NVIC Questions FDA Fast Tracking of Squalene Adjuvanted Flu Vaccine

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.

Read full story here: NVIC Questions FDA Fast Tracking of Squalene Adjuvanted Flu Vaccine

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