The American College of Obstetricians and Gynecologists (ACOG) recently released updated recommendations for the use of COVID-19 vaccines in obstetric-gynecologic care. The full report was published on their website.
The draft was prepared by the ACOG Immunization, Infectious Disease, and Public Health Preparedness Expert Work Group in collaboration with Laura E. Riley, MD; Richard Beigi, MD; Denise J. Jamieson, MD, MPH; Brenna L. Hughes, MD, MSc; Geeta Swamy, MD; Linda O’Neal Eckert, MD; Mark Turrentine, MD; and Sarah Carroll, MPH.
Overall, the ACOG recommends that all eligible persons, including pregnant and lactating individuals, receive a COVID-19 vaccine. Health care providers, especially obstetricians-gynecologists and other women’s health practitioners, encourage patients to be vaccinated and should lead by example by being vaccinated against COVID-19.
Efficacy of COVID-19 Vaccines
The Pfizer-BioNTech and Moderna COVID-19 vaccines were found 95% and 94.1% effective, respectively, at preventing laboratory-confirmed COVID-19 in persons who had no evidence of prevention infection after they received 2 doses.
In a prospective cohort study, pregnant and lactating women who received the Pfizer-BioNTech and Moderna vaccines produced similar immune responses as nonpregnant control individuals and higher antibody titers than those who had contracted COVID-19 during pregnancy. Antibodies from the COVID-19 vaccines were also found in umbilical cord blood and breastmilk.
The single-dose of the Janssen COVID-19 vaccine was 66.9% effective at preventing moderate/severe COVID-19; 76.7% effective at preventing severe/critical COVID-19; and 93.1% effective at preventing hospitalization 14 days after vaccination.
Safety of COVID-19 Vaccines
Health care providers should explain to their patients the expected side effects of vaccination and counseled that they may be a normal part of the body’s reaction to the vaccine and the development of antibodies against COVID-19. Providers should also counsel patients about the more severe side effects of vaccination and when medical care is necessary.
Most patients who received the Pfizer-BioNTech and Moderna vaccines experienced mild, influenza-like symptoms, most of which resolved by day 3 post-vaccination.
Side effects for the Janssen COVID-19 vaccine were also generally mild and resolved by day 2 post-vaccination.
All vaccine recipients and their caregivers should receive the respective Emergency Use Authorization (EUA) fact sheet prior to vaccination.
The Vaccine Adverse Event Reporting System found that anaphylaxis occurred in 50 cases of the 10 million administered doses of the Pfizer-BioNTech vaccine and 28 cases of 7.5 million administered doses of the Moderna vaccine. Anaphylaxis rates have not yet been reported for the Janssen COVID-19 vaccine.
Pregnant persons should receive the same care for anaphylaxis as nonpregnant persons: rapidly assess airway breathing, circulation, and mental activity; call for emergency medical services; place the patient in a supine position; and administer epinephrine. Following anaphylaxis, patients should be monitored for several hours for recurrence of anaphylaxis.
Thrombosis with thrombocytopenia symptom (TTS) has occurred in women of reproductive age (18-49 years) in approximately 8.9 cases per 1 million doses of the Janssen COVID-19 vaccine. Patients should be informed of the rare risk for TTS and TTS symptoms after the Janssen COVID-19 vaccine, and if they choose not to receive the vaccine, they should be strongly encouraged to receive another COVID-19 vaccine. The risk for thrombosis increases during pregnancy, the postpartum period, and with the use of certain hormonal contraceptives, but there is no recommendation for women who use hormonal contraception to change their method after receiving the Janssen COVID-19 vaccine.
Patients who take aspirin or anticoagulants may not need to stop or change the dose of their medications before receiving the Janssen COVID-19 vaccine. Patients who experience TTS symptoms, which most commonly appear 6 to 14 days after vaccination, should seek immediate medical evaluation. The American Society for Hematology has issued guidance on the diagnosis and treatment of TTS, which includes avoiding aspirin.
Investigations into the diagnosis of Guillain-Barré syndrome following the use of the Janssen COVID-19 vaccine are ongoing; however, it appears that the absolute risk following vaccination may be very low. The benefits of prevention of severe COVID-19 outweigh the risks.
General Recommendations and Considerations
- Eligible persons should receive a 2-dose series of the Pfizer-BioNTech or Moderna COVID-19 vaccine or a single-dose Janssen COVID-19 vaccine.
- Individuals may receive the COVID-19 vaccine simultaneously with other vaccines, including those routinely administered during pregnancy (eg, influenza), and within 14 days of receipt of another vaccine.
- Health care providers should discuss precautions with any patients who have a history of immediate allergic reactions to others vaccines or injectable therapy.
- Those administering COVID-19 vaccines should adhere to guidance provided by the CDC and should screen patients for contraindications and precautions, have supplies prepared to manage anaphylaxis, implement postvaccination observation periods, and immediately treat suspected cases of anaphylaxis with intramuscular injection of epinephrine.
- Health care providers should educate patients who receive vaccines about the CDC’s V-safe program and encourage them to participate.
- Obstetrician-gynecologists are encouraged to document patients’ COVID-19 vaccination status in medical records.
Obstetric Care Recommendations and Considerations
Studies have suggested that symptomatic pregnant and recently pregnant patients with COVID-19 are at an increased risk for more severe illness than nonpregnant individuals, indicating that pregnant persons have an increased risk for intensive care unit (ICU) admission, need for mechanical ventilation and ventilator support, and death. Patients with comorbidities may be a higher risk of severe illness.
