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FDA Fast-Tracks Licensure of MF59 Adjuvanted Influenza Vaccine

Posted: 9/16/2015 9:33:17 AM | with 2 comments


During the Sept. 15, 2015 meeting of the FDA's advisory committee on vaccines, Vaccines and Related Biological Products Advisory Committee (VRBPAC), the committee voted to fast-track licensure of the MF59 adjuvanted Fluad influenza vaccine. NVIC's President and Co-Founder, Barbara Loe Fisher gave the following public comment in opposition to licensure of the Fluad vaccine. NVIC has also issued a press release on the VRBPAC decision that may be read here.
 

Public Comment
Barbara Loe Fisher, Co-founder and President
 National Vaccine Information Center
Opposition to Fast Track Licensure of MF59 Adjuvanted Fluad
FDA Vaccines and Related Biological Products Advisory Committee (VRBPAC)
Sept. 15, 2015
 
 
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.5If 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 percent Caucasian, 9 percent Black, 7 percent Hispanic and 4 percent 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.
  
References:

1 Kuroda Y, Nacionales DC et al. Autoimmunity induced by adjuvant hydrocarbon oil components of vaccine. Biomed Pharmacother 2004; 58(5): 325-327.
 
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.
 
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.
 


Posted: 9/16/2015 9:33:17 AM | with 2 comments


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