Glaxo’s vaccine characterised by regulators as EU and USA biodefense stockpile drug


Glaxo’s pandemic influenza vaccine is characterised by regulatory authorities as a susbtance that needs to be stockpiled in the EU’s and USA’s biodefense stockpiles.

“Regulatory/Status Index:
EU666 Biodefense stockpile
US666 Biodefense stockpile

This classificiation by regulatory authorities underscores fears that the pandemic flu vaccines, which contain toxic adjuvants, are indeed actually bioweapons, designed to cause death and injury. Furthermore, the Glaxo vaccine is categorised as having “controlled or government distribution in the EU and USA” only. Below is the entry for the Glaxo pandemic influenza vaccine on a biopharma database. Scroll down to see the Regulatory/Status Index.

———

“Prepandrix; Pandemrix – influenza virus H5N1, inactivated, vaccine, with AS03 adjuvant; bird flu vaccine; avian influenza vaccine; pandemic influenza vaccine”

Company roles:

Centers for Disease Control and Prevention (CDC) — R&D ; Tech. ; USA mark.
GlaxoSmithKline Biologicals S.A. (GSK) — Manuf. ; R&D ; Tech. ; Europe mark.
GlaxoSmithKline plc (GSK) — Parent
Monograph size = 15988 characters (not including indexing, nomenclature, links, etc. on this page)

Partial monograph text:
393 Influenza Vaccine, H5N1/GSK

Pandemic Influenza vaccine, surface antigen, inactivated; influenza vaccine, pandemic – Prepandrix; Pandemrix; influenza virus H5N1 vaccine; bird flu vaccine; influenza virus H5N1, inactivated, vaccine; avian influenza vaccine; influenza H5N1 virus (A/Indonesia) vaccine

Status: vaccine approved in EU in May 2008; being added to U.S. and other countries’ stockpiles

Organizations involved:

GlaxoSmithKline Biologicals S.A. – Manuf.: R&D; Tech.; Europe mark.

GlaxoSmithKline plc – Parent

Centers for Disease Control & Prevention (CDC) – R&D; Tech.; U.S. mark..

Description: Prepandrix “prepandemic vaccine” is a conventional egg-cultured influenza virus H5N1 (A/VietNam/1194/2005 NIBRG-14) clade 2 inactivated split-antigen vaccine. The H5N1 clade 2 bulk material is being manufactured from a laboratory version seed virus of the wild-type virus provided by the U.S. Centers for Disease Control and Prevention (CDC). The reference virus, A/Vietnam/1194/2004 (H5N1) NIBRG-14, was developed using reverse genetics, with reassortment strain combining the H5 and N1 segments to with an influenza virus PR8 strain backbone. In addition the H5 was engineered to eliminate the polybasic stretch of amino-acids at the HA cleava … truncated (just the beginning)

Nomenclature:

Infleunza Vaccine, H5N1/GSK [BIO]
Prepandrix [TR]
Pandemrix [TR]
Pandemic Influenza vaccine, surface antigen, inactivated [EU]
Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) A/VietNam/1194/2004 NIBRG-14 [EU]
Pandemic influenza vaccine (H5N1) (split, inactivated, adjuvanted) [EU]
avian influenza vaccine [SY]
bird flu vaccines [SY]
influenza H5N1 virus (A/Indonesia)vaccine [SY]
influenza vaccine, pandemic [SY]
influenza virus H5N1, inactivated, vaccine with AS03 adjuvant [SY]

Index Terms:

Product Class Index:
biopharmaceutical products
bovine materials used
chicken source materials
vaccines, inactivated
vaccines, subunit
vaccines, viral

SB001 BIOPHARMA prod. (mainstream)

Regulatory/Status Index:
EU200 Currently Approved in EU
EU666 Biodefense stockpile
UM100 Controlled/Gov’t Distribution in US
US666 Biodefense stockpile
EM160 Controlled/Gov’t Distribution in EU

Biological Index:
chicken embryos (eggs)
influenza virus, H5N1
virus culture

Chemical Index:
alpha-tocopherol
aluminum adjuvant
AS03 adjuvant
Daronrix
disodium phosphate
formaldehyde
magnesium chloride
octoxynol 10
polysorbate 80 (Tween 80
potassium chloride
potassium dihydrogen phosphate
sodium chloride
sodium deoxycholate
squalene
thiomersal
vitamin E

One Response to Glaxo’s vaccine characterised by regulators as EU and USA biodefense stockpile drug

  1. Desiree L. Rover says:

    It is bad journalism to mix H1N1 vaccine information with H5N1 vaccine information.

Follow

Get every new post delivered to your Inbox.

Join 209 other followers

%d bloggers like this: