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

Abstract

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.

Barriers and Facilitators Associated With Vaccine Acceptance and Uptake Among Pregnant Women in High Income Countries: A Mini-Review

“…In the absence of trial data among pregnant women, guidance from governments and professional bodies is highly variable with respect to pregnancy and vaccination, and subject to change; many currently recommend an individual risk-benefit approach which is challenging given the evidence gap (46). The recent announcement of a Phase 2/3 study to assess the safety, tolerability, and immunogenicity of the Pfizer-BioNTech COVID-19 vaccine (BNT162b2) in preventing COVID-19 in healthy pregnant women is therefore very welcome (ClinicalTrials.gov Identifier: NCT04754594).…”

Perspectives on COVID-19 vaccination for pregnant women in South Africa

“…The coronavirus disease 2019 (COVID- 19) is a pandemic that has created a global health crisis that necessitated a public health response to limit all nidi of infection. South African data from 2020 demonstrated a 30% increase in maternal deaths since the pandemic started.…”

Reply to professionally responsible COVID-19 vaccination counseling

“…We thank Dr Habiba for his interest in our article. 1 Dr Habiba claims that our article failed to be "rooted in scientific rigor" because "vaccines have not been tested in pregnant women" in a randomized controlled clinical trial. In February 2021, Pfizer and BioNTech embarked on studying the effects of COVID-19 vaccination on pregnant women.…”