- Pregnant individuals should be vaccinated against COVID-19. Any of the currently authorized vaccines can be administered to pregnant, recently pregnant, or lactating patients.
- There is no need for a patient to avoid or discontinue breastfeeding after receiving a COVID-19 vaccine.
- Pregnant, lactating, and recently pregnant people aged less than 50 years should be aware of the rare risk for TTS following the Janssen COVID-19 vaccine.
- Health care providers should routinely assess their patients’ vaccination status and recommend vaccines accordingly.
- There is no evidence of adverse maternal or fetal effects from the COVID-19 vaccine, and data demonstrate safety.
- Pregnant individuals can be encouraged to discuss vaccine considerations with their clinical care team when feasible, but a discussion should not be required prior to receiving a COVID-19 vaccine.
- Patients should have access to information regarding the safety and efficacy of the vaccines, and health care providers should review with patients the data on risks and benefits of vaccination and not getting vaccinated, considering the patient’s current health and risk of exposing high-risk household members.
- Conversations regarding risk should be respectful and supportive of patients’ autonomous decision-making.
- Vaccination of pregnant individuals with a COVID-19 vaccine may occur in any site authorized to administer the vaccines.
- Pregnant individuals who experience fever after the vaccine should take acetaminophen, which has been proven to be safe for use in pregnancy and does not appear to impact antibody response to the vaccines.
- Anti-D immunoglobulin should not be withheld from an individual who is planning to or has recently received a COVID-19 vaccine as it will not interfere with the immune response to the vaccine.
- A discussion with a patient who has not received the vaccine should be documented in the medical records. Obstetrician-gynecologists should address ongoing questions and concerns and offer vaccination again during subsequent office visits. The importance of handwashing, physical distancing, and wearing a mask should also be reinforced.
Gynecologic Care Recommendations and Considerations
- The ACOG recommends vaccination for individuals who are considering or actively trying to become pregnant. It is not necessary to delay pregnancy after completing both doses of the COVID-19 vaccine.
- There is no scientific evidence to support claims linking COVID-19 vaccines to infertility.
- If an individual becomes pregnant after the first dose of a two-dose COVID-19 vaccine, the second dose should be administered as indicated.
- Routine pregnancy testing is not recommended and is not required prior to receiving a COVID-19 vaccine.
“Given the mechanism of action and the safety profile of the mRNA vaccines in non-pregnant individuals, COVID-19 mRNA vaccines are not a cause of infertility,” the ACOG noted. “Adenovirus vector vaccines such as the Janssen COVID-19 vaccine cannot replicant following administration, and available data demonstrate that it is cleared from tissues following injection. Because it does not replicate in the cells, the vaccine cannot cause infection or alter the DNA of a vaccine recipient and is also not a cause of infertility. Therefore, ACOG recommends vaccination for all eligible people who may consider future pregnancy.”
A Radiology Expert Scientific Panel recommends mammograms be conducted prior to COVID-19 vaccination or postponed for 4 to 6 weeks after the second vaccine dose to avoid uncertainty in interpreting mammogram results.
- Postponing screening mammograms should only be considered if that will not unduly delay care.
- Patients who receive a mammogram fewer than 4 to 6 weeks after COVID-19 vaccination should inform the mammogram technologist or radiologist as to which vaccine they received and where they received it.
- The ACOG is monitoring reports and gathering data on temporary changes in menstruation patterns in individuals who recently received COVID-19 vaccines.
- Vaccines can be given to patients who are currently menstruating.
Health Equity Considerations and Communities of Color
In discussing COVID-19 vaccines with a patient who expresses concerns, it is critical that health care providers:
- Be aware of injustices on communities of color.
- Actively listen to and validate the patient’s concerns.
- Be aware of existing venues for vaccine access in traditionally underserved communities.
- Support patients who decide not to be vaccinated, share resources with them, and encourage them to continue to engage in prevention measures.
- If the patient is amenable to further discussion:
- Inform the patient about the testing process, existing safety data, and continued monitoring of safety and efficacy data on COVID-19 vaccines.
- Discuss the increased incidence of infection and severe illness from COVID-19 in communities of color.
- Note that individuals from communities of color were included in clinical trials (9.8% of Pfizer-BioNTech overall Phase 2/3 participants were Black and 26.2% were Hispanic/Latinx; 9.7% of Moderna overall Phase 2/3 participants were Black and 20% were Hispanic/Latinx; 13% of Janssen overall Phase 2/3 participants were Black and 14.7% were Hispanic/Latinx) and that the vaccine was equally effective among different demographics.
“Vaccine hesitancy, particularly around COVID-19 vaccines, exists among all populations,” the authors of the report said. “When communicating with patients it is extremely important to underscore the general safety of vaccines and emphasize the fact that no steps were skipped in the development and evaluation of COVID-19 vaccines. This can be done by briefly highlighting the safety requirements of vaccines, and ongoing safety monitoring even after vaccines are made available.”
In the guidance, ACOG also provided several messaging approaches for healthcare providers to consider in discussing COVID-19 vaccines with patients.
American College of Obstetricians and Gynecologists. COVID-19 vaccination considerations for obstetric–gynecologic care. Published December 2020. Updated July 30, 2021. Accessed August 12, 2021. https://www.acog.org/clinical/clinical-guidance/practice-advisory/articles/2020/12/covid-19-vaccination-considerations-for-obstetric-gynecologic-care