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COVID-19 Vaccine and Pregnancy and Lactation
DISCLAIMER: I AM NOT A LICENSED MEDICAL PROFESSIONAL AND I AM NOT GIVING YOU ANY ADVICE ON MAKING ANY MEDICAL DECISION. This is simply a list of the most current science based information on covid19 vaccines and pregnancy and lactation. It is essential that you review the information available and discuss it with your medical provider in order to make an individual informed decision.
WORLD HEALTH ORGANIZATION (also known as WHO)
On January 26th, 2021 the WHO changed its previous position. The text below is directly from their website specifically regarding the Moderna COVID-19 (mRNA-1273) vaccine.
“Should pregnant women be vaccinated? While pregnancy puts women at higher risk of severe COVID-19, very little data are available to assess vaccine safety in pregnancy.
Nevertheless, based on what we know about this kind of vaccine, we don’t have any specific reason to believe there will be specific risks that would outweigh the benefits of vaccination for pregnant women. For this reason, those pregnant women at high risk of exposure to SARS-CoV-2 (e.g. health workers) or who have comorbidities which add to their risk of severe disease, may be vaccinated in consultation with their health care provider.
How efficacious is the vaccine? The Moderna vaccine has been shown to have an efficacy of approximately 92 percent in protecting against COVID-19, starting 14 days after the first dose.
Does it work against new variants? Based on the evidence so far, the new variants of SARS-CoV-2, including the B.1.1.7 and the 501Y.V2, do not alter the effectiveness of the Moderna mRNA vaccine. The monitoring, collection and analysis of data on new variants and their impact on the effectiveness of COVID-19 diagnostics, treatments and vaccines continues.
Does it prevent infection and transmission? We do not know whether the vaccine will prevent infection and protect against onward transmission. Immunity persists for several months, but the full duration is not yet known. These important questions are being studied.
In the meantime, we must maintain public health measures that work: masking, physical distancing, handwashing, respiratory and cough hygiene, avoiding crowds, and ensuring good ventilation.”
You can access the WHO page HERE for all of the pertinent information.
Academy of Breastfeeding Medicine (also known as ABM)
This statement was made in December of 2020 when the FDA emergency approval was given for Pfizer and the Moderna vaccine was anticipated to be approved next, just as it was. The text below is a direct quote from their statement.
“Although there is currently no clinical data on use of COVID-19 mRNA vaccines in lactation, the United States Food and Drug administration EUA left open the possibility of administering the vaccine to both pregnant and lactating individuals.
Many lactating individuals fall into categories prioritized for vaccination, such as front-line health care workers. The Academy of Breastfeeding Medicine does not recommend cessation of breastfeeding for individuals who are vaccinated against COVID-19. Individuals who are lactating should discuss the risks and benefits of vaccination with their health care provider, within the context of their risk of contracting COVID-19 and of developing severe disease. Health care providers should use shared decision making in discussing the benefits of the vaccine for preventing COVID-19 and its complications, the risks to mother and child of cessation of breastfeeding, and the biological plausibility of vaccine risks and benefits to the breastfed child.
These conversations are challenging, because the Pfizer/BioNtech vaccine trial excluded lactating individuals. As a result, there are no clinical data regarding the safety of this vaccine in nursing mothers. However, there is little biological plausibility that the vaccine will cause harm, and antibodies to SARS-CoV-2 in milk may protect the breastfeeding child.
The vaccine is made of lipid nanoparticles that contain mRNA for the SARS-CoV-2 spike protein; the mRNA sequence only encodes this protein. These particles are injected into muscle, where the nanoparticles are taken up by muscle cells. These muscle cells then transcribe the mRNA to produce spike protein. The spike protein made by the cell stimulates an immune response, protecting the individual from COVID-19 illness.
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.”
You can access the ABM page HERE for the entire statement which includes links to scientific information they link.
Society for Maternal-Fetal Medicine: High-Risk Pregnancy Experts (also known as SMFM)
On January 27th, 2021 SMFM, in a joint effort with ACOG, revised their previous statement from December 1st, 2020 regarding covid19 vaccination and pregnant people to reinforce their expert support for covid19 vaccination of pregnant people.
