The non-profit National Vaccine Information Center is blasting the FDA over the fast-tracking 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 on Sept. 15.
According to a press release from the group, it was approved by, "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."
“Novartis failed to demonstrate that squalene adjuvanted Fluad was more effective or safer than an unadjuvanted influenza vaccine in the small clinical trial being used to justify accelerated licensure," said NVIC Co-founder and President Barbara Loe Fisher. " In fact, Fluad was shown to be far more reactive and, in some studies, the vaccine was associated with even more serious reactions in the elderly when given a second time."