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
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
inflammation
- 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
systems?
–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.