Tuesday, September 15, 2009

FDA licensed the "Swine Flu" vaccine today

HHS Secretary Sebelius appeared today before House Energy and Commerce Committee where she announced that the so-called "Swine Flu" was licensed today. No mention was made whether an Emergency Use Authorization under the Project Bioshield Act of 2005 was involved. She told Congress that www.flu.gov will full details.

Rep deGette asked about adjuvants and the Secretary said "no adjuvants are currently anticipated" to which she added, "the scientists don't want to head down that path."*

[By the way, the quotes and notes are from our Eyes in DC, Maury Silverman. Maury attends hours of government hearings and plies the Halls of Congress for health and freedom.]

According to his notes, Sebelius said, "5 facilities are currently to be licensed" and "FDA has approved vaccine applications." This announcement was made about 2 PM today.

Secretary Sebelius also opined, "The influenza is going to be unpredictable..."

Rep Markey of Massachusetts questioned "Swine Flu" vaccines safety compared to the 1976 "Swine Flu" vaccine. Sebelius said the government gathered the experts from 1976 to consult and is not concerned about safety questions.

[Note: the position of the Secretary is consistent with comments by FDA figures, for example:

“Norman Baylor, PhD, director of FDA's Office of Vaccines Research and Review, explained the FDA's probable decision to go ahead with the simplified approval process, rather than a lengthy new drug application process. "We have decades of experience with H1N1, that's why we feel we can do this with a strain-change," said Dr. Baylor.” http://www.medpagetoday.com/ProductAlert/DevicesandVaccines/15230

The only time the government previously approved a "Swine Flu" vaccination was during the 1976 fiasco, resulting in hundreds of deaths and thousands maimed for life, all for a pandemic that never happened. That's the government's experience that gives rise to their claim not to need comprehensive safety testing.]

Contnuing, the HHS Secretary outlined a central distribution system of the vaccines from the 5 approved facilities to 90,000 predetermined sites. The distibution system will be run by a single contractor. The Agency has allocated $1.44 billion allocated to the States to operate the vaccine program. She further claimed there will be enough vaccine to all who "need it" and people should consult their physicians.

This vaccine has the dubious distinction of being approved for what the government has claimed was a "novel" flu virus under a "change of strain" review that is never used for novel diseases. Thus the FDA has violated the requirement of Title 21 of the US Code that new drugs must be show, with significant scientific agreement, to be both safe and effective, with the benefits outweighing the risks. Without comprehensive safety testing, how can that standard be met?

See the Citizens Petition which sought to stop approval of the vaccines and which will now form the basis of a Court appeal to reverse their licensing.


* Note: While we don’t particularly trust the Secretary’s intent to avoid adjuvants and know that the US purchased nearly a half billion dollars worth of squalene, according to an HHS press release of July 13, 2009, we do agree, this time, with their scientists! Push Back Works!

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