March 2001
BETHESDA, Md. - A Food and Drug Administration (FDA) advisory committee chairman said the manufacturer of the Lyme disease vaccine (LYMErix, GlaxoSmithKline) needs to accelerate post-marketing data gathering to more decisively settle issues regarding safety.
"There were some concerns about safety and efficacy when the vaccine was licensed (in December 1998). Not great concerns, or the vaccine wouldn't have been licensed," said Robert Daum, MD, professor of pediatrics, University of Chicago Children's Hospital and chair of the Vaccine and Related Biological Products Advisory Committee. "Two years later, we're still left with them. They're not worse; they're not better. They're still there."
Daum said that after listening to the available post-marketing data presented to the committee, he "didn't hear anything new about safety that makes me think the original decision the FDA made was an incorrect one."
He noted however, that patients and physicians who receive or administer the vaccine should be better informed about its overall safety profile. He also said there are remaining questions about Lyme disease, the vaccine and its mechanism of action, that need to be addressed through basic scientific research.
At the meeting, the committee suggested updating package inserts to reflect issues such as hypersensitivity; conducting further studies to address diverse complaints from vaccine recipients; and providing physicians with the framework to engage in dialogue with a patient before administering the vaccine.
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The advisory committee meeting was unusual in that the FDA called on committee members to talk about safety data in a licensed product. During the public comment portion of the meeting, committee members heard from vaccine recipients and those speaking on behalf of vaccine recipients, who attribute their debilitating or life-altering symptoms to the vaccine.
Benjamin Luft, MD, professor and chair, department of medicine, State University of New York (SUNY) at Stony Brook, said that while there is a need for a Lyme vaccine, there's a need for one that people have confidence in, a vaccine that "once it's given its license, there will be ongoing research and surveillance that will meet the privilege of being out there in the public and administered to patients."
Luft said that GlaxoSmithKline "got a gift" when the Lyme vaccine was approved. "I'm disappointed today because I hear some information here and there, but I don't hear good data. We're in a situation where we're in a sea of what we `feel' because no one is giving us hard data."
Burke A. Cunha, MD, chief of the infectious disease division, Winthrop-University Hospital in Mineola, N.Y. and professor of medicine, SUNY School of Medicine in Stony Brook, N.Y, said, "It's amazing to me that adverse effects of the Lyme vaccine have not been better publicized. Lyme disease is easily treatable with a short course of oral ß-lactam antibiotics or doxycycline, which are highly effective and have few side effects."
Because Lyme disease is so easily treated, the rationale for a Lyme vaccine with so many severe side effects should be questioned, noted Cunha.
An ad-hoc member of the advisory committee said "back-of-the-napkin calculations" suggest between 5% and 6% of current reports to the Vaccine Adverse Events Reporting System (VAERS) are attributed to LYMErix.
From licensure on Dec. 21, 1998, through Oct. 31, 2000, there were approximately 1.4 million doses distributed and approximately 1,000 reports to VAERS, according to Robert Ball, MD, DA. "The vast majority of the reports occurred after Lyme vaccine alone; there were no other simultaneously administered vaccines."
Four deaths and 85 serious reports defined as hospitalization, prolongation of hospitalization, disability or life-threatening illness were reported. Of selected adverse events, there were 24 reports of hypersensitivity; 133 arthritis-type reports; 13 reports of facial paralysis; 16 reports of Lyme disease; and 76 people reporting a history of Lyme disease.
VAERS reports, however, have a temporal, and not necessarily a causal, relationship with the vaccine. According to Carmel Hogan, spokesman, GlaxoSmithKline, the company has data on approximately 14,000 vaccine recipients. "[Post-marketing surveillance data] suggest that the safety profile of the vaccine has not changed since it was licensed, and we believe the vaccine is safe and well tolerated," said Hogan. "There remains, based on post-marketing surveillance and clinical trials, no reliable clinical evidence to suggest the vaccine causes arthritis. We take all adverse events very seriously. We have a commitment to continue to monitor adverse events and to report them."
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