Delving into the Latest Updates on Inactivated Monovalent Influenza virus A/Vietnam/1194/2004 NIBRG 14 vaccine(Sanofi pasteur) with Synapse

Overview

Basic Info

Drug Type

Inactivated vaccine, Prophylactic vaccine

Synonyms

Emerflu

Target-

Action

stimulants

Mechanism

Immunostimulants

Therapeutic Areas

Infectious DiseasesRespiratory Diseases

Active Indication

influenza A subtype H5N1 infection

Inactive Indication-

Originator Organization

Sanofi Pasteur SA

Active Organization

Sanofi Pasteur SA

Inactive Organization-

License Organization-

Drug Highest PhaseNDA/BLA

First Approval Date-

Regulation-

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Emerflu is an inactivated, split-virion pandemic preparedness vaccine, containing 30 μg of hemagglutinin (HA) and 600 μg of aluminum hydroxide adjuvant. It is administered in two doses, 3 weeks apart. Only moderate immunogenicity was evident from clinical studies with the vaccine in adults, and HA antibody responses were below the criteria established by the EMA and US FDA for licensure. With the exception of Australia, the vaccine remains unlicensed. Further clinical development appears to have been suspended, and newer adjuvants such as MF59 and AS03 have since demonstrated safety and superior immunogenicity with lower HA doses. Emerflu is symbolic of the failure of aluminum salts as an adjuvant for influenza vaccines. Reasons for this failure are unclear, and may reflect problems with the adjuvant-antigen complex or interference in the immune response by heterosubtypic immunity.

100 Deals associated with Inactivated Monovalent Influenza virus A/Vietnam/1194/2004 NIBRG 14 vaccine(Sanofi pasteur)

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