MODERNA COVID-19 VACCINE CX-024414 Suspension for injection (2021)

Βιβλιογραφική αναφορά

Συγγραφείς

Moderna US, Inc.

Λέξεις κλειδιά

80777-273

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1. Indications and Usage

Authorized use Moderna COVID-19 Vaccine is authorized for use under an Emergency Use Authorization (EUA) for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory ...

2. Dosage and Administration

For intramuscular injection only. 2.1 Preparation for Administration The Moderna COVID-19 Vaccine multiple-dose vial contains a frozen suspension that does not contain a preservative and must be thawed ...

3. Dosage Forms and Strengths

Moderna COVID-19 Vaccine is a suspension for intramuscular injection. A single dose is 0.5 mL.

4. Contraindications

Do not administer the Moderna COVID-19 Vaccine to individuals with a known history of severe allergic reaction (e.g., anaphylaxis) to any component of the Moderna COVID-19 Vaccine <em>[see Description ...

5. Warnings and Precautions

5.1 Management of Acute Allergic Reactions Appropriate medical treatment to manage immediate allergic reactions must be immediately available in the event an acute anaphylactic reaction occurs following ...

6. Adverse Reactions

Overall safety summary <b>It is MANDATORY for vaccination providers to report to the Vaccine Adverse Event Reporting System (VAERS) all vaccine administration errors, all serious adverse events, cases ...

6.1. Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a vaccine cannot be directly compared with rates in the clinical trials ...

7. Drug Interactions

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

8.1. 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 ...

8.2. 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.

8.4. Pediatric Use

Safety and effectiveness have not been assessed in persons less than 18 years of age. Emergency Use Authorization of Moderna COVID-19 Vaccine does not include use in individuals younger than 18 years of ...

8.5. Geriatric Use

Clinical studies of Moderna COVID-19 Vaccine included participants 65 years of age and older receiving vaccine or placebo, and their data contribute to the overall assessment of safety and efficacy. In ...

11. Description

Moderna COVID-19 Vaccine is provided as a white to off-white suspension for intramuscular injection. Each 0.5 mL dose of Moderna COVID-19 Vaccine contains 100 mcg of nucleoside-modified messenger RNA (mRNA) ...

12.1. 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 ...

14. Clinical Studies

18. Clinical trial results and supporting data for EUA A Phase 3 randomized, placebo-controlled, observer-blind clinical trial to evaluate the efficacy, safety, and immunogenicity of the Moderna COVID-19 ...

16.1. How Supplied

Moderna COVID-19 Vaccine Suspension for Intramuscular Injection, Multiple-Dose Vials are supplied as a carton of 10 multiple-dose vials (NDC 80777-273-99).

16.2. Storage and Handling

Store frozen between -25° to -15°C (-13° to 5°F). Store in the original carton to protect from light. Do not store on dry ice or below -40°C (-40°F). Vials can be stored refrigerated between 2° to 8°C ...

17. Patient Counseling Information

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 jurisdictions Immunization Information ...