National Vaccine Information Center Questions FDA Fast Tracking of Squalene Adjuvanted Flu Vaccine

WASHINGTON–(BUSINESS WIRE)–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.^{1, 2}

“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. 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,” said NVIC Co-founder and President Barbara
Loe Fisher.

At public comment time, Fisher asked the FDA advisory committee, “Why
does Fluad need to be fast tracked to licensure for the elderly without
additional evidence? There is public concern that fast tracking Fluad is
really about fast tracking MF59 to licensure so it can be added to lots
of new vaccines targeting infants, pregnant women and every American
without adequate evidence for safety or effectiveness.”³

Before the FDA advisory committee had taken a vote on whether Novartis
had demonstrated the safety and effectiveness of Fluad in seniors,
agency officials indicated they would approve accelerated licensure of
the vaccine even though fast tracking is supposed to be reserved for
instances when there are vaccine shortages. There are nine influenza
vaccines licensed by the FDA as safe and effective for seniors,
including two high dose options, and the Centers for Disease Control
(CDC) estimates more than 170 million doses of influenza vaccine will be
delivered to the U.S. market for the 2015-2016 flu season.⁴

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.⁵
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.⁶

In her Sept. 15 public statement at the FDA advisory committee meeting,
Fisher pointed out that the Novartis clinical trial did not provide
sufficient evidence for fast track licensure of Fluad when:

• It is known that responses to vaccination are affected by genetic
  factors and only 30 percent of the Fluad study population was
  ethnically representative of U.S. seniors over age 65;
• The majority of Fluad study participants did not have heart, lung and
  kidney disease or other chronic health conditions that affect
  two-thirds of U.S. seniors, although chronically ill seniors will be
  recipients of Fluad after licensure;
• Fluad produced a much higher number of pain, tenderness, redness and
  swelling reports; a higher number of systemic adverse reaction reports
  and more deaths and cases of new onset chronic disease;
• The study did not evaluate the safety of giving repeated doses of
  squalene adjuvanted Fluad year after year to seniors with multiple
  chronic conditions;
• There is no information on how Fluad performs when given
  simultaneously with other vaccines (such as pneumococcal vaccine).

The National Vaccine Information Center (NVIC) is a charitable
educational organization founded in 1982 to prevent vaccine injuries and
deaths through public education. NVIC does not make vaccine use
recommendations and advocates for the inclusion of informed consent
protections in U.S. vaccine policies and laws. NVIC monitors vaccine
science, policy and law and provides public comment at federal vaccine
advisory committee meetings. Visit www.NVIC.org
for more information.

References:

¹ FDA. Briefing
Document: Influenza Vaccine, Adjuvanted Fluad, Novartis Vaccines and
Diagnostics, Inc, Applicant.

² Novartis. FDA
Advisory Committee Briefing Document: Fluad, Seasonal Adjuvanted
Trivalent Influenza Vaccine (aTIV).

³ Fisher BL. Public
Comment Statement Opposing FDA Fast Track Licensure of Fluad. VRBPAC
Sept. 15, 2015 Meeting.

⁴ CDC. Seasonal
Influenza Vaccine Supply for the U.S. 2015-2016 Influenza Season.
Aug. 19, 2015.

⁵ FDA. Briefing
Document: Influenza Vaccine, Adjuvanted Fluad, Novartis Vaccines and
Diagnostics, Inc, Applicant. Pages 4 and 5.

⁶ See Reference #3.

Contacts

National Vaccine Information Center
Barbara Loe Fisher, 703-938-0342