IMHO any 'qualification' of this new vaccine MUST insist on inclusion of several of the best devised DIRECT antigen detection methods and NOT accept serology ONLY as 'proof' of 'effectiveness'.
Seronegative disease and long-term outcomes (e.g. Years of careful study would be a minimum. 21st Cent. Cures Act might undermine these pre-requisites. FDA & ACIP should be 'on notice' lest "LymeRixII' be pushed out without proper evaluation taking in to account the biologic complexity of the borrelioses. KL
LymeRix was said to be 80+% effective-
But they defined "effective" as GENERATING ANTIBODY but it was never proven to prevent infection.
I say begin with non human primates. See if vaccinated animals are protected from infection from bites of infected, wild ticks.
And of course watch for side effects. JB
Lymrix intended mechanism was to activate the immune system to attack outer surface protein A (Osp A) within the tick and kill Borrelia before transmission. The problems were 3 fold,
it didn't work, it created an autoimmune arthritis in a percentage of patients (HLA DR4) that was incurable, and ........oh yeah.......lies were told that covered this up claiming 'poor sales due to Lyme Loonies having access to the internet. (Step away from your computer and let the pros handle this please).
This simplified, and hopefully factual, line has been told hundreds of times in my office as a response to general inquiries on the subject.
It took me weeks of heavy reading to tease out this simple story.
Anyone have a handle on the new vaccine mechanism, and any clue on the dangers/side effects we should watch for?
Molecular level analysis of the immune system, especially when we are getting spin and marketing instead of cold hard facts, is well beyond my pay grade. M. Mad.
The CDC themselves published a paper showing by PCR and sequencing in about a dozen patients, that a second infection with Bb was a different strain - excellent evidence that primary infection (obviously including OspA) does not provide protection against future repeat infection. what are these vaccine developers thinking? Where is the science? Someone should sue them, probably only possible after an adverse event. Cheers, HD