Q&A: COVID-19 vaccination ‘appears to be safe’ for pregnant women
According to the CDC, more than 9,300 women with COVID-19 have 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.
In a recent editorial published in JAMA, Emily H. Adhikari, MD, and Catherine Y. Spong, MD, both of the University of Texas Southwestern Medical Center in Dallas, 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 [messenger RNA (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.”
Healio spoke with Adhikari about vaccinating pregnant women against COVID-19.
Q: Is it safe for pregnant women to get vaccinated against COVID-19?
A: 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.
Importantly, context is important. Choosing not to get 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. 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. The best way to prevent COVID-19 infection is by vaccination.
Q: What does the CDC say, and what does WHO say?
A: The CDC acknowledges that limited data are available so far, including animal developmental and reproductive toxicity (DART) studies. From these data, no safety concerns were demonstrated. They say that pregnant persons may choose to get vaccinated if they are in a prioritized group, and that pregnant people with COVID-19 have an increased risk of severe illness.
Q: What was the recent WHO revision?
A: The WHO statement published on Jan. 26 explicitly recommended against vaccinating pregnant women with the Moderna mRNA vaccine. This statement was not based on new data or published information. WHO then revised its statement on Jan. 29 with more permissive language. WHO now says that although data are limited, that based on what we know about this kind of vaccine, we don’t have any specific reason to believe there will be specific risks that would outweigh the benefits of vaccination for pregnant women.
Q: Are vaccine manufacturers testing COVID-19 vaccines in pregnant women?
A: Manufacturers did some preliminary animal DART studies, and there are additional registry studies planned. They invite pregnant women who are vaccinated to enroll in their vaccine-specific registry studies. Additionally, vaccinated pregnant women can be followed through the CDC’s V-safe smartphone app that is collecting data after vaccination. As time passes, it becomes less likely that a placebo-controlled vaccine trial will happen for pregnant patients, but observational data from local institutions (including ours) who follow vaccinated pregnant women over time will be published.
Q: Even before including pregnant women in trials, are there data indicating that the vaccines should be considered safe for administration to pregnant women?
A: Vaccination during pregnancy is common to prevent maternal and infant morbidity from other infectious diseases. Influenza immunization in pregnancy reduces maternal influenza-like illness by 19%, low birth weight by 15% and infant influenza by 30%. Pregnant women who received the pertussis (Tdap) vaccine in the third trimester compared with postpartum vaccination reduced infant pertussis by 85%.
These mRNA vaccine platforms may be new to COVID-19, but they are not completely new. Similar mRNA vaccines have been used in clinical trials targeting other infections such as Zika virus, as well as several types of cancer. These mRNA vaccines stimulate an immune response but are not infectious, and you can’t get COVID-19 from these vaccines. They don’t integrate into or mutate DNA.
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.
Q: Is one vaccine or vaccine technology better than another when it comes to pregnant women?
A: There are no data to suggest one type of vaccine is better than another, and because pregnant women were excluded from the initial clinical trials, we do not distinguish between the two in terms of safety. Both vaccines (Pfizer and Moderna) use the mRNA vaccine platform, and both vaccines appear to be very protective against COVID-19 illness after two doses are received.
Reference:
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.
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