Vepacel - Influenza Virus Vaccine, H5N1; bird flu vaccine; avian influenza vaccine; influenza virus H5N1, inactivated
Status: approved in EU in March 2012
Organizations involved:
Baxter AG – Manuf; R&D; Tech.; World mark.
Baxter Healthcare Corp. – Parent
Description: Vepacel is a monovalent whole inactivated virion H5N1-type pandemic influenza vaccine consisting of virus cultured in Vero cells and inactivated with formaldehyde.
Each 1 mL dose contains 0.5 ml contains (in 2011/2012 formulation) Influenza virus (whole virion, inactivated), containing antigen of A/Vietnam/1203/2004 (H5N1) 7.5 micrograms [(propagated in Vero cells, a continuous cell line of mammalian origin; production target value expressed in micrograms haemagglutinin (SRD)].
Excipients used are Trometamol; Sodium chloride; Water for injections; and Polysorbate 80 (Tween 80). The finished vaccine may contain traces of formaldehyde, benzonase, sucrose, trypsin and Vero cell proteins.
The vaccine is provided in a 10-dose vial for delivery of 5 ml suspension (10 x 0.5 ml doses) in a vial (type I glass) with a stopper (bromobutyl rubber). The vial should be stored refrigerated (2˚-8˚C).
Nomenclature: influenza vaccine, H5N1/Baxter [BIO]; Vepacel [TR]; A/H5N1 pre-pandemic influenza vaccine (whole virion, vero cell derived, inactivated) [INN]; Prepandemic influenza vaccine (A/H5N1) (whole virion, Vero cell derived, inactivated) [EU name]; avian influenza vaccine [SY]
bird flu vaccine [SY]; influenza virus H5N1, inactivated [SY]
Companies.: Vepacel manufacture is attrributed by EMA to Baxter BioScience s.r.o., Kostelec nad Cernymi lesy, Czech Republic and Baxter AG, Orth/Donau, Austria, with product batch release by Baxter Innovations GmbH, Vienna, Austria.
FDA class: Biologic BLA
Indications: [Full text ot the the "Therapeutic indications: " section of the EMA EPAR]:
Active immunisation against H5N1 subtype of influenza A virus. This indication is based on immunogenicity data from healthy subjects from the age of 18 years onwards as well as immunocompromised and chronically ill subjects following administration of two doses of vaccine prepared with H5N1 subtype strains. Vepacel should be used in accordance with Official guidance.
Status: EMA/EU approval for use in adults over 18 years of age granted on March 2, 2012
Vepacel is indicated for adult immunization against H5N1 in a pre-pandemic situation.
Trials: This indication is based on immunogenicity data (surrogate marker) from healthy subjects from the age of 18 years onwards as well as immunocompromised and chronically ill subjects following administration of two doses of vaccine prepared with H5N1 subtype strains. Specifically, the immunogenicity of the A/Vietnam/1203/2004 strain vaccine was evaluated in three clinical studies in adults aged 18 – 59 years (N=961) and in two clinical studies in subjects aged 60 years and older (N=391) following a 0, 21 day schedule. In addition, the immunogenicity was evaluated in a Phase 3 study in specified risk groups of immunocompromised subjects (N=122) and patients with chronic disease conditions (N=123) following a 0, 21 day schedule.
Index Terms:
Companies involvement:
Full monograph
488.1 Influenza Vaccine, H5N1/Baxter
Nomenclature:
influenza vaccine, H5N1/Baxter [BIO]
Vepacel [TR]
A/H5N1 pre-pandemic influenza vaccine (whole virion, vero cell derived, inactivated) [INN]
Prepandemic influenza vaccine (A/H5N1) (whole virion, Vero cell derived, inactivated) [EU name]
avian influenza vaccine [SY]
bird flu vaccine [SY]
influenza virus H5N1, inactivated [SY]
FDA Class: Biologic BLA
biopharmaceutical products
vaccines, inactivated
vaccines, viral
influenza virus
vegetable oil extraction
virus culture
polysorbate 80 (Tween 80)
sodium chloride
trisodium citrate
Water for Injection
BHK-21 (C-13)
conjugates
EU200 Currently Approved in EU
UM999 Not Available/Not Marketed in US
US000 never filed/no plans
EM001 Marketed Product in EU
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