Vaccine Information: Moderna COVID-19 Vaccine, Bivalent (Page 5 of 11)


4
Moderna COVID-19 Vaccine is marketed as SPIKEVAX (COVID-19 Vaccine, mRNA), which is approved for use in individuals 18 years of age and older.

6.2 Post-Authorization Experience

The following adverse reactions have been identified during post-authorization use of Moderna COVID-19 Vaccine. Because these reactions are reported voluntarily, it is not always possible to reliably estimate their frequency or establish a causal relationship to vaccine exposure.

Cardiac Disorders: myocarditis, pericarditis

Immune System Disorders: anaphylaxis

Nervous System Disorders: syncope

8 REQUIREMENTS AND INSTRUCTIONS FOR REPORTING ADVERSE EVENTS AND VACCINE ADMINISTRATION ERRORS

See Overall Safety Summary (Section 6) for additional information.

The vaccination provider enrolled in the federal COVID-19 Vaccination Program is responsible for the MANDATORY reporting of the listed events following administration of the Moderna COVID-19 Vaccine, Bivalent to the Vaccine Adverse Event Reporting System (VAERS)

Vaccine administration errors whether or not associated with an adverse event
Serious adverse events* (irrespective of attribution to vaccination)
Cases of myocarditis
Cases of pericarditis
Cases of Multisystem Inflammatory Syndrome (MIS) in adults and children
Cases of COVID-19 that results in hospitalization or death

*Serious Adverse Events are defined as:

Death;
A life-threatening adverse event;
Inpatient hospitalization or prolongation of existing hospitalization;
A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions;
A congenital anomaly/birth defect;
An important medical event that based on appropriate medical judgement may jeopardize the individual and may require medical or surgical intervention to prevent one of the outcomes listed above.

Instructions for Reporting to VAERS

The vaccination provider enrolled in the federal COVID-19 Vaccination Program should complete and submit a VAERS form to FDA using one of the following methods:

Complete and submit the report online: https://vaers.hhs.gov/reportevent.html, or
If you are unable to submit this form electronically, you may fax it to VAERS at 1-877-721-0366. If you need additional help submitting a report, you may call the VAERS toll-free information line at 1-800-822-7967 or send an email to info@vaers.org.

IMPORTANT: When reporting adverse events or vaccine administration errors to VAERS, please complete the entire form with detailed information. It is important that the information reported to FDA be as detailed and complete as possible. Information to include:

Patient demographics (e.g., patient name, date of birth)
Pertinent medical history
Pertinent details regarding admission and course of illness
Concomitant medications
Timing of adverse event(s) in relationship to administration of Moderna COVID-19 Vaccine, Bivalent
Pertinent laboratory and virology information
Outcome of the event and any additional follow-up information if it is available at the time of the VAERS report. Subsequent reporting of follow-up information should be completed if additional details become available.

The following steps are highlighted to provide the necessary information for safety tracking:

1.
In Box 17, provide information on Moderna COVID-19 Vaccine, Bivalent and any other vaccines administered on the same day; and in Box 22, provide information on any other vaccines received within one month prior.
2.
In Box 18, description of the event:
a.
Write “Moderna COVID-19 Vaccine, Bivalent EUA” as the first line
b.
Provide a detailed report of vaccine administration error and/or adverse event. It is important to provide detailed information regarding the patient and adverse event/medication error for ongoing safety evaluation of this unapproved vaccine. Please see information to include listed above.
3.
Contact information:
c.
In Box 13, provide the name and contact information of the prescribing healthcare provider or institutional designee who is responsible for the report.
d.
In Box 14, provide the name and contact information of the best doctor/healthcare professional to contact about the adverse event.
e.
In Box 15, provide the address of the facility where vaccine was given (NOT the healthcare provider’s office address).

Other Reporting Instructions

Vaccination providers may report to VAERS other adverse events that are not required to be reported using the contact information above.

To the extent feasible, report adverse events to ModernaTX, Inc. using the contact information below or by providing a copy of the VAERS form to ModernaTX, Inc.

Email

Fax number

Telephone number

ModernaPV@modernatx.com

1-866-599-1342

1-866-MODERNA(1-866-663-3762)

10 DRUG INTERACTIONS

There are no data to assess the concomitant administration of Moderna COVID-19 Vaccine, Bivalent with other vaccines.

