Baxter, Novartis, GSK “swine flu” vaccines will not be part of official clinical trials in the US – only two vaccines without adjuvants from CSL and Sanofi Pasteur will be tested by vaccine watchdog

By JB

The US federal agency responsible for conducting clinical trials has revealed that there will be no official tests of the “swine flu” vaccine of five manufactures who already produce US-licenced seasonal vaccine, including Baxter, Novartis and GSK.

Baxter, Novartis and GSK will conduct their own trials on the vaccine under secret contract with the HHS Department.

The National Institute for Allergies and Infectious Diseases, NIAID, has revealed that the five official government clinical trials to evaluate the safety of the “swine flu” vaccine will involve two candidate vaccines from sanofi pasteur and CSL from Australia – and not the candidate vaccines from the major suppliers Baxter, GSK or Novartis in spite of the growing controversy over the safety record of these vaccine manufacturers.

Moreover, the NIAID clinical trials are of two vaccines that will not have the dangerous adjuvant ingredient planned for the vast majority of “swine flu” vaccines, fuelling concerns the US government is deliberately, systematically and wilfully manipulating the clinical trials and the resulting data to give a false picture of the safety of the H1N1 vaccines and hide the risks from the population.

“These two vaccines were chosen initially for the VTEU trials based on Department of Health and Human Services (HHS) projections that these vaccines may make up the bulk of the unadjuvanted vaccine supply in the United States,” says the NIAID website.

http://www3.niaid.nih.gov/news/QA/vteuH1N1qa.htm

QUESTIONS AND ANSWERS
Clinical Trials of 2009 H1N1 Influenza Vaccines
Conducted by the NIAID-Supported
Vaccine and Treatment Evaluation Units

In addition, two of the trials will compare the “simultaneous and sequential administration” of seasonal flu vaccine and sanofi pasteur candidate 2009 H1N1 influenza vaccine, sparking concerns over the use of multiple flu shots and how they interact inside the body.

Contact NIAID, HHS and these principal investigators today and ask them why clinical trials of the vaccines with adjuvants that are going to make up the bulk of the “swine flu” vaccines are not being conducted – except under secret contract with the HHS.

The following clinical trials will be conducted according to NIAID:

University of Maryland School of Medicine VTEU (Dr. Karen Kotloff, principal investigator) will lead the two trials testing the sanofi pasteur vaccine in healthy adults, elderly, and children.

University of Iowa VTEU (Dr. Pat Winokur, principal investigator) will lead the trials testing the CSL vaccine in healthy adult and elderly volunteers.

Saint Louis University VTEU (Dr. Sharon Frey, principal investigator) will lead the two trials testing the H1N1 vaccines given at the same time as or sequentially with the seasonal flu vaccine in healthy adult and elderly volunteers and in children.

“Detailed information about the trials is available from the NIH www.clinicaltrials.gov Web site. Listed below are the specific links for the initial group of five VTEU trials.

Trial comparing two different strengths (15 microgram versus 30 microgram) and one versus two doses of sanofi pasteur candidate 2009 H1N1 influenza vaccine in healthy adults (18 to 64 years old) and healthy elderly adults (65 years and older). Each of the four groups in this trial will enroll up to 100 volunteers, for a target number of 400 volunteers. For more information, see NCT00943631.

Trial comparing two different strengths (15 microgram versus 30 microgram) and one versus two doses of CSL Limited candidate 2009 H1N1 flu vaccine in healthy adults (18 to 64 years old) and healthy elderly adults (65 years and older). Each of the four groups in this trial will enroll up to 100 volunteers, for a target number of 400 volunteers. For more information, see NCT00943488.

Trial comparing two different strengths (15 microgram and 30 microgram) and one and two doses of sanofi pasteur candidate 2009 H1N1 flu vaccine in healthy children (6 months to 17 years old). This trial will be conducted only if safety data from the trials in healthy adults and elderly adults show the vaccine is safe. Each of the two groups in this trial will enroll up to 300 volunteers, for a target number of 600 volunteers. For more information about this trial, see NCT00944073.

Trial comparing simultaneous and sequential administration of seasonal flu vaccine and sanofi pasteur candidate 2009 H1N1 influenza vaccine in healthy adults (18 to 64 years old) and elderly adults (65 years and older) volunteers. Each of the four groups in this trial will enroll up to 200 volunteers, for a target number of 800 volunteers. For more information, see NCT00943878.

Trial comparing simultaneous and sequential administration of seasonal flu vaccine and sanofi pasteur candidate 2009 H1N1 influenza vaccine in primed children (children who have received two doses of seasonal vaccine in one year or are older than 9 years). Each of the four groups in this trial will enroll up to 150 children, for a target number of 600 volunteers. For more information, see NCT00943202.”

Leave a Reply