SmithKline Beecham's LYMErix Lyme Disease Vaccine Safety Update

Disclaimer

The statements contained in this document are those of the product's sponsor, not FDA, and FDA does not necessarily agree with the sponsor's statements. FDA has not made a final determination about the safety or effectiveness of the product described in this document.

Introduction, Claire Kahn

Theoretical Considerations of Treatment-resistant Lyme Arthritis, Yves N Lobet

Safety Assessment for Licensure, Francois P Meurice, MD

Post-licensure Safety Assesment, Bernard J Hoet

Post-licensure Safety Assessment, R Platt MD MSc

Final Conclusions, Claire Kahn

Food and Drug Administration

Review of Pre-Licensure Safety Data and Update, Patricia Rohan MD, FDA

LYMErix Safety Data Reported to the Vaccine Adverse Event Reporting System (VAERS) Robert Ball MD   ppt  html

Statement from Lori Gelbort

"Vaccine Volunteer" written by Lynn Lane

Statement of Kathleen Dickson

Statement of Kenneth R Dardick, MD

Statement of an individual

Additions to LymeRix Vaccine Victims' Stories and Related Articles, package compiled by Jenny Marra