August 18, 2009

an h1n1 vaccine; synbio virus bred in genetically engineered insect cells

Novavax is making a swine flu vaccine using remarkably strange and potentially dangerous technology that will not be adequately tested before use.

The proprietary process engineers virus-like particles (VLP) - manufactured viruses put together with a recipe of dna. It is synthetic biology not requiring a sample to make.

Genetically engineered insect cell lines are used to grow the VLP, as the usual process (in chicken eggs) is too slow. They use caterpillar cells.

They have started the year long trial of this revolutionary new...vaccine.... but shockingly:
"The vaccine will likely be on the market before the trial finishes."

An April 09 Reuter's story on this "innovative" process reported that "Novavax would have to get U.S. Food and Drug Administration approval before it could test its new vaccine in people. Years of testing are likely to be required before such a new formulation of a vaccine could be widely used in people". See Reuters story
And here is a video link with CEO Singhvi, former 11 year Merck director, discussing, (along with the vaccine) Emergency Use Authorization.

"The “Emergency Use Authorization” (EUA) is a recent federal program, authorized by Public Law 108-276 (1) (2007), which broadens and strengthens the federal authority of the U.S. Food and Drug Administration (FDA) during an actual or a potential emergency to approve use of:
1. Unapproved drugs, biological products (e.g., vaccines, blood products, and biological products), and devices (e.g., in vitro diagnostics); ..."
What is the "Emergency Use Authorization" for FDA-Unapproved Vaccines

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