Comirnaty

— THERAPEUTIC CATEGORIES —
  • Vaccines

Comirnaty Generic Name & Formulations

General Description

COVID-19 vaccine (mRNA); contains 30mcg of nucleoside-modified mRNA encoding the viral spike S glycoprotein of SARS-CoV-2; per 0.3mL; susp for IM inj; preservative-free.

Pharmacological Class

COVID-19 vaccine.

How Supplied

Single-dose vials, prefilled syringes—1, 10

Storage

During storage, minimize exposure to room light, and avoid exposure to direct sunlight and ultraviolet light. Do not refreeze thawed vials or prefilled syringes.

  • Storage of Single Dose Vials and Prefilled Syringes Prior to Use:

    • Cartons of single dose vials and prefilled syringes may arrive frozen at ultra-cold conditions in thermal containers with dry ice.

    • When received, frozen vials and prefilled syringes may be immediately transferred to the refrigerator [2ºC to 8ºC (35ºF to 46ºF)], thawed, and stored for up to 10 weeks. Record the 10-week refrigerated expiry date on the carton at the time of transfer. Cartons of 10 single dose vials or cartons of 10 single dose prefilled syringes may take up to 2 hours to thaw at this temperature.

    • Alternatively, frozen vials and prefilled syringes may be stored in an ultra-low temperature freezer at -90ºC to -60ºC (-130ºF to -76ºF). Do not store vials at -25°C to -15°C (-13°F to 5°F). Once thawed, they should not be refrozen.

    • If cartons of Comirnaty single dose vials and prefilled syringes are received at 2ºC to 8ºC (35ºF to 46ºF), they should be stored at 2ºC to 8ºC.

    • Do not use the vaccine after the expiration date printed on the vials, prefilled syringes, and cartons regardless of storage conditions.

  • Storage of Single Dose Vials During Use:

    • If not previously thawed at 2ºC to 8ºC (35ºF to 46ºF), allow vials to thaw at room temperature [up to 25ºC (77ºF)] for 30 minutes.

    • Thawed Comirnaty single dose vials may be stored at room temperature [8°C to 25°C (46°F to 77°F)] for a total of 12 hours.
  • Thawing and Storage of Prefilled Syringes:
    • Frozen prefilled syringes should be thawed at 2ºC to 8ºC (35ºF to 46ºF), for 2 hours.

    • A full carton of prefilled syringes may also be thawed at room temperature [up to 25ºC (77ºF)] for
      60 minutes.
    • Prefilled syringes thawed in the carton by either method may be stored in the refrigerator for 10 weeks and at room temperature [8°C to 25°C (46°F to 77°F)] for 12 hours prior to use.

    • If individual frozen prefilled syringes are thawed at room temperature outside of the carton, they can be kept at room temperature and must be used within 4 hours of thawing.

    • After removing the tip cap and attaching an appropriate needle, the prefilled syringe should be used immediately. If it cannot be used immediately, it must be used within 4 hours.
  • Transportation of Vials and Prefilled Syringes:

    • If local redistribution is needed, single dose vials and prefilled syringes may be transported at -90°C to -60°C (-130°F to -76°F), or at 2°C to 8°C (35°F to 46°F).

    • Prefilled syringes should only be transported at -90°C to -60°C if the cartons are sealed in the original aluminum shipping pouches.

Manufacturer

Generic Availability

NO

Mechanism of Action

The nucleoside-modified mRNA in Comirnaty is formulated in lipid particles, which enable delivery of the 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.

Comirnaty Indications

Indications

Active immunization to prevent COVID-19.

Comirnaty Dosage and Administration

Adults and Children

<12yrs: not established. Give by IM inj only. ≥12yrs: 0.3mL as a single dose. Previously vaccinated with any COVID-19 vaccine: give dose at least 2 months after the last dose.

Administration

Visually inspect parenteral drug products for particulate matter and discoloration prior to administration. The vaccine will be a white to white-off suspension.

Administer the 0.3mL dose intramuscularly immediately after preparation. For the prefilled syringe, administer entire volume to deliver a single 0.3mL dose.

Comirnaty Contraindications

Not Applicable

Comirnaty Boxed Warnings

Not Applicable

Comirnaty Warnings/Precautions

Warnings/Precautions

Have epinephrine inj available. Increased risks of myocarditis and pericarditis (esp. within 7 days after vaccination); highest among males 12–17yrs of age. Syncope. Immunocompromised. Pregnancy. Nursing mothers.

