NAV

Tozinameran

Identification

Summary

Tozinameran is an mRNA vaccine for the prevention of COVID-19 caused by the SARS-CoV-2 virus.

Generic Name
Tozinameran
DrugBank Accession Number
DB15696
Background

The Pfizer-BioNTech COVID-19 vaccine (also known as BNT162b2, Tozinameran, and Comirnaty), is one of four advanced mRNA-based vaccines developed through "Project Lightspeed," a joint program between Pfizer and BioNTech.2,3,13 Comirnaty is a nucleoside modified mRNA (modRNA) vaccine encoding an optimized full-length version of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) spike (S) protein. It is designed to induce immunity against SARS-CoV-2, the virus responsible for causing COVID-19.2 The modRNA is formulated in lipid nanoparticles for administration via intramuscular injection in two doses, three weeks apart.1,3

Comirnaty is undergoing evaluation in clinical trials in both the USA (NCT04368728) and Germany (NCT04380701).4,5 Comirnaty received fast track designation by the U.S. FDA on July 13, 2020.6 On December 11, 2020, the FDA issued an Emergency Use Authorization (EUA) based on 95% efficacy in clinical trials and a similar safety profile to other viral vaccines over a span of approximately 2 months.1 Comirnaty was granted a EUA in the UK on December 2, 2020,8 and in Canada on December 9, 20207 for active immunization against SARS-CoV-2.12 Full FDA approval was granted on August 23, 2021.13

Currently, sufficient data are not available to determine the longevity of protection against COVID-19, nor direct evidence that the vaccine prevents the transmission of the SARS-CoV-2 virus from one individual to another.9 Fact sheets for caregivers, recipients, and healthcare providers are now available.10,11 In November 2021, Health Canada 16 and the EMA 18 approved the vaccine to be administered as a booster dose approximately six months after the second dose. Comirnaty is also approved for use as a fourth booster shot in adults 50 years of age and older.22

Type
Biotech
Groups
Approved, Investigational
Biologic Classification
Vaccines
Other vaccines
Synonyms
  • Pfizer-BioNTech COVID-19 Vaccine
  • Tozinameran
External IDs
  • BNT162b2
  • BNT162b2 SARS-CoV-2 Vaccine
  • RNA ingredient BNT-162B2

Pharmacology

Indication

Comirnaty is fully approved by the FDA and Health Canada for active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals aged five years and older.14,15,20 A third booster shot is also approved by Health Canada for individuals five years and older and by the FDA for individuals 16 or older, to be given more than 6 months after their second immunization.16,18,19 The interchangeability of Comirnaty with COVID-19 vaccines from other manufacturers to complete the primary vaccination course or the booster dose (third dose) has not been established.18 Comirnaty is also approved for use as a fourth booster shot in adults 50 years of age and older.22 In the US, under the emergency use authorization, Comirnaty is used for the prevention of COVID-19 in children 6 months of age and older.23

Comirnaty is also available as an Omicron BA.4/BA.5 bivalent-adapted booster.26

This vaccine should only be administered where appropriate medical treatment for immediate allergic reactions are immediately available in the case of an acute anaphylactic reaction after vaccine administration.12,7,8,14 Comirnaty administration should be postponed in any individual suffering from an acute febrile illness. Immunocompromised individuals maybe have a weaker immune response to Comirnaty.14

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Associated Conditions
Contraindications & Blackbox Warnings
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Pharmacodynamics

Comirnaty is a nucleoside modified mRNA (modRNA) vaccine encoding an optimized full-length version of the SARS-CoV-2 spike (S) protein, translated and expressed in cells in vaccinated individuals to produce the S protein antigen against which an immune response is mounted. As with all vaccines, protection cannot be guaranteed in all recipients, and full protection may not occur until at least seven days following the second dose.7,8

In U.S. clinical trials, the vaccine was 95% effective in preventing COVID-19; eight COVID-19 cases occurred in the vaccine group and 162 cases occurred in the placebo group. Of the total 170 COVID-19 cases, one case in the vaccine group and three cases in the placebo group were considered to be severe infections.1,9 The clinical study C4591001 assessed the clinical efficacy of Comirnaty as a booster shot: in this study, adult subjects who were given a booster shot approximately six months after the second dose displayed antibody levels that were 3-fold higher after the booster dose relative to levels after the second dose.16

Mechanism of action

Comirnaty contains nucleoside modified mRNA (modRNA) encapsulated in lipid nanoparticles that deliver the modRNA into host cells. The lipid nanoparticle formulation facilitates the delivery of the RNA into human cells.12 Once inside these cells, the modRNA is translated by host machinery to produce a modified SARS-CoV-2 spike (S) protein antigen, which is subsequently recognized by the host immune system. Comirnaty has been shown to elicit both neutralizing antibody and cellular immune responses to the S protein, which helps protect against subsequent SARS-CoV-2 infection.7,8

Absorption

Not Available

Volume of distribution

Not Available

Protein binding

Not Available

Metabolism
Not Available
Route of elimination

Not Available

Half-life

Not Available

Clearance

Not Available

Adverse Effects
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Toxicity

Overdose data regarding Comirnaty are not readily available. Patients experiencing an overdose are at an increased risk of severe adverse effects such as injection site reactions, headache, arthralgia, myalgia, fatigue, chills, and pyrexia.7,8 Symptomatic and supportive measures are recommended.

