FDA Approves Experimental H5N1 Bird Flu Vaccine with Reactive AS03 Adjuvant for U.S. Stockpile
by Patrice La Vigne
http://www.NVIC.org
For some time now, vaccine researchers around the world have been on the prowl to create the perfect swine and bird flu vaccines that are both effective and safe, but have come up far short of perfection. In the process, they have added squalene-type "oil-in-water" adjuvants to some influenza vaccines, only to find that it can be risky business.
Squalene Adjuvants Never Licensed Before in U.S.
Squalene adjuvants, which ramp up the immune response, have never been licensed for use in the U.S. However, the Food and Drug Administration (FDA) paved the way for a squalene adjuvant to be included in U.S. vaccines with its November 2013 approval of the first influenza A (H5N1) monovalent "bird flu" vaccine: GlaxoSmithKline's Q-Pan vaccine that contains the controversial oil-in-water emulsion adjuvant AS03.
Q-Pan vaccine will be added to the U.S. pandemic emergency vaccine stockpile. Although there is no H5N1 influenza pandemic underway to justify fast-tracked approval of the experimental AS03-adjuvanted bird flu vaccine, the speedy FDA approval comes amid mounting evidence that AS03 adjuvants are associated with development of serious autoimmune and neurological disorders like narcolepsy.
by Patrice La Vigne
http://www.NVIC.org
For some time now, vaccine researchers around the world have been on the prowl to create the perfect swine and bird flu vaccines that are both effective and safe, but have come up far short of perfection. In the process, they have added squalene-type "oil-in-water" adjuvants to some influenza vaccines, only to find that it can be risky business.
Squalene Adjuvants Never Licensed Before in U.S.
Squalene adjuvants, which ramp up the immune response, have never been licensed for use in the U.S. However, the Food and Drug Administration (FDA) paved the way for a squalene adjuvant to be included in U.S. vaccines with its November 2013 approval of the first influenza A (H5N1) monovalent "bird flu" vaccine: GlaxoSmithKline's Q-Pan vaccine that contains the controversial oil-in-water emulsion adjuvant AS03.
Q-Pan vaccine will be added to the U.S. pandemic emergency vaccine stockpile. Although there is no H5N1 influenza pandemic underway to justify fast-tracked approval of the experimental AS03-adjuvanted bird flu vaccine, the speedy FDA approval comes amid mounting evidence that AS03 adjuvants are associated with development of serious autoimmune and neurological disorders like narcolepsy.
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