Dec. 18, 2020 -- Pregnant women or nursing moms who want the COVID-19 vaccine should get one, experts say.
That’s true even though there’s a lack of safety data in these groups, according to guidance from the CDC, the American College of Obstetricians and Gynecologists (ACOG), and the Society for Maternal-Fetal Medicine.
Pregnant women who opt not to receive the vaccine should be supported in that decision as well, a practice advisory from ACOG recommends.
In addition, women do not need to avoid getting pregnant after receiving Pfizer’s COVID-19 vaccine, according to the CDC. The FDA issued an emergency use authorization (EUA) for the vaccine on Dec. 11.
Although investigators excluded pregnant women from vaccine clinical trials, experts believe that mRNA vaccines, which are not live vaccines, "are unlikely to pose a risk for people who are pregnant" and "are not thought to be a risk to the breastfeeding infant," the CDC notes.
At the same time, women who are pregnant may be at greater risk of severe COVID-19, even though the absolute risk of severe illness is low. COVID-19 also may increase the risk of serious pregnancy outcomes, such as preterm birth.
"If pregnant people are part of a group that is recommended to receive a COVID-19 vaccine (eg, healthcare personnel), they may choose to be vaccinated," the CDC says. Patients can talk to their health care provider if they need more information, the guidance says.
Acknowledging Side Effects and Uncertainty
The ACOG's advisory backs that approach. The group notes that even though the vaccine wasn’t tested in pregnant women, it expects the safety profile would be similar to other groups. But they added as a caveat that “there are no safety data specific to mRNA vaccine use in pregnant or lactating individuals and the potential risks to a pregnant individual and the fetus are unknown."
In clinical trials, some participants had mild flu-like symptoms after vaccination, including reactions where they got the shot, fatigue, chills, muscle and joint pain, and headache. Among participants ages 18-55 years, fever greater than 100.4 F occurred in 3.7% of people after the first dose and in 15.8% after the second dose. Most symptoms ended in a few days.
Women who are pregnant should treat fever with acetaminophen, because "fever has been associated with adverse pregnancy outcomes," according to the ACOG guidance. The drug is safe to use during pregnancy and doesn’t appear to have an effect on the vaccine. Patients may treat other vaccine side effects, such as soreness where they got the shot, with acetaminophen as well.
More Data Expected
Data from studies in animals are expected soon, the CDC says. Also, the drugmaker is following people who took part in clinical trials who became pregnant during the study.
Women who are pregnant and their doctors should weigh things like the extent of COVID-19 transmission in the community, the patient's risk of contracting COVID-19, risks of COVID-19 to the patient and baby, how well the vaccine works and its side effects, and the lack of data about COVID-19 vaccination during pregnancy.
The Society for Maternal-Fetal Medicine recommends that pregnant women and nursing moms have access to COVID-19 vaccines in general and has advocated to include these groups in vaccine trials. The society has suggested that health care professionals "counsel their patients that the theoretical risk of fetal harm from mRNA vaccines is very low." It published resources this week for doctors and patients focused on COVID-19 vaccination and pregnancy.
In a review published online on Dec. 10 in the American Journal of Obstetrics & Gynecology MFM, Amanda M. Craig, MD, of Duke University Health System in Durham, NC, and coauthors note that there "is a theoretical risk for fetal harm from any untested medical intervention and this is no different for COVID-19 vaccines."
"Pregnant individuals should be given the opportunity, along with their obstetric provider, to weigh the potential risk of severe maternal disease against the unknown risk of fetal exposure, and make an autonomous decision about whether or not to accept vaccine until pregnancy safety data are available," they write.