The wait is finally over as we transition into Phase 1 of COVID-19 vaccinations. Many patients have been inquiring about the safety of the COVID-19 vaccine in pregnancy and lactation. I often am asked if it is safe to get the vaccine while pregnant or breastfeeding. Due to the lack of data regarding the safety and effectiveness of the vaccine in these populations, this decision can be difficult to make.
The following is a summary regarding the current available COVID-19 vaccines, the original research data behind each vaccine, and the current distribution protocol. Since pregnant and lactating women were not included in the initial research studies, each individual will need to decide for herself what the right decision is. There is unknown safety in the setting of pregnancy and lactation. However, there are also potentially devastating complications that can arise with COVID-19 infection.
There are currently 2 vaccines that have been FDA approved and are available for administration.
Neither of these vaccines have been studied in pregnant or lactating individuals.
Pfizer-BioNtech mRNA vaccine is approved for individuals 16 years and older. This is given as 2 doses, 21 days apart.
Moderna mRNA-1273 vaccine is approved for individuals 18 years and older. This is given as 2 doses, 28 days apart.
Unfortunately, there is no data regarding the outcomes and symptoms that pregnant women, lactating women, or their babies may experience. These women were not included in the research that has been published so far. However, the American College of Obstetricians and Gynecologists (ACOG) advises that COVID-19 vaccination should not be withheld from these women who qualify based on the target categories outlined by the Advisory Committee on Immunization Practices (ACIP). Based on these phase groups, pregnant and lactating women should be given equal importance and priority when they meet requirements for obtaining the vaccine.
The current recommendation of the American College of Obstetricians and Gynecologists is that COVID-19 vaccines should not be withheld from pregnant individuals and lactating individuals who meet criteria for vaccination based on the priority groups outlined by the Advisory Committee on Immunization Practices (ACIP).
ACIP has made recommendations regarding the top priority groups for COVID-19 vaccination. This is referred to as Phase 1 and is broken down further into subcategories. This is currently the phase we are in.
Both vaccines are mRNA vaccines. These vaccines teach our cells how to make “spike protein.” Spike protein is found on the surface of the COVID-19 virus. Once our cells make the spike protein, this protein is displayed on the surface of the cell. Our immune system recognizes this spike protein as foreign and begins to develop antibodies against it. In the future, if an individual who has previously been vaccinated is exposed to the COVID-19 virus, the immune system is prepared to attack the virus and prevent disease.
The Pfizer vaccine was studied in 43,548 individuals in a multinational, placebo-controlled trial. These individuals were age of 16 years or older and healthy or had stable chronic medical issues. Individuals with a history of COVID-19 disease were excluded. The studied population was equally divided to receive either the vaccine or placebo. There were 8 cases of COVID-19 in the vaccine group and 162 cases in the placebo group. Thus, the 2-dose regimen of the Pfizer vaccine has been shown to be 95% effective in reducing COVID-19 disease.
This initial study includes data for 2 months after the second dose. Occurrence of adverse events more than 2 months after the second dose and the duration of immunity remain to be determined.
For more information the Pfizer vaccine, please refer to the original research published in the New England Journal of Medicine.
The Moderna trial included 30,420 participants spread across 99 centers in the United States only. The participants were age 18 years or older. People with prior COVID-19 disease were excluded. These individuals were equally divided to receive either the vaccine or placebo. There were 11 cases of COVID-19 in the vaccine group and 185 cases of COVID-19 in the placebo group. It is interesting to note that all severe COVID-19 cases occurred in the placebo group only. Thus, the 2-dose regimen of the Moderna vaccine has been shown to be 94.1% effective in reducing COVID-19 disease.
Only data for the initial 2 months after the second dose has been released. The trial is ongoing and plans are to follow participants for 2 years.
For more information regarding the Moderna vaccine, please refer to the original research published in The New England Journal of Medicine.
The side effects of both the Pfizer and Moderna vaccines are similar. Most commonly, people have experienced mild to moderate pain at the injection site. Additional side effects include but are not limited to fatigue, headache, body aches, joint pain, fever, and chills. These side effects usually resolved within a few days.
Deaths were reported in both trials and in both the vaccine and placebo groups. Reasons for death included cardiac arrest, stroke, and suicide. None of these deaths were thought to be caused by the vaccine.
There are unsubstantiated claims the COVID-19 vaccine can alter a person’s DNA, cause auto-immune disorder, and cause infertility. These are theoretical claims and there is no proof. These claims also have to be taken in context of the ongoing pandemic. On one hand, there are theoretical claims of long-term harm with the COVID-19 vaccine. On the other hand, there is the actual likelihood of contracting the virus and dealing with the acute and chronic complications of COVID-19 infection. All of our organ systems have been shown to be vulnerable to long-term effects of COVID-19. Examples include cardiovascular disease, lung disease, mood disorders, and blood clots leading to strokes.
People who have severe allergic reaction to the first dose of either the Pfizer or Moderna vaccine, should not receive the second dose.
People who have severe allergic reaction to any of the vaccine ingredients should also not receive it.
The ingredients of the Pfizer COVID-19 vaccine are: mRNA, lipids ((4-hydroxybutyl)azanediyl)bis(hexane-6,1-diyl)bis(2-hexyldecanoate), 2 -N,N-ditetradecylacetamide, 1,2-Distearoyl-sn-glycero-3- phosphocholine, and cholesterol), potassium chloride, monobasic potassium phosphate, sodium chloride, dibasic sodium phosphate dihydrate, and sucrose.
The ingredients of the Moderna COVID-19 vaccine are: mRNA, lipids (SM-102, polyethylene glycol 2000 dimyristoyl glycerol , cholesterol, and 1,2-distearoyl-sn-glycero-3-phosphocholine ), tromethamine, tromethamine hydrochloride, acetic acid, sodium acetate, and sucrose.
Additional research and data are needed regarding the safety of the vaccines in populations that were not initially studied. This includes children, adolescents, pregnant individuals, and lactating individuals.
Additional research and data are also needed regarding the duration of immunity provided by the vaccine.
There are several more COVID-19 vaccines that are expected to become available and the data for these additional vaccines will also need to be examined.
Given the proven efficacy of Pfizer and Moderna COVID-19 vaccines in initial trials, emergency approval has been given to help reduce the catastrophic loss of life, economic, and social well-being that has resulted from the ongoing pandemic. Adding these vaccines to our arsenal against COVID-19 will hopefully lead to an end of this devastating disease.
Pregnancy – This includes every trimester.
Cancer – This is inclusive of all different types of cancer.
Chronic kidney disease – This can include, but is not limited to, kidney stones, Glomerulonephritis, Polycystic kidney disease, and Urinary tract infections (UTIs).
COPD – COPD stands for chronic obstructive pulmonary disease – a lung disease that restricts your airflow.
Heart conditions – This includes, but is not limited to heart failure, coronary artery disease, or cardiomyopathies.
Immunocompromised state – This means having a weakened immune system from a solid organ transplant, such as if a patient recently had a kidney transplant.
Obesity – This includes patients that have a body mass index BMI of 30 kg/m2 or higher but < 40 kg/m2.
Severe Obesity – This includes patients that have a BMI ≥ 40 kg/m2
Sickle cell disease
Smoking– This includes patients that currently smoke or have a history of smoking.