“The American College of Obstetricians and Gynecologists (ACOG) and the Society for Maternal-Fetal Medicine (SMFM) are aware of the World Health Organization’s (WHO) recommendation to withhold COVID-19 vaccines from pregnant individuals unless they are at high risk of exposure. ACOG and SMFM continue to stress that both COVID-19 vaccines currently authorized by the U.S. Food and Drug Administration should not be withheld from pregnant individuals who choose to receive the vaccine. ACOG’s and SMFM’s current guidance on the COVID-19 vaccine in pregnant patients remains in place.
Despite efforts by ACOG and SMFM to advocate for their inclusion, clinical trials that informed the emergency use authorization (EUA) of the vaccines did not include pregnant individuals. 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.
As physicians who care for pregnant individuals, and as vaccine rollout expands to other eligible populations, ACOG and SMFM continue to firmly assert that pregnant individuals should be given the opportunity to make their own decision as to whether to receive the COVID-19 vaccine and that barriers should not be put in place to prevent access and hinder the ability of pregnant people to protect themselves from a virus that could potentially be life-threatening.”
You can access the full statement from SMFM HERE.
Infant Risk Center At Texas Tech University Health Sciences Center
On December 18th, 2020, Infant Risk Center updated their statement on covid19 vaccines and lactating and pregnant people.
“Plain Language Summary: Similar to other medications, pregnant and/or breastfeeding women have not been included in studies to determine how well COVID-19 vaccines work or how safe they are. Based on what we understand from similar vaccines, we believe the risks that come with vaccination will probably be low. Therefore, while we wait for more information, each mother and provider should discuss what choice fits their situation best. The risk and benefit of the vaccine should be compared to each mother’s individual risk for getting COVID-19 as well as how well she is expected to tolerate the disease.
BREASTFEEDING and the COVID-19 Vaccine: The use of these new vaccines in breastfeeding mothers has not been studied, largely because none of them have been approved for use. That said, it is our opinion that most of the COVID-19 vaccines are probably going to be quite safe for breastfeeding mothers and their infants. In these situations, physicians and breastfeeding mothers in consult, will have to weigh the relative risks of the vaccine to that of the infection with Corona virus in that specific mother.
At this time, none of the new vaccines are live or infectious. They are made of very few ingredients: the fragile mRNA, some fats to protect the mRNA for long enough for your body to respond to it, and some salts to make the shot sting less. There are NO preservatives!
All the mRNA vaccines thus far (produced by Pfizer and Moderna) are prepared by stimulating the human mRNA within the cell to build the “spike” proteins. In another set of vaccines, the structure of the spike protein from the virus is synthetically rebuilt by recombinant means and presented bound to another carrier protein to the patient in the injection. The body then creates antibodies to this “spike” protein.
As for breastfeeding, little or none of these vaccine components would ever reach the milk compartment, or even be transferred into human milk. Even if they were, they would simply be digested like any other protein by the infant. It is our opinion, that the present group of vaccines are probably going to be quite safe for breastfeeding mothers. The infant may even gain a small amount of maternal IgG in the breastmilk, which may even be beneficial.
Unfortunately, the safety of these vaccines will only be determined after significant use in patients.
You can find the entire statement HERE with additional commentary on the covid19 vaccine and pregnant people which references the above statement from the Society for Maternal-Fetal Medicine and ACOG.
The American College of Obstetricians and Gynecologists (also known as ACOG)
On January 27th, 2021, ACOG updated its statement on its position on covid19 vaccination and pregnant and lactating people.
The U.S. Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) for the following vaccines: Pfizer-BioNtech mRNA vaccine (BNT162b2): for use in individuals age 16 years and older as a 2-dose regimen given 3 weeks (21 days) apart. Moderna mRNA-1273 vaccine: for use in individuals age 18 and older as a 2-dose regimen given 1 month (28 days) apart.
After an explicit, evidence-based review of all available data, the Advisory Committee on Immunization Practices (ACIP) issued interim recommendations for use of the Pfizer-BioNTech COVID-19 vaccine in persons aged ≥16 years for the prevention of COVID-19 (CDC 2020) and the use of the Moderna-1273 COVID-19 vaccine in persons aged ≥ 18 years (CDC 2020).
