COVID-19 Vaccine, mRNA Bivalent (Moderna)

Information from clinical trials is available at this time to support the use of COVID-19 vaccine, mRNA, bivalent (Moderna) to prevent COVID-19.

The FDA has approved an EUA for the COVID-19 vaccine, mRNA, bivalent for individuals 6 months of age or older who have not received any previous COVID-19 vaccine, to be given as:

• a single dose for individuals 6 years of age through 64 years of age
• a 2-dose series for individuals 6 months through 5 years of age, given 1 month apart
• a single dose for individuals 65 years of age and older with an additional dose 4 months or more later

The FDA has also approved an EUA for the COVID-19 vaccine, mRNA, bivalent for individuals 6 months through 5 years of age who have previously been vaccinated against COVID-19 with COVID-19, mRNA, monovalent (Moderna) (no longer authorized for use in the United States) to be given as a single dose. If the individual had received more than 1 dose of the previous vaccine, at least two months should pass since the last dose before the COVID-19, mRNA, bivalent is given,

The FDA has also approved an EUA for the COVID-19 vaccine, mRNA, bivalent for individuals 6 years of age and older who have previously been vaccinated with 1 or more dose of any monovalent COVID-19 vaccine given as a single dose at least 2 months after their last dose of the monovalent COVID-19 vaccine. For individuals over 65 years of age, one additional dose may be given at least 4 months after the first dose of COVID-19, mRNA, bivalent vaccine.

Talk to your doctor or vaccine provider about the risks and benefits of receiving this medication.

🔔 What is COVID-19?

COVID-19 disease is caused by a coronavirus called SARS-CoV-2. This type of coronavirus has not been seen before. You can get COVID-19 through contact with another person who has the virus. It is predominantly a respiratory (lung) illness, but it can also affect other organs. People with COVID-19 have had a wide range of symptoms reported, ranging from mild symptoms to severe illness. Symptoms may appear 2 to 14 days after exposure to the virus. Symptoms may include: fever, chills, cough, shortness of breath, fatigue, muscle or body aches, headache, loss of taste or smell, sore throat, congestion, runny nose, nausea, vomiting, or diarrhea.

Pre-tax flexible spending accounts (FSAs) are often touted as the answer to high out-of-pocket medical costs, but many FSAs have “use it or lose it” rules. FSA holders lose $50 to $100 per year on average, CBS News reported, but since you’re allowed to contribute up to $2,650, you could risk losing thousands of dollars if you don’t spend your FSA money in time.

🔔 How is the COVID-19, mRNA, bivalent (Moderna) vaccine given?

The COVID-19, mRNA, bivalent (Moderna) vaccine will be given to you as an injection into the muscle.

🔔 What should you tell the person who is giving the vaccine?

Tell your vaccine provider about all of your medical conditions, including if you:

• have any allergies.
• 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 such as warfarin (Coumadin, Jantoven).
• have a weakened immune system or are on a medicine that affects your immune system.
• are pregnant or plan to become pregnant.
• are breastfeeding.
• have received another COVID-19 vaccine.
• have ever fainted after getting a vaccine or a shot
• have had a severe allergic reaction after a previous dose of this vaccine.
• have had a serious allergic reaction to any ingredient in this vaccine.

🔔 What are the benefits of the Moderna COVID-19 vaccine?

In ongoing clinical trials, the COVID-19, mRNA, bivalent vaccine has been shown to prevent COVID-19 against the two known circulating strains of the virus (original and Omicron). How long you are protected against COVID-19 is currently unknown.

🔔 What are the risks of the Moderna COVID-19 vaccine?

Side effects that have been reported with the Moderna COVID-19 vaccine include:

• injection site pain, swelling, and redness
• tenderness and swelling of lymph nodes (in the same arm where you got the injection)
• tiredness
• headache
• muscle pain
• joint pain
• chills
• nausea
• vomiting
• fever
• rash
• fainting at the time you receive your injection

There is a remote 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.

