Moderna COVID-19 Vaccine
Pronunciation: muh-DURR-nah
Generic name: COVID-19 vaccine, mRNA
Brand names: Moderna COVID-19 Vaccine, Spikevax
Dosage form: Intramuscular injection
Drug class: Viral vaccines
What is the Moderna COVID-19 Vaccine (2023-2024 Formula)?
The Moderna COVID-19 (2023-2024 Formula) (COVID-19 Vaccine, mRNA) is a vaccine that may help your body develop immunity to SARS-CoV-2, the virus that causes COVID-19. The Moderna COVID-19 vaccine is an FDA-approved vaccine for adults and adolescents aged 12 years and also has emergency use authorization (EUA) for children aged 6 months to 11 years.
This updated vaccine contains spike proteins for the XBB.1.5 sublineage of SARS-CoV-2 and trials have shown it elicits robust immune responses across multiple XBB sublineages including XBB.1.5, XBB.1.16, and also against EG.5, FL.1.5.1, and BA.2.86. Vaccination with the Moderna COVID-19 Vaccine may not protect all people who receive the vaccine.
For individuals previously vaccinated with any COVID-19 vaccine, the dose of the Moderna COVID-19 Vaccine should be administered at least 2 months after the last dose of the COVID-19 vaccine.
The Moderna COVID-19 Vaccine (2023-2024 Formula) was FDA-approved and granted EUA on September 11, 2023.
Warnings
Contraindicated in people who have had a severe allergic reaction (such as anaphylaxis) to any component of the Moderna COVID-19 Vaccine.
Postmarketing data has revealed there is an increased risk of myocarditis and pericarditis, particularly within the first week following vaccination. The highest observed risk for the Moderna COVID-19 Vaccine is in males aged 18 years through 24 years of age.
Immunocompromised persons, including individuals receiving immunosuppressive therapy, may have less of a response to the Moderna COVID-19 Vaccine.
Who should not receive the Moderna COVID-19 Vaccine?
You should not receive the Moderna COVID-19 Vaccine if you have had:
- a severe allergic reaction to a previous dose of the Moderna COVID-19 Vaccine (also called Spikevax) or any of the components of the vaccine (see below 'What are the ingredients in the Moderna COVID-19 Vaccine?').
There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to the Moderna COVID-19 Vaccine during pregnancy and women should enroll by calling 1-866-MODERNA (1-866-663-3762).
There is insufficient data to inform vaccine-associated risks in pregnancy, but animal studies have revealed no evidence of harm to the fetus. Pregnant women infected with SARS-CoV-2 are at increased risk of severe COVID-19 compared with non-pregnant women.
It is not known whether the Moderna COVID-19 Vaccine is excreted in human milk or its effects on the breastfed infant or milk production/excretion. Consider the benefits versus the risks.
Safety and effectiveness have not been established in children less than 12 years of age. Evidence from clinical studies strongly suggests that a single dose of the Moderna COVID-19 Vaccine is ineffective in individuals younger than 2 years of age.
What should I tell my healthcare provider?
Tell your healthcare provider about all your medical conditions, including if you:
- have any allergies
- had a severe allergic reaction after receiving a previous dose of any COVID-19 vaccine
- have had myocarditis (inflammation of the heart muscle) or pericarditis (inflammation of the lining outside the heart)
- have a fever
- have a bleeding disorder or are on a blood thinner
- are immunocompromised or are on a medicine that affects your immune system
- are pregnant or plan to become pregnant
- are breastfeeding
- have received any other COVID-19 vaccine
- have ever fainted in association with an injection.
How is the Moderna COVID-19 Vaccine given?
The Moderna COVID-19 Vaccine is given as an injection into the muscle, usually the deltoid muscle of the arm.
A single dose is 0.5 mL.
For individuals previously vaccinated with any COVID-19 vaccine, the dose of the Moderna COVID-19 Vaccine should be administered at least 2 months after the last dose of the COVID-19 vaccine.
What are the side effects of the Moderna COVID-19 Vaccine?
