Comirnaty

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  • Vaccines
PAGE CONTENTS
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  • Generic Name & Formulations
  • Indications
  • Dosage and Administration
  • Contraindications
  • Boxed Warnings
  • Warnings/Precautions
  • Pharmacokinetics
  • Interactions
  • Adverse Reactions
  • Clinical Trials
  • Note
  • Patient Counseling

    • Comirnaty Generic Name & Formulations

    Legal Class

    Rx

    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 after dilution; preservative-free.

    Pharmacological Class

    COVID-19 vaccine.

    How Supplied

    Multiple-dose vials—25, 195 (w. diluent; shipped separately)

    Storage

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

    • Vial Storage Prior to Use:

      • Cartons of Comirnaty multiple dose vials with gray caps and labels with gray borders will arrive frozen at ultra-cold conditions in thermal containers with dry ice.

      • When received, frozen vials 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. A carton of 10 vials may take up to 6 hours to thaw at this temperature.

      • Alternatively, frozen vials 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 vials are thawed, they should not be refrozen.

      • If cartons of Comirnaty multiple dose vials 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 vial and cartons regardless of storage conditions.

    • Vial Storage 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.

      • Comirnaty multiple dose vials with gray caps and labels with gray borders may be stored at room temperature [8°C to 25°C (46°F to 77°F)] for a total of 12 hours prior to the first puncture. After first puncture, the vial should be held between 2ºC to 25°C (35°F to 77°F). Vials should be discarded 12 hours after first puncture.

    • Transportation of Vials:

      • If local redistribution is needed, vials 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).

    Manufacturer

    Pfizer and BioNTech

    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 in individuals ≥12yrs of age.

    Comirnaty Dosage and Administration

    Adults and Children

    <12yrs: not established. Give by IM inj only. ≥12yrs: 0.3mL given as a 2-dose series 3 weeks apart.

    Administration

    • DO NOT DILUTE prior to use for Comirnaty multiple dose vials with gray caps and labels with gray borders.

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

    • Give a single 0.3mL dose of Comirnaty intramuscularly. 

    • May use dead-volume syringes and/or needles to extract 6 doses from a single vial.

    • Do not pool excess vaccine from multiple vials.

    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 the second dose); higher risk among males <40yrs of age, and 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 the second dose. 

    • Males under 40 years of age have a higher risk vs females and older males. 

    • Males 12 to 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

    There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to Comirnaty during pregnancy. Women who are vaccinated with COMIRNATY during pregnancy are encouraged to enroll in the registry by visiting https://mothertobaby.org/ongoing-study/covid19-vaccines/.

    Risk Summary

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

    Nursing Mother Considerations

    Risk Summary

    • 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 younger than 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. 

    • Inform of the importance of completing the 2 dose vaccination series. 

    • There is a pregnancy exposure registry for Comirnaty. Encourage individuals exposed to Comirnaty around the time of conception or during pregnancy to register by visiting https://mothertobaby.org/ongoingstudy/covid19-vaccines/.

    • 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.

    • Prior to administering the vaccine, give the vaccine recipient the Vaccine Information Fact Sheet for Recipients and Caregivers about Comirnaty (COVID-19 Vaccine, mRNA) and the Pfizer-BioNTech COVID-19 Vaccine to Prevent Coronavirus Disease 2019 (COVID-19) for Use in Individuals 12 Years of Age and Older. The Vaccine Information Fact Sheet for Recipients and Caregivers is available at www.cvdvaccine-us.com. 

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