Is the COVID-19 vaccine safe for pregnant patients? Could it render patients infertile? Clinicians have fielded a battery of questions like these since COVID-19 vaccines first gained emergency approval in 2020.
Thankfully, leading professional societies have released updated clinical guidance regarding the COVID vaccine and pregnancy, shaping a thoughtful discussion of what is known — and what remains unknown. This conversation is an essential step in addressing uncertainties and putting patients' fears to rest about their health and plans to start or grow their families after vaccination.
Should Pregnant Women Get Vaccinated?
The American College of Obstetricians and Gynecologists (ACOG), the Society for Maternal-Fetal Medicine (SMFM) and the American Society for Reproductive Medicine all recommend access to COVID-19 vaccination for pregnant women and those trying to conceive.
The recommendations come amid scientific evidence demonstrating the virus's significant toll on pregnant people, who are not only at greater risk of becoming severely ill from coronavirus, but who are also three times more likely to be admitted to the ICU with a severe form of the disease than their nonpregnant counterparts.
Women who contract COVID-19 earlier in their pregnancy also face a higher risk of complications, adds a multi-national study in the Journal of Perinatal Medicine. The risks included an increased need for maternal oxygen and fetal mortality. Pregnant patients with symptomatic COVID-19 infections may also experience higher rates of cesarean delivery, preterm birth and possibly stillbirth, explains updated guidance from SMFM.
Still, pregnant patients or those planning to start a family may hesitate to get inoculated, in part because pregnant women were not included in early COVID-19 vaccine trials, causing some to question the vaccine's safety.
COVID Vaccine and Pregnancy
Tests of COVID-19 vaccines specifically among pregnant populations are now underway, as the Pfizer-BioNTech, Moderna and Johnson & Johnson vaccines are administered throughout many regions under emergency use authorizations.
Pfizer-BioNTech is currently recruiting approximately 4,000 healthy pregnant women for trials set to run through 2022. Participants will either be vaccinated between 24 and 34 weeks gestation or given a placebo and then followed for up to 10 months. Infants born to study participants will be monitored until approximately six months of age.
Reassuringly, preliminary findings published in June 2021 in the New England Journal of Medicine show no notable difference between pregnancy complications and adverse neonatal outcomes in vaccinated pregnant women and pre-COVID reports in the medical literature of pregnancy complications. The paper included 3,958 pregnant women inoculated with the Pfizer-BioNTech and Moderna vaccines, reporting into the Vaccine Adverse Event Reporting System and other surveillance trackers.
Evolving Guidance on Vaccination
Vaccination guidance is evolving as adverse events emerge among the millions of people globally being inoculated against COVID-19. With investigations continuing into rare instances of serious blood clots from the Johnson & Johnson vaccine, ACOG currently advises pregnant and postpartum patients in the U.S. to opt for the Pfizer-BioNTech or Moderna vaccines, rather than the Johnson & Johnson vaccine.
Interim guidance from the World Health Organization (WHO) suggests pregnant women may also be inoculated with the Oxford-AstraZeneca, Sinopharm or Sinovac-CoronaVac shots when vaccination benefits outweigh risks. When discussing COVID-19 vaccination, the WHO encourages healthcare providers to address factors such as underlying health conditions, working conditions and community transmission rates. Notably, the agency draws particular attention to the overall lack of data on possible vaccine-associated risks in pregnancy with the Sinovac-CoronaVac and Sinopharm shots.
Among women trying to conceive, data thus far suggests there is no reason to delay pregnancy after completing the vaccine series, reports SMFM's "Provider Considerations for Engaging in COVID-19 Vaccine Counseling With Pregnant and Lactating Patients." Vaccines may be offered throughout pregnancy, although SMFM adds that data is lacking on whether the vaccine series should be administered in the first, second or third trimesters.
COVID Vaccine and Fertility
Some patients who hope to become pregnant may express hesitation about COVID-19 vaccines based on social media rumors claiming the vaccination causes infertility. The rumors come from an unfounded report suggesting the spike protein the immune system creates after inoculation fights off a beneficial spike protein, called syncytin-1, which helps the placenta to grow and attach during pregnancy.
You can comfort patients by explaining the rumor is rooted in false information and the available research suggests vaccinated people do go on to conceive and deliver healthy babies. Patients may be relieved to know that 23 volunteers involved in the initial Pfizer vaccine trial went on to become pregnant. The sole volunteer who miscarried received a placebo, not the actual vaccine.
Fertility Assistance and Vaccination
Given the dearth of information on the possible effects of COVID-19 vaccination on assisted reproductive technology (ART) treatment or embryo development, the European Society of Human Reproduction and Embryology (ESHRE) has issued no recommendations on whether couples attempting to conceive via fertility assistance should receive the vaccine before starting treatment.
However, ESHRE does advise postponing the start of sperm collection, ovarian stimulation and embryo transfer for at least a few days after a patient's last dose to allow time for the immune response to wane. Additionally, a more cautious approach, such as postponing the start of ART for up to two months following the final shot, may be warranted given the absence of data on COVID-19 and reproduction, ESHRE adds.
However, when treating women with underlying health issues that put them at greater risk of COVID-19 or pregnancy complications, ESHRE advises clinicians to consider encouraging vaccination before ART starts.
The organization further recommends monitoring treatment outcomes to compare results between vaccinated and non-vaccinated patients. ESHRE guidance advises against denying fertility treatment to patients living in countries without vaccine access or to those who refuse inoculation.
COVID-19 Vaccine Counseling
When counseling patients, ACOG encourages OB/GYNs to emphasize the general safety of vaccines. Studies thus far have found the Pfizer-BioNTech and Moderna are both about 95 percent effective — with no reports of severe or life-threatening side effects.
Clinicians may wish to begin by briefly noting that the rapid pace of COVID-19 vaccine development does not mean manufacturers skipped important safety steps. Highlight ongoing safety monitoring that continues amid the growing availability of COVID-19 vaccines.
Gently explain that getting COVID-19 may jeopardize a person's health and pregnancy more than any vaccine. Recent SMFM guidance recommends balancing the available data on vaccine safety with what is presently known about maternal and fetal health risks. Consider inviting patients who choose to be vaccinated to participate in the Centers for Disease Control and Prevention's smartphone-based pregnancy registry to help expand real-world understanding of vaccine safety.
Unfortunately, not every patient will wish to be vaccinated. ACOG advises OB/GYNs to support the decision of pregnant patients who decline vaccination. Clinicians may use the opportunity to remind patients about the importance of other preventive measures, such as wearing a mask, handwashing and social distancing.
A thoughtful dialogue about vaccination not only helps to ease your patient's anxiety, but it also provides an opportunity to further the doctor-patient relationship.
