Frequently Asked Questions About Moderna COVID-19 Vaccine (mRNA-1273)
Class: Biological Therapy
Generic Name: mRNA-1273
Name: Moderna COVID-19 Vaccine
For which conditions is Moderna COVID-19 Vaccine drug used? The U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) for the Moderna COVID-19 Vaccine for immunization to prevent COVID-19 in individuals 18 and older. The EAU permits the emergency use of the vaccine although it has not been FDA approved. There are currently no FDA approved vaccines to prevent COVID-19.
What is the mechanism of action? The Moderna COVID-19 Vaccine works by using genetic material (messenger-RNA) to initiate the body to create a protein from the virus which then promotes an immune system response to recognize the virus and learn to attack the virus. There are no vaccines using this technology that have ever been approved by the FDA.
How is the Moderna COVID-19 Vaccine typically given (administered)? Moderna COVID-19 Vaccine is an intramuscular injection given in two doses, four weeks apart. Individuals who have received one dose of the Moderna COVID-19 Vaccine should receive a second dose of the Moderna COVID-19 Vaccine. There is no data to support interchangeability of this vaccine with other COVID-19 vaccines.
How are patients typically monitored? Patients will be monitored for immediate allergic reactions after receiving the Moderna COVID-19 Vaccine.
What side effects have been reported? Side effects that have been reported include the following:
- Injection site pain
- Muscle pain
- Joint pain
- Injection site swelling
- Injection site redness
- Feeling unwell
- Swollen lymph nodes
It is important to report side effects to your healthcare provider. Some patients may experience other side effects that are not listed here and additional side effects may become apparent with more widespread use of the Moderna COVID-19 Vaccine.
What can patients do to help alleviate or prevent discomfort and side effects?
- If you have a history of severe allergic reaction to any component of the Moderna COVID-19 Vaccine, tell your healthcare provider and do not receive the vaccine. Components of the Moderna COVID-19 Vaccine include lipids, cholesterol, tromethamine, tromethamine hydrochloride, acetic acid, sodium acetate and sucrose.
Are there any special precautions patients should be aware of before receiving the Moderna COVID-19 Vaccine?
- Tell your vaccination provider if any of the following apply to you:
- Have any allergies
- Have a fever
- Have a bleeding disorder or are on a blood thinner
- Are immunocompromised
- Are on a medicine that affects your immune system
- Are pregnant or plan to become pregnant
- Are breastfeeding
- Have received another COVID-19 vaccine
- Tell your healthcare provider if you have a history of a severe allergic reaction to any component of the Moderna COVID-19 Vaccine.
- Individuals who are immunocompromised, should be aware that they could have a diminished immune response to the vaccine.
- The Moderna COVID-19 Vaccine may not protect all vaccine recipients from contracting COVID-19.
- At this time, the vaccine-associated risks are unknown in individuals who are pregnant or breastfeeding.
- The EUA of the Moderna COVID-19 Vaccine does not include use in individuals younger than 18.
When should patients notify their physician? Notify your physicians of any signs of severe allergic reaction that include difficulty breathing, swelling of your face and throat, rapid heartbeat, rash, dizziness and weakness. You should also notify your physician of any side effects that bother you or do not go away.
What is a package insert?
A package insert is required by the FDA and contains a summary of the essential scientific information needed for the safe and effective use of the drug for healthcare providers and consumers. A package insert typically includes information regarding specific indications, administration schedules, dosing, side effects, contraindications, results from some clinical trials, chemical structure, pharmacokinetics and metabolism of the specific drug. By carefully reviewing the package insert, you will get the most complete and current information about how to safely use this drug. If you do not have the package insert for the drug you are using, your pharmacist or physician may be able to provide you with a copy.
Last updated on 12/20.
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