OBGYN experts say the COVID-19 vaccine should be made available to pregnant women who are at higher risk of complications when infected with the virus.
Will pregnant women be able to be vaccinated with the new COVID-19 vaccines? A panel of experts in maternal-fetal medicine recently made the case that they should at least have the option.
Without explicit data on safety in pregnant women, the Food and Drug Administration (FDA) typically recommends caution in using a drug or therapy in pregnant women. In the case of the COVID-19 vaccine trials, pregnant women were excluded from participating. The trials did show, however, that the vaccines have good safety profiles across multiple demographics around the world. Moreover, the type of vaccines studied the most so far, i.e., mRNA vaccines from Pfizer and Moderna, should be safe in pregnancy given their biology and mode of action.
In the case of COVID-19, the known risks of infection with during pregnancy outweigh the unlikely risks of vaccination. In recent studies, pregnant women sick with COVID-19 were at higher risk for needing a ventilator and for death, than women with COVID-19 who were not pregnant. Experts in maternal fetal medicine published their recommendations for vaccination online on December 7th in the American Journal of Obstetrics & Gynecology – Maternal-Fetal Medicine (AJOG MFM).
Dr. Vincenzo Berghella, the Editor-in-Chief of AJOG MFM, and the chair of Maternal-Fetal Medicine at Jefferson, agrees and argues that pregnant women should be allowed to assess their risk of exposure to the virus, and make the decision together with their providers.
We speak to Dr. Berghella here about the paper and the case experts are making.
Should pregnant women get the COVID-19 vaccine?
COVID-19 vaccines can be life-saving. Pregnant women and their fetuses are at increased risk from severe COVID-19-infection complications. The paper, and many physicians like myself strongly argue that COVID-19 vaccines should not be withheld solely on the basis of pregnancy/lactation alone for those who are eligible for and desire the vaccination. However, we are not sure how the FDA will decide tomorrow (Dec. 10, 2020) on this issue. We have made the FDA aware of our recommendation.
Patient counseling should balance available data on vaccine safety, risks to pregnant patients from SARS-CoV-2 infection, and the patient’s individual risk for severe COVID-19 disease. Some vaccines such as mRNA vaccines may be more suitable for pregnant women than vaccines containing infectious virus (e.g., adenoviral vector vaccines).
Is there research that recommends not vaccinating pregnant women?
There is no proven harm of these vaccines to pregnant women. Unfortunately the UK has so far recommended against vaccinating pregnant women, just based on theoretical, but not proven risks. We hope the FDA does not follow the same path.
How do you think this paper could change practice or policy about vaccination?
Pregnant women should be one of the first groups to which COVID-19 vaccines are made available. In the U.S., healthcare workers are in the top tiers of people recommended to receive COVID-19 vaccine by the CDC. We recommended that pregnant healthcare workers, of which it’s estimated there are thousands now in the U.S., be allowed to get the COVID-19 vaccine together with their co-workers, as soon as the vaccine is available.
What are the barriers to pregnant women receiving the COVID-19 vaccine?
There should be no barriers to pregnant women receiving the COVID-19 vaccine. In fact, pregnant women already routinely receive many vaccines, such as the flu vaccine, the TDap vaccine, the hepatitis B vaccine and others.
Can this paper be called a consensus among OBGYN providers?
The overall consensus among obstetrical providers is that it would be unethical to withhold the COVID-19 vaccine from pregnant women. Recently, the Society for Maternal-Fetal Medicine (SMFM) in the U.S. has also recommended that pregnancy or breastfeeding should not be reasons to withhold the COVID-19 vaccine from women.
How will this inform how you discuss vaccination with the pregnant women you care for?
We will be recommending COVID-19 mRNA vaccines to pregnant women who desire them. We are already recommending the COVID-19 vaccine to women, including our pregnant health care workers, as well as our patients. We want to keep moms and their babies safe and healthy.