA-1273) or natural SARS-CoV-2 infection. Main Outcome(s) and Measure(s): Plasma and milk samples were collected from lactating individuals before first vaccine dose, on the day of the second dose, and 4 weeks after the second dose. Maternal plasma was evaluated for vaccine-derived IgM and IgG antibodies. Human milk was evaluated by ELISA for vaccine-induced IgA antibodies specific for SARS-CoV-2. Results: Twenty-three lactating individuals were recruited for this study. Levels of IgG and IgM were significantly increased in plasma samples on the day of the second vaccine dose (post vaccine 1), when compared to pre-vaccine samples. In addition, plasma IgG levels 4 weeks after second vaccine dose were significantly higher than plasma IgG levels pre-vaccine or on the day of the second dose. In addition, our results show transfer of anti-SARS-CoV2-Receptor Binding Domain (RBD) IgA antibodies to human milk, 3-4 weeks after each dose of the COVID-19 mRNA vaccines (BNT-162b2 and mRNA-1273). The levels of anti-SARS-CoV2-RBD IgA antibody in milk of vaccinated individuals were not significantly different from levels among participants who experienced SARS-CoV-2 infection. Conclusions and Relevance: Administration of anti-COVID-19 mRNA vaccines during lactation leads to increased anti-SARS-CoV2 IgM and IgG levels in the plasma of lactating mothers and increased anti-SARS-CoV2-RBD IgA levels in human milk. Lactating women who receive the vaccine should continue breastfeeding their infant human milk to allow continuing transfer of anti-SARS-CoV-2 IgA antibodies to the neonate. Additional studies are needed to evaluate the effect of these vaccines on lactation outcomes and infant health.

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Section: Discussionmentioning

confidence: 99%

COVID-19 mRNA Vaccination in Lactation: Assessment of adverse events and vaccine related antibodies in mother-infant dyads

Golan

Prahl

Cassidy

et al. 2021

Preprint

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“…The theoretical risk of the COVID-19 vaccine must be assessed in the context of the documented increased risk for a severe COVID-19 disease course in pregnant women and their fetuses. 4 Immunization with inactivated virus vaccines or toxoids during pregnancy is not expected to be associated with an increased risk to the pregnant patient or the fetus. 5,6 In an overview of 17 systematic reviews reporting on maternal-fetal and neonatal outcomes after immunizations during pregnancy, no major safety concerns and risks were identified for any of the vaccines or outcomes of interest.…”

Section: Challenges With Counseling Patientsmentioning

confidence: 99%

“…The fetal patient is not exposed to the documented risk, based on indirect evidence, nor is the breastfed newborn. 4,5,7 The mRNA strands are unlikely to cross the placenta and in mice models, mRNA Zika virus vaccines have been shown to protect the placenta. 8 The theoretical risks should not shape the informed consent process and the physician's evaluation that, when balanced, COVID-19 vaccinations confer significant clinical benefit.…”

Section: Counseling Pregnant Patients the Physician's Evaluationmentioning

confidence: 99%

Professionally responsible coronavirus disease 2019 vaccination counseling of obstetrical and gynecologic patients

