Vaccine Information: Moderna COVID-19 Vaccine, Bivalent (Page 10 of 11)

18.8 Immunogenicity of Moderna COVID-19 Vaccine Administered as a First Booster Dose Following Primary Vaccination with Another Authorized or Approved COVID-19 Vaccine

Effectiveness of a Moderna COVID-19 Vaccine booster dose in individuals who completed primary vaccination with another authorized or approved COVID-19 vaccine (heterologous booster dose) is inferred from immunogenicity data supporting effectiveness of a Moderna COVID-19 Vaccine booster dose administered following completion of a Moderna COVID-19 Vaccine primary series and from immunogenicity data from an independent Phase 1/2 open-label clinical trial (NCT04889209) conducted in the United States that evaluated a booster dose of the Moderna COVID-19 Vaccine. The booster dose that study participants received contained twice the amount of mRNA compared to the authorized booster dose of the Moderna COVID-19 Vaccine. In this study, adults who had completed primary vaccination with a Moderna COVID-19 Vaccine 2-dose series (N=151), a Janssen COVID-19 Vaccine single dose (N=156), or a Pfizer-BioNTech COVID-19 Vaccine 2-dose series (N=151) at least 12 weeks (range 12 to 20 weeks) prior to enrollment and who reported no history of SARS-CoV-2 infection were randomized 1:1:1 to receive a booster dose of one of three vaccines: Moderna COVID-19 Vaccine, Janssen COVID-19 Vaccine, or Pfizer-BioNTech COVID-19 Vaccine. Neutralizing antibody titers, as measured by a pseudovirus neutralization assay using a lentivirus expressing the SARS-CoV-2 Spike protein with D614G mutation, were assessed on Day 1 prior to administration of the booster dose and on Day 15 after the booster dose. A booster response to the Moderna COVID-19 Vaccine was demonstrated regardless of the vaccine used for primary vaccination.

19 HOW SUPPLIED/STORAGE AND HANDLING

The information in this section applies to Moderna COVID-19 Vaccine, Bivalent (Original and Omicron BA.4/BA.5) that is supplied in multiple-dose vials with dark blue caps and labels with a gray border. These multiple-dose vials are supplied as follows:

NDC 80777-282-99 Carton of 10 multiple-dose vials

NDC 80777-282-05 Multiple-dose vial containing 2.5 mL

During storage, minimize exposure to room light, and avoid exposure to direct sunlight and ultraviolet light.

Frozen Storage

Store frozen between -50°C to -15°C (-58°F to 5°F).

Storage after Thawing

Storage at 2°C to 8°C (36°F to 46°F):
o
Vials may be stored refrigerated between 2°C to 8°C (36°F to 46°F) for up to 30 days prior to first use, provided the expiration date is not exceeded.
o
Vials should be discarded 12 hours after the first puncture.
Storage at 8°C to 25°C (46°F to 77°F):
o
Vials may be stored between 8°C to 25°C (46°F to 77°F) for a total of 24 hours.
o
Vials should be discarded 12 hours after the first puncture.
o
Total storage at 8°C to 25°C (46°F to 77°F) must not exceed 24 hours.

Do not refreeze once thawed.

Thawed vials can be handled in room light conditions.

Transportation of Thawed Vials at 2°C to 8°C (36°F to 46°F)

If transport at -50°C to -15°C (-58°F to 5°F) is not feasible, available data support transportation of one or more thawed vials for up to 12 hours at 2°C to 8°C (36°F to 46°F) when shipped using shipping containers which have been qualified to maintain 2°C to 8°C (36°F to 46°F) and under routine road and air transport conditions with shaking and vibration minimized. Once thawed and transported at 2°C to 8°C (36°F to 46°F), vials should not be refrozen and should be stored at 2°C to 8°C (36°F to 46°F) until use.

20 PATIENT COUNSELING INFORMATION

Advise the recipient or caregiver to read the “VACCINE INFORMATION FACT SHEET FOR RECIPIENTS AND CAREGIVERS.”

