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FDA Gives Green Light to Test Lyme Disease Vaccine on Humans
by Patrice La Vigne and Barbara Loe Fisher
Published January 26, 2017
http://www.thevaccinereaction.org/2017/ ... on-humans/
Clinical trials for a new Lyme disease vaccine will be conducted in the U.S. and Belgium after the U.S. Food and Drug Administration (FDA) and European Union’s Clinical Trial Application gave Biotech firm Valneva of France clearance to begin Phase I testing.1
Valneva is developing VLA15, a hexavalent, protein subunit-based vaccine for protection against Lyme’s disease, a tick-transmitted bacterial infection characterized by fever, headache, fatigue and skin rash that, if left untreated, can spread to the joints, heart and nervous system and cause severe, chronic health problems.2 The vaccine targets the outer surface protein A (OspA), one of the most dominant antigens expressed by the Borrelia bacteria transmitted by a tick.1
The serotypes expressed by the U.S. species of the Borrelia bacteria differ from the European version of the bacteria. In fact, there are six types of the proteins. Valneva’s vaccine aims to target all different strains of OspA and teach the body’s immune system to recognize the bacteria and launch an attack.3
First Lyme Vaccine Withdrawn After Injury Claims
This is not the first time a company has pursued a Lyme disease vaccine candidate, although there are no vaccines currently on the market.
In 1998, the FDA approved LYMErix, manufactured by SmithKline Beecham (now GlaxoSmithKline) of the United Kingdom. Patients received three doses of the vaccine, which was manufactured using a recombinant Burellia burgdorferi outer surface protein (OspPA). The company claimed an effectiveness rate of 80 percent.
However, almost immediately after the vaccine was licensed and distributed, there were complaints that LYMErix vaccine was causing Lyme disease symptoms and in some cases was causing permanently disabling brain and immune system damage, including treatment resistant autoimmune arthritis.