The Food and Drug Administration on December nine two thousand sixteen approved clinical trial testing on people for Lyme disease. A French biotechnology company named Valneva was given approval to begin testing on humans. Also, European Union’s Clinical Trial Application gave them approval to test on humans in Europe.
A Lyme disease that was approved in nineteen ninety eight, LYMErix, was no longer produced after a two thousand two lawsuit. The Centers For Disease Control and Prevention claim that around three hundred thousand cases of Lyme disease occur in the United States of America annually. This data is according to two thousand thirteen statistics.
Around eighty five thousand cases occur in Europe. Tiny bacteria Borrelia cause Lyme disease, which are spread by ticks. Generally, amoxicillin or doxycycline antibiotics are used to combat this disease.
This first clinical trial is a phase one safety test. One hundred eighty individuals in America and Belgium will participate. Food and Drug Administration requires three phases before a vaccine is approved for retail distribution.
Also, this can cost companies up to one billion dollars to complete. Valneva has named this Lyme disease vaccine VLA15. This vaccine is based on LYMErix from late nineteen eighties and early two thousands.
Currently there is no vaccine made to combat Lyme disease. Valneva released a statement pertaining to this vaccine:
“We are very pleased to be able to advance our Lyme vaccine candidate which is intended to address such an important unmet medical need. We are committed to finding ways to accelerate the clinical development path to licensure, given that we are conducting the only active vaccine program in the industry.”
You can check out a .pdf document pertaining to Valneva’s VLA15 lyme disease vaccine.