Ethical Issues With Vaccination in Obstetrics and Gynecology

Informed Consent and Patient Counseling

Obstetrician–gynecologists should counsel their patients about vaccination in an evidence-based manner that allows patients to make an informed decision. Given the public health benefit of vaccines as well as their potential to safeguard an individual patient’s health, obstetrician–gynecologists should recommend routine vaccination in accordance with current guidelines provided by the CDC and ACOG.

Informed consent is a core component of the ethical clinical relationship 9. As with all forms of medical therapy, informed consent should precede vaccination administration. In the informed consent discussion, health care professionals should present information central to the decision-making process for vaccination, including the indications, risks and benefits of the vaccine, and available alternatives. Health care professionals also should counsel patients about the risks of nonvaccination for themselves, close contacts who may be at risk of the disease to be prevented, and the population at large. Withholding vaccination, or information about vaccination, is unacceptable because it violates the ethical obligations to respect patient autonomy and promote patient well-being.

There is evidence that recommendations from obstetrician–gynecologists or other health care professionals strongly influence patients’ decisions to accept vaccination 10. Data to inform these discussions are available to health care professionals and the general public through Vaccine Information Statements found on the CDC’s website 11. Federal law requires that a Vaccine Information Statement be given to patients (or their parents or guardians) before each dose of certain routine vaccines, such as Tdap, HPV, and influenza. In addition, ACOG has multiple immunization resources for obstetrician–gynecologists to help guide patient counseling and increase vaccination rates 4 6.

Vaccination Hesitancy and Refusal

The World Health Organization has named vaccine hesitancy —defined as the reluctance or refusal to be vaccinated despite the availability of vaccines—among the top ten threats to global health 12 13. The root causes of vaccination hesitancy are complex, but complacency, lack of confidence, mistrust in the medical field, and inconvenience have been identified as important reasons why individuals choose not to get vaccinated 12.

Lack of confidence may be related to exposure to misinformation about vaccination efficacy and safety on social media, which has enabled widespread dissemination of myths and inaccurate information about vaccination, which helps to further fuel the antivaccination movement in the United States and abroad 14 15 16. For example, although no causal link between vaccination and autism has been identified, anxiety about unscientifically based claims that vaccine preparations cause autism remains widespread, and concern about autism often is cited as a reason for hesitancy and refusal regarding childhood vaccination and vaccination during pregnancy 17 18 19.

Concerns about vaccination should be discussed and understood within the context of patients’ lived experience and social determinants of health as well as their cultural and religious beliefs and values. For example, individuals from communities of color may understandably have vaccination hesitancy because of historic and ongoing injustices and systemic racism that have eroded trust in the health care system 20 21 22 23 24 25. Similarly, there are religious communities whose vaccination rates are suboptimal because of faith-based concerns 26 27.

Active listening and validation of expressed fears and concerns can help foster rapport and trust. Interventions that are most effective tend to be multi-faceted, dialogue-based, and individualized to address patient-specific concerns and circumstances 28. There are a variety of resources available to help physicians address and overcome vaccine hesitancy in their patients 29 30 31. Further strategies for enhancing public trust in vaccines are addressed in detail in the CDC’s Vaccinate with Confidence campaign resources 32. As public health advocates, obstetrician–gynecologists also are encouraged to partner with trusted community and religious leaders to provide accurate information about vaccinations in a supportive environment that is tailored to the needs and concerns of local communities 24.

If a patient continues to be unsure about vaccination after counseling, obstetrician–gynecologists should inquire about the reasons for this hesitation to help address patient-specific questions and concerns. If the patient declines, this informed refusal of recommended vaccination should be respected. The discussion should be documented in the patient’s medical record. During subsequent office visits, obstetrician–gynecologists should address ongoing questions and concerns and offer vaccination again if the patient seems amenable. Patients who decline vaccination should continue to be supported with appropriate care options that honor their autonomous choices. In these scenarios, obstetrician–gynecologists have the opportunity to put alternative strategies in place to protect the health of the patient and that of the general community, including accommodations to avoid putting other patients in jeopardy, providing patients with instruction on monitoring and managing symptoms at home, and recommending behavioral approaches to reduce risks associated with infection and transmission. Although these strategies help to mitigate harms, they remain inferior to reducing risk by vaccination.

