FOOD AND DRUG ADMINISTRATION
CENTER FOR BIOLOGICS EVALUATION AND RESEARCH
January 31, 2001
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.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
"Vaccine Volunteer" written by Lynn Lane
Statement of Kenneth R Dardick, MD
Additions to LymeRix Vaccine Victims' Stories and Related Articles, package compiled by Jenny Marra