Vaccine Information: Moderna COVID-19 Vaccine (Page 5 of 8)


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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 the 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 8

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 Moderna COVID-19 Vaccine 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
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 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 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:
a.
In Box 13, provide the name and contact information of the prescribing healthcare provider or institutional designee who is responsible for the report.
b.
In Box 14, provide the name and contact information of the best doctor/healthcare professional to contact about the adverse event.
c.
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)


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Vaccination providers administering SPIKEVAX (COVID-19 Vaccine, mRNA) must adhere to the same reporting requirements.

10 DRUG INTERACTIONS

There are no data to assess the concomitant administration of the Moderna COVID-19 Vaccine 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 during pregnancy. Women who are vaccinated with Moderna COVID-19 Vaccine 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.

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 on the breastfed infant or on milk production/excretion.

11.3 Pediatric Use

Moderna COVID-19 Vaccine is authorized for use in individuals 6 months through 17 years of age. This authorization is based on safety and effectiveness data in this age group and adults.

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

11.4 Use in Immunocompromised Individuals

Safety and effectiveness of the Moderna COVID-19 Vaccine in individuals 6 months through 17 years of age with immunocompromise have been extrapolated from adult data. In an independent study (Hall VG, Ferreira VH, Ku T et al. Randomized Trial of a Third Dose of mRNA-1273 Vaccine in Transplant Recipients. N Engl J Med 2021 DOI: 10.1056/NEJMc2111462; NCT04885907), safety and effectiveness of a third primary series dose of the Moderna COVID-19 Vaccine have been evaluated in participants who received solid organ transplants. In this study, in 60 adult participants who had undergone various solid organ transplant procedures (heart, kidney, kidney-pancreas, liver, lung, pancreas) a median of 3.57 years previously (range 1.99-6.75 years) who received a third vaccine dose, the adverse event profile was similar to that after the second dose and no Grade 3 or Grade 4 events were reported. The administration of a third primary series vaccine dose appears to be only moderately effective in increasing antibody titers. Patients should be counseled to maintain physical precautions to help prevent COVID-19. In addition, close contacts of immunocompromised persons should be vaccinated, as appropriate for their health status.

13 DESCRIPTION

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

Each 0.5 mL primary series dose of Moderna COVID-19 Vaccine supplied in a multiple-dose vial with a dark blue cap and a label with a teal border contains 50 mcg of nucleoside-modified messenger RNA (mRNA) encoding the pre-fusion stabilized Spike glycoprotein (S) of the SARS-CoV-2 Wuhan-Hu-1 strain. Each 0.5 mL dose of the Moderna COVID-19 Vaccine supplied in a multiple-dose vial with a dark blue cap and a label with a teal border 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.

Moderna COVID-19 Vaccine does not contain a preservative.

The vial stoppers are not made with natural rubber latex.

14 CLINICAL PHARMACOLOGY

14.1 Mechanism of Action

The nucleoside-modified mRNA in the Moderna COVID-19 Vaccine is formulated in lipid particles, which enable delivery of the nucleoside-modified mRNA into host cells to allow expression of the SARS-CoV-2 S antigen. The vaccine elicits an immune response to the S antigen, which protects against COVID-19.

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