Nonmedical Exemptions

Although state laws require certain vaccinations for school enrollment, all states allow for medical exemption and most states have provisions for religious exemptions, philosophical exemptions, or both 33 34. Increasing rates of nonmedical exemptions to state-mandated vaccinations are another important barrier to vaccine acceptance and have been associated with a rise in vaccine-preventable diseases 2. State laws that permit nonmedical exemptions from immunizations—personal, philosophical, or religious—are problematic because they endanger the health of the exempted individual, those individuals with medical contraindications to vaccinations, and the general public. Although obstetrician–gynecologists should respect an individual patient’s decision to decline vaccination, they also have the dual role of promoting public health by ensuring herd immunity to vaccine-preventable diseases. It is the position of ACOG and other major medical societies that vaccine exemptions to highly communicable diseases should be granted only when medical contraindications exist that would compromise a patient’s health 35 36 37 38 39 40. It also is important to recognize that some medical exemptions may be for temporary reasons; it is important to periodically reassess the need for medical exemptions 35. Outbreaks of vaccine-preventable diseases such as measles have resulted in several states removing nonmedical exemptions to increase population rates of vaccination 41. Thus, obstetrician–gynecologists should be aware of vaccination laws and policies that affect their practice. Because obstetrician–gynecologists play an integral role in recommending evidence-based medical therapy such as vaccination, they are encouraged to advocate for removal of nonmedical exemptions from state laws, counsel and educate patients about the importance of vaccination, and provide needed vaccinations.

Public Health Emergencies

Patients may understandably raise questions and concerns about the long-term consequences of vaccines that are developed on an expedited timeline during an emergent infectious disease outbreak. Patient counseling about urgently developed vaccines should include a discussion of the maternal and fetal risks and benefits (of both vaccination and nonvaccination) that is based on known available data 42 43. Patients’ questions should be integrated into the decision-making process, with the clinician listening to the patient’s concerns and recognizing that information evolves over time, while also making every reasonable effort to address fears that are not justified by scientific data. Obstetrician–gynecologists should encourage patient participation in research initiatives regarding vaccination, including in pregnancy if appropriate, to contribute to a better understanding in the future 44 45. Additional information about ethical issues related to pandemic planning and pregnancy is included in a separate ACOG publication 46.

Adolescents

The vaccination of adolescents poses unique ethical challenges related to confidentiality and informed consent. Obstetrician–gynecologists should protect adolescents’ access to reproductive health care services, including HPV vaccination, while adhering to current guidelines from the CDC and ACOG and applicable legal requirements for parental consent or notification. Patient acceptance of vaccination can be greatly influenced by recommendations from obstetrician–gynecologists and other health care professionals 10 19, and obstetrician–gynecologists should educate adolescent patients and parents to help inform decision-making regarding vaccination. Adolescents should receive a thorough age-appropriate discussion of the benefits and potential risks of any vaccination. Providing alone time, apart from a parent or guardian, for discussion between the adolescent patient and clinician is important to help increase discussion about sensitive topics and behaviors that may substantially affect their health and well-being 47 48.

Parental consent requirements for vaccinations such as the HPV vaccine can pose a barrier to adolescents’ access to confidential sexual and reproductive health care. Laws regarding the ability of adolescents to consent to medical treatment vary by state and by the type of treatment 47 49 50, and obstetrician–gynecologists should familiarize themselves with the current laws, regulations, and policies in their jurisdictions 49. However, even when consent is required by a parent or guardian for provision of a vaccine, an obstetrician–gynecologist should still obtain assent from the adolescent by counseling the adolescent about immunization and involving them in discussions and decisions about their care as appropriate for their developmental stage 51. Ultimately, shared decision making between patient, parent or guardian, and obstetrician–gynecologist, when possible, is the goal in order to include adolescents as integral participants in their health care and optimize the adolescent’s medical care 47 52.

Pregnancy and Lactation

Obstetrician–gynecologists should counsel their pregnant and lactating patients about the safety and efficacy of routine vaccination in an evidence-based manner that allows patients to make an informed decision about their use. Most vaccines are appropriate for use in pregnancy and lactation, and obstetrician–gynecologists should recommend needed vaccines during pregnancy and lactation in accordance with current guidelines from the CDC and ACOG.

Immunization is an essential part of care for adults, including pregnant and lactating patients 53 54. Despite the demonstrated benefits and safety of immunization during pregnancy and lactation, the rate of maternal vaccination remains below optimal levels 19 55. An important barrier to maternal immunization is vaccine hesitancy, which often is related to concerns about vaccine safety and efficacy, for both pregnant patients and their fetuses or breastfed children 18 56. Studies consistently demonstrate that when the recommendation for vaccination during pregnancy or lactation comes directly from a patient’s obstetrician or other obstetric care professional, and the vaccine is available in the physician’s office, the odds of vaccine acceptance are significantly increased 53 56 57 58 59.

Obstetrician–gynecologists play a critical role in ensuring pregnant and lactating patients receive recommended vaccines. As such, obstetrician–gynecologists should counsel pregnant and lactating patients about the safety and benefits of immunization for themselves and their fetuses or breastfed children and educate patients about the benefits of passive immunity from maternal immunization for their newborns 57. Concerns about the effect of vaccination on the fetus should be discussed in light of relevant medical evidence and understood within the context of each patient’s broad social network, cultural beliefs, and values. Emphasizing the fetal and neonatal risks of nonvaccination has been reported to be an effective strategy to overcome vaccine hesitancy among pregnant and lactating patients 19. Pregnant patients should be informed that inactivated vaccines are considered safe in pregnancy, and there is no evidence of adverse fetal effects from vaccinating pregnant individuals with inactivated virus, bacterial vaccines, or toxoids 53 57 60. Additionally, patients can be counseled that live vaccines are safe in lactation and there is no need to discontinue or avoid initiation of breastfeeding when receiving vaccinations 61 62.

If a pregnant or lactating patient still is unsure about immunization after counseling, obstetrician–gynecologists should inquire about the reasons for this hesitation to help address patient-specific questions and concerns. As with nonpregnant patients, if a pregnant or lactating patient declines vaccination after counseling, informed refusal of recommended vaccination should be respected, and the discussion should be documented in the patient’s medical record. Pregnant or lactating patients who decline vaccination should continue to be supported with appropriate care options that honor their autonomous choices. During subsequent office visits, obstetrician–gynecologists should address ongoing questions and concerns and offer vaccination again if the patient seems amenable.

Vaccination of Health Care Professionals

To avoid their own personal contribution to the spread of disease, obstetrician–gynecologists have an ethical obligation to be vaccinated, unless they have a recognized medical contraindication, according to current guidelines from the CDC and ACOG. Any perceived burdens to clinicians from vaccination do not outweigh their professional responsibility to limit the spread of harmful infectious diseases.

In providing vaccines to patients, clinicians should weigh the interests of the individual patient with the interests of the greater population. Matters can become even more complicated for health care professionals, who should consider their own interests, rights, and responsibilities when presented with the professional expectation of being vaccinated themselves in order to protect patients regardless of whether they personally have objections to or concerns about vaccination. Obstetrician–gynecologists should recognize the personal role that they play in preventing transmission of infectious agents. As a result of their occupation, they may be exposed to highly contagious diseases and become ill or sources of transmission for infection.

Several perspectives support the ethical imperative that health care professionals should be vaccinated when clinically appropriate. First, data demonstrate that vaccination among health care professionals can reduce the spread of infectious disease throughout inpatient and outpatient populations 63. Second, vaccination prevents infectious illness among medical staff, thus minimizing the use of health care resources. Third, with the prevention of illness, fewer physicians will be absent because of illness, potentially increasing the number of health care personnel available during an infectious outbreak 63. Fourth, obstetrician–gynecologists, like all health care workers, make autonomous decisions when they choose their profession. In doing so, they accept the obligation to protect patients, and this includes following vaccination guidelines 64. Finally, vaccination among health care professionals sends an important message to their patients about the benefits of vaccination, which, in turn, may increase their patients’ willingness to be vaccinated.

Despite the evidence pointing to the benefit of vaccination, adherence with voluntary vaccination programs for health care professionals has been suboptimal 65. Some of the leading reasons cited for nonadherence are perception of low risk of contracting the infectious agent, diminished perception of the potential severity of an infectious outbreak, fear of adverse events from vaccination, and lack of time and opportunity for vaccination 66.

Consideration of mandatory vaccination has emerged in response to poor adherence rates among physicians. Evidence shows that the rate of influenza vaccination among health care professionals is about twice as high when required for employment, versus those settings where vaccinations are not mandated or not readily available 65. Mandatory vaccination of health care professionals may be an ethically justified strategy in cases in which the risk of harm to patients and the general population is believed to outweigh the autonomy interests of individual physicians 67 68 69. Mandates should be put in place, however, only if supported by valid data about the efficacy and safety of the vaccine. In addition, public health plans that include mandatory vaccination will be most beneficial if they are developed in cooperation with key stakeholders and consider the needs of individual practitioners, institutions, and communities. Any such vaccine mandates for health care professionals should include recognized exceptions for medical contraindications, but nonmedical vaccination exemptions should not be permitted. Given that ACOG, along with many other medical organizations, opposes nonmedical vaccination exemptions for patients, a similar policy should apply to health care professionals, particularly given their duty to protect patients as well as the public at large 35 36 67.