Our belief is that a pregnant patient should be ALLOWED the opportunity to get the coronavirus vaccine

One quick internet search for the coronavirus vaccine and you may be overwhelmed! And in this day of, might I say, interesting fictitious news stories and personal agendas, it can be hard to know who to trust on this subject. We know you have worked tremendously hard for this pregnancy and that this may be your one chance to be parents. So, we MUST get it right!

The doctors at RSC have reviewed the available literature and recommendations from advocacy groups that have had access to the original scientific data. We believe pregnant patients should have the opportunity to get the coronavirus vaccine.

Pregnant women were not included in the current studies of the vaccine safety and efficacy. Therefore, it is difficult for RSC to make a statement that the coronavirus vaccine is safe. Additionally, there is no data or science to indicate that pregnant women and their fetuses would be at risk from the current vaccines on the market for COVID-19.

CDC, ACOG and ASRM on the coronavirus vaccine for pregnant patients

The Centers for Disease Control and Prevention’s (CDC’s) experts say that, based on how mRNA vaccines work, which are the two currently available, “they are unlikely to pose a risk for people who are pregnant.” This is because mRNA vaccines do not contain the live virus that causes COVID-19, so the shot cannot give a pregnant woman the disease. But the CDC says that the potential risks of the COVID-19 vaccine to a pregnant woman and her fetus are not yet fully known.

The American College of Obstetricians and Gynecologists’ (ACOG’s) COVID-19 working group reports that while pregnant women are typically excluded from most clinical trials, they have been vaccinated for decades with few complications. One ACOG working group doctor, Denise J. Jamieson, MD, MPH, said that because the coronavirus vaccine uses messenger RNA (mRNA) technology and not a live dose of the actual virus, she anticipates the vaccine should be very safe in pregnancy.

For otherwise healthy people in general, the COVID Task Force of the American Society for Reproductive Medicine (ASRM) does not recommend withholding the vaccine from patients who are planning to conceive, who are currently pregnant, or who are breastfeeding. It does encourage patients undergoing fertility treatment to receive the vaccination based on current eligibility criteria. Because the vaccine is not a live virus, the Task Force says there is no reason to delay pregnancy attempts due to vaccine administration or to defer treatment until receiving the second dose.

At the same time, the ASRM Task Force notes that recent studies suggest that pregnancy poses a higher risk for severe COVID-19 disease along with factors such as obesity, hypertension and diabetes.

Individualizing your decision on the coronavirus vaccine

So that leads us to individualize the discussion based upon several factors:

1. What is the risk in your community of getting COVID-19?
2. What is your personal risk based upon your daily activities/workplace?
3. What is your risk of serious complications from COVID-19? Serious complications in pregnancy?
4. Do you have any contraindications (things that make a treatment inadvisable) to the vaccine?
5. Do you have the ability to lower your risk of getting COVID-19 in any other way than the vaccine?

For example, if you are in a community that has a very low incidence of COVID-19, you do not have a job that places you around others, you have no underlying health risks, and have a very uncomplicated pregnancy, it may be just fine for you to limit your contact with others until the baby is born and NOT get the vaccine. (But please take care of yourself emotionally and reach out to others for virtual support!) On the other hand, if you have asthma or heart disease, which can become worse in pregnancy, and work around others, especially children who are not able to get the vaccine at present, you may decide the vaccine is right for you!

What are the available coronavirus vaccines and how do I get one?

The U.S. Food and Drug Administration (FDA) issued Emergency Use Authorizations for the Pfizer-BioNtech mRNA vaccine that has been 95% effective in clinical trials and for the Moderna vaccine called mRNA-1273, with an efficacy rate reported to be 94%.

Most likely your primary healthcare provider and local pharmacies will be providing it, first to healthcare workers and those at high risk, then later to the general public. The Pfizer vaccine and Moderna vaccine will require 2 doses, 21 days apart for Pfizer’s and 28 days apart for Moderna’s.

The Johnson & Johnson vaccine has also been authorized for emergency use by the FDA.  This alternative vaccine requires only one dose and uses DNA technology that is more stable, but not necessarily more effective. It is thought to be around 73% effective in the U.S. with the initial variants of COVID-19.