Pathways
Not Available
Pharmacogenomic Effects/ADRs
Not Available

Interactions

Drug Interactions
This information should not be interpreted without the help of a healthcare provider. If you believe you are experiencing an interaction, contact a healthcare provider immediately. The absence of an interaction does not necessarily mean no interactions exist.
Not Available
Food Interactions
No interactions found.

Products

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dosage, form, labeller, route of administration, and marketing period.
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Brand Name Prescription Products
NameDosageStrengthRouteLabellerMarketing StartMarketing EndRegionImage
Comirnaty30 µgIntramuscularBio N Tech Manufacturing Gmb H2021-01-06Not applicableEU flag
ComirnatySuspension10 mcg / 0.2 mLIntramuscularBiontech Manufacturing Gmbh2021-11-22Not applicableCanada flag
ComirnatySuspension30 mcg / 0.3 mLIntramuscularBiontech Manufacturing Gmbh2022-06-07Not applicableCanada flag
Comirnaty30 µgIntramuscularBio N Tech Manufacturing Gmb H2022-06-06Not applicableEU flag
ComirnatyInjection, suspension0.048 mg/0.48mLIntramuscularPfizer Laboratories Div Pfizer Inc2022-08-252022-08-25US flag
Comirnaty10 µgIntramuscularBio N Tech Manufacturing Gmb H2022-06-06Not applicableEU flag
ComirnatySuspension30 mcg / 0.3 mLIntramuscularBiontech Manufacturing Gmbh2020-12-14Not applicableCanada flag
ComirnatyInjection, suspension0.225 mg/2.25mLIntramuscularPfizer Laboratories Div Pfizer Inc2022-05-18Not applicableUS flag
Comirnaty30 µgIntramuscularBio N Tech Manufacturing Gmb H2022-06-06Not applicableEU flag
ComirnatySuspension3 mcg / 0.2 mLIntramuscularBiontech Manufacturing Gmbh2022-09-15Not applicableCanada flag
Mixture Products
NameIngredientsDosageRouteLabellerMarketing StartMarketing EndRegionImage
Comirnaty Original & Omicron Ba.4/ba.5Tozinameran (5 mcg / 0.2 mL) + Famtozinameran (5 mcg / 0.2 mL)SuspensionIntramuscularBiontech Manufacturing Gmbh2022-12-19Not applicableCanada flag
Comirnaty Original & Omicron Ba.4/ba.5Tozinameran (1.5 mcg / 0.2 mL) + Famtozinameran (1.5 mcg / 0.2 mL)SuspensionIntramuscularBiontech Manufacturing GmbhNot applicableNot applicableCanada flag
Comirnaty Original & Omicron Ba.4/ba.5Tozinameran (15 mcg / 0.3 mL) + Famtozinameran (15 mcg / 0.3 mL)SuspensionIntramuscularBiontech Manufacturing Gmbh2022-10-11Not applicableCanada flag
Comirnaty Original/omicron Ba.1Tozinameran (15 mcg / 0.3 mL) + Riltozinameran (15 mcg / 0.3 mL)SuspensionIntramuscularBiontech Manufacturing GmbhNot applicableNot applicableCanada flag

Categories

Drug Categories
Classification
Not classified
Affected organisms
  • Humans and other mammals