11 USE IN SPECIFIC POPULATIONS

11.1 Pregnancy

Pregnancy Exposure Registry

There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to Moderna COVID-19 Vaccine, Bivalent during pregnancy. Women who are vaccinated with Moderna COVID-19 Vaccine, Bivalent during pregnancy are encouraged to enroll in the registry by calling 1-866-MODERNA (1-866-663-3762).

Risk Summary

All pregnancies have a risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Available data on Moderna COVID-19 Vaccine administered to pregnant women are insufficient to inform vaccine-associated risks in pregnancy. Data are not available on Moderna COVID-19 Vaccine, Bivalent administered to pregnant women.

In a developmental toxicity study, 0.2 mL of a vaccine formulation containing the same quantity of nucleoside-modified messenger ribonucleic acid (mRNA) (100 mcg) and other ingredients included in a single primary series dose of Moderna COVID-19 Vaccine for individuals 12 years of age and older was administered to female rats by the intramuscular route on four occasions: 28 and 14 days prior to mating, and on gestation days 1 and 13. No vaccine-related adverse effects on female fertility, fetal development, or postnatal development were reported in the study.

11.2 Lactation

Risk Summary

Data are not available to assess the effects of Moderna COVID-19 Vaccine, Bivalent on the breastfed infant or on milk production/excretion.

11.3 Pediatric Use

Moderna COVID-19 Vaccine, Bivalent is authorized for use in individuals 6 years through 17 years of age. This authorization is based on safety with Moderna COVID-19 Vaccine in individuals 6 months of age and older, effectiveness data with Moderna COVID-19 Vaccine in individuals 6 years of age and older, and safety and immunogenicity data with the bivalent vaccine (Original and Omicron BA.1) in adults.

Moderna COVID-19 Vaccine, Bivalent is not authorized for use in individuals younger than 6 years of age.

11.4 Geriatric Use

Clinical studies of Moderna COVID-19 Vaccine and the bivalent vaccine (Original and Omicron BA.1) included participants 65 years of age and older, and their data contribute to the overall assessment of safety and effectiveness of Moderna COVID-19 Vaccine, Bivalent. [see Overall Safety Summary (6.1) and Clinical Trial Results and Supporting Data for EUA (18.1)]. Some local and systemic adverse reactions were reported in a lower proportion of participants 65 years of age and older compared to participants 18 through 64 years of age [see Overall Safety Summary (6.1)].

In an ongoing Phase 3 clinical study (Study 1) of primary series dosing of Moderna COVID-19 Vaccine, 24.8% (n=7,520) of participants were 65 years of age and older and 4.6% (n=1,399) of participants were 75 years of age and older.

In an ongoing Phase 2/3 clinical study (Study 5) of a single booster dose of bivalent vaccine (Original and BA.1), 39.8% (n=174) were 65 years of age and older

In a Phase 2 clinical study (Study 2) of a single booster dose of Moderna COVID-19 Vaccine, 22.2% (n=38) of participants were 65 years of age and older.

13 DESCRIPTION

Moderna COVID-19 Vaccine, Bivalent is provided as a sterile white to off-white suspension for intramuscular injection.

Each 0.5 mL booster dose of Moderna COVID-19 Vaccine, Bivalent (Original and Omicron BA.4/BA.5) contains 25 mcg nucleoside-modified messenger RNA (mRNA) encoding the pre-fusion stabilized Spike glycoprotein (S) of the SARS-CoV-2 Wuhan-Hu-1 strain (Original) and 25 mcg mRNA encoding the pre-fusion stabilized S-protein of the SARS-CoV-2 Omicron variant lineages BA.4 and BA.5 (Omicron BA.4/BA.5). The S-proteins of the SARS-CoV-2 Omicron variant lineages BA.4 and BA.5 are identical. 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. Each 0.25 mL dose of Moderna COVID-19 Vaccine, Bivalent contains half of these ingredients.

Moderna COVID-19 Vaccine, Bivalent does not contain a preservative.

The vial stoppers are not made with natural rubber latex.

14 CLINICAL PHARMACOLOGY

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