COVID-19 vaccination ‘appears to be safe’ for pregnant women
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According to the CDC, as of Feb. 18, more than 11,700 women with COVID-19 completed pregnancies in the United States.
Research has shown that pregnancy increases the risk for severe COVID-19 illness, and that COVID-19 is linked to ICU admission during pregnancy and preterm birth.
A WHO statement published on Jan. 26 recommended against vaccinating pregnant women with the Moderna messenger RNA (mRNA) COVID-19 vaccine — a decision that was “not based on new data or published information,” Emily H. Adhikari, MD, an assistant professor of obstetrics and gynecology at the University of Texas Southwestern Medical Center in Dallas, told Infectious Disease News. It contradicted with CDC advice that says women “may choose to be vaccinated” against COVID-19 if they are part of a group recommended for vaccination.
WHO revised its statement 3 days later with more permissive language saying that, although data are limited, there is no reason to believe the risks of COVID-19 vaccination outweigh the benefits for pregnant women, according to Adhikari.
“From our experience over the past few months, it appears to be safe for pregnant women to be vaccinated against COVID-19, but we need published, peer-reviewed data to confirm this,” she said.
‘Be prepared to dispel myths’
William Hartman, MD, PhD, a principal investigator for AstraZeneca’s COVID-19 vaccine trial at the University of Wisconsin’s Madison campus and an assistant professor of anesthesiology at the school, said the lack of “established safety or effectiveness data” for pregnant women should not deter health care professionals from offering them COVID-19 vaccines.
“Various vaccines have been safely administered to pregnant women without issues for decades,” he told Infectious Disease News. “Further, the COVID-19 vaccines have proven to be safe and effective in nonpregnant individuals and the mRNA does not enter cell nuclei, so altering the individual’s genome does not occur.”
In an editorial published in JAMA, Adhikari and colleague Catherine Y. Spong, MD, a professor and vice chair in the department of obstetrics and gynecology at UT Southwestern Medical Center, wrote that “physicians can empower women to make an informed decision” about getting vaccinated against COVID-19.
“With an understanding of the important practice of vaccination in pregnancy, the use of other vaccines during pregnancy, the efficacy and safety of COVID-19 mRNA vaccines in nonpregnant populations and their mechanism of inducing an immune response, clinicians can outline the benefit of prevention of COVID-19 illness, as well as the undefined but possibly limited risk to the fetus, and potential benefit to the neonate,” they wrote.
“As part of the discussion,” they continued, “clinicians should acknowledge with empathy the limited available evidence, as well as the tension over the potential benefits of vaccination weighed against the potential risks — whether real or theoretical — and be prepared to dispel myths.”
Adhikari said providing context is important — for instance, choosing not to receive the vaccine “has implications when the virus is spreading quickly, and variant strains are emerging.”
“COVID-19 causes significant illness requiring hospitalization in 5% to 6% of all SARS-CoV-2-infected pregnant women. Pregnant women with severe or critical COVID-19 illness are at increased risk for preterm birth and pregnancy loss. This risk comes primarily from illness in the mother, rather than a direct effect on the fetus,” Adhikari said.
“Pregnant women may also be at higher risk for severe illness and death from COVID-19 than nonpregnant women of similar age — so preventing infection is important for both mother and fetus,” she added.
COVID-19 vaccine data for pregnant women will be available eventually. Pfizer and BioNTech, makers of the first COVID-19 vaccine authorized in the U.S., announced in February the start of a global phase 2/3 trial testing the safety, tolerability and immunogenicity of its mRNA vaccine in pregnant women.
‘No red flags’
Adhikari also noted that pregnant women are commonly vaccinated to prevent maternal and infant morbidity from infectious diseases other than COVID-19.
“Influenza immunization in pregnancy reduces maternal influenza-like illness by 19%, low birth weight by 15% and infant influenza by 30%,” she said. “Pregnant women who received the pertussis (Tdap) vaccine in the third trimester compared with postpartum vaccination reduced infant pertussis by 85%.”
Moreover, Adhikari said mRNA platforms like the ones used in the first two vaccines authorized for use in the U.S. also have been used in clinical trials for other infections, including Zika virus, and for several types of cancer.
“Since the emergency use authorization was given for the two vaccines made by Pfizer and Moderna, more than 10,000 pregnant women in the U.S. have been vaccinated, and thus far, there have been no red flags, which is reassuring,” she said.
In addition to the CDC, the American College of Obstetricians and Gynecologists (ACOG) said that pregnant patients who are in a prioritized group should be offered a COVID-19 vaccine. The recommendation was made after the FDA issued EUAs for the Pfizer-BioNTech and Moderna mRNA vaccines, but before the authorization of Johnson & Johnson’s one-shot adenovirus-based vaccine.
Kurt R. Wharton, MD, FACOG, vice chair of obstetric operations and medical director of the Family Birth Center at Beaumont Hospitals in Royal Oak, Michigan and a professor of obstetrics and gynecology at Oakland University in Rochester, Michigan, agreed that COVID-19 vaccines can be safely administered in pregnant women.
“It is absolutely safe for the majority of women to receive a vaccine if they are pregnant, breastfeeding or considering becoming pregnant in the immediate future as the majority of these women meet the criteria established by the Advisory Committee on Immunization Practices,” he told Infectious Disease News.
Similar to the advice given by Adhikari and Spong, ACOG encouraged pregnant patients and their health care teams to have discussions regarding COVID-19 vaccination that cover topics such as the level of activity of the virus in the community, the potential efficacy and safety of the vaccine, and the risk for and potential severity of maternal disease, including the adverse events that COVID-19 could have on the fetus and newborn.
Mary Jane Minkin, MD, a clinical professor of obstetrics and gynecology at the Yale School of Medicine, acknowledged these conversations could be “difficult.”
“A physician would feel awful if a person got really sick from COVID,” she told Infectious Disease News. “Pregnant women who refuse the vaccine should be supported in their decision, as there isn’t a right or a wrong answer since there is really not a lot of literature on the topic available.”
- References:
- ACOG. Vaccinating pregnant and lactating patients against COVID-19. https://www.acog.org/clinical/clinical-guidance/practice-advisory/articles/2020/12/vaccinating-pregnant-and-lactating-patients-against-covid-19. Accessed December 29, 2020.
- Adhikari EH, et al. JAMA. 2021;doi:10.1001/jama.2021.1658.
- CDC. Data on COVID-19 during pregnancy: Birth and infant outcomes. https://www.cdc.gov/coronavirus/2019-ncov/cases-updates/special-populations/birth-data-on-covid-19.html. Accessed February 10, 2021.
- Pfizer. Pfizer and BioNTech commence global clinical trial to evaluate COVID-19 vaccine in pregnant women. https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-commence-global-clinical-trial-evaluate. Accessed March 1, 2021.
- WHO. The Moderna COVID-19 (mRNA-1273) vaccine: What you need to know. https://www.who.int/news-room/feature-stories/detail/the-moderna-covid-19-mrna-1273-vaccine-what-you-need-to-know. Accessed March 1, 2021.
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