The vaccination provider must include vaccination information in the state/local jurisdiction’s Immunization Information System (IIS) or other designated system. Advise recipient or caregiver that more information about IISs can be found at: https://www.cdc.gov/vaccines/programs/iis/about.html.

21 CONTACT INFORMATION

For general questions, send an email or call the telephone number provided below.

Email

Telephone number

medinfo@modernatx.com

1-866-MODERNA

(1-866-663-3762)

This EUA Prescribing Information may have been updated. For the most recent Full EUA Prescribing Information, please visit www.modernatx.com/covid19vaccine-eua.

Moderna US, Inc.
Cambridge, MA 02139

©2022 ModernaTX, Inc. All rights reserved.
Patent(s): www.modernatx.com/patentsRevised: Oct/12/2022

VACCINE INFORMATION FACT SHEET FOR RECIPIENTS AND CAREGIVERS

ABOUT SPIKEVAX (COVID-19 VACCINE, mRNA), MODERNA COVID-19 VACCINE, AND MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5) TO PREVENT CORONAVIRUS DISEASE 2019 (COVID-19)

FOR 6 YEARS OF AGE AND OLDER

You or your child are being offered either SPIKEVAX (COVID-19 Vaccine, mRNA), Moderna COVID-19 Vaccine, or Moderna COVID-19 Vaccine, Bivalent (Original and Omicron BA.4/BA.5), hereafter referred to as Moderna COVID-19 Vaccine, Bivalent, to prevent Coronavirus Disease 2019 (COVID-19) caused by SARS-CoV-2.

This Vaccine Information Fact Sheet for Recipients and Caregivers comprises the Fact Sheet for the authorized Moderna COVID-19 Vaccine and the authorized Moderna COVID-19 Vaccine, Bivalent for use in individuals 6 years of age and older, and also includes information about the FDA-licensed vaccine, SPIKEVAX (COVID-19 Vaccine, mRNA) for use in individuals 12 years of age and older.5

The FDA-approved SPIKEVAX (COVID-19 Vaccine, mRNA) and the Moderna COVID-19 Vaccine authorized for Emergency Use Authorization (EUA) for individuals 12 years of age and older can be used interchangeably, when used according to their respective instructions for use.6

SPIKEVAX (COVID-19 Vaccine, mRNA) is an FDA-approved COVID-19 vaccine made by ModernaTX, Inc. It is approved as a two-dose series for prevention of COVID-19 in individuals 18 years of age and older. It is also authorized under EUA to provide:

a two-dose primary series to individuals 12 years through 17 years of age; and
a third primary series dose to individuals 12 years of age and older who have been determined to have certain kinds of immunocompromise.

The Moderna COVID-19 Vaccine has received EUA from FDA to provide:

a two-dose primary series to individuals 6 years of age and older; and
a third primary series dose to individuals 6 years of age and older with certain kinds of immunocompromise.

Moderna COVID-19 Vaccine, Bivalent has received EUA from FDA to provide either:

a single booster dose to individuals 6 years of age and older at least 2 months after completion of primary vaccination with any authorized or approved monovalent 7 COVID-19 vaccine; or
a single booster dose to individuals 6 years of age and older at least 2 months after receipt of the most recent booster dose with any authorized or approved monovalent COVID-19 vaccine.

This Vaccine Information Fact Sheet contains information to help you understand the risks and benefits of SPIKEVAX (COVID-19 Vaccine, mRNA), Moderna COVID-19 Vaccine, and Moderna COVID-19 Vaccine, Bivalent, which you or your child may receive because there is currently a pandemic of COVID-19. Talk to the vaccination provider if you have questions.

SPIKEVAX (COVID-19 Vaccine, mRNA), Moderna COVID-19 Vaccine, and Moderna COVID-19 Vaccine, Bivalent may not protect everyone.

