18.4 Immunogenicity of a Booster Dose Following Primary Vaccination with Another Authorized or Approved COVID-19 Vaccine
Effectiveness of a Moderna COVID-19 Vaccine (0.25 mL) 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 (0.25 mL) 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 heterologous booster dose (0.5 mL) 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 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 (0.5 mL) was demonstrated regardless of primary vaccination.
Moderna COVID-19 Vaccine Suspension for Intramuscular Injection Multiple-Dose Vials are supplied as follows:
NDC 80777-273-99 Carton of 10 multiple-dose vials, each vial containing 5.5 mL
NDC 80777-273-98 Carton of 10 multiple-dose vials, each vial containing 7.5 mL
During storage, minimize exposure to room light.
Store frozen between -50º to -15ºC (-58º to 5ºF). Store in the original carton to protect from light.
Do not store on dry ice or below -50ºC (-58ºF). Use of dry ice may subject vials to temperatures colder than -50°C (-58°F).
Vials may be stored refrigerated between 2° to 8°C (36° to 46°F) for up to 30 days prior to first use. Do not refreeze.
Vials may be stored between 8° to 25°C (46° to 77°F) for a total of 24 hours.
After the first dose has been withdrawn, the vial should be held between 2° to 25°C (36° to 77°F). Vials should be discarded 12 hours after the first puncture.
Thawed vials can be handled in room light conditions.
Do not refreeze once thawed.
Transportation of Thawed Vials at 2° to 8°C (36° to 46°F)
If transport at -50° to -15°C (-58° to 5°F) is not feasible, available data support transportation of one or more thawed vials for up to 12 hours at 2° to 8°C (36° to 46°F) when shipped using shipping containers which have been qualified to maintain 2° to 8°C (36° to 46°F) and under routine road and air transport conditions with shaking and vibration minimized. Once thawed and transported at 2° to 8°C (36° to 46°F), vials should not be refrozen and should be stored at 2° to 8°C (36° to 46°F) until use.
Advise the recipient or caregiver to read the 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.
For general questions, send an email or call the telephone number provided below.
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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
©2021 ModernaTX, Inc. All rights reserved.
Patent(s): www.modernatx.com/patentsRevised: Nov/19/2021
EMERGENCY USE AUTHORIZATION (EUA) OF THE MODERNA COVID-19 VACCINE TO PREVENT CORONAVIRUS DISEASE 2019 (COVID-19) IN INDIVIDUALS 18 YEARS OF AGE AND OLDER
You are being offered the Moderna COVID-19 Vaccine to prevent Coronavirus Disease 2019 (COVID-19) caused by SARS-CoV-2. This Fact Sheet contains information to help you understand the risks and benefits of the Moderna COVID-19 Vaccine, which you may receive because there is currently a pandemic of COVID-19.
The Moderna COVID-19 Vaccine is a vaccine and may prevent you from getting COVID-19.
Read this Fact Sheet for information about the Moderna COVID-19 Vaccine. Talk to the vaccination provider if you have questions. It is your choice to receive the Moderna COVID-19 Vaccine .
The Moderna COVID-19 Vaccine has received EUA from FDA to provide:
- a two-dose primary series to individuals 18 years of age and older;
- a third primary series dose to individuals 18 years of age and older who have been determined to have certain kinds of immunocompromise;
- a single booster dose to the individuals 18 years of age and older who have completed a primary series with the Moderna COVID-19 Vaccine; and
- a single booster dose to individuals 18 years of age and older who have completed primary vaccination with a different authorized or approved COVID-19 vaccine.
The Moderna COVID-19 Vaccine 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 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.
WHAT IS THE MODERNA COVID-19 VACCINE?
The Moderna COVID-19 Vaccine is an unapproved vaccine that may prevent COVID-19.
The FDA has authorized the emergency use of the Moderna COVID-19 Vaccine to prevent COVID-19 in individuals 18 years of age and older under an Emergency Use Authorization (EUA).
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 YOUR VACCINATION PROVIDER BEFORE YOU GET THE MODERNA COVID-19 VACCINE?
Tell your vaccination 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
- are immunocompromised 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 in association with an injection
WHO SHOULD GET THE MODERNA COVID-19 VACCINE?
FDA has authorized the emergency use of the Moderna COVID-19 Vaccine in individuals 18 years of age and older.
WHO SHOULD NOT GET THE MODERNA COVID-19 VACCINE?
