The non-profit National Vaccine Information Center (NVIC) is questioning the basis for the fast tracked licensure by the U.S. Food and Drug Administration (FDA) of a squalene-adjuvanted influenza vaccine for use in seniors over age 65. The Novartis MF59 adjuvanted Fluad vaccine was approved for accelerated licensure by the FDA Vaccines and Related Biological Products Advisory Committee (VRBPAC) on Sept. 15, 2015 primarily using limited immunogenicity and safety evidence from a small clinical trial in which only about 1,000 healthy Americans over age 65 were given the adjuvanted vaccine. Although MF59 is bioactive and designed to stimulate a strong immune response, FDA does not require that vaccine adjuvants be proven safe in a placebo controlled trial and they are not licensed separately. Fluad will be the first influenza vaccine licensed in the U.S. containing squalene, a controversial oil in water adjuvant that has been linked with development of autoimmunity, narcolepsy and other immune and neurological disorders.

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