This Fact Sheet may have been updated. For the most recent Fact Sheet, please visit www.modernatx.com/covid19vaccine-eua.

WHAT YOU NEED TO KNOW BEFORE YOU OR YOUR CHILD GET THIS VACCINE

WHAT IS COVID-19?

COVID-19 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 illness that can 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 or chills; cough; shortness of breath; fatigue; muscle or body aches; headache; new loss of taste or smell; sore throat; congestion or runny nose; nausea or vomiting; diarrhea.

HOW ARE SPIKEVAX (COVID-19 VACCINE, mRNA), MODERNA COVID-19 VACCINE, AND MODERNA COVID-19 VACCINE, BIVALENT RELATED?

SPIKEVAX (COVID-19 Vaccine, mRNA) and Moderna COVID-19 Vaccine can be used interchangeably.8 Moderna COVID-19 Vaccine, Bivalent is made in the same way as SPIKEVAX and Moderna COVID-19 Vaccine, but it also contains an Omicron component to help prevent COVID-19 caused by the Omicron variant of SARS-CoV-2.

For more information on EUA, see the “What is an Emergency Use Authorization (EUA)? ” section at the end of this Fact Sheet.

WHAT SHOULD YOU MENTION TO THE VACCINATION PROVIDER BEFORE YOU OR YOUR CHILD GET ANY OF THESE VACCINES?

Tell the vaccination provider about all of your or your child’s medical conditions, including if you or your child:

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
are immunocompromised or are on a medicine that affects your or your child’s immune system
are pregnant or plan to become pregnant
are breastfeeding
have received another COVID-19 vaccine
have ever fainted in association with an injection

WHO SHOULD NOT GET SPIKEVAX (COVID-19 VACCINE, mRNA), MODERNA COVID-19 VACCINE, OR MODERNA COVID-19 VACCINE, BIVALENT?

You or your child should not get any of these vaccines if you or your child:

had a severe allergic reaction after a previous dose of SPIKEVAX (COVID-19 Vaccine, mRNA) or Moderna COVID-19 Vaccine
had a severe allergic reaction to any ingredient in these vaccines

WHAT ARE THE INGREDIENTS IN THESE VACCINES?

SPIKEVAX (COVID-19 Vaccine, mRNA), Moderna COVID-19 Vaccine, and Moderna COVID-19 Vaccine, Bivalent contain the following ingredients: messenger ribonucleic acid (mRNA), lipids (SM-102, polyethylene glycol [PEG] 2000 dimyristoyl glycerol [DMG], cholesterol, and 1,2-distearoyl-sn-glycero-3-phosphocholine [DSPC]), tromethamine, tromethamine hydrochloride, acetic acid, sodium acetate trihydrate, and sucrose.

HOW ARE THESE VACCINES GIVEN?

SPIKEVAX (COVID-19 Vaccine, mRNA), Moderna COVID-19 Vaccine, or Moderna COVID-19 Vaccine, Bivalent will be given to you or your child as an injection into the muscle.

Primary Series: SPIKEVAX (COVID-19 Vaccine, mRNA) and Moderna COVID-19 Vaccine are administered as a two-dose series, 1 month apart. A third primary series dose may be administered at least 1 month after the second dose to individuals with certain kinds of immunocompromise.

Booster Dose: Moderna COVID-19 Vaccine, Bivalent is administered as a single booster dose at least 2 months after:

completion of primary vaccination with any authorized or approved monovalent COVID-19 vaccine; or
receipt of the most recent booster dose with any authorized or approved monovalent COVID-19 vaccine.

HAVE THESE VACCINES BEEN USED BEFORE?

Millions of individuals 18 years of age and older have received the Moderna COVID-19 Vaccine under EUA since December 18, 2020. In clinical trials, approximately 30,000 individuals 12 years of age and older, 4,000 individuals 6 years through 11 years of age, and 5,000 individuals 6 months through 5 years of age have received at least 1 dose of Moderna COVID-19 Vaccine.

In a clinical trial, approximately 400 individuals 18 years of age and older received 1 dose of a bivalent vaccine that differs from the Moderna COVID-19 Vaccine, Bivalent in that it contains a different Omicron component.

WHAT ARE THE BENEFITS OF THESE VACCINES?

SPIKEVAX (COVID-19 Vaccine, mRNA) and Moderna COVID-19 Vaccine have been shown to prevent COVID-19. FDA has authorized Moderna COVID-19 Vaccine, Bivalent to provide better protection against COVID-19 caused by the Omicron variant of SARS-CoV-2.

The duration of protection against COVID-19 is currently unknown.

WHAT ARE THE RISKS OF THESE VACCINES?

There is a remote chance that these vaccines could cause a severe allergic reaction. A severe allergic reaction would usually occur within a few minutes to one hour after getting a dose. For this reason, the vaccination provider may ask you or your child to stay at the place where you or your child received the vaccine for monitoring after vaccination. 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 (inflammation of the heart muscle) and pericarditis (inflammation of the lining outside the heart) have occurred in some people who have received SPIKEVAX (COVID-19 Vaccine, mRNA) or Moderna COVID-19 Vaccine, more commonly in adult males under 40 years of age than among females and older males. In most of these people, symptoms began within a few days following receipt of the second dose of the vaccine. The chance of having this occur is very low. You should seek medical attention right away if you or your child have any of the following symptoms after receiving the vaccine:

Chest pain
Shortness of breath
Feelings of having a fast-beating, fluttering, or pounding heart

Side effects that have been reported in clinical trials with these vaccines include:

Injection site reactions: pain, tenderness and swelling of the lymph nodes in the same arm of the injection, swelling (hardness), and redness
General side effects: fatigue, headache, muscle pain, joint pain, chills, nausea and vomiting, fever, and rash

Side effects that have been reported during post-authorization use 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 these vaccines. Serious and unexpected side effects may occur. The possible side effects of these vaccines are still being studied.

WHAT SHOULD I DO ABOUT SIDE EFFECTS?

If you or your child experience a severe allergic reaction, call 9-1-1, or go to the nearest hospital.

Call the vaccination provider or your or your child’s healthcare provider if you or your child 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 either “SPIKEVAX (COVID-19 Vaccine, mRNA)”, “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-MODERNA (1-866-663-3762).

You may also be given an option to enroll in v-safe. V-safe is a 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: www.cdc.gov/vsafe.

WHAT IF I DECIDE NOT TO GET OR NOT TO HAVE MY CHILD GET SPIKEVAX (COVID-19 VACCINE, mRNA), MODERNA COVID-19 VACCINE, OR MODERNA COVID-19 VACCINE, BIVALENT?

Under the EUA, there is an option to accept or refuse receiving the vaccine. Should you decide not to receive, or for your child not to receive, any of these vaccines, it will not change the standard medical care.

ARE OTHER CHOICES AVAILABLE FOR PREVENTING COVID-19 BESIDES SPIKEVAX (COVID-19 VACCINE, mRNA), MODERNA COVID-19 VACCINE, OR MODERNA COVID-19 VACCINE, BIVALENT?

For primary vaccination in individuals 12 years of age and older, another choice for preventing COVID-19 is COMIRNATY (COVID-19 Vaccine, mRNA), an FDA-approved COVID-19 vaccine. For individuals 6 years of age and older, other vaccines to prevent COVID-19 may be available under EUA, including bivalent vaccines that contain an Omicron component of SARS-CoV-2.

CAN I OR MY CHILD RECEIVE SPIKEVAX (COVID-19 VACCINE, mRNA), MODERNA COVID-19 VACCINE, OR MODERNA COVID-19 VACCINE, BIVALENT AT THE SAME TIME AS OTHER VACCINES?

Data have not yet been submitted to FDA on administration of SPIKEVAX (COVID-19 Vaccine, mRNA), Moderna COVID-19 Vaccine, or Moderna COVID-19 Vaccine, Bivalent at the same time as other vaccines. If you are considering receiving or having your child receive SPIKEVAX (COVID-19 Vaccine, mRNA), Moderna COVID-19 Vaccine, or Moderna COVID-19 Vaccine, Bivalent with other vaccines, discuss your options with your or your child’s healthcare provider.

WHAT IF I AM, OR MY CHILD IS, IMMUNOCOMPROMISED?

If you are, or your child is, immunocompromised, you or your child may receive a third primary series dose of Moderna COVID-19 Vaccine or SPIKEVAX (COVID-19 Vaccine, mRNA). Individuals 6 years of age and older may receive a booster dose with Moderna COVID-19 Vaccine, Bivalent. Vaccinations may not provide full immunity to COVID-19 in people who are immunocompromised; therefore, you or your child should continue to maintain physical precautions to help prevent COVID-19. Your close contacts should be vaccinated as appropriate.

WHAT ABOUT PREGNANCY OR BREASTFEEDING?

If you are, or your child is, pregnant or breastfeeding, discuss the options with your healthcare provider.

WILL THESE VACCINES GIVE ME OR MY CHILD COVID-19?

No. These vaccines do not contain SARS-CoV-2 and cannot give you or your child COVID-19.

KEEP THE VACCINATION CARD

When you, or your child, receive the first COVID-19 vaccine, you will get a vaccination card. Remember to bring the card when you return.

ADDITIONAL INFORMATION

If you have questions, visit the website or call the telephone number provided below.

To access the most recent Fact Sheets, please scan the QR code provided below.

Moderna COVID-19 Vaccine website

Telephone number

www.modernatx.com/covid19vaccine-eua

Moderna QR Code

1-866-MODERNA

(1-866-663-3762)

HOW CAN I LEARN MORE?

Ask the vaccination provider
Visit CDC at https://www.cdc.gov/coronavirus/2019-ncov/index.html
Visit FDA at https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization
Contact your state or local public health department

WHERE WILL VACCINATION INFORMATION BE RECORDED?

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

CAN I BE CHARGED AN ADMINISTRATION FEE FOR RECEIPT OF THESE COVID-19 VACCINES?

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.

WHAT IS THE COUNTERMEASURES INJURY COMPENSATION PROGRAM?

The Countermeasures Injury Compensation Program (CICP) is a federal program that may help pay for costs of medical care and other specific expenses of certain people who have been seriously injured by certain medicines or vaccines, including these vaccines. Generally, a claim must be submitted to the CICP within one (1) year from the date of receiving the vaccine. To learn more about this program, visit www.hrsa.gov/cicp/ or call 1-855-266-2427.

WHAT IS AN EMERGENCY USE AUTHORIZATION (EUA)?

An EUA is a mechanism to facilitate the availability and use of medical products, including vaccines, during public health emergencies, such as the current COVID-19 pandemic. An EUA is supported by a Secretary of Health and Human Services (HHS) declaration that circumstances exist to justify the emergency use of drugs and biological products during the COVID-19 pandemic. A product authorized for emergency use has not undergone the same type of review by FDA as an FDA approved product.

FDA may issue an EUA when certain criteria are met, which includes that there are no adequate, approved, and available alternatives. In addition, the FDA decision is based on the totality of the scientific evidence available showing that the product may be effective to prevent COVID-19 during the COVID-19 pandemic and that the known and potential benefits of the product outweigh the known and potential risks of the product. All of these criteria must be met to allow for the product to be used during the COVID-19 pandemic.

An EUA is in effect for the duration of the COVID-19 EUA declaration justifying emergency use of this product, unless terminated or revoked (after which the product may no longer be used).

Moderna US, Inc.
Cambridge, MA 02139

©2022 ModernaTX, Inc. All rights reserved.
Patent(s): www.modernatx.com/patentsRevised: Oct/12/2022

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