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Public Comment: Opposition to Fast Track Licensure of MF59 Adjuvanted Fluad

MF59 Adjuvanted Fluad influenza vaccine

Why does Fluad need to be fast tracked to licensure for seniors without additional evidence?

Squalene adjuvants hyper-stimulate the immune system and have been linked with development of autoimmunity, narcolepsy and other chronic disease.1 2 3 Based on the very limited safety and immunogenicity evidence submitted by Novartis,4 MF59 adjuvanted Fluad vaccine should not be fast tracked to licensure for use by seniors over age 65 in the U.S. for the following reasons:

1. FDA states there is uncertainty about how MF59 affects immune function but it is “thought” to activate local cells and has been “shown to directly increase phagocytosis” in human immune cells and to induce cytokines.5 If MF59 does that, it is an active ingredient and should be proven safe in a placebo controlled trial.

2. Influenza vaccines induce immune mediated responses, whether adjuvanted or unadjuvanted. Comparing adverse responses following receipt of one adjuvanted bioactive product to those of an unadjuvanted bioactive product does not prove safety unless both are compared to an inactive placebo.6 7 Novartis did not compare Fluad to an inactive placebo.

3. It is well known that responses to vaccination are affected by genetic factors. The Pivotal Study population clearly was not genetically representative of U.S. seniors over age 65, a population that is over 80% Caucasian, 9%  Black, 7%  Hispanic and 4%  Asian.8 Fluad was only given to about 1,000 U.S. seniors, while more than 2,400 Fluad recipients were from countries with high majority Asian or Hispanic populations.9

4. The trial exclusion criteria is so broad that the health of most of the study participants does not match that of the majority of U.S. seniors over age 65, of whom two-thirds have two or more chronic conditions such as heart, lung and kidney disease,10 11 and will be candidates for receipt of Fluad post-licensure.

5. Compared to Agriflu, Fluad produced a much higher number of pain, tenderness, redness and swelling reports; a higher number of systemic adverse event reports and more deaths and cases of new onset chronic disease.12

6. The Pivotal Study provides no information about the safety of giving seniors with multiple chronic conditions repeated doses of squalene adjuvanted Fluad every year and no information about how Fluad performs when given simultaneously with other vaccines.

7. Using surrogate markers in the Pivotal Study, Novartis was not able to demonstrate that Fluad was superior to Agriflu with regard to immunogenicity, while Novartis was able to demonstrate that squalene adjuvanted Fluad is more reactive.13

Why does Fluad need to be fast tracked to licensure for seniors 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.


Note: This public comment was read by the author before the U.S. Food and Drug Administration (FDA) Vaccines and Related Biological Products Advisory Committee on September 15, 2015.

References:

1 Kuroda Y, Nacionales DC et al. Autoimmunity induced by adjuvant hydrocarbon oil components of vaccine. Biomed Pharmacother 2004; 58(5): 325-327.
2 Miller E, Andrews N et al. Risk of narcolepsy in children and young people receiving AS)3 adjuvanted pandemic A/H1N1 2009 influenza vaccine: retrospective analysis. BMJ 2013; 346
3 Autoimmune Technologies. Gulf War Syndrome: Anti-Squalene Antibodies Link Gulf War Syndrome to Anthrax Vaccine.
4 Novartis. FDA Advisory Committee Briefing Document: Fluad, Seasonal Adjuvanted Trivalent Influenza Vaccine (aTIV). FDA Vaccines and Related Biological Products Advisory Committee Meeting Sept. 15, 2015.
5 FDA. Briefing Document: Influenza Vaccine, Adjuvanted Fluad, Novartis Vaccines and Diagnostics, Inc, Applicant. Vaccines and Related Biological Products Advisory Committee Sept. 15, 2015 Meeting. Page. 6.
6 Drugs.com. What is a placebo? Feb. 10, 2013.
7 Massachusetts General Hospital. Clinical Trials 101: Placebo Controlled Trials.
8 Ortman JM, Velkoff VA, Hogan H. An Aging Nation: The Older Population in the United States. US Census Bureau May 2014. Table 3, page 12.
9 FDA. Briefing Document: Influenza Vaccine, Adjuvanted Fluad, Novartis Vaccines and Diagnostics, Inc, Applicant. Vaccines and Related Biological Products Advisory Committee Sept. 15, 2015 Meeting. Table 3, page 11.
10 DHHS. Chronic Conditions Among Medicare Beneficiaries. Center for Medicare and Medicaid Services 2012. Page 6.
11 Novartis. . FDA Advisory Committee Briefing Document: Fluad, Seasonal Adjuvanted Trivalent Influenza Vaccine (aTIV). FDA Vaccines and Related Biological Products Advisory Committee Meeting Sept. 15, 2015. Table 29, page 62.
12 FDA. Briefing Document: Influenza Vaccine, Adjuvanted Fluad, Novartis Vaccines and Diagnostics, Inc, Applicant. Vaccines and Related Biological Products Advisory Committee Sept. 15, 2015 Meeting. Tables 9 & 10, pages 17 and 18.
13 FDA. Briefing Document: Influenza Vaccine, Adjuvanted Fluad, Novartis Vaccines and Diagnostics, Inc, Applicant. Vaccines and Related Biological Products Advisory Committee Sept. 15, 2015 Meeting. Page 5.

One Response to Public Comment: Opposition to Fast Track Licensure of MF59 Adjuvanted Fluad

  1. Redpill1 Reply

    September 17, 2015 at 6:23 am

    The FDA has turned into a rogue organization. The people who work there have the same mentality as the people who work at the CDC-Pharma First. They completely disregard the foundation of their existence-protection of the public because the people who work there (most likely pharam researchers on contract to the FDA) benefit from pharma largess.

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