Sunday, September 13, 2009

Dr. Jesse Goodman (Deputy FDA Commissioner)'s December 2, 2008 slides note adjuvant safety questionable

On December 2-3, 2008, FDA with joint NIAID sponsorship held a public workshop
"for academics, government researchers, government regulators, vaccine clinical trial experts and industry representatives. The purpose of this workshop is to assess the scientific knowledge base regarding vaccine adjuvants and to facilitate the development of a research agenda to improve the safety and efficacy assessments of adjuvanted vaccines for the treatment and prevention of disease."
Jesse Goodman, M.D., now deputy FDA Commissioner, presented a talk that listed some adjuvant concerns.  It included the following information (slide 7):

Adjuvants: Potential Concerns/Risks

– Potentially antigen specific or non-specific potent
immune and inflammatory stimulation

– Increased reactogenicity, local +/-systemic
  • Unclear which, if any, correlate with risk of rare SAEs [serious adverse events]
 – Potential role in autoimmunity, short or long term?
  • Antigen specific (e.g. neural or cardiac antigens)
  • Auto-immune/inflamm[atory] disease, e.g. SLE [systemic lupus erythematosus], “idiopathic”
– Are there plausible risks to [childrens'] developing immune

--Reassuring observations to date:
  • Even strong TLR/PRR signaling likely similar to natural
    infection (caveat w/ recent UK CD28 agonist trial)
  • No strong evidence to date of major problems with
    compounds being most actively considered – but limited
    numbers w/ controls, long term active follow-up, or in children
It might be interesting to inquire of Dr. Goodman whether these concerns still hold, and if not, what data have become available to mitigate them.

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