A new guidance suggests that COVID-19 vaccines should not be withheld from pregnant or lactating women who want to be vaccinated, despite a lack of safety data.
Issued by the American College of Obstetricians and Gynecologists (ACOG; Washington DC, USA), the practice advisory recommends that COVID-19 vaccines should not be withheld from pregnant individuals who meet criteria, and recommends use of the Pfizer-BioNTech COVID-19 vaccine in persons aged 16 years or older, and the Moderna-1273 COVID-19 vaccine for those aged 18 years or older. COVID-19 vaccines should be offered to both lactating and non-lactating women individuals when they meet criteria for receipt of the vaccine.
ACOG reiterates that the vaccines currently available have not been tested in pregnant women, and that therefore there are no safety data specific to use in pregnancy. Important points to consider prior to vaccination include level of activity of the virus in the community, potential efficacy of the vaccine, risk and potential severity of maternal disease, the effects of disease on the fetus and newborn, and safety of the vaccine for the pregnant mother and the fetus. Pregnancy testing should not be a requirement prior to receiving any COVID-19 vaccine.
ACOG also suggests that while a conversation with a clinician may be helpful, it should not be required prior to vaccination, as this may cause unnecessary barriers to access. Pregnant patients who decline vaccination should be supported in their decision; regardless of their decision to receive or not receive the vaccine, these conversations provide an opportunity to remind patients about the importance of other prevention measures such as hand washing, physical distancing, and wearing a mask.
“Expected side effects should be explained as part of counseling, including that they are a normal part of the body’s reaction to the vaccine and developing antibodies to protect against COVID-19 illness,” concluded the statement by the ACOG immunization, infectious disease, and public health preparedness expert work group. “mRNA vaccines are not live virus vaccines, nor do they use an adjuvant to enhance vaccine efficacy; these vaccines do not enter the nucleus and do not alter human DNA in vaccine recipients. As a result, mRNA vaccines cannot cause any genetic changes.”
Available data suggest that symptomatic pregnant patients with COVID-19 are at increased risk of ICU admission, need for mechanical ventilation, and death, compared to symptomatic non-pregnant women. Pregnant patients with comorbidities such as obesity and diabetes may be at an even higher risk of severe illness, consistent with the general population with similar comorbidities.