Like all vaccines, they were tested in animals and subsequently by human volunteers _before_ reaching the Phase III clinical trials. Those are double-blind, randomized, placebo-controlled experiments which are generally considered the gold standard for medical testing which test cohorts of people who are exposed to the threat and compare both positive and negative outcomes across those populations without either the recipients or the experimenters knowing which people are in which group until afterwards.
> An adjuvanted recombinant vaccine (LYMErix™) has been approved in the United States for the prevention of Lyme disease in adults, and has demonstrated both safety and efficacy. A clinical trial of over 10 000 adults showed 76% efficacy following the third dose of a 0, 1, 12 schedule. Accelerated schedules demonstrate equivalent levels of protective antibody. Up to 100% of children 2–14 years of age achieve seroprotective levels of antibody. Booster doses induced protective levels of antibody in more than 96% of recipients when administered at months 12 and 24. Only mild or moderate, transient vaccine-associated adverse events have been reported after immunization. The vaccine is a safe and effective method of preventing Lyme disease.
> The OspA vaccines proved effective in animal models and safe in human volunteers [18]. Both manufacturers conducted clinical trials in a race to gain the first license for their vaccine [19, 20]. In the LYMErix™ phase III safety and efficacy trial, researchers enrolled 10 906 subjects between 15 and 70 years old who lived in endemic areas and randomized them to receive either the three-dose Lyme vaccine regimen or placebo injections. Vaccinated individuals showed a 76% reduction in Lyme disease in the year following vaccination [20], with no significant side-effects noted. Based on these promising findings, the U.S. Food and Drug Administration (FDA) approved LYMErix™ on 21 December 1998.
Wasn't trying to answer your question...just pointing out that FDA approval means fuck-all. Seems you've put quite a bit of value to it either way. Good luck on your path.
>It's the kind of thing that's made HN so... different... over the last year (or four)
You think so? I thought it was the youthful boot-lickers and random "software developers" constantly marketing their "web apps". Also, feel free to express your emotions, I feel that you may be hiding your true feelings with that word - "different". It seems you don't feel the same, but I'm not concerned about quality of "contributions" on a random message board on the internet...I'm just having a random conversation with random strange strangers. It seems you've held the HN board at as high of a pedestal as the FDA approval process (but perhaps I'm projecting).
Not sure what your argument is though? You don't like the term fuck-all (sorry, English is not my native tongue), or you don't understand that the FDA process is ementhal-cheese-like by comparison to European standards?
His comment contained information (namely that the FDA process is not particularly strict compared to European standards) whereas your comment had zero information. On an objective level, he had a higher quality contribution.
