Friday, April 23, 2010

What the FDA Says About Vaccines

I found this quite astonishing presentation on the FDA website that talks about "adjuvants" in vaccines. This presentation was created by a special panel full of MDs and PhDs. I reprint here slide 7 so you can just read it for yourself, in all its glory.

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 – Potential role in autoimmunity, short or long term?
– Antigen specific (e.g. neural or cardiac antigens) – Auto-immune/inflamm disease, e.g. SLE, “idiopathic”
– Are there plausible risks to 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

Compare this from the CDC:

Which childhood vaccines contain adjuvants?

The adjuvant aluminum is present in U.S. childhood vaccines that prevent hepatitis A, hepatitis B, diphtheria-tetanus-pertussis (DTaP, Tdap) Haemophilus influenzae type b (Hib), human papillomavirus (HPV) and pneumococcus infection. This adjuvant has been used safely in vaccines for decades.

I think the CDC is just not telling us the whole story.

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