PharmaRadar360

PharmaRadar360

VaccinesDrug intelligence

Comirnaty

BNT162b2

mRNA vaccine expressing the SARS-CoV-2 spike (S) antigen. Developed by Pfizer. Clinical, regulatory, and source evidence are connected below.

Company
Pfizer
Target / MOA
SARS-CoV-2 spike protein
Aliases
Comirnaty · Pfizer-BioNTech COVID Vaccine
Signals
21
Clinical trials
13
Approvals
0
Evidence sources
21

Latest signals

What changed

The three most recent source-backed changes linked to this drug.

clinical trialClinicalTrials.gov

A Phase 2b, Randomized, Double-blind, Active-controlled Study of Single Dose CVXGA Intranasal COVID-19 Vaccine in Adults

Phase 2 · COMPLETED · CyanVac LLC

clinical trialClinicalTrials.gov

A Study to Evaluate VXA-CoV2-3.3 COVID-19 Vaccine Against Currently Approved/Authorized mRNA COVID-19 Injectable Booster Vaccine in Adults Previously Immunized Against COVID-19 Infection

Phase 2 · ACTIVE_NOT_RECRUITING · Vaxart

clinical trialClinicalTrials.gov

Self-Amplifying mRNA COVID-19 Vaccine (LUNAR-COV19) Versus Comirnaty Vaccine in Adult Hematopoietic Cell Transplant Patients

Phase 2 · NOT_YET_RECRUITING · Fred Hutchinson Cancer Center

Approved uses

What regulators have approved

The indications section of each current US label, word for word, and the EU summary of each authorised product. Official sources as of Oct 18, 2026.

United States (FDA label)

Comirnaty · BLA125742 · label version 22, effective Sep 2, 2026 · DailyMed

Label section 1

1 INDICATIONS AND USAGE COMIRNATY is a vaccine indicated for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). COMIRNATY is approved for use in individuals who are: • 65 years of age and older, or • 5 years through 64 years of age with at least one underlying condition that puts them at high risk for severe outcomes from COVID-19.

European Union (EMA)

Comirnaty · EMEA/H/C/005735 · Authorised, authorised Dec 21, 2020 (Commission decision C(2020) 9598) · EPAR

Comirnaty JN.1 dispersion for injection is indicated for active immunisation to prevent COVID-19 caused by SARS-CoV-2 in individuals 6 months of age and older. The use of this vaccine should be in accordance with official recommendations. Comirnaty JN.1 concentrate for dispersion for injection is indicated for active immunisation to prevent COVID-19 caused by SARS-CoV-2 in infants and children aged 6 months to 11 years. The use of this vaccine should be in accordance with official recommendations. Comirnaty KP.2 dispersion for injection is indicated for active immunisation to prevent COVID-19 caused by SARS-CoV-2 in individuals 6 months of age and older. The use of this vaccine should be in accordance with official recommendations. Comirnaty LP.8.1 dispersion for injection is indicated for active immunisation to prevent COVID-19 caused by SARS-CoV-2 in individuals 6 months of age and older. The use of this vaccine should be in accordance with official recommendations. Comirnaty XFG dispersion for injection is indicated for active immunisation to prevent COVID-19 caused by SARS-CoV-2 in individuals 6 months of age and older. The use of this vaccine should be in accordance with official recommendations.

EMA's summary; the full indication is in the product information on the EPAR page.

Regulatory history

Approvals over time

US original approvals and efficacy supplements (new indications, populations or dosing) from Drugs@FDA; EU authorisations and CHMP opinions on extensions. Official sources as of Oct 18, 2026.

United States

BLA125742 · BioNTech Manufacturing GmbH · first licensed Aug 23, 2021

Drugs@FDA does not cover vaccines: the licence date is from FDA's Purple Book, and the linked FDA page lists each approval letter since.

European Union

  • Comirnaty: Authorised since Dec 21, 2020

Patents and exclusivity

What FDA lists (US)

Patents and exclusivity as FDA lists them in the Orange Book (drugs) and the Purple Book (biologics), with approved generics and biosimilars. Expired listings are not shown. Official sources as of Oct 18, 2026.

BLA125742 (Purple Book)

No exclusivity date listed.

Generics and biosimilars

The Purple Book lists no licensed biosimilar.

FDA's listings only: an approved generic or licensed biosimilar may not be on the market yet. Not a forecast of when they may launch, and not legal advice.

Safety

Boxed warnings and FDA safety communications

The boxed warning on each current US label, and FDA Drug Safety Communications that name the drug (FDA's list from January 2020). Official sources as of Oct 18, 2026.

Boxed warning

The current US label has no boxed warning.

FDA Drug Safety Communications

None on FDA's list names this drug.

The list is FDA's for drugs (CDER); safety communications about vaccines come from FDA's CBER and are not covered here.

Clinical trials

Key active studies

A focused view of recently updated studies · 13 linked records.

Phase 2COMPLETEDNCT06742281

A Phase 2b, Randomized, Double-blind, Active-controlled Study of Single Dose CVXGA Intranasal COVID-19 Vaccine in Adults

CyanVac LLC · Updated Oct 13, 2026

Phase 2ACTIVE NOT RECRUITINGNCT06672055

A Study to Evaluate VXA-CoV2-3.3 COVID-19 Vaccine Against Currently Approved/Authorized mRNA COVID-19 Injectable Booster Vaccine in Adults Previously Immunized Against COVID-19 Infection

Vaxart · Updated Oct 9, 2026

Phase 2NOT YET RECRUITINGNCT07390968

Self-Amplifying mRNA COVID-19 Vaccine (LUNAR-COV19) Versus Comirnaty Vaccine in Adult Hematopoietic Cell Transplant Patients

Fred Hutchinson Cancer Center · Updated Sep 17, 2026

Phase 3WITHDRAWNNCT05534048

Booster Study of PTX-COVID19-B in Adults Aged 18 Years and Older

Everest Medicines (Singapore) Pte. Ltd. · Updated Sep 11, 2026

EARLY/Phase 1RECRUITINGNCT07605520

An Experimental Medicine Multicenter Trial to Evaluate the Safety and Immunogenicity of Experimental Versus Authorized SARS-CoV-2 Vaccine Candidates as a Booster Dose in Healthy Participants Previously Vaccinated With Authorized mRNA SARS-CoV-2 Vaccines.

ANRS, Emerging Infectious Diseases · Updated Jun 2, 2026

Phase 4COMPLETEDNCT05057182

Third Dose of mRNA Vaccination to Boost COVID-19 Immunity (mBoost Study)

The University of Hong Kong · Updated May 15, 2026

Source evidence

Where this profile comes from

Facts link back to original registries, regulators, labels, and publishers. Counts change as source records update.

ClinicalTrials.govofficial · Latest Oct 13, 202620EMA Human Medicinesofficial · Latest Sep 30, 20261
Professional referenceThis profile summarizes linked public evidence. It is not medical, legal, regulatory, or investment advice. Verify decisions against original sources.