Dear Spring Family,
For the first time in many months, we now have some positive news around the pandemic, as we anticipate approval of two vaccines for use in the United States and Canada. While this news is reassuring, it has prompted many questions from our patients regarding the efficacy and safety of these vaccinations if they are trying to conceive or are currently pregnant.
In summary, we encourage everyone who has access to get the vaccine if they have a negative pregnancy test. While we believe that the mRNA vaccine is likely safe for pregnant women, we do not currently have data to support that. Therefore, until more data become available, we do not recommend getting the vaccine while you are pregnant if you are at low risk for severe COVID infection.
- If you are pregnant and at a higher risk of severe diseases, women with diabetes or pre-existing lung diseases, we recommend receiving the vaccine even while pregnant.
- We also support the recommendation that front line healthcare workers who are pregnant should consider getting vaccinated due to their higher risk of exposure.
- Patients who are trying to conceive should be vaccinated if they are not currently pregnant.
- For patients undergoing active fertility treatments: Since we do not know the effect of the vaccine on treatment, we would not recommend the vaccine within 1 week of when an embryo is implanting. This means holding off on the vaccine AFTER we trigger ovulation for IUI or a cycle with a projected embryo transfer. If you have any questions and you are in treatment, your care team can clarify.
For additional context on our recommendations, we’ve included more information on what we know about the vaccine below. As always, we’re committed to sharing our perspectives and information and as data become available. We greatly value the trust that you place in us as your partners in your fertility care.
What is an mRNA vaccine?
Unlike many vaccines that we are familiar with such as the flu shot and chicken pox, an mRNA vaccine does not use the virus itself or any parts of it. Instead, it transfers mRNA that allow cells in our body to produce a critical protein that the virus needs to infect our cells. This allows our immune system to learn how to attack the virus by making antibodies to this protein. These antibodies protect us from future infection, without ever having been infected.
Think of mRNA as a set of instructions for the cells in our body to use. The mRNA provides a set of instructions to the machinery in our cells that make proteins, so that they will make a specific protein that is found on the surface or capsule of the SARS-Cov-2 virus. Once our cells make that protein, they break down the instructions (mRNA) and the cell is not infected with the virus. Our cells will then begin to display this protein piece on their cell surface so that it can be recognized by our immune system as foreign, causing our body to produce antibodies to the protein. This is similar to what would happen during a natural infection with COVID-19.
Do the vaccine trials look promising at preventing COVID-19?
So far initial data looked great. There are currently two vaccine manufacturers seeking emergency use authorization for COVID 19 vaccine distribution in the US, the Moderna mRNA vaccine and the Pfizer and BioNTech mRNA vaccine.
Interim results from the Phase III Moderna vaccine trial included over 30,000 participants across the United States randomized to receive either a two-dose COVID 19 vaccination or a two-dose placebo. The interim results noted 95 cases of COVID 19. 90 cases occurred in the group that received the placebo and 5 cases occurred in the group who received the vaccine. There were 11 severe cases of COVID 19 and all were from the group that received the placebo. Their interim trial results give the vaccine an efficacy rate of approximately 94.5% after 2 doses of the vaccine.
The Pfizer and BioNTech vaccine phase III trial enrolled over 43,000 participants globally to receive either a two-dose COVID 19 vaccination or a two-dose placebo. At the time of their report, over 41,000 participants had received two COVID 19 vaccine doses and their vaccine has a reported 95% efficacy rate. According to their data, they had 170 confirmed cases of COVID 19 with 162 observed in the placebo group. The most common side effects reported in the Pfizer trial were fatigue and headache, each occurring in less 4% of participants.
How do we know if it is safe?
The mRNA vaccine, unlike other vaccines, does not contain a weakened or inactivated virus so there is no risk of developing COVID-19 disease. Additionally, data from the two leading vaccine makers have shown no serious safety concerns.
Who will initially be eligible to receive the vaccine?
According to the CDC, the initial release of the vaccination will likely be focused on high risk groups including healthcare workers, workers in essential industries, people in long term care facilities, people at high risk for severe COVID-19 disease due to underlying medical conditions and people 65 years and older.
Were pregnant women included in the vaccine trials?
No. As a general rule, pregnant women and children are considered a “protected class” for medical research and are therefore excluded from participating in most initial vaccine and medical trials. Thus, pregnant patients were excluded from participation in the COVID-19 early vaccine trials. Both the American College of Obstetricians and Gynecologists (ACOG) and the Society for Maternal Fetal Medicine (SMFM) are strongly advocating that the vaccine be tested in pregnant women in order to accumulate efficacy and safety data in pregnant women.
Is the vaccine harmful or potentially harmful to a pregnant woman or fetus?
Unfortunately, since pregnant women were not included in the studies, we can’t say for sure. We do know that current studies have shown a very favorable safety profile and there does not seem to be significant risk in taking the vaccine for you. It stands to reason that it is safe during pregnancy, but unfortunately, we do not have data to support.
Given the molecular makeup of the virus, the risk of fetal harm is low (no case of fetal harm has ever been reported, despite using a similar vaccine for ebola in pregnant women). Although new, our best science suggests that the vaccine is safe for pregnant women and their fetuses.
Should I get the vaccine if I am CURRENTLY pregnant?
While we believe that the mRNA vaccine is likely safe for pregnant women, we do not currently have data to support that. Therefore, until more data become available, we do not recommend getting the vaccine while you are pregnant if you are at low risk for severe COVID infection.
Spring Fertility joins our colleagues at ACOG and SMFM in advocating that pregnant women with underlying conditions should be encouraged to obtain the COVID vaccine. First responders or healthcare workers who are pregnant and breastfeeding should consider getting the vaccine as well. In general, we believe that pregnant women should be eligible to receive it based on shared and informed decision making with the patient and their obstetrician.
While pregnancy can increase the risk of more severe disease when infected with COVID-19, overall mortality risk remains low in young women, including pregnant women. Most severe cases of COVID in pregnant women have been limited to women with co-existing conditions, like diabetes or respiratory disease.
I heard the vaccine is dangerous or can cause infertility, is that true?
No. Sadly, there is a campaign of misinformation circulating on the internet, including claims that the vaccine will cause infertility. This is absolutely not true. Many of these malicious rumors use pseudoscientific terms and physician names to try to give the appearance of credibility. Please be careful about where your get information and help family members and friends find trusted sources of information like the CDC website.
Should I get the vaccine if I am trying to become pregnant (but not pregnant now)?
Yes, we encourage everyone who has access to get the vaccine if they have a negative pregnancy test. We would not recommend the vaccine within 1 week of embryo implantation if you are going through treatment.
More to come…
As always, we appreciate the trust you place in us. We will continue to stay current as more data emerge and will update you with any new studies that may influence decisions that you need to make for yourself and your family.
We’re wishing you a safe and happy holiday season. We acknowledge what a stressful year 2020 has been for everyone as we have now been dealing with the COVID 19 pandemic for over 9 months. We understand that COVID fatigue and the desire to gather with family and friends is particularly strong right now, especially given the holiday season. However, we encourage everyone to continue to follow the CDC guidelines regarding holiday gatherings to keep themselves and their loved ones safe.
Your partners at Spring Fertility