Warnings/Precautions

Management of Acute Allergic Reactions 

  • Have appropriate medical treatment immediately available to manage immediate allergic reactions in the event an acute anaphylactic reaction occurs after administration of Comirnaty.

Myocarditis and Pericarditis

  • Postmarketing data showed increased risks of myocarditis and pericarditis, especially within 7 days after vaccination. 

  • Males 12–17 years of age have the highest risk.
  • Short-term follow-up showed that most individuals have symptoms resolved with conservative management but some cases required intensive care support.

Syncope

  • Syncope may occur. Procedures should be in place to avoid injury from fainting.

Altered Immunocompetence

  • Immunocompromised persons, including individuals receiving immunosuppressant therapy, may have a diminished immune response to the Comirnaty.

Limitation of Effectiveness

  • May not protect all vaccine recipients.

Pregnancy Considerations

Insufficient available data on Comirnaty in pregnant women to inform of vaccine-associated risks in pregnancy.

Nursing Mother Considerations

It is not known whether Comirnaty is excreted in human milk.

Consider the developmental and health benefits of breastfeeding along with the mother’s clinical need for Comirnaty and any potential adverse effects on the breastfed child from Comirnaty or from the underlying maternal condition.

Pediatric Considerations

Safety and efficacy of Comirnaty in individuals <12 years of age have not been established.

Geriatric Considerations

No overall differences in safety or effectiveness were observed between these recipients and younger recipients. 

Comirnaty Pharmacokinetics

See Literature

Comirnaty Interactions

Interactions

Immunosuppressants: may get suboptimal response.

Comirnaty Adverse Reactions

Adverse Reactions

Inj site reactions (eg, pain, swelling, redness), fatigue, headache, muscle pain, chills, joint pain, fever.

Comirnaty Clinical Trials

Clinical Trials

Efficacy in Participants 16 Years of Age and Older

The ongoing, multicenter, multinational, randomized, placebo-controlled, observer-blind, dose-finding, vaccine candidate–selection, and efficacy study (Study 2) evaluated Comirnaty in approximately 44,000 participants 12 years of age and older. 

Patients were stratified by age: 12 through 15 years of age, 16 through 55 years of age, or 56 years of age and older. The study excluded patients who were immunocompromised and those who had previous diagnosis of COVID-19. The study included patients with preexisting stable disease. Patients were randomly assigned to receive 2 doses of Comirnaty or placebo.

Efficacy Against COVID-19

  • 36,621 participants 12 years of age and older who did not have evidence of prior infection with SARS-CoV-2 through 7 days after the second dose were evaluable for analysis.

  • Vaccine efficacy against confirmed COVID-19 occurring at least 7 days after the second dose was 95.0% (95% credible interval: 90.3, 97.6), which met the pre-specified success criterion.

Efficacy Against Severe COVID-19 

  • Vaccine efficacy against first severe COVID-19 occurrence was 95.3% (95% CI, 70.9, 99.9).

  • Vaccine efficacy against first severe COVID-19 occurrence based on CDC definition was 100% (95% CI, 87.6, 100.0).

 

Efficacy in Adolescents 12 Through 15 Years of Age 

  • Among 2260 adolescents 12 to 15 years of age, Study 2 evaluated the efficacy of Comirnaty against confirmed COVID-19 cases up to a data cutoff date of September 2, 2021.

  • Vaccine efficacy against first COVID-19 occurrence from 7 days after dose 2 without evidence of prior SARS-CoV-2 infection was 100% (95% CI, 86.6, 100.0).

Immunogenicity in Adolescents 12 Through 15 Years of Age

  • Study 2 evaluated SARS-CoV-2 50% neutralizing titers (NT50) 1 month after Dose 2 in a randomly selected subset of participants which demonstrated non-inferior immune responses (within 1.5-fold) comparing adolescents 12 through 15 years of age to participants 16 through 25 years of age who had no serological or virological evidence of past SARS-CoV-2 infection up to 1 month after Dose 2.

Comirnaty Note

Not Applicable

Comirnaty Patient Counseling

Patient Counseling

  • Inform of the potential benefits and risks of vaccination with Comirnaty.

  • Advise vaccine recipient to report any adverse events to their healthcare provider or to the Vaccine Adverse Event Reporting System at 1-800-822-7967 and www.vaers.hhs.gov.