Pfizer has received priority review for their vaccine, TicoVac, that protects against tick-borne encephalitis. This tick-borne virus can cause meningitis and trigger long-term neurological symptoms. If approved, the vaccine would potentially protect travelers as well as members of the US military that are deployed to regions where the virus is common, such as Europe and parts of Asia.
HHS/Food & Drug Administration (FDA)
The Food and Drug Administration is responsible for protecting the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices; and by ensuring the safety of our nation’s food supply, cosmetics, and products that emit radiation.
Articles in this section will include approvals for treatments, vaccines, and other items related to the prevention, treatment and cure of Lyme and other tick-borne diseases.
First announced at the HHS Tick-Borne Disease Working Group’s (TBDWG) September 22 meeting, the Centers for Disease Control (CDC), in a Capitol Hill Announcement, presented plans to join with five federal departments and the Environmental Protection Agency in developing the National Public Health Framework for the Prevention and Control of Vector-Borne Diseases in Humans (Framework). […]
The Lyme Disease Association announces that the Food and Drug Administration (FDA) yesterday cleared for marketing four previously cleared tests for the diagnosis of Lyme disease. Called the modified two-tier, enzyme immune assay, (EIA), the new tests are able to be run at the same time or sequentially. The current two-tier testing has an EIA […]
On January 22, 2002 in Bethesda, MD., the LDA was able to get a private meeting with the FDA on the vaccine issue, despite reluctance by the FDA to grant the meeting. Congressman Chris Smith helped facilitate the setup of this meeting. On February 25, 2002, a month after meeting with FDA, LDA received written […]
This is an FDA powerpoint by Robert Ball, M.D., M.P.H., Sc.M., on the Lymerix Vaccine, LYMErix® Safety Data Reported to the Vaccine Adverse Event Reporting System (VAERS), January 31, 2001. Robert Ball, M.D., M.P.H., Sc.M., Division of Epidemiology, Office of Biostatistics and Epidemiology, Center for Biologics Evaluation and Research, Food and Drug Administration (FDA), Rockville, […]
Signons from Lyme Group Leaders on FDA Test TakeoverThe Lyme Disease Association, Inc. (LDA) has formulated a response to FDA to be included in its comment period on its testing Guidance which will affect specialty lab Lyme tests. Therefore, groups who want to support the position taken by the LDA may join in on the […]
FDA is moving forward in the process of finalizing its new Laboratory Developed Test (LDT) Guidance proposal. The proposal would move LDTs from under the jurisdiction of Clinical Laboratory Improvement Amendment (CLIA) regulated by Medicare & Medicaid Services to under the jurisdiction of the Food & Drug Administration (FDA). The FDA now regulates non-LDT lab tests under […]
Time Sensitive Survey: The Food & Drug Administration (FDA) is poised to develop new regulations which may affect access to existing tests for Lyme and other tick-borne diseases. Please click on the link to complete a survey being done by LymeDisease.org, an affiliate of the Lyme Disease Association. The information is needed for upcoming meetings […]
REMARKS OF PAT SMITH, PRESIDENT, LYME DISEASE ASSOCIATION, INC. BEFORE THE VACCINES AND RELATED BIOLOGICAL PRODUCTS ADVISORY COMMITTEE, MAY 21, 2002. Why more adverse events were seen after the vaccine reached the market: People receiving Lymerix after product launch lived in Lyme-endemic areas. REMARKS OF PAT SMITH, PRESIDENT, LYME DISEASE ASSOCIATION, INC. BEFORE […]
SPECIAL REPORT: LDA MEETS WITH FDA ON LYMERIX On January 22, 2002 in Bethesda, MD., the LDA was able to get a private meeting with the FDA on the vaccine issue, despite reluctance by the FDA to grant the meeting. Congressman Chris Smith helped facilitate the