In this pandemic season of uncertainty and fear, images from around the world of the first health care workers and elderly people being vaccinated has brought hope to many hearts that we may finally bring the COVID-19 pandemic under control and get back to a more normal way of life.
But for women who are pregnant or breastfeeding, or intended parents who are trying to conceive, the question of whether or not to receive the COVID-19 vaccine comes with an additional set of considerations and concerns that most of us don’t have to think about: Is the vaccine safe for my health during pregnancy, for my baby, or for the baby I am hoping to conceive?
The good news is that the reproductive medicine experts of the American Society for Reproductive Medicine (ASRM) concur: In most cases, women who are pregnant, breastfeeding, pumping breast milk or who are currently trying to become pregnant should get vaccinated, according to the organization’s most recent update on the COVID-19 pandemic and its impact on conception and pregnancy.
Disclaimer: International Fertility Law Group is not a medical provider, and all individuals are urged to consult with their personal physicians when making decisions about vaccination or any other medical issues.
Although some people remain distrustful of the three new vaccines that have thus far received FDA Emergency Use Authorization, recent polls indicate a growing number of Americans (69 percent in February 2021, up from 60 percent in November 2020) are ready and willing to receive the vaccines. Epidemiologists such as Dr. Anthony Fauci, Director of the National Institute of Allergy and Infectious Diseases, estimate that some 70 percent to 85 percent of Americans must be immunized in order for the country to achieve “blanket” or “herd immunity” protection from COVID-19 outbreaks. “We don’t really know what that magical point of herd immunity is, but we do know that if we get the overwhelming population vaccinated, we’re going to be in good shape. We ultimately would like to get and have to get children into that mix,” Fauci said during a hearing of the Senate Health, Education, Labor and Pensions Committee in March.
Released on March 23, 2021, the latest guidance from the Coronavirus/COVID-19 Task Force of the American Society for Reproductive Medicine is provided as a service to ASRM members, physicians and their patients and comes with the caveat that clinicians should act based on their own best judgement and the unique needs of each patient.
Here is a summary of recommendations from the task force updates so far:
The Task Force does not recommend withholding the COVID-19 vaccine from patients who are planning to conceive, are currently pregnant, or are breastfeeding—in agreement with the guidance from other professional healthcare associations, including the World Health Organization (WHO), the American College of Obstetricians and Gynecologists (ACOG), the Society for Maternal-Fetal Medicine (SMFM), and the ASRM.
The Task Force recommends that ‘patients scheduled for elective surgery or outpatient procedures, including oocyte retrieval, embryo transfer, and intrauterine insemination, avoid COVID-19 vaccination at least three days prior and three days after their procedure’. The ASRM assures patients that this recommendation is not because being vaccinated is unsafe, but rather because known vaccine side effects may impact intra-operative and post-surgical monitoring.
In connection, the Task Force’s latest update addresses clinic policies regarding partners or support persons. While the Task Force does not advise relaxing any risk mitigating policy, it does note that one of the factors to consider (among others) for allowing partners or support people to be physically present might include their vaccination status.
In a joint statement issued on February, 5, 2021 (prior to the approval of the third vaccine), the ASRM, the American College of Obstetricians and Gynecologists (ACOG), and the Society for Maternal-Fetal Medicine (SMFM) assured everyone that, “As experts in reproductive health, we continue to recommend that the vaccine be available to pregnant individuals. We also assure patients that there is no evidence that the vaccine can lead to loss of fertility. While fertility was not specifically studied in the clinical trials of the vaccine, no loss of fertility has been reported among trial participants or among the millions who have received the vaccines since their authorization, and no signs of infertility appeared in animal studies. Loss of fertility is scientifically unlikely.”
The decision of whether or not a patient should be vaccinated should be made by the patient and her doctor, keeping in mind the “ethical principles of autonomy, beneficence, and non-maleficence.
Recent studies have suggested that women who are pregnant are at higher risk of becoming severely ill from COVID-19, even more so for patients with conditions such as obesity, hypertension or diabetes. The ASRM notes that these data highlight the importance of vaccination for those desiring or planning to conceive and/or who are pregnant: ‘the known risks of COVID-19 in pregnant women outweigh the theoretical risk of harm from COVID-19 vaccination’.
As studies indicate that pregnancy is a time of COVID-19 vulnerability for both the mother and potentially the fetus, the ASRM Task Force recommends that pregnant women, considering state guidance, should be prioritized to receive the vaccine. They further recommend that ‘patients receive vaccination at the soonest possible time, whether pre-conception or during pregnancy, while considering the timing of any surgical procedure’.
