One of the biggest questions for those that are pregnant or lactating right now is if they should get the COVID vaccine while pregnant or lactating. This can be a very difficult question to answer since the vaccine was not studied in pregnant or lactating women. I wanted to put together this blog post for those of you looking for resources to weigh your decision and have them all in one place. It is important to remember that all of us need to make this decision based on what is right for your family. Every family’s situation is unique and the risks/benefits need to be weighed in order to make your own personal decision. This blog post is written to simply give you the resources you need to help you in your decision making. At the very end I will link out to studies or registries that are currently available if you decide to get the vaccine. These are especially important in collecting data from those of us who are choosing to get the vaccine and put together that much needed research we need. 

UPDATED INFO AS WE GET IT WILL BE ADDED TO THE BOTTOM OF THIS POST!

How do mRNA vaccines work?

mRNA vaccines are NEW but the research behind them is not. Researchers have been studying them for decades and early stage clinical trials have been carried out in the past. You can read more about that here.  The vaccine contains messenger RNA (mRNA) that is encapsulated by a lipid nanoparticle for delivery into host cells. The vaccine utilizes the body’s own cells to create the coronavirus spike protein which then stimulates your immune system to create antibodies against COVID-19. It is important to note that mRNA vaccines are NOT live virus vaccines. These mRNA vaccines will NOT alter your DNA (Advances in mRNA Vaccines & Developing mRNA-vaccine technologies).

Highly suggest this –> Science NEVER sleeps – mRNA vaccines – 60 years in the making

I put together a podcast episode with infectious disease epidemiologist, Jessica Malaty Rivera and we went through 25 of your most asked questions in regards to the COVID vaccine! She is extremely educated on the subject and answers so many of your concerns. 

Via the BMJ, there is no evidence that vaccines can affect fertility

COVID-19 Shot Earlier in Pregnancy Better for Baby || a small study suggests that the earlier a pregnant women receives her vaccine, the more likely she is to transfer those protective antibodies. The study found that “a longer time between vaccination and delivery was associated with greater transfer of COVID-19 antibodies to the baby.”

ACOG | American College of Obstetricians and Gynecologists 

“ACOG recommends that COVID-19 vaccines should not be withheld from pregnant individuals. While safety data on the use of COVID-19 vaccines in pregnancy are limited, there are also no data to indicate that the vaccines should be contraindicated, and no safety signals were generated from DART studies for the Pfizer-BioNtech, Moderna, and Janssen COVID-19 vaccines. “

“ACOG recommends COVID-19 vaccines be offered to lactating individuals. While lactating individuals were not included in most clinical trials, COVID-19 vaccines should not be withheld from lactating individuals who otherwise meet criteria for vaccination. Theoretical concerns regarding the safety of vaccinating lactating individuals do not outweigh the potential benefits of receiving the vaccine. There is no need to avoid initiation or discontinue breastfeeding in patients who receive a COVID-19 vaccine (ABM 2020).”

“As of February 16, 2021, there have been over 30,000 pregnancies reported in CDC’s v-safe post-vaccination health checker (CDC 2021). Based on limited self-reported information, no specific safety signals have been observed in pregnant people enrolled in v-safe; however longitudinal follow-up is needed.”

With regards to fertility:

“Vaccination is strongly encouraged for non-pregnant individuals. Further, ACOG recommends vaccination of individuals who are actively trying to become pregnant or are contemplating pregnancy and meet the criteria for vaccination based on ACIP prioritization recommendations. Additionally, it is not necessary to delay pregnancy after completing both doses of the COVID-19 vaccine.

Importantly, unfounded claims linking COVID-19 vaccines to infertility have been scientifically disproven. ACOG recommends vaccination for all eligible people who may consider future pregnancy. Given the mechanism of action and the safety profile of the mRNA vaccines in non-pregnant individuals, COVID-19 mRNA vaccines are not a cause of infertility. Adenovirus vector vaccines such as the Janssen COVID-19 vaccine cannot replicate following administration, and available data demonstrate that it is cleared from tissues following injection. Because it does not replicate in the cells, the vaccine cannot cause infection or alter the DNA of a vaccine recipient and is also not a cause of infertility (Evans, 2021).”

In a nutshell, making an informed decision based off a risk vs. benefit conversation with your provider is recommended. 

SMFM | Society for Maternal Fetal Medicine

“In general, SMFM strongly recommends that pregnant women have access to COVID-19 vaccines in all phases of future vaccine campaigns, and that she and her healthcare professional engage in shared decision-making regarding her receipt of the vaccine.”

“Healthcare professionals should also counsel their patients that the theoretical risk of fetal harm from mRNA vaccines is very low.”

“However, preliminary developmental and reproductive toxicity (DART) studies for both the Pfizer-BioNtech and Moderna vaccines are encouraging, with no safety signals reported. DART animal studies provide the first safety data to help inform the use of these vaccines in pregnancy until there are more data in this specific population. These studies do not indicate any adverse effects on female reproduction or fetal/embryonal development. ACOG and SMFM strongly urge manufacturers and federal agencies to collect and report data regarding the use of these vaccines in pregnancy”

ACOG & SMFM response to the WHO recommendations for the vaccine in pregnancy | in a nutshell, nothing changes from what they have already recommended above. 

SMFM response to the pause in the J&J vaccine –> here

CDC | Center for Disease Control

“People who are pregnant and part of a group recommended to receive COVID-19 vaccine, such as healthcare personnel, may choose to be vaccinated. A conversation between pregnant patients and their clinicians may help them decide whether to get vaccinated with a vaccine that has been authorized for use under Emergency Use Authorization (EUA).”

