COVID-19 Vaccines and Pregnancy: ACOG Task Force Develops Evolving Practice Advisory for Clinicians

COVID-19 continues to wage its deadly assault on populations around the globe. As of the time of this writing, case counts and mortalities in the United States continue to set daily new records and push the nation's health care infrastructure to its limits. According to preliminary research, new strains of the virus have emerged that are more easily transmitted from person to person while not appearing to be more lethal.

However, the first two vaccines (Moderna mRNA-1273 and Pfizer-BioNtech mRNA vaccine BNT162b2) against the SARS-CoV-2 virus that causes COVID-19 illness have  been approved by the U.S. Food and Drug Administration (FDA) under emergency use authorization. Additional vaccine candidates from numerous pharmaceutical entities and academic medical centers continue their journeys through the research, development, and clinical trials.

“We will eventually contain, suppress, and with hope aim to eradicate this disease from our daily existence,” says Richard H. Beigi, MD, MSc, president of UPMC Magee-Womens Hospital. The approved vaccines are enormous steps in this process, achieved with unprecedented speed. We also must continue to reinforce the basic measures all individuals must take to help limit spread – masks, hand hygiene, physical distancing, and not congregating in groups."

With the approval of the first two vaccines for use, The American College of Obstetricians and Gynecologists (ACOG) released in December 2020 an important Practice Advisory¹ with guidelines and information for clinicians for the use of the vaccines in women who are pregnant or lactating, or those women considering becoming pregnant. ACOG's Immunization, Infectious Disease, and Public Health Preparedness Expert Work Group developed the guidance in collaboration with a number of clinicians. Dr. Beigi is a long-time member of the ACOG Work Group and is a part of the team that developed the Practice Advisory and its ongoing evolution.

“While pregnant and lactating women were not specifically included in the initial clinical trials of the two approved vaccines (ACOG has been a vocal advocate for including these patient groups in clinical trials), all of the evidence to date from the various preclinical studies and the large-scale clinical safety and efficacy trials leading to the vaccine’s approvals appears to show they are safe and effective for use by women who are pregnant or lactating, or those considering pregnancy,” says Dr. Beigi. “Pregnant and lactating women are planned for inclusion in follow-up trials, however.”

Pregnancy is not a risk factor for contracting the disease. However, pregnancy has been deemed a high-risk factor by the Centers for Disease Control and Prevention (CDC) for potentially more severe manifestations of COVID-19. Pregnant women with specific comorbidities also are at increased risk for a more severe disease course if they contract the virus and develop symptomatic disease.

"We know there is a great deal of hesitancy and concern by individuals of all groups about receiving the vaccinations. Clinicians should be well versed in the data and information about the vaccines to answer their patients' questions and provide counsel when asked. ACOG's position is that all individuals, unless they have a specific contraindication, should receive the vaccine according to the prioritization schedule set by ACIP and when it is feasible given their geographic location or individual situation. We understand and value that it is a patient's choice to receive the vaccine, and we support this approach. Regardless of their decision, pregnant or lactating women should be supported, cared for, and counseled on best practices to mitigate the spread of the disease or contracting it in the first place," says Dr. Beigi.

Highlights and Points of Reinforcement From the Practice Advisory

Assuming individuals meet all of the criteria for the COVID-19 vaccines and do not have health issues or contraindications that would preclude them from receiving the vaccines, COVID-19 vaccinations should not be withheld from women who are pregnant or lactating.

Additionally, ACOG's position is that pregnant and lactating women should not be required to consult with or have a conversation with their physician prior to receiving the vaccine. However, for some individuals, it may be beneficial. Again, clinicians should be armed with the facts and data to answer their patients’ questions.

Clinicians should be transparent with patients who inquire whether the vaccines have been specifically tested in pregnant and lactating women.

“We also do not recommend that individuals who believe they may be pregnant need to receive a confirmatory pregnancy test prior to getting vaccinated,” says Dr. Beigi.

With respect to side effects from the vaccinations, pregnant women who develop a fever should be counseled by their physician to take acetaminophen to control the fever, given the known potential risks of persistent fever during pregnancy. Data accumulated so far shows no apparent effects of acetaminophen use on the efficacy of the vaccine.

Keeping Pace With the Changes

As the clinical and research evidence base evolves, so will the ACOG Practice Advisory on COVID-19 vaccinations.

"The guidelines and recommendations are a living document on the ACOG website. As we learn more and the task force discusses new findings and recommendations, the Practice Advisory will be updated to keep pace with the rapidly evolving pandemic. I encourage my clinical colleagues across the United States and beyond to regularly visit the site to keep abreast of the latest news and recommendations and get in touch with the group or individual members should they desire to open a more direct dialogue. We welcome discussions with our colleagues around the nation about the very challenging situation we are all navigating together,” says Dr. Beigi.

Reference

Below is a link to the ACOG Practice Advisory. Additional information and resource links for physicians are included toward the end of the document.

Vaccinating Pregnant and Lactating Patients Against COVID-19. Practice Advisory from The American College of Obstetricians and Gynecologists. First published December, 2020.  The Practice Advisory was developed by the American College of Obstetricians and Gynecologists’ 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; Cynthia Gyamfi-Bannerman, MD, MSc; Mark Turrentine, MD; and Sarah Carroll, MPH.

More About Dr. Beigi

Richard H. Beigi, MD, MSc, is president of UPMC Magee-Womens Hospital and professor of Reproductive Sciences in the Department of Obstetrics, Gynecology, and Reproductive Sciences at the University of Pittsburgh School of Medicine. Dr. Beigi leads numerous investigations that study immunizations and therapeutics in pregnant and lactating women, a predominantly understudied patient population. He also investigates the impact of emerging infectious diseases in women, particularly pregnant women. Dr. was appointed president of UPMC Magee in January 2019 and is the first physician to lead a UPMC Hospital.