Signs of a severe allergic reaction can include:

• difficulty breathing
• swelling of your face and throat
• a fast heartbeat
• a bad rash all over your body
• dizziness and weakness

Myocarditis and pericarditis have occurred in some people who have received the Moderna COVID-19 vaccine, more commonly in males under 40 years of age than among females and older males. In most of these people, symptoms began within a few days after getting the second dose of the Moderna COVID-19 vaccine. The chance of having this occur 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

These may not be all the possible side effects of the Moderna COVID-19 vaccine. Serious and unexpected side effects may occur. Moderna COVID-19 vaccine is still being studied in clinical trials.

🔔 What should I do about side effects?

What should I do about side effects?:

• If you experience a severe allergic reaction, call 9-1-1, or go to the nearest hospital.
• Call the vaccination provider or your healthcare provider if you have any side effects that bother you or do not go away.
• Report vaccine side effects to FDA/CDC Vaccine Adverse Event Reporting System (VAERS). The VAERS toll-free number is 1-800-822-7967 or report online to https://vaers.hhs.gov/reportevent.html. Please include “Moderna COVID-19 Vaccine EUA” or “Moderna COVID-19 Vaccine, Bivalent EUA”, as appropriate, in the first line of box #18 of the report form.
• In addition, you can report side effects to ModernaTX, Inc. at 1-866-663-3762.
• You may also be given an option to enroll in v-safe. V-safe is a new voluntary smartphone-based tool that uses text messaging and web surveys to check in with people who have been vaccinated to identify potential side effects after COVID-19 vaccination. V-safe asks questions that help CDC monitor the safety of COVID-19 vaccines. V-safe also provides second-dose reminders if needed and live telephone follow-up by CDC if participants report a significant health impact following COVID-19 vaccination. For more information on how to sign up, visit: http://www.cdc.gov/vsafe.

🔔 What if I am immunocompromised?

If you are immunocompromised (have a weakened immune system), you may not have as good of a response to COVID-19 vaccine, mRNA, bivalent (Moderna). However, no data currently exists to support giving additional vaccine doses to immunocompromised.

🔔 Will the Moderna COVID-19 vaccine give me COVID-19?

No. The Moderna COVID-19 vaccine does not contain SARS-CoV-2 and cannot give you COVID-19.

🔔 Keep your vaccination card

When you get your first dose, you will get a vaccination card to show you when to return for your second dose of Moderna COVID-19 vaccine. If you are immunocompromised (have a weakened immune system), you may receive information on when to return for a third dose. Remember to bring your card when you return.

🔔 Where will my vaccination information be recorded?

The vaccination provider may include your vaccination information in your state/local jurisdiction’s Immunization Information System (IIS) or other designated system. This will ensure that you receive the same vaccine when you return for your next dose of Moderna COVID-19 vaccine. For more information about IISs visit: https://www.cdc.gov/vaccines/programs/iis/about.html.

🔔 How can I learn more?

You can learn more:

• Ask the vaccination provider.
• Visit CDC at https://www.cdc.gov/coronavirus/2019-ncov/index.html.
• Visit FDA at http://bit.ly/3qI0njF.
• Contact your local or state public health department.

🔔 Can I be charged an administration fee for receiving the COVID-19 vaccine?

No. At this time, the provider cannot charge you for a vaccine dose and you cannot be charged an out-of-pocket vaccine administration fee or any other fee if only receiving a COVID-19 vaccination. However, vaccination providers may seek appropriate reimbursement from a program or plan that covers COVID-19 vaccine administration fees for the vaccine recipient (private insurance, Medicare, Medicaid, HRSA COVID-19 Uninsured Program for non-insured recipients).

🔔 Where can I report cases of suspected fraud?

Individuals becoming aware of any potential violations of the CDC COVID-19 Vaccination Program requirements are encouraged to report them to the Office of the Inspector General, U.S. Department of Health and Human Services, at 1-800-HHS-TIPS or TIPS.HHS.GOV.