VACCINES AND RELATED BIOLOGICAL PRODUCTS ADVISORY COMMITTEE
January 31, 2001
LYMErix™ Lyme Disease Vaccine Safety Update
Briefing Information
Food and Drug Administration
Summary Basis for Approval entitled "Product License Application"
LYMErixÒ Phase 4 Study Synopsis doc pdf
LYMErix Safety Data Reported to the FDA Vaccine Adverse Event Reporting System (VAERS) doc pdf
Vaccine Adverse Event Reporting System Form
Frequency Distribution of All VAERS LYMErix Reports ppt html
January 15, 2001 Letter to Nancy Cherry re LYMErix vaccine
LymeRix Vaccine Victim's Stories
DuPont Children's Hospital, Paul T Fawcett PhD, Carlos D Rose MD
Mansfield Family Practice, Kennedth Dardick, MD
SmithKline Beecham
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.