American College of Obstetricians and Gynecologists states pregnant women shouldn’t be left out.
Frontline health workers celebrate the arrival of Covid-19 vaccines. But obstetricians, like me, are frustrated that the clinical guidance for vaccinating pregnant women is unclear. More than 3.7 million women give birth in the U.S. per year. Excluding pregnant women from vaccine eligibility creates a significant risk for moms and babies.
On December 11, the Pfizer-BioNTech mRNA vaccine was approved under an Emergency Use Authorization (EUA) by the U.S. Food and Drug Administration (FDA). Data shows this vaccine to be 95% effective at preventing Covid-19 illness. The Advisory Committee on Immunization Practices (ACIP) issued an interim recommendation allowing vaccination of those 16 years and older. The guidance did not include specific recommendations for pregnant women.
On December 13, the American College of Obstetricians and Gynecologists (ACOG) issued a strong response advocating for the inclusion of pregnant women in a practice advisory release titled “Vaccinating Pregnant and Lactating Patients Against Covid-19,” ACOG is clear in its clinical guidance; pregnant and breastfeeding women should not be left out.
Much remains unknown about the novel coronavirus’s effects on pregnant women and babies. New research shows most pregnant women with Covid-19 do well but have an increased risk of ICU admission and preterm labor.
Under Operation Warp Speed, data is collected on outcomes from vaccine recipients who are pregnant or become pregnant. Retrospective data can be analyzed in the future to perform bridge studies indicating pregnancy safety.
ACOG does not support waiting for more data before taking protective action. The practice advisory statement supports immediate access to Covid-19 vaccines for pregnant and breastfeeding women.
Covid-19 vaccines should be offered to lactating individuals similar to non-lactating individuals when they meet the criteria for receipt of the vaccine based on prioritization groups outlined by the ACIP.
The mRNA vaccines, such as Pfizer-BioNtech and Moderna, contain no live virus. Since no live virus is present, one can not get Covid-19 from this technology.
These vaccines do not use an adjuvant to enhance vaccine efficacy. An adjuvant is an agent used to provoke a more robust immune response. These vaccines do not make use of adjuvants.
Pregnant patients can rest assured mRNA vaccines cannot cause genetic changes. The mRNA vaccines do not enter the nucleus of our cells. They do not alter the human DNA of vaccine recipients.
Pregnant women are a high-risk population
Based on our current scientific understanding of Covid-19 infection in pregnancy, there is no evidence indicating pregnant women are more at risk of catching Covid-19 than the general public. In general, viral infections in pregnancy increase risk and lead to poor outcomes in mothers and newborns.
Pregnant women have a suppressed immune system and experience changes in the way the respiratory system functions. These physiological changes put pregnant women at a higher risk for respiratory problems when they contract other similar viruses such as MERS, SARS, influenza, or pneumonia.
Research from the University of Texas Southwestern in Dallas published in JAMA showed that 95% of women who tested positive for Covid-19 during pregnancy had no adverse outcomes. Still, 5% of infected women experienced severe complications such as pneumonia and respiratory distress.
This study also showed a low 3% rate of newborn infections, consistent with our previous reporting. Data from the PRIORITY Study (Pregnancy Coronavirus Outcomes Registry) showed babies born to Covid-19-positive women do well with no increase in negative outcomes such as low birth weight, difficulty breathing, apnea, or respiratory infections through the first eight weeks of life.
With Covid-19 cases surging across the country, ACOG recommends protecting pregnant women and their babies now. Their practice advisory statement does not recommend waiting for physician approval or pregnancy testing before administering the vaccine.
ACOG encourages informed consent
The practice advisory statement advocates health care providers focus attention on proper informed consent. Patients and providers must be aware of the lack of data regarding the use of Covid-19 vaccines in pregnancy and weigh that against the known risks to pregnant women infected with the coronavirus.
ACOG encourages providers and patients to consider the level of community viral prevalence, the 95% vaccine efficacy, and the risk of infection to mom and baby.
Patients should be informed of the expected immune response leading to side effects such as injection site pain, swelling, fatigue, headache, and low-grade fever.
ACOG also encourages physicians to support those who choose not to receive the Covid-19 vaccine.
What about vaccinating breastfeeding women?
ACOG takes a similar stance on vaccinating women who are breastfeeding. The Covid-19 vaccine trials did not include lactating women, but the practice advisory statement recommends that Covid-19 vaccines be offered to breastfeeding women.
ACOG recommendations state breastfeeding women who meet the vaccination criteria should be eligible because the theoretical vaccine concerns do not outweigh the potential benefits.
How do pregnant women protect themselves from Covid-19?
We all must do our part to prevent the spread of the virus. Pregnant women should follow the same global recommendations:
- Wash your hands with soap and water for at least 20 seconds.
- Use hand sanitizer containing at least 60% alcohol.
- Avoid touching your face.
- Practice social distancing.
- Cover your mouth if you cough or sneeze.
- Clean your cellphone and household surfaces.
- Avoid travel.
- Wear a mask when out in public.
- Get your flu shot.
Blog Author: Dr. Jeff Livingston