As the pandemic moves along and more information is learned about COVID-19, the vaccine, and treatments, we can expect recommendations to change and be updated on a frequent basis. Many women who are pregnant (or planning to become pregnant) have been keeping an eye on recommendations for the COVID-19 vaccine and pregnancy. While there are not definitive conclusions at this time, we have seen many recommendations come out.
Rate of COVID-19 infection higher among pregnant women, study shows
The authors of a publication in the American Journal of Obstetrics & Gynecology recently concluded that pregnant women “should be broadly prioritized for COVID-19 vaccine allocation in the United States.” This conclusion was based on their analysis of data from 35 hospitals and clinic systems in the state of Washington. These systems account for 61% of deliveries in the state each year.1
The research team led by Erica M. Lokken, PhD, MS, and Kristina M. Adams Waldorf, MD from the University of Washington identified 240 women who tested positive for the severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) via polymerase chain reaction (PCR) tests from March 1 to June 30, 2020. This came out to a rate of 13.9 cases for every 1,000 deliveries. Comparing this to the 7.3 per 1,000 rate among all 20 to 39 year old adults in Washington State meant that those pregnant were 70% more likely to have been infected with the COVID-19 coronavirus. Excluding the 45 cases of patients who didn’t have any symptoms when they screened for SARS-CoV2 dropped the rate to 11.3 COVID-19 coronavirus cases per thousand deliveries. That’s still 30% higher than the rate for 20 to 39 year old adults in general.
The authors note that there may have been other reasons why those pregnant happened to be at greater risk for being exposed to the virus. For example, perhaps pregnancy may have meant on average more visits to health care settings, which during those months could have had more of the virus going around, especially those settings that were not taking proper precautions. Of note, in the study, 70.7% of the 240 pregnant women who tested positive for SARS-CoV-2 were from racial and ethnic minority groups.
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Infected pregnant women may have increased risk of severe illness
Studies have shown that pregnant people may do worse after getting infected with the COVID-19 coronavirus. The Centers for Disease Control and Prevention (CDC) warns on its website that “pregnant people with COVID-19 have an increased risk of severe illness, including illness that results in ICU admission, mechanical ventilation, and death compared with non-pregnant women of reproductive age. Additionally, pregnant people with COVID-19 might be at increased risk of adverse pregnancy outcomes, such as preterm birth, compared with pregnant women without COVID-19.”2
This came after the recommendation by the American College of Obstetricians and Gynecologists (ACOG) in December of 2020. In December of 2020, ACOG posted recommendations on vaccinating pregnant and lactating patients against COVID-19.
As per ACOG, some data suggests that symptomatic pregnant patients with COVID-19 are at a greater risk of more severe illness. This data indicates an increased ICU admission, need for mechanical ventilation and ventilatory support. With this in mind, it is important for women who are pregnant or breast feeding to assess their individual risk verses benefit of the vaccine with their physician.
When can pregnant women receive the vaccine?
The Advisory Committee on Immunization Practices (ACIP) develops recommendations on how to use vaccines to control disease in the United States. The Committee’s recommendations are sent to CDC’s Director for approval. Once the ACIP recommendations have been reviewed and approved by the CDC Director and the U.S. Department of Health and Human Services, they are published in CDC’s Morbidity and Mortality Weekly Report (MMWR). The MMWR publication represents the final and official CDC recommendations for immunization of the U.S. population (ACIP). ACOG has representation on the ACIP, including on the ACIP COVID-19 working groups.
ACIP has made the following recommendations for prioritization of COVID-19 vaccine allocation:
Phase 1a: Health care workers and long-term care facility residents
Phase 1b: Persons aged ≥75 years and frontline essential workers
Phase 1c: Persons aged 65-75 years, persons aged 16-64 years with high-risk* medical conditions (including pregnancy), and other essential workers
*High-risk medical conditions outlined by the CDC include:
- Pregnancy
- Cancer
- Chronic kidney disease
- COPD (chronic obstructive pulmonary disease)
- Heart conditions, such as heart failure, coronary artery disease, or cardiomyopathies
- Immunocompromised state (weakened immune system) from solid organ transplant
- Obesity (body mass index [BMI] of 30 kg/m2 or higher but < 40 kg/m2)
- Severe Obesity (BMI ≥ 40 kg/m2)
- Sickle cell disease
- Smoking (current or history)
- Type 2 diabetes mellitus
For pregnant women considering receiving the vaccine, some of the recommendations listed are as follows:
- 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.
- Pregnancy testing should not be a requirement prior to receiving any EUA-approved COVID-19 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.
ACOG also 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.
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What about individuals contemplating pregnancy?
ACOG’s position at this time is that the 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.
Furthermore, given the mechanism of action and the safety profile of the vaccine in non-pregnant individuals, COVID-19 mRNA vaccines are not thought to cause an increased risk of infertility.
While there seem to be good reasons to accept the vaccine, some women are still hesitant to follow through with this recommendation. At this time there is limited amount of data on the safety and efficacy of COVID-19 vaccines in pregnant people. For example, during the Phase 3 clinical trial, so far only about a couple dozen people have become pregnant after receiving the Pfizer/BioNTech Covid-19 vaccine, based on available reports. None of them to date have had substantial problems with the vaccine based on what data has been published. However, this isn’t enough to draw any strong conclusions.
On January 8, 2021, this lack of data was the reason the World Health Organization did not recommend the vaccination of pregnant women. Since then, their position has changed and was updated on January 29, 2021, stating that “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., healthcare workers) or who have comorbidities which add to their risk of severe disease may be vaccinated in consultation with their health care provider. Pregnant people at high risk of exposure (i.e., healthcare workers) may consider vaccination because of the higher risk of severe Covid-19 infection in pregnancy.”
The CDC currently states that getting vaccinated if you are pregnant is “a personal choice.” It is recommended that pregnant women talk to their doctor to review their risk of being exposed to the SARS-CoV2 and weighing it against the current unknowns about the COVID-19 vaccine.