“There are no data on the safety of COVID-19 vaccines in lactating women or on the effects of mRNA vaccines on the breastfed infant or on milk production/excretion. mRNA vaccines are not thought to be a risk to the breastfeeding infant. People who are breastfeeding and are part of a group recommended to receive a COVID-19 vaccine, such as healthcare personnel, may choose to be vaccinated.”

ABM | Academy of Breastfeeding Medicine 

“During lactation, it is unlikely that the vaccine lipid would enter the blood stream and reach breast tissue. If it does, it is even less likely that either the intact nanoparticle or mRNA transfer into milk. In the unlikely event that mRNA is present in milk, it would be expected to be digested by the child and would be unlikely to have any biological effects.

“While there is little plausible risk for the child, there is a biologically plausible benefit. Antibodies and T-cells stimulated by the vaccine may passively transfer into milk. Following vaccination against other viruses, IgA antibodies are detectable in milk within 5 to 7 days. Antibodies transferred into milk may therefore protect the infant from infection with SARS-CoV-2.”

ASRM | American Society for Reproductive Medicine

“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.”

All of these reputable groups suggest that the decision to receive/not receive the vaccine should be a case by case basis that involves a discussion with one’s provider. 

With regards to infertility/pregnancy, preliminary results in rats show that it is safe thus far. You can read about this on pages 44-45 here. 

“A combined developmental and perinatal/postnatal reproductive toxicity study of mRNA-1273 in rats was submitted to FDA on December 4, 2020. FDA review of this study concluded that mRNA1273 given prior to mating and during gestation periods at dose of 100 µg did not have any adverse effects on female reproduction, fetal/embryonal development, or postnatal developmental except for skeletal variations which are common and typically resolve postnatally without intervention.”

Other tidbits of information/more resources below:

 “Leaders in Women’s Health Encourage Healthcare Workers to Receive the COVID-19 vaccine” – written by all of the top leaders that I mentioned above! Very informative!

This decision making tool is great for those of you that are pregnant and want to see if the COVID-19 vaccine may be for you.

Moderna mentioned this week that its vaccine does produce neutralizing antibodies (study is not peer reviewed yet) for the UK and South African variants, but it is less effective against the latter. It will be exploring a possible booster shot that would increase efficacy against emerging variants that we are seeing globally.    

If you received your COVID vaccine and you are PREGNANT, LACTATING or TRYING TO GET PREGNANT, opt into this registry here! This is a research study that is going to ask you some questions (takes about 20 minutes) and then they will follow-up if / when needed to gather more information! If you are nursing, they will ask you if you would be okay with donating some of your milk to test for antibodies 🙂 

Mother to Baby is currently enrolling in some studies – fill out this form HERE if you are trying to conceive, currently pregnant or breastfeeding and received the vaccine.

Mother’s Milk Study out of UCSD is currently full (this is the one I am in) but will be accepting more participants March 1st. You can also email milk@ucsd.edu to the study coordinators if you have any other questions. They are also accepting donations to help fund the study. You can donate HERE and in the notes section, write “Mommy’s Milk Study”)

Calling all pregnant women <10 weeks! This study is following women all the way through their pregnancy – This UCSF Aspire study is a nationwide prospective cohort study of pregnant women and their offspring during the COVID-19 pandemic. 

If you are PREGNANT and received the MODERNA vaccine: There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to Moderna COVID‑19 Vaccine during pregnancy. Women who are vaccinated with Moderna COVID‑19 Vaccine during pregnancy are encouraged to enroll in the registry by calling 1‑866‑MODERNA (1‑866‑663‑3762)

NEW RESEARCH

• We have our first known case of an infant with SARS-CoV2 IgG antibodies detectable in cord blood after maternal vaccination! This is not peer reviewed yet but I am HERE FOR IT! 🙂 
• Mom to baby transmission of antibodies | this post written by one of my favorite epidemiologists talks about 3 studies that have proven that mom does transmit antibodies of Sars-CoV-2 to her baby in most cases
• “There is “absolutely no evidence” that covid-19 vaccines can affect the fertility of women or men, says new expert guidance.” – article in the BMJ found here!
• Most up to date guidance from SMFM was released on March 3 and states…..”To date, over 30,000 pregnant people have self-reported within the CDC V-safe program, which collects and reports outcomes including miscarriages and stillbirth, pregnancy complications, maternal ICU admissions, adverse birth complications, neonatal death, infant hospitalizations, and birth defects. The reactogencicity and adverse events observed among pregnant people in v-safe DO NOT indicate any concerning pregnancy outcomes, pregnancy complications or neonatal outcomes compared with background data”.      read more here
• WE HAVE DOCUMENTED ANTIBODIES IN BREASTMILK AFTER VACCINATION!! This moved me to tears this week! Read more about it here! It is a pre print and not peer reviewed but I was VERY confident that we would have antibodies which is now confirmed! 
• The CDC just released their public health recommendations for those that are fully vaccinate this week!

• Update on Breastfeeding after COVID-19 vaccination HERE
• Current summary of data on asymptomatic cases and transmission after COVID vaccination – (hint, WE ARE SIGNIFICANTLY DECREASING THE TRANSMISSION)
• This preprint study on Covid-19 vaccine response in pregnant and lactating women had some great takeaways – these vaccines generated a robust humoral immunity that surpasses the immunity from natural disease // dominant serum antibody response was IgG //
• Breastfeeding moms with COVID-19 pass antibodies to their babies
• A study released this Monday out of Morbidity and Mortality Weekly report shows that Pfizer & Moderna vaccines were 90% effective in real – world after 2 doses and 80% after ONE! 🙂
• Should I worry that the COVID vaccine will cause long term issues?
• Update on Breastfeeding after COVID-19 vaccination HERE