Chervenak

McCullough

Bornstein

et al. 2021

American Journal of Obstetrics and Gynecology

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The development of COVID-19 vaccines in current and planned clinical trials is essential for the success of this public health response. This paper focuses on how physicians should implement the results of these clinical trials: counseling patients who are pregnant, planning to become pregnant, breastfeeding or planning to breastfeed about vaccines with government authorization for clinical use. Determining the most effective approach to counseling patients about COVID-19 vaccination is challenging. We address the professionally responsible counseling of three groups of patients – those who are pregnant, those planning to become pregnant, and those breastfeeding or planning to breastfeed. We begin with an evidence-based account of five major challenges: the limited evidence base; documented increased risk of severe disease among pregnant COVID-19-infected patients; conflicting guidance from government agencies and professional associations; false information about COVID-19 vaccines; and maternal mistrust and vaccine hesitancy. We then provide evidence-based, ethically justified, practical guidance for meeting these challenges in professionally responsible counseling of patients about COVID-19 vaccination. To guide professionally responsible counseling of patients who are pregnant, planning to become pregnant, and breastfeeding or planning to breastfeed, we explain how obstetrician-gynecologists should evaluate current clinical information and why a recommendation of COVID-19 vaccination should be made and how this assessment should be presented to patients in the informed consent process with the goal of empowering them to make informed decisions. We also present a pro-active account of how to respond when patients refuse recommended vaccination, the elements of which are the legal obligation of informed refusal and the ethical obligation to ask patients to reconsider. During this process, the physician should be alert to vaccine hesitancy, ask patients to express their hesitation and reasons for it, and respectfully address them. In contrast to the conflicting guidance from government agencies and professional associations, evidence-based professional ethics in obstetrics and gynecology provides unequivocal and clear guidance: The physician should recommend COVID-19 vaccination to patients who are pregnant, planning to become pregnant, and breastfeeding or planning to breastfeed. To prevent widening health inequities, to build trust in the health benefits of vaccination and to encourage COVID-19 vaccine and treatment uptake, in addition to recommending COVID-19 vaccinations, physicians should engage with communities to tailor strategies to overcome mistrust and deliver evidence-based information, robust educational campaigns and novel approaches to immunization.

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“…However, other vaccines using similar technology have previously been successfully and safety used in pregnancy. In general, it must be considered that different types of vaccines are allowed during pregnancy when the benefit of the vaccination is considered to outweigh the potential risk [35,36]. Although developmental and reproductive toxicology studies in pre-clinical models conducted to assess the potential effects of a new medication or vaccine on the full spectrum of reproduction, have not yet been completed for any of the COVID-19 vaccines, the results so far available indicate these vaccines as safe [37].…”

Section: Covid-19 Vaccines During Pregnancymentioning

confidence: 99%

COVID-19 vaccination in pregnant and lactating diabetic women

Sculli

Formoso

Sciacca

2021

Nutrition, Metabolism and Cardiovascular Diseases

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To discuss available information on the opportunity for pregnant women affected by diabetes/obesity to receive COVID-19 vaccine. Data synthesis: Pregnant women with SARS-CoV-2 (COVID-19) infection are at high risk for severe acute respiratory syndrome and adverse outcomes. Pregnant women with severe COVID-19 present increased rates of preterm delivery (<37 gestational weeks), cesarean delivery and neonatal admissions to the intensive care unit. Comorbidity such as diabetes (pregestational or gestational) or obesity further increased maternal and fetal complications. It is known that diabetic or obese patients with COVID-19 present an unfavorable course and a worse prognosis, with a direct association between worse outcome and suboptimal glycol-metabolic control or body mass index (BMI) levels. Critical COVID-19 infection prevention is important for both mother and fetus. Vaccination during pregnancy is a common practice. Vaccines against COVID-19 are distributed across the world with some population considered to have a priority. Since pregnant women are excluded from clinical trials very little information are available on safety and efficacy of COVD-19 vaccines during pregnancy. However, it is well known the concept of passive immunization of the newborn obtained with transplacental passage of protective antibodies into the fetal/neonatal circulation after maternal infection or vaccination. Moreover, it has been reported that COVID-19 vaccine-induced IgG pass to the neonates through breastmilk. Therefore, maternal vaccination can protect mother, fetus and baby. Conclusions: After an individual risk/benefit evaluation pregnant and lactating women should be counselled to receive COVID-19 vaccines.

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Coronavirus disease 2019 vaccines in pregnancy

Cited by 59 publications

References 22 publications

COVID-19 mRNA Vaccination in Lactation: Assessment of adverse events and vaccine related antibodies in mother-infant dyads

COVID-19 mRNA Vaccination in Lactation: Assessment of adverse events and vaccine related antibodies in mother-infant dyads

Professionally responsible coronavirus disease 2019 vaccination counseling of obstetrical and gynecologic patients

COVID-19 vaccination in pregnant and lactating diabetic women

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