ACOG recommends that COVID-19 vaccines should not be withheld from pregnant individuals who meet criteria for vaccination based on ACIP-recommended priority groups.
COVID-19 vaccines should be offered to lactating individuals similar to non-lactating individuals when they meet criteria for receipt of the vaccine based on prioritization groups outlined by the ACIP.
Individuals considering a COVID-19 vaccine should have access to available information about the safety and efficacy of the vaccine, including information about data that are not available. A conversation between the patient and their clinical team may assist with decisions regarding the use of vaccines approved under EUA for the prevention of COVID-19 by pregnant patients. Important considerations include:
the level of activity of the virus in the community
the potential efficacy of the vaccine
the risk and potential severity of maternal disease, including the effects of disease on the fetus and newborn
the safety of the vaccine for the pregnant patient and the fetus.
While a conversation with a clinician may be helpful, it should not be required prior to vaccination, as this may cause unnecessary barriers to access.
The entire ACOG statement can be read HERE.
V-Safe Vaccine Health Checker
In order to best ascertain any potential risks, it is important that if a person decides to get the covid19 vaccine they take the time to report any and all side effects.
The American College of Obstetricians and Gynecologists is asking any pregnant and lactating person that chooses to vaccinate with the covid19 vaccine to use V-Safe to report their experience. Below is the information from their website and at the end a link to the Ap.
“V-safe is a smartphone-based tool that uses text messaging and web surveys to provide personalized health check-ins after you receive a COVID-19 vaccine. Through v-safe, you can quickly tell CDC if you have any side effects after getting the COVID-19 vaccine. Depending on your answers, someone from CDC may call to check on you and get more information. V-safe will also remind you to get your second COVID-19 vaccine dose if you need one.
Note: V-safe cannot schedule vaccine appointments, including second doses of COVID-19 vaccines. If you need to schedule, reschedule, or cancel a COVID-19 vaccination appointment, contact the location that set up your appointment or a vaccine provider in your area. This may be your state or local health department, employer, or vaccine provider. "
You can register for V-Safe HERE.
AETNA MEMBERS/CLIENTS
YOU ARE RESPONSIBLE FOR INFORMING US OF ANY INSURANCE COVERAGE CHANGES FOR YOU AND YOUR BABY
It is your responsibility to check with Aetna to ensure that you are covered for lactation services. Even though Aetna may tell you that you are covered 100 percent, it is possible that some Aetna plans may assign you a ‘Patient Responsibility’ fee which will be charged to the card you have on file. If only your baby is covered under Aetna and you, the lactating parent, are not covered under Aetna, you MUST book a self-pay consult. If your baby is not on the lactating parent’s Aetna plan you must book the baby not on plan appointment and you must pre-pay the appropriate fee for each appointment.
Aetna typically assigns patient financial responsibility to tele-health consults which varies from plan to plan.
CIGNA + BCBS MEMBERS/CLIENTS
YOU ARE RESPONSIBLE FOR INFORMING US OF ANY INSURANCE COVERAGE CHANGES FOR YOU AND YOUR BABY
It is your responsibility to check with Lactation Network to ensure that you are covered for lactation services.
TELE-HEALTH DISCLAIMER
There are inherent limitations because a digital suckling assessment and a physical breast/chest can not be completed. Potential risks to the technology used for tele-health, are beyond the control of the provider, including interruption of connectivity, unauthorized access, and other technical difficulties.
LANGUAGE
If we have used any language that has caused you harm or if there is a better option that we could use, please let us know.
CANCELLATION POLICY
Appointments canceled with less than 48 hour notice will be charged the FULL consult fee which is not covered by insurance. ALL fees for services are non refundable and expire 60 days after the original purchase. The payment and no refund policy is SEPARATE from the cancellation policy. Refunds will NOT be issued once you book. Each client is responsible for all fees associated with each consult. Payment is charged at the time the appointment is scheduled. By scheduling your consult, you grant me permission to communicate with your insurance company regarding the services provided to you and to your child(ren).
Rental agreements: no refunds will be issued for any unused part of the rental terms. All equipment must be returned the day prior to the scheduled new charge in order to avoid being charged for a new rental term.