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Influenza A Virus A/Victoria/4897/2022 IVR-238 (H1N1) antigen (formaldehyde inactivated)

Generic Name
Influenza A Virus A/Victoria/4897/2022 IVR-238 (H1N1) antigen (formaldehyde inactivated)
Brand Names
Fluad Quadrivalent, Fluarix Quadrivalent, Fluzone High-Dose Quadrivalent, Fluzone Quadrivalent
Drug Type
Biotech

Overview

A seasonally-specific component of the influenza vaccine. The influenza vaccine, also known as the "flu shot", is a vaccine that helps to protect against infection from influenza viruses. These vaccines provide protection from influenza by exposing the immune system to the virus (or parts of the virus) which results in an immunological defense against future exposure to the virus, or "antigen". This defense includes the production of humoral immunity through the development of antibodies and of cell-mediated immunity through the production of T-lymphocytes. Upon re-exposure to an influenza virus, the immune system is prepared with circulating antibodies that identify and destroy the virus. There are three basic types of vaccines available: inactivated influenza vaccine (IIV), live attenuated influenza vaccine (LAIV), and recombinant influenza vaccines (RIV). Inactivated vaccines contain a virus particle that has been grown in media and then subsequently killed, or inactivated, through exposure to heat or chemicals such as formaldehyde. Inactivated viruses cannot replicate and thus cannot cause disease from infection, even in immunocompromised individuals. In contrast, live vaccines are produced from "wild-type" or disease-causing viruses that have been attenuated, or weakened, through various laboratory techniques. Live vaccines maintain their replicative ability. Recombinant influenza vaccines are produced by synthesizing recombinant influenza hemagglutinin antigen in a laboratory and do not require the use of candidate viruses or egg-based manufacturing processes.

Indication

No indication information available.

Associated Conditions

No associated conditions information available.

FDA Drug Approvals

Approved Product
Manufacturer
NDC Code
Route
Strength
Effective Date
Sanofi Pasteur Inc.
49281-357
INTRAMUSCULAR
15 ug in 0.5 mL
3/21/2025
Sanofi Pasteur Inc.
49281-326
INTRAMUSCULAR
15 ug in 0.5 mL
3/21/2025
Seqirus, Inc.
70461-025
INTRAMUSCULAR
15 ug in 0.5 mL
7/1/2025
Deseret Biologicals, Inc.
43742-2266
ORAL
12 [hp_C] in 1 mL
5/6/2025
Sanofi Pasteur Inc.
49281-124
INTRAMUSCULAR
60 ug in 0.5 mL
5/6/2025

EMA Drug Approvals

Approved Product
Authorization Holder
Status
Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product
Manufacturer
Approval Number
Dosage Form
Strength
Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

Approved Product
Company
Approval Number
Drug Type
Dosage Form
Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product
Registration No.
Company
Licence No.
Strength
Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product
ARTG ID
Sponsor
Registration Type
Status
Registration Date
No TGA approvals found for this drug.

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