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.
acdha|4 years ago
https://www.sciencedirect.com/science/article/pii/S0264410X0...
> 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.
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2870557/
> 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.
coolgeek|4 years ago
Do you not understand the FDA approval process? Or do you not understand how to Google that question yourself? Or is it something else?
Seriously. What possessed you to create an account to challenge this comment without doing any research at all, yourself?
holdupnow|4 years ago
daddylongstroke|4 years ago
There are industrial-grade chemicals fully FDA approved for ingestion by the US populace which are outright banned by various European countries.