Coronavirus disease (COVID-19) is a highly infectious disease caused by a coronavirus, SARS-CoV-2, that has caused a global pandemic. The U.S. Food and Drug Administration (FDA) granted Emergency Use Authorization to two vaccines for COVID-19—the Pfizer-BioNTech COVID-19 vaccine on and the Moderna COVID-19 vaccine in December of 2020. Ahead, what to know about these vaccines if you have hypothyroidism or Hashimoto's disease.
There are several stages in the drug development process. Stage 1 is discovery and development, meaning that research for a new drug begins in the laboratory. Stage 2 is preclinical research. This second stage is the step in which medicines undergo laboratory testing to answer basic safety questions. Stage 3 is clinical research, meaning drugs are tested on people to ensure they are safe and effective. In stage 4, the FDA examines all of the submitted data related to the drug or device and decide to approve or not to approve it. Finally, in the fifth, post-market safety monitoring stage in the FDA monitors all drug and device safety once products are available for use by the public.
The Pfizer vaccine gained authorization based on data from an ongoing phase 1/2/3 trial. This trial includes approximately 44,000 participants who are randomized to receive either the Pfizer vaccine or a saline placebo.
The Moderna vaccine gained authorization based on an ongoing phase 3 trial. This trial includes approximately 30,000 participants who are randomized to receive the Moderna vaccine or a saline placebo.
Both vaccines' authorization has been extremely fast, relative to typical FDA approvals. This speedy authorization leaves many of us with questions about the vaccines and who should get the vaccination. The FDA has provided guidelines for both vaccines, including administration to special populations.
Scientists make vaccines by administering one of the following:
The Pfizer and Moderna COVID-19 vaccines are both mRNA-based vaccines. mRNA is "messenger" RNA. mRNA is a copy made from DNA that takes the code from the DNA to ribosomes, the cell's protein factories. The cell breaks down the mRNA after it finishes its instructions, and mRNA never enters the cell's nucleus, which is where our DNA (genetic material) lives.
While mRNA vaccines are a new type of vaccine, the research has been around for decades. Researchers previously studied mRNA vaccines for other infections like the flu, Zika, and rabies. Once the relevant information about the coronavirus that causes COVID-19 became available, scientists started designing the mRNA instructions for our cells to make unique spike protein into an mRNA vaccine.
A spike protein exists on the surface of the virus that causes COVID-19. COVID-19 mRNA vaccines give our cells instructions to make a piece of this spike protein that triggers an immune response inside our bodies. That immune response make antibodies which protect us from getting infected if the real virus enters our bodies.
No, you cannot get COVID-19 from the COVID-19 mRNA vaccines. mRNA vaccines do not contain the live COVID-19 coronavirus.
The ACIP recommends that everyone is vaccinated regardless of whether or not they have had COVID-19. The vaccine trials included people who had previously been sick with COVID, and results suggest that the vaccine provides stronger immunity than immunity from having COVID in the first place.
Recommendations for who should receive the vaccine first come from the Centers for Disease Control and Prevention (CDC). Each state then makes its own plan accordingly. Visit the CDC website to choose your state or territory to find your health department and specific state's plan.
The CDC's recommendations come from the Advisory Committee on Immunization Practices (ACIP), an independent panel of medical and public health experts. These recommendations aim to:
The CDC recommends the following rollout for the COVID-19 vaccine:
The ultimate goal is for everyone to easily get a COVID-19 vaccination as soon as there are enough vaccine quantities available.
People with certain underlying medical conditions may be at increased risk of severe illness (hospitalization, ICU admission, intubation or mechanical ventilation, or death) from COVID-19.
Studies show that adults with the following conditions ARE at increased risk of severe illness from the virus that causes COVID-19:
Adults with the following conditions MIGHT be at an increased risk for severe illness from the virus that causes COVID-19:
Immunodeficiency is when the immune system doesn't respond adequately to infection. Autoimmunity is when the immune system is overactive and responds to healthy cells as though they were foreign.
However, sometimes people with an autoimmune condition develop more than one, called polyautoimmunity. So, if you have Hashimoto's, you may be at higher risk of developing another autoimmune condition. Some autoimmune conditions like myasthenia gravis or lupus do cause immunodeficiency.
Similarly, some autoimmune conditions like psoriasis, lupus, rheumatoid arthritis, Crohn's disease, multiple sclerosis, and alopecia areata are treated with immunosuppressant drugs. Immunosuppressants suppress the immune system to reduce the autoimmune reaction, possibly causing immunodeficiency.
So, if you have only Hashimoto's disease, you are not immunocompromised. If you have another illness in addition to Hashimoto's that causes immunodeficiency or requires immunosuppressants, then you may be immunocompromised.
People with underlying medical conditions can receive the mRNA COVID-19 vaccines if they have not had a severe or immediate allergic reaction to any vaccine ingredients.
The following groups should still get the vaccine even though there is limited safety data:
People with Hashimoto's disease can receive the COVID-19 vaccine. However, you should know that there is currently no data available on mRNA COVID-19 vaccines' safety for Hashimoto's patients. Phase 3 of both vaccines included people with autoimmune conditions with no recorded autoimmune flare-ups. Experts will get more information on the risk of inflammatory response for people living with an autoimmune disease like Hashimoto's as more people get the vaccines.
You receive the COVID-19 vaccine by intramuscular injection—a shot in the upper arm. Both the Pfizer and Modern vaccines require two shots, spaced apart, to get the most protection. The length of time between each shot depends on which vaccine you receive. You should get your second Pfizer dose three weeks (21 days) apart, or your second Moderna dose one month (28 days) apart. Your second dose should come as close to the recommended interval as possible, but no earlier.
The most common side effects reported with both COVID-19 vaccines are redness and swelling at the injection site. There may also be pain, tenderness, and swelling of the lymph nodes in the same arm as the injection. Other side effects may include fatigue, headache, muscle pain, joint pain, chills, nausea or vomiting, and fever.
There is a small chance that either vaccine could cause a severe allergic reaction. If this happens, it would usually occur very shortly after getting a dose. Signs of a severe allergic reaction may include difficulty breathing, face or throat swelling, rapid heartbeat, rash all over your body, dizziness, or weakness.
If you experience a severe allergic reaction, call 9-1-1, or go to the nearest hospital.
Researchers continue to evaluate the protection that COVID-19 vaccines provide. Until we know more, and more people are vaccinated, you should continue to follow the current guidelines after receiving your vaccination to prevent the spread of COVID-19.
To protect yourself and others, follow these recommendations:
If you have specific questions about how the COVID-19 vaccine may interact with your particular thyroid condition and health history, be sure to talk to your doctor. If you need hypothyroid care while you continue to stay home to protect yourself and others, all of Paloma Health's services are still available from the comfort of your home.
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