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Comirnaty

Tozinameran

The Pfizer-BioNTech mRNA COVID-19 vaccine.

mRNA vaccine
Reviewed by Sreepriya Prasannan
MSc Digital Transformation of Life Sciences (Innopharma Education / Griffith College); MSc & BSc Botany HSE Spark Ignite 2026 — Top 14 finalist
Compiled from official FDA data · Last verified · Editorial standards
Generic name
Tozinameran
Brand name
Comirnaty

Where Tozinameran is approved

All regulators →

Of the three regulators tracked here, the first to approve Tozinameran was Canada, on 16 Sep 2021.

USUnited States (FDA)
No FDA approval of a single-substance product in Drugs@FDA
First original NDA/BLA approval
EUEuropean Union (EMA)
No centralised EU authorisation (it may be authorised nationally)
First centralised authorisation
CACanada (Health Canada)
16 Sep 2021
Comirnaty
Notice of Compliance 26914
First new-drug NOC

From the regulators' own registers: FDA Drugs@FDA, the EMA medicines list and Health Canada's Notice of Compliance database. Dates are the first listed approval of a product containing only this substance; combination products and nationally authorised EU medicines are not counted.

How Tozinameran works

All drug targets →
  • Spike glycoprotein vaccine antigen Vaccine antigen
    ChEMBL only
Diseases it has been tested for in clinical trials, by furthest phase
  • COVID-19Phase 2
  • Juvenile dermatomyositisPhase 2
  • Juvenile idiopathic arthritisPhase 2
  • Multiple sclerosis symptom measurementPhase 2
  • PemphigusPhase 2
  • Rheumatoid arthritisPhase 2
  • Systemic lupus erythematosusPhase 2
  • Systemic sclerosisPhase 2
  • Burkitt lymphomaPhase 1
  • Hodgkins lymphomaPhase 1
20 diseases in all

Mechanisms and diseases from ChEMBL via the Open Targets Platform (release 26.09), ChEMBL record CHEMBL4650429, CC BY-SA 3.0. The Guide to Pharmacology has no record of this medicine, so its targets rest on ChEMBL alone. Trial phases are not approvals: approved uses are shown from the regulators' own records where we hold them.

Patient leaflets for Tozinameran

The package leaflet is the official guide for patients that comes with every medicine. These links go to the regulators that publish it.

  • UK
    United Kingdom: Search MHRA Products
    Patient information leaflets and SmPCs for UK-licensed products.
  • US
    United States: Search DailyMed
    FDA-approved labels, including patient and medication guides.

Leaflets differ between brands and countries; always read the one that comes with your own medicine. This is regulatory information, not medical advice.

What Comirnaty is used for

Tozinameran (Comirnaty) is the Pfizer-BioNTech mRNA COVID-19 vaccine. It belongs to the mRNA vaccine class.

Explore more

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How this page is built

The facts on this page are pulled directly from official U.S. FDA datasets — they are not written from memory. Each field below names the dataset it came from, so you can check it yourself.

Plain-English summaries and drug-class explainers are written and reviewed by Sreepriya Prasannan (MSc Digital Transformation of Life Sciences (Innopharma Education / Griffith College); MSc & BSc Botany). Data is retrieved automatically from the sources above and cross-checked with AI-assisted verification (Anthropic's Claude) — brand and generic names are matched against the exact FDA product record so that a combination product or a different formulation cannot be mistaken for the drug on this page. An editor reviews the result before publication. We describe this in full in our editorial standards and corrections policy. The FDA data on this page was last retrieved on 11 Oct 2026. How every register is built: methodology · fixes we have made: corrections log.

Please verify before you rely on this. This page is general information for life-science and pharmaceutical professionals. It is not medical advice, and it has not been reviewed by a clinician — our editorial team holds life-science qualifications, not clinical ones. It is not exhaustive and may not reflect the most recent label change. Always check the official prescribing information (US Prescribing Information or EU SmPC) and speak to your doctor or pharmacist before acting on anything here. Drugs in the same class are not automatically interchangeable, and approvals, brand names and indications differ between the US, the EU/Ireland (EMA/HPRA) and other regions. Spotted an error? Tell us — we correct promptly and log it.