Letter sent to Valneva Austria GmbH: (Posted as a comment on PLOS One as: Safety and effectiveness of an OsPA vaccine. Posted by Carl_Tuttle on 15 Dec 2016 at 13:03 GMT) http://journals.plos.org/plosone/article/comment?id=10.1371/annotation/0b376f0c-6dad-43aa-9684-ea91080c0096 NO RESPONSE AS OF DEC 18, 2016 ______________________________________________________________________________ Design and Development of a Novel Vaccine for Protection against Lyme Borreliosis Pär Comstedt, Markus Hanner, Wolfgang Schüler, Andreas Meinke, Urban Lundberg http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0113294 Excerpt: “In order to target all these pathogenic Borrelia species, we have designed a multivalent OspA-based vaccine.” Dec 13, 2016 Valneva Austria GmbH Campus Vienna Biocenter 3 1030 Vienna, Austria Attn: Pär Comstedt, Phd Dear Dr. Comstedt, In reference to your announcement of a novel OspA-based vaccine for Lyme disease, please refer to the following study identifying neurological complications as a result of a previous human Lyme vaccine: Int J Risk Saf Med. 2011;23(2):89-96. doi: 10.3233/JRS-2011-0527. Neurological complications of vaccination with outer surface protein A (OspA). Marks DH1. http://www.ncbi.nlm.nih.gov/pubmed/21673416 Abstract A wide range of neurological complications have been reported via the medical literature and the VAERS system after vaccination with recombinant outer surface protein A (OspA) of Borrelia. To explore this issue, 24 patients reporting neurological adverse events (AE) after vaccination with Lymerix, out of a group of 94 patients reporting adverse events after Lymerix vaccination, were examined for causation. Five reports of cerebral ischemia, two transient Ischemic attacks, five demyelinating events, two optic neuritis, two reports of transverse myelitis, and one non-specific demyelinating condition are evaluated in this paper. Caution is raised on not actively looking for neurologic AE, and for not considering causation when the incidence rate is too low to raise a calculable difference to natural occurrence. ____________ Questions: 1. With evidence showing that outer surface protein A of the Borrelia spirochete can cause serious adverse events what has changed since these events were reported in 2011 allowing Valneva to pursue a potential vaccine focusing on OspA? It remains questionable that a Lyme disease vaccine is practical for an infection that produces a lack of immunological memory (unlike Measles, Mumps etc.) The paper by Elsner et al found no immunological memory to Borrelia in the mice model and to my knowledge those researchers are not looking to develop a vaccine. The immune system cannot generate immunological memory during infection with the Lyme disease agent B. burgdorfer http://www.sciencedirect.com/science/article/pii/S1043466613003542 2. How would this lack of immunological memory be addressed with this new vaccine? A response to this inquiry is requested. Sincerely, Carl Tuttle Hudson, NH USA Cc: Dr. Joerg Heber, Editor-in-Chief of PLOS ONE DONALD HARVEY MARKS, M.D., Ph.D. Nicole Baumgarth- DVM, PhD