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EU approval granted to untested bioweapons for use as “swine flu” vaccines

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The Flu Case
Monday, Sept 28th, 2009

The European Medicines Agency (EMEA) has granted marketing authorisation to two swine flu vaccines: Focetria produced by Novartis and Pandemrix produced by GlaxoSmithKline, which is classified by the EU as a bioweapon.

The authorisation has been given in spite of the fact the vaccines have not been tested.

“There is currently no clinical experience with Focetria (H1N1) in adults, including the elderly, children or adolescents,” says the EMEA on its pandemic influenza H1N1 website after giving approval to the vaccine on September 24th.

http://www.emea.europa.eu/influenza/vaccines/focetria/focetria.html

In addition, EMEA states on its pandemic website there is “no clinical experience in the elderly, in children or in adolescents” with pandemrix.
“There is currently very limited clinical experience with an investigational formulation of Pandemrix (H1N1) containing a higher amount of antigen (see section 5.1) in healthy adults aged 18-60 years and no clinical experience in the elderly, in children or in adolescents.”

http://www.emea.europa.eu/influenza/vaccines/pandemrix/pandemrix.html

The European Commission is expected to give approval to the two untested vaccines at the beginning of October, clearing the way for governments to begin mass vaccination campaigns throughout the European Union.

  • A d v e r t i s e m e n t

Pregnant women and children as young as six months have been identified as priority groups by the European Commission and WHO for the “swine flu” jab even though no clinical data is available.

EU approval granted to untested bioweapons for use as swine flu vaccines  230909banner1

“There are currently no data available on the use of Focetria in pregnancy,” states the EMEA  on its website.

http://www.emea.europa.eu/influenza/vaccines/focetria/focetria.html

 
The EMEA says Novartis is to assess the safety of the vaccine and its side effects after Foceteria has been given.

 

„The company that makes Focetria will collect information on the safety of the vaccine while it is being used. This will include information on its side effects and its safety in children, pregnant women, patients with severe conditions and people who have problems with their immune systems.“

The EMEA also says GSK is to assess the safety of the Pandemrix vaccine after it is given to people.

http://www.emea.europa.eu/influenza/vaccines/pandemrix/pandemrix.html

 

“”Pandemrix has been authorised under ‘Exceptional Circumstances’. This means that it has not been possible to obtain full information about the pandemic vaccine.

What information is still awaited for Pandemrix?

The company that makes Pandemrix will collect information on the safety and effectiveness of the vaccine, and submit this to the CHMP for evaluation.

Which measures are being taken to ensure the safe use of Pandemrix?

The company that makes Pandemrix will collect information on the safety of the vaccine while it is being used. This will include information on its side effects and its safety in the elderly, pregnant women, patients with severe conditions and people who have problems with their immune systems.”

 

The EMEA approval for these vaccines was based on data from so-called “mock up” vaccines dating from 2007 and 2008, but these “mock up” vaccines are actually different vaccines altogether.

”The approval was given on the basis of data from a mock up H5N1 mock-up vaccine for Focetria to Novartis Vaccines and Diagnostics S.r.l. on 2 May 2007.

“This information was recommended by the CHMP on 24 September 2009.”

http://www.emea.europa.eu/influenza/vaccines/focetria/focetria.html

The European Commission granted a marketing authorisation valid throughout the EU for the H5N1 mock-up vaccine for Pandemrix to GlaxoSmithKline Biologicals s.a. on 20 May 2008.”

 

The use of the Swedish and Swiss military, widely reported in the media, to guard the “swine flu” vaccines highlights their danger.

EMEA appears to have systematically misrepresented the data on foceteria and pandemrix in order to present it as safe and tested when it is unsafe and untested in an act of criminal fraud.

EMEA is two thirds funded by pharma companies, raising question marks about just how independent the body is.

This is an entry on a bipharma database on GSK’s Pandemrix bioweapon.

 

 

———

“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

This article was posted: Monday, September 28, 2009 at 10:29 am





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