COVID-19 Vaccines and Pregnancy – Sarah Carroll (ACOG)
Sarah Carroll, Director of Immunization, Infectious Disease, & Public Health Preparedness at ACOG, presented an informative overview on the risk of severe outcomes from COVID-19 disease and current vaccination recommendations during pregnancy. Available data suggest that pregnant women with symptomatic COVID-19 disease are at increased risk of more severe illness than their non-pregnant peers. Although the risk for severe COVID is low, data indicate an increased risk of ICU admission, need for mechanical ventilation, and death. This has led CDC to include pregnancy as a factor leading to increased risk for severe COVID-19 illness.
The Advisory Committee on Immunization Practices (ACIP)’s clinical considerations for COVID-19 vaccination, including vaccination of pregnant and lactating individuals, has been posted on CDC’s Interim Clinical Considerations for Use of mRNA Vaccines webpage. This information notes that a pregnant person who is part of a group recommended to receive COVID-19 vaccine may choose to be vaccinated. However, ACOG and the CDC both state that a discussion with a healthcare professional could help in making an informed decision, but this should not be required prior to vaccination.
(The following information is on the CDC website, but was not discussed during the call. CDC also notes that there are few data on the safety of COVID-19 vaccines in pregnant and lactating individuals and provides some considerations for patients about COVID-19 vaccination, such as the level of COVID-19 community transmission; the patient’s personal risk of contracting COVID-19; the risks of COVID-19 to the patient and potential risks to the fetus; the efficacy of the vaccine; the side effects of the vaccine; and the lack of data about the vaccine during pregnancy.)
The Emergency Use Authorizations (EUA) for the Pfizer-BioNTech and Moderna mRNA vaccines indicate the data on vaccination of pregnant women is insufficient and that individuals should talk with their provider. Neither vaccine has been explicitly tested in pregnant women. However, based on the mechanism of action and safety and efficacy profile of the vaccines, it is expected that the safety profile would be the same as for non-pregnant individuals. Importantly, data from the Developmental and Reproductive Toxicity (DART) animal studies for the Pfizer-BioNTech vaccine do not indicate direct or indirect harmful effects regarding pregnancy, embryo/fetal development, parturition, or post-natal development.
ACOG has established several COVID-19 expert work groups to provide clinical guidance for members, including a COVID-19 work group focused specifically on obstetric topics. These work groups develop clinical recommendations on COVID-19 illness and vaccines based on the data and recommendations from CDC, NIH, the Vaccines and Related Biological Products Committee (VRBPAC), and ACIP.
ACOG recommends that COVID-19 vaccines should not be withheld from pregnant or lactating individuals who meet criteria for vaccination based on ACIP recommended priority groups, and these women should be free to make their own decision regarding vaccination. Pregnant individuals are encouraged to discuss this decision with their healthcare team, but neither a discussion nor documentation of a discussion are required prior to vaccination.
ACOG guidance also states that vaccination of pregnant women can occur in any setting, including at mass vaccination sites. Pregnant women who experience fever following vaccination should be counseled to take acetaminophen. There is no preference for one mRNA vaccine over the other, other than that only the Pfizer vaccine is authorized for use in persons 16–17 years of age. In addition, ACOG notes that all persons, including pregnant individuals, should complete their 2-dose series with the same vaccine product. Because COVID-19 vaccine should not be administered within 14 days of another vaccine, Tdap and influenza vaccines should be deferred for 14 days after administration of COVID-19 vaccines. However, anti-D immunoglobulin (i.e., Rhogam) should not be withheld from an individual who is planning to receive or has recently received a COVID-19 vaccine, as this will not interfere with the immune response to the vaccine.
ACOG recommends that COVID-19 vaccines be offered to lactating individuals based on their prioritization group as outlined by ACIP. There is no need to avoid initiation or discontinue breastfeeding in patients who receive a COVID-19 vaccine.
ACOG also recommends vaccination of individuals who are actively trying to become pregnant or who are contemplating pregnancy. Based on their mechanism of action and safety profile, COVID-19 mRNA vaccines are not thought to cause an increased risk of infertility. It is not necessary to delay pregnancy after completing both doses of the COVID-19 vaccine, and pregnancy testing should not be a requirement prior to receipt of the vaccine.
Recent recommendations from the World Health Organization (WHO) have caused some level of confusion over COVID-19 vaccine use in pregnant individuals. Initially, WHO explicitly stated that these vaccines should not be given to pregnant individuals unless they were at high risk of exposure, such as healthcare workers. However, these recommendations do not align with those of CDC, ACOG, or other obstetric medical societies in the United States, United Kingdom, and Canada. Recognizing that the WHO recommendations would create confusion among clinicians and the public, ACOG and the Society for Maternal-Fetal Medicine issued (SMFM) a joint statement affirming their recommendations that COVID-19 vaccines should be available to all pregnant individuals who are eligible and choose to be vaccinated. Shortly after this statement was released, WHO revised its recommendation to be slightly more permissive by including women who have comorbidities which add to their risk of severe disease. U.S. medical providers are encouraged to follow the ACOG and CDC guidance.
ACOG has just added/updated a wealth of helpful resources on COVID-19 and pregnancy to its webpages. These are highlighted below and are excerpted on a handy one-page document.
ACOG Practice Advisory: Vaccinating Pregnant and Lactating Patients Against COVID-19
Comprehensive clinical guidance for ACOG members
COVID-19 Vaccines and Pregnancy: Conversation Guide for Clinicians
2-page reference guide for clinicians highlighting the main risk/benefit conversation points from the ACOG Practice Advisory on Vaccinating Pregnant and Lactating Patients Against COVID-19
ACOG and SMFM Joint Statement on WHO Recommendations Regarding COVID-19 Vaccines and Pregnant Individuals
Statement from ACOG and the Society for Maternal-Fetal Medicine (SMFM) affirming recommendations that COVID-19 vaccines should be available to all pregnant individuals who are eligible and choose to be vaccinated
Vaccinating Pregnant Individuals: Eight Key Recommendations for COVID-19 Vaccination Sites
New resource providing an overview of key recommendations from ACOG for all variations of COVID-19 vaccination sites
Maternal Immunization Task Force and Partners Urge that COVID-19 Vaccine Be Available to Pregnant Individuals
Joint statement from ACOG and 17 partner organizations on COVID-19 vaccine access, advocating for pregnant individuals to make their own decision regarding their health, in conjunction with their clinical care team when appropriate.
Coronavirus (COVID-19), Pregnancy and Breastfeeding: A Message for Patients
COVID-19 patient education resources and FAQs
Coding for COVID-19 Immunizations
New practice management resource outlining coding specifics for COVID-19 vaccines
At the close of the meeting, Summit partners asked whether ACOG would support peer-to-peer education to help OB/GYNs deal with patient concerns about COVID vaccine causing infertility. A recent MMWR indicated just under 40% of long-term care facility staff reported being hesitant to receive COVID-19 vaccine, largely due to safety concerns. AGOG plans to partner with the Infectious Diseases Society of America (IDSA) to provide this type of outreach. Education efforts also are underway with the American Medical Association and American Dental Association, as many dental offices employ women of reproductive age.