Chemical Identifiers

UNII
5085ZFP6SJ
CAS number
2417899-77-3

References

General References
  1. Polack FP, Thomas SJ, Kitchin N, Absalon J, Gurtman A, Lockhart S, Perez JL, Perez Marc G, Moreira ED, Zerbini C, Bailey R, Swanson KA, Roychoudhury S, Koury K, Li P, Kalina WV, Cooper D, Frenck RW Jr, Hammitt LL, Tureci O, Nell H, Schaefer A, Unal S, Tresnan DB, Mather S, Dormitzer PR, Sahin U, Jansen KU, Gruber WC: Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine. N Engl J Med. 2020 Dec 10. doi: 10.1056/NEJMoa2034577. [Article]
  2. Gen Eng News: BNT162 vaccine candidates [Link]
  3. BioNTech BNT162 Update [Link]
  4. Clinical Trial NCT04368728 [Link]
  5. Clinical Trial NCT04380701 [Link]
  6. FDA fast track designation: BNT162b1 and BNT162b2 [Link]
  7. Health Canada Approved Drug Products: COMIRNATY (COVID-19 Vaccine, mRNA) Suspension for Intramuscular Injection [Link]
  8. MHRA Interim Product Monograph: BNT162b2 SARS-CoV-2 Vaccine [Link]
  9. FDA News Release: FDA Takes Key Action in Fight Against COVID-19 By Issuing Emergency Use Authorization for First COVID-19 Vaccine [Link]
  10. Pfizer: Fact Sheet for Healthcare Providers Administering Vaccine, Pfizer-BioNtech COVID-19 vaccine [Link]
  11. Pfizer: Fact Sheet for Recipients and Caregivers, Pfizer BioNTech COVID-19 vaccine [Link]
  12. FDA Emergency Use Authorization: Full EUA Prescribing information, Pfizer-BioNTech COVID-19 vaccine [Link]
  13. FDA Press Announcements: FDA Approves First COVID-19 Vaccine [Link]
  14. FDA Approved Drug Products: Comirnaty (COVID-19 mRNA vaccine) Intramuscular Injection [Link]
  15. FDA News Release: FDA Authorizes Pfizer-BioNTech COVID-19 Vaccine for Emergency Use in Children 5 through 11 Years of Age [Link]
  16. Health Canada: Regulatory Decision Summary for COMIRNATY [Link]
  17. FDA News Release: FDA Expands Eligibility for COVID-19 Vaccine Boosters [Link]
  18. Summary of Product Characteristics: Comirnaty (COVID-19 mRNA Vaccine, nucleoside modified) Intramuscular Injection [Link]
  19. GlobeNewswire: Pfizer and BioNTech Receive U.S. FDA Emergency Use Authorization of COVID-19 Vaccine Booster for Individuals 16 Years and Older [Link]
  20. Health Canada: Pfizer-BioNTech Comirnaty COVID-19 vaccine [Link]
  21. EMA COVID-19 Vaccine Safety Update: Comirnaty (Dec 9/21) [Link]
  22. BioSpace News: Going it Alone, FDA Authorizes Second Booster for Adults 50 Plus [Link]
  23. FDA NEWS RELEASE: Coronavirus (COVID-19) Update; FDA Authorizes Moderna and Pfizer-BioNTech COVID-19 Vaccines for Children Down to 6 Months of Age [Link]
  24. Health Canada Approved Drug Products: COMIRNATY (COVID-19 Vaccine, mRNA) Suspension for Intramuscular Injection 2022 [Link]
  25. FDA Emergency Use Authorization: Pfizer-BioNTech COVID-19 Vaccine (Original & Omicron BA.4/BA.5 strain) suspension for intramuscular injection [Link]
  26. Health Canada Approved Drug Products: COMIRNATY Original & Omicron BA.4/BA.5 [COVID-19 mRNA vaccine, Bivalent (Original and Omicron BA.4/BA.5)] Suspension for Intramuscular Injection [Link]
RxNav
2468230
Wikipedia
Pfizer%E2%80%93BioNTech_COVID-19_vaccine

Clinical Trials

Clinical Trials
PhaseStatusPurposeConditionsCount
4Active Not RecruitingPreventionBullous Dermatoses / Coronavirus Disease 2019 (COVID‑19) / Covid19, Vaccines / Psoriasis1
4Active Not RecruitingPreventionCoronavirus Disease 2019 (COVID‑19)1
4Active Not RecruitingPreventionCoronavirus Disease 2019 (COVID‑19) / COVID-19 Pandemics1
4Active Not RecruitingPreventionCoronavirus Disease 2019 (COVID‑19) / COVID19 Vaccination1
4Active Not RecruitingPreventionCoronavirus Disease 2019 (COVID‑19) / Covid19, Vaccines1
4CompletedBasic ScienceCoronavirus Disease 2019 (COVID‑19) / Immunization; Infection / Vaccine Reaction1
4CompletedPreventionCoronavirus Disease 2019 (COVID‑19)1
4CompletedTreatmentCoronavirus Disease 2019 (COVID‑19)1
4Not Yet RecruitingPreventionAcute Respiratory Distress Syndrome Caused by COVID-19 / Coronavirus Disease 2019 (COVID‑19) / Immunosuppression1
4RecruitingOtherCoronavirus (SARS-CoV) / Coronavirus Disease 2019 (COVID‑19)1

Pharmacoeconomics

Manufacturers
Not Available
Packagers
Not Available
Dosage Forms
FormRouteStrength
Injection, suspensionIntramuscular0.048 mg/0.48mL
SuspensionIntramuscular10 mcg / 0.2 mL
SuspensionIntramuscular3 mcg / 0.2 mL
SuspensionIntramuscular30 mcg / 0.3 mL
Solution30 mcg
InjectionParenteral10 mcg
SuspensionIntramuscular
Injection, suspensionIntramuscular0.225 mg/2.25mL
Injection, suspensionIntramuscular
Prices
Not Available
Patents
Not Available

Properties

State
Liquid
Experimental Properties
Not Available

Drug created at July 13, 2020 15:14 / Updated at December 23, 2022 00:49