CDC and ACOG: Updated Covid-19 Vaccination Recommendations for Pregnant and Lactating Populations

The CDC and the independent Advisory Committee on Immunization Practices (ACIP) have recently provided information to assist pregnant people with their decision to receive the COVID-19 vaccine. At this time, ACIP recommends that healthcare personnel be offered vaccination in the initial phase of the COVID-19 vaccination program. Healthcare personnel who are pregnant may choose to be vaccinated. If they have questions around getting vaccinated, a discussion with a healthcare provider might help them make an informed decision.

While it is understood that more than 1/3 of Healthcare provider could be pregnant or become pregnant during the vaccine role it outs important to undestand the available data.

Limited Data for Pregnancy and Breast/Chestfeeding.

At present, there is limited data available on the safety of COVID-19 vaccines for people who are pregnant. Animal developmental and reproductive toxicity (DART) studies are ongoing and studies in people who are pregnant are planned. CDC and the Food and Drug Administration (FDA) have safety monitoring systems in place to capture information about vaccination during pregnancy and will closely monitor reports.

While studies have not yet been done, based on how mRNA vaccines work, experts believe they are unlikely to pose a risk for people who are pregnant. mRNA vaccines do not contain the live virus that causes COVID-19 and therefore cannot give someone COVID-19. Additionally, mRNA vaccines do not interact with genetic material DNA because the mRNA does not enter the nucleus of the cell. Cells break apart the mRNA quickly. However, the potential risks of mRNA vaccines to the pregnant person and her fetus are unknown because these vaccines have not been studied in pregnant women.

According the the American College of Obstetricians and Gynecologist ACOG

COVID-19 vaccine development and regulatory approval are rapidly progressing. Thus, information and recommendations will evolve as more data are collected about these vaccines and their use in specific populations. This Practice Advisory is intended to be an overview of currently available COVID-19 vaccines and guidance for their use in pregnant and lactating patients.

  • On December 11, 2020, the U.S. Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) for the Pfizer-BioNtech mRNA vaccine (BNT162b2) for use in individuals age 16 years and older as a 2-dose regimen given 3 weeks apart. This vaccine has shown to be 95% effective at preventing COVID-19 illness after the second dose.
  • On December 12, 2020, after an explicit, evidence-based review of all available data, the Advisory Committee on Immunization Practices (ACIP) issued an interim recommendation for use of the Pfizer-BioNTech COVID-19 vaccine in persons aged ≥16 years for the prevention of COVID-19 illness. 
  • 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.
  • Vaccines currently available under EUA have not been tested in pregnant women. Therefore, there are no safety data specific to use in pregnancy. See details about the Food and Drug Administration’s (FDA) EUA process below.
  • Pregnancy testing should not be a requirement prior to receiving Pfizer-BioNTech vaccine. 
  • Pregnant patients who decline vaccination should be supported in their decision. Regardless of their decision to receive or not receive the vaccine, these conversations provide an opportunity to remind patients about the importance of other prevention measures such as hand washing, physical distancing, and wearing a mask. 
  • Expected side effects should be explained as part of counseling patients, including that they are a normal part of the body’s reaction to the vaccine and developing antibodies to protect against COVID-19 illness.
  • The mRNA vaccines are not live virus vaccines, nor do they use an adjuvant to enhance vaccine efficacy. These vaccines do not enter the nucleus and do not alter human DNA in vaccine recipients. As a result, mRNA vaccines cannot cause any genetic changes.

Are You at Risk?

Observational data demonstrate that, while the chances for these severe health effects are infrequent, pregnant people with COVID-19 have an increased risk of severe illness, including illness that results in ICU admission, mechanical ventilation, and death. Additionally, pregnant people with COVID-19 might be at increased risk of adverse pregnancy outcomes, such as preterm births.

Because supplies are currently limited, CDC recommends certain groups receive the first supply of COVID-19 vaccines

At this time, healthcare personnel are recommended to be among the first to receive the vaccine because they are at increased risk of exposure to the virus that causes COVID-19.

Recommendations for the Pregnant, Lactating, and those Trying to Conceive

Pregnant Individuals

ACOG recommends that COVID-19 vaccines should not be withheld from pregnant individuals who meet criteria for vaccination based on ACIP-recommended priority groups. While safety data on the use of COVID-19 vaccines in pregnancy are not currently available, there are also no data to indicate that the vaccines should be contraindicated, and no safety signals generated from DART studies for the Pfizer-BioNtech vaccine. Therefore, in the interest of allowing pregnant individuals who would otherwise be considered a priority population for a vaccine approved for use under EUA, make their own decisions regarding their health, ACOG recommends that pregnant individuals should be free to make their own decision in conjunction with their clinical care team.

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 pandemic in the community, the potential efficacy of the vaccine, the potential risk and severity of maternal disease, including the effects of disease on the fetus and newborn, and 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. 

Clinicians should review the available data on risks and benefits of vaccination with pregnant patients, including the risks of not getting vaccinated in the context of the individual patient’s current health status, and risk of exposure, including the possibility for exposure at work or home and the possibility for exposing high-risk household members. Conversations about risk should take in to account the individual patient’s values and perceived risk of various outcomes and should respect and support autonomous decision-making (ACOG 2013). 

Pregnant women who experience fever following vaccination should be counseled to take acetaminophen, as fever has been associated with adverse pregnancy outcomes. Acetaminophen has been proven to be safe for use in pregnancy and does not appear to impact antibody response to COVID-19 vaccines. 

Pregnant patients who decline vaccination should be supported in their decision. Regardless of their decision to receive or not receive the vaccine, these conversations provide an opportunity to remind patients about the importance of other prevention measures such as hand washing, physical distancing, and wearing a mask. 

Lactating Individuals

ACOG recommends COVID-19 vaccines 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. 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. 

Individuals Contemplating Pregnancy

Vaccination is strongly encouraged for non-pregnant individuals within the ACIP prioritization group(s). 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. 

If an individual becomes pregnant after the first dose of the COVID-19 vaccine series, the second dose should be administered as indicated. If an individual receives a COVID-19 vaccine and becomes pregnant within 30 days of receipt of the vaccine, participation in CDC’s V-SAFE program should be encouraged (see below for more information on CDC’s V-SAFE program).

Importantly, routine pregnancy testing is not recommended prior to receiving a COVID-19 vaccine. 

If you or your loved one is still undecided and would like more resources to aid in the decision making process specifically due to the harm caused within communities of color over the centuries which has lead to feelings of distrust, here are a few resources:

Additional Resources for Communicating with Communities of Color