RSC will not be able to provide the vaccine to patients. According to CDC guidelines, frontline healthcare workers and residents of long-term care facilities will be the first to be inoculated. However, the decision about priority rests with each state’s governor.

 

Vaccine effectiveness

Using Pfizer’s vaccine as an example, they determined its 95% effective rate by giving ½ of the 43,538 volunteers the vaccine and ½ a placebo. They then collected data on subjects who had symptoms at least seven days after the second dose. Ninety patients in the placebo arm had symptoms of COVID-19 and 19 in the vaccine arm. We assume that each group had equal risks of getting COVID-19.

It is important to know that the available data is about getting COVID-19, not about developing antibodies. As you can see, there were people in both groups who still had COVID-19 symptoms, so it is still critical to use precautions like masks, hand-washing, and avoiding close prolonged contact with people who may have the virus. The coronavirus vaccine may lower your risk of contracting COVID-19 but will not eliminate your risk.

What are the side effects of the coronavirus vaccine?

The vaccine has some side effects. Following are two brief reports of those.

“Side effects may occur in the first 3 days after getting the COVID-19 vaccine. These include mild to moderate fever, headache, and muscle aches. In the COVID-19 trials, less than 4% of people developed a fever after the first dose, and about 16% developed a fever after the second dose. Experts recommend that pregnant people receiving the COVID-19 vaccine who develop fever take acetaminophen (Tylenol). This medication is safe to use during pregnancy and does not affect how the vaccine works.” — Society of Maternal Fetal Medicine statement 2020

“The injection into your arm won’t feel different than any other vaccine, but the rate of short-lived side effects does appear higher than a flu shot. Tens of thousands of people have already received the vaccines, and none of them have reported any serious health problems. The side effects, which can resemble the symptoms of Covid-19, last about a day and appear more likely after the second dose. Early reports from vaccine trials suggest some people might need to take a day off from work because they feel lousy after receiving the second dose. In the Pfizer study, about half developed fatigue. Other side effects occurred in at least 25 to 33 percent of patients, sometimes more, including headaches, chills and muscle pain. While these experiences aren’t pleasant, they are a good sign that your own immune system is mounting a potent response to the vaccine that will provide long-lasting immunity.” — Abby Goodnough, Carl Zimmer

Concerns for the fetus

Pregnancy is an amazing thing – the pregnant woman is growing a human being inside her body! Every pregnancy has a risk of developmental or structural problems in the child, and no one wants to increase that risk by getting a vaccine.

The current COVID-19 vaccine is not a live vaccine and so it will not give you the virus. The Pfizer and Moderna vaccines use mRNA technology to introduce a small particle that resembles a part of the virus to induce an immune response. Those who are concerned about the vaccine are typically concerned about the body’s immune response and whether this can affect the growing fetus.

Other vaccines that use this same process to induce an immune response, like vaccines for the flu diphtheria and tetanus, have been given in pregnancy for a long time. And we have not seen a greater incidence of developmental problems – and this process can even help protect the newborn from these diseases for a period of time.

Other vaccine concerns about transmissibility, infertility and miscarriage

To date, no published scientific research suggests that the coronavirus is transmissible from gametes (reproductive cells such as embryos, eggs and sperm) to an intended mother or a gestational carrier.

Currently, there is no data connecting the vaccine and infertility, and social media posts saying otherwise are “inaccurate,” according to Yale University vaccine expert Saad Omer in a Dec. 11, 2020, The New York Times wire story.

Regarding miscarriage, Dr. Mary Jane Minkin of Yale School of Medicine, tells USA Today that there has been no evidence among the 53,641 COVID-19 cases (at the time of this blog’s publication) in pregnant women this year that the vaccines’ spike protein antibodies attacked any cells in the placenta, which would cause pregnancy complications or miscarriage.

What’s next?

While it still might be hard to make a decision about what to do if you are pregnant and offered the vaccine, we hope this information from your RSC doctors can help you think about the pros and cons, the knowns and unknowns, and do what is right for you. Parenting is a process of making the best decision with the information you have at the time in the best interest of your child, and then trusting that you will figure out what to do next.

I wish you well in this process, and please know we are here to support you!