Severe allergic reactions have occurred in some people who have received the Moderna COVID-19 Vaccine(also called Spikevax). There is a very small chance that the Moderna COVID-19 Vaccine could cause a severe allergic reaction. A severe allergic reaction would usually occur within a few minutes to one hour after getting a dose of the Moderna COVID-19 Vaccine. For this reason, your healthcare provider may ask you to stay for a short time at the place where you received your vaccine.
Signs of a severe allergic reaction can include:
- Difficulty breathing
- Swelling of your face and throat
- A fast heartbeat
- A rash all over your body
- Dizziness and weakness.
Myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the lining outside the heart) have occurred in some people who have received the Moderna COVID-19 Vaccine (also called Spikevax), more commonly in males aged 18 years through 24 years of age than among females and older males. In most of these people, symptoms began within a week of the Moderna COVID-19 vaccination. The chance of this happening is very low. You should seek medical attention right away if you have any of the following symptoms after receiving the Moderna COVID-19 vaccine:
- Chest pain
- Shortness of breath
- Feelings of having a fast-beating, fluttering, or pounding heart.
The most common side effects reported with the Moderna COVID-19 Vaccine include:
- Pain at the injection site (up to 91%)
- Fatigue (up to 58%)
- Headache (up to 56%)
- Muscle pain (up to 40%)
- Chills (up to 30%)
- Under the armpit swelling/tenderness (up to 28%)
- Joint pain (up to 24%)
- Nausea/vomiting (up to 18%)
- Swelling at the injection site (up to 13%).
Side effects that have been reported during post-authorization use of the vaccine include:
- Severe allergic reactions
- Myocarditis (inflammation of the heart muscle)
- Pericarditis (inflammation of the lining outside the heart)
- Fainting in association with injection of the vaccine.
These may not be all the possible side effects of the Moderna COVID-19 Vaccine. Ask your healthcare provider about any side effects that concern you. You may report side effects to the Vaccine Adverse Event Reporting System (VAERS) at 1-800-822-7967 or https://vaers.hhs.gov
What other drugs will affect the Moderna COVID-19 Vaccine?
Tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Tell your healthcare provider if you take:
- a blood thinner
- a medicine that affects your immune system.
Also, tell your healthcare provider if you have received any other COVID-19 vaccines.
What are the ingredients in the Moderna COVID-19 Vaccine?
Active ingredients: Each 0.5 mL dose of the Moderna COVID-19 Vaccine (2023-2024 Formula) contains 50 mcg nucleoside-modified messenger RNA (mRNA) encoding the pre-fusion stabilized Spike glycoprotein (S) of the SARS-CoV-2 Omicron variant lineage XBB.1.5.
Other ingredients: Each dose also contains the following ingredients: a total lipid content of 1.01 mg (SM-102, polyethylene glycol [PEG] 2000 dimyristoyl glycerol [DMG], cholesterol, and 1,2-distearoyl-sn-glycero-3-phosphocholine [DSPC]), 0.25 mg tromethamine, 1.2 mg tromethamine hydrochloride, 0.021 mg acetic acid, 0.10 mg sodium acetate trihydrate, and 43.5 mg sucrose.
The Moderna COVID-19 Vaccine does not contain a preservative.
The vial stoppers, rubber tip cap, and plunger used for the single-dose syringes are not made with natural rubber latex
The Moderna COVID-19 Vaccine does not contain SARS-CoV-2, the virus that causes COVID-19, and cannot give you COVID-19.
Storage
Store frozen between -50°C to -15°C (-58°F to 5°F).
- Vials may be stored refrigerated between 2°C to 8°C (36°F to 46°F) for up to 30 days before first use.
- Vials should be discarded 12 hours after the first puncture.
- Vials may be stored between 8°C to 25°C (46°F to 77°F) for a total of 24 hours.
- Vials should be discarded 12 hours after the first puncture.
- Total storage at 8°C to 25°C (46°F to 77°F) must not exceed 24 hours.
Syringes may be stored refrigerated between 2°C to 8°C (36°F to 46°F) for up to 30 days.
- Syringes may be stored between 8°C to 25°C (46°F to 77°F) for up to 24 hours.
Do not refreeze once thawed.
Thawed vials and syringes can be handled in room light conditions.
Manufacturer
Moderna US, Inc.
References
More about Moderna COVID-19 Vaccine (sars-cov-2 (covid-19) mrna-1273 vaccine)
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