Valneva Receives FDA and European Approvals to Start Clinical Testing of Lyme Disease Vaccine Candidate
Lyon (France), December 9, 2016 - Valneva SE ("Valneva" or "the Company"), a fully integrated, commercial stage biotech company focused on developing innovative life-saving vaccines, today announced that its vaccine candidate VLA15 against Lyme disease is now progressing into clinical testing (Phase I) following the Investigational New Drug application (IND) clearance from the Food & Drug Administration (FDA) and the approval of the Clinical Trial Application (CTA) in Europe (Belgium).
Currently, there is no licensed vaccine available to protect humans against Lyme disease, a multi systemic tick-transmitted infection that can cause serious health problems and disabilities. Each year, an estimated 300,000 Americans and 85,000 Europeans develop Lyme disease and according to the CDC (Centers for Disease Control and Prevention), it is the fastest growing vector-borne infectious disease in the United States.
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https://www.ncbi.nlm.nih.gov/pubmed/9829450
Clin Ther. 1998 Sep-Oct;20(5):993-1008; discussion 992.
A cost-of-illness study of Lyme disease in the United States.
Erratum in
Clin Ther 1999 Feb;21(2):430.
Abstract
Lyme disease produces a diverse clinical picture that can include serious and potentially debilitating cardiac, neurologic, joint, and skin involvement. It is characterized in three stages--early localized (stage I), early disseminated (stage II), and late disseminated (stage III)--and medical management is highly dependent on the stage at which the patient presents and the physician's awareness of available treatment options. This study was conducted to establish the medical and economic burden of Lyme disease in the overall US population, which included determining its endemicity in high-risk states and counties, describing current treatment patterns, measuring direct and indirect costs, and defining the cost burden by age group (<18 years and > or =18 years of age). Medical, epidemiologic, and economic data were collected, and an algorithm was developed representing the natural course of Lyme disease and the progress of health states over time following medical intervention. Using an annual mean incidence of 4.73 cases of Lyme disease per 100,000 population in the decision analysis model yielded an expected national expenditure of $2.5 billion (1996 dollars) over 5 years for therapeutic interventions to prevent 55,626 cases of Lyme disease sequelae. This estimate included both direct medical and indirect costs. However, there is evidence of considerable variation in incidence within states. Our findings support development of vaccination strategies for specific target groups.
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I found some additional data from the study…these costs were based on 1996 values
The treatment costs for early disseminated disease accounted for 36% of the total direct costs and 64% spent of antibiotic treatments as well as treatment of side effects.
With the costs of late disseminated disease, the values were reversed,
roughly 2/3rds spent on treatment of the manifestations.
Early disseminated disease cost from:
$731/per patient/per year for arthritis to
$3,445/patient/year for cardiac sequelae
Costs for late disseminated:
Musculoskeletal complications $2740/patient/year and
cardiac complications came to $8270/patient/year