The Task Force notes that, while pregnant women were not included in vaccine trials, there is growing data involving pregnant individuals who received the first two approved vaccines. Data is collected through V-safe, a smartphone-based tool that collects voluntary data using text messaging and web surveys from those who received the Covid-19 vaccine. As of March 8, 2021, more than 44,000 V-safe participants were pregnant at the time they received the vaccine. According to the CDC:
– As of February 16, 2021, a total of 30,494 pregnant women reported to V-safe. For both vaccines, there were no concerning differences between pregnant and non-pregnant women in terms of side effects.
– As of February 9, 2021, the V-safe Pregnancy Registry included 1,815 enrolled participants of which 275 completed pregnancies, resulting in 232 live births. “The rates of miscarriage, still birth, gestational diabetes, preeclampsia or gestational hypertension, eclampsia and intauterine growth restriction were lower in the V-safe pregnancy registry compared to background rates.”
The Task Force’s latest update specifically addresses vaccine hesitancy. The Task Force emphasizes that the responsibility to lead is urgent: “With the increasing availability of vaccines, the priority must shift to persuading those that remain skeptical to vaccination to become vaccinated, as that is the most direct and sure way to achieve herd immunity and ultimate control of the pandemic”. They continue, “as reproductive care specialists and staff who have a privileged relationship and influence with our patients, we must embrace the responsibility and opportunity to serve as vaccine ambassadors and help promote vaccine utilization and combat hesitancy and misinformation, to facilitate the health and safety of our patients, our communities and overall society.”
Studies suggest that if the mother is infected with the Covid-19 virus during pregnancy, her baby may get passive immunity. While the February ASRM update notes that it remains to be seen if vaccination also confers passive immunity to newborns, recent reports suggest it may. On March 17th, researchers at Florida Atlanta University announced that the vaccine’s protection may be passed from mother to child after a healthy baby was born with coronavirus antibodies to a frontline worker who received the vaccine at 36 weeks pregnant.
Similarly, researchers at Massachusetts General Hospital, Brigham and Women’s Hospital and the Ragon Institute of MGH, MIT and Harvard studied 131 women who received either the Pfizer/BioNTech or Moderna Covid-19 vaccine. Among these, 84 were pregnant, 31 were lactating and 16 were not pregnant. Both pregnant and lactating women, and non-pregnant women had the same level of vaccine-induced antibodies. They also found that women passed protective antibodies to their babies through breastmilk and the placenta. Of course, questions remain. Researchers still don’t know how long protection from antibodies lasts for nor how many antibodies must be present for continued protection.
Egg donors can still get the Covid vaccine. As noted above, in line with the ASRMs recommendations, ‘patients scheduled for elective surgery or outpatient procedures, including oocyte retrieval, avoid COVID-19 vaccination at least three days prior and three days after their procedure.’
Vaccines can be a delicate issue to discuss, but it’s essential that intended parents and gestational carriers have an honest and respectful dialogue on the subject. It also helps to get a doctor’s recommendation for a more clear and comfortable course of action. The surrogacy contract may contain a clause on Covid-19 vaccination and preventive measures, such as mask wearing and physical distancing so that both parties are clear about what is expected.
As we hope that the vaccines will make it possible for us to safely gather again with family and friends, it’s also important not to let down our guards too soon. Even with a fast and efficient rollout of the three existing vaccines and others on the horizon, the logistics of getting enough people vaccinated to provide widespread protection in the United States mean we must continue safe practices to continue protecting one another for the next several months.
There is still a lot we don’t know about the vaccines’ effectiveness and the extent of the protection they provide. As the ASRM update reminds us, “it is not yet clear whether vaccinated individuals can acquire asymptomatic infection or transmit infection to others”. This means mask wearing, physical distancing and hand hygiene continue to be imperative.
If you are considering becoming a parent using assisted reproductive technology, contact IFLG today! Our team of experienced ART attorneys and paralegals can answer all your questions about how to legally protect your family. You can also follow IFLG on Facebook, Instagram, Twitter and YouTube. We look forward to seeing you in 2021 and beyond!
About Rich Vaughn
Attorney Rich Vaughn is founder and principal of International Fertility Law Group, one of the world’s largest and best-known law firms focused exclusively on assisted reproductive technology, or ART, including in vitro fertilization (IVF), surrogacy, sperm donation or egg donation. Rich is co-author of the book “Developing A Successful Assisted Reproduction Technology Law Practice,” American Bar Association Publishing, 2017.