Q: What do we know about the COVID-19 Vaccine and Pregnancy?
A: We understand it can be confusing when respected physicians or their organizations come to different conclusions. However, the virus and what we know about treatments and vaccines are all rapidly changing. As we learn more about COVID-19 care and management, recommendations will evolve. In reality, currently, there is little data on which to evaluate the impact of the vaccine or the disease on pregnant individuals. Also, given the challenges of enrolling pregnant individuals in clinical trials, it is unlikely we will have full data for many years. Meanwhile, patients must make decisions about their health now. Our conclusion is that the vaccines are safe for pregnant individuals or those contemplating pregnancy. However, it is important that each patient discuss vaccination with their physician and decide what the best course of action is for them and their family.Please review the ASRM COVID-19 Task Force Update 11 and Update 12 for information on which the Task Force bases its recommendations.
What we know:
- While the majority of those infected will survive, the overall death rate from COVID-19 remains over 1%. It is increasingly recognized that some people suffer from long term consequences after COVID-19 infection. These lingering symptoms can include muscle weakness, sleep difficulties, anxiety, depression, hair loss, anosmia, joint pain, palpitations and decreased pulmonary function. In a recent study, 76% of patients hospitalized with COVID-19 reported at least one lingering symptom six months after infection, and this proportion was higher in women. Given the continued morbidity and mortality of COVID-19, prevention remains a top priority.
- Widespread vaccination is critical to slowing the spread of SARS-CoV-2 virus, reducing COVID-19, and bringing an end to the pandemic.
- Currently available mRNA-based COVID-19 vaccines from Pfizer-BioNTech and Moderna have documented safety and efficacy in large randomized clinical trials, preventing up to 95% of severe disease.
- The known and potential benefits of these vaccines outweigh the known and potential harms of COVID-19 infection.
- Available data indicate that COVID-19 vaccines do not cause infertility in women or men.
- In the randomized blinded Pfizer-BioNTech trial, a similar number of women conceived after receiving the vaccine as those who received the placebo.
- mRNA vaccines are taken up rapidly by muscle cells at the injection site and the mRNA is degraded in the cell once the protein is made so it does not cross the placenta.
- COVID-19 vaccination is recommended for women who are contemplating pregnancy or who are pregnant in order to minimize risks to themselves and their pregnancy.
- The Task Force does not recommend withholding the vaccine from patients who are planning to conceive, who are currently pregnant, or who are lactating. These recommendations are in line with those of the Advisory Committee for Immunization Practices (ACIP) of the U.S. Centers for Disease Prevention and Control (CDC), the American College of Obstetricians and Gynecologists (ACOG), and the Society for Maternal-Fetal Medicine (SMFM).
- Patients undergoing fertility treatment and pregnant patients should be encouraged to receive vaccination based on eligibility criteria. Since the vaccine is not a live virus, there is no reason to delay pregnancy attempts because of vaccination administration or to defer treatment until the second dose has been administered.
- A shared decision-making model between patients and providers should be used when considering vaccination and should take into consideration the ethical principles of autonomy, beneficence, and non-maleficence. Consideration of local COVID-19 transmission and risk of acquisition, personal risk of contracting COVID-19, risks of COVID-19 to the patient and potential risks to a fetus, efficacy of the vaccine and known side effects, and the lack of data about the vaccine during pregnancy should all be taken into consideration as patients make decisions regarding vaccination. Some individuals may elect to defer conception attempts until both doses of vaccine have been administered.
- Recent studies have suggested that pregnancy is a risk factor for severe COVID-19 disease. Furthermore, many women who are pregnant or contemplating pregnancy have additional risk factors such as obesity, hypertension or diabetes which may further increase the chance of severe disease from COVID-19 infection. These considerations should be included in decisions regarding vaccination.
- Because COVID-19 mRNA vaccines are not composed of live virus, they are not thought to cause an increased risk of infertility, first or second trimester loss, stillbirth, or congenital anomalies. It should be noted that pregnant and lactating women were excluded from the initial phase III trials of these two vaccines, so specific safety data in these populations are not yet available and further studies are planned. However, the mechanism of action of mRNA vaccines and existing safety data provide reassurance regarding the safety of COVID-19 mRNA vaccines during pregnancy. The FDA EUA letter permits the vaccination of pregnant and breastfeeding individuals with a requirement that the company engage in post-authorization observational studies in pregnancy.
- While COVID-19 vaccination can cause fever in some patients (up to 16% of those vaccinated and mostly after the second dose), this risk should not be a concern when deciding whether to vaccinate a pregnant individual or a patient desiring pregnancy. While fever in pregnancy (particularly the 1st trimester) has been associated with an increased risk of neural tube defects, a recent study demonstrated the association no longer remained significant if the patient is taking >400 mcg of folic acid daily. Another large Danish cohort study did not demonstrate any increased risk of congenital anomalies of those who reported fever in the first trimester. Additionally, the most common symptom of COVID-19 infection itself is fever (83-99% of affected patients). Patients who experience fever following vaccination should take an antipyretic medication, like acetaminophen.