You should not get the Moderna COVID-19 Vaccine if you:
- had a severe allergic reaction after a previous dose of this vaccine
- had a severe allergic reaction to any ingredient of this vaccine
WHAT ARE THE INGREDIENTS IN THE MODERNA COVID-19 VACCINE?
The Moderna COVID-19 Vaccine contains 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 IS THE MODERNA COVID-19 VACCINE GIVEN?
The Moderna COVID-19 Vaccine will be given to you as an injection into the muscle.
Primary Series: The Moderna COVID-19 Vaccine is administered as a 2-dose series, one month apart. A third primary series dose may be administered at least one month after the second dose to individuals who are determined to have certain kinds of immunocompromise.
- A single booster dose of the Moderna COVID-19 Vaccine may be administered at least 6 months after completion of a primary series.
- A single booster dose of the Moderna COVID-19 Vaccine may be administered to individuals 18 years of age and older who have completed primary vaccination with a different authorized or approved COVID-19 vaccine. Please check with your healthcare provider regarding timing of the booster dose.
HAS THE MODERNA COVID-19 VACCINE BEEN USED BEFORE?
The Moderna COVID-19 Vaccine is an unapproved vaccine. In clinical trials, approximately 15,400 individuals 18 years of age and older have received at least 1 dose of the Moderna COVID-19 Vaccine. Millions of individuals have received the vaccine under EUA since December 18, 2020.
WHAT ARE THE BENEFITS OF THE MODERNA COVID-19 VACCINE?
In an ongoing clinical trial, the Moderna COVID-19 Vaccine has been shown to prevent COVID-19 following 2 doses given 1 month apart. The duration of protection against COVID-19 is currently unknown.
WHAT ARE THE RISKS OF THE MODERNA COVID-19 VACCINE ?
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. For this reason, your vaccination provider may ask you to stay at the place where you received your 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 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 following receipt of 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
Side effects that have been reported in clinical trials with the Moderna COVID-19 Vaccine 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 of the Moderna COVID-19 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. Serious and unexpected side effects may occur. The Moderna COVID-19 Vaccine is still being studied in clinical trials.
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” 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 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: www.cdc.gov/vsafe.
WHAT IF I DECIDE NOT TO GET THE MODERNA COVID-19 VACCINE?
It is your choice to receive or not receive the Moderna COVID-19 Vaccine. Should you decide not to receive it, it will not change your standard medical care.
ARE OTHER CHOICES AVAILABLE FOR PREVENTING COVID-19 BESIDES MODERNA COVID-19 VACCINE?
Another choice for preventing COVID-19 is Comirnaty, an FDA-approved COVID-19 vaccine. Other vaccines to prevent COVID-19 may be available under Emergency Use Authorization.
CAN I RECEIVE THE MODERNA COVID-19 VACCINE AT THE SAME TIME AS OTHER VACCINES?
Data have not yet been submitted to FDA on administration of Moderna COVID-19 Vaccine at the same time as other vaccines. If you are considering receiving Moderna COVID-19 Vaccine with other vaccines, discuss your options with your healthcare provider.
WHAT IF I AM IMMUNOCOMPROMISED?
If you are immunocompromised, you may receive a third primary series dose of the Moderna COVID-19 Vaccine. The third dose may still not provide full immunity to COVID-19 in people who are immunocompromised, and you should continue to maintain physical precautions to help prevent COVID-19. In addition, your close contacts should be vaccinated as appropriate.
WHAT IF I AM PREGNANT OR BREASTFEEDING?
If you are pregnant or breastfeeding, discuss your options with your healthcare provider.
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 receive your first dose, you will get a vaccination card to show you when to return for your second dose of the Moderna COVID-19 Vaccine. Remember to bring your card when you return.
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
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 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 the second dose. 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 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.
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 this vaccine. 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)?
The United States FDA has made the Moderna COVID-19 Vaccine available under an emergency access mechanism called an EUA. The 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.
The Moderna COVID-19 Vaccine has not undergone the same type of review as an FDA- approved or cleared 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.
The EUA for the Moderna COVID-19 Vaccine is in effect for the duration of the COVID-19 EUA declaration justifying emergency use of these products, unless terminated or revoked (after which the products may no longer be used).
Moderna US, Inc.
Cambridge, MA 02139
©2021 ModernaTX, Inc. All rights reserved.
Patent(s): www.modernatx.com/patentsRevised: Nov/19/2021
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