January 31, 2001

LYMErix™ Lyme Disease Vaccine Safety Update

Briefing Information

Food and Drug Administration


Briefing Document   doc   pdf

Package Insert for LYMErix

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

Report on LYMErix, Sheller, Ludwith, & Badey, Stephen A Sheller, Esq & Albert J Brooks, Jr, January 24, 2001

Supplemental Scientific Summary and Bibliography, Sheller, Ludwith, & Badey, Albert J Brooks, Jr, January 26, 2001

SmithKline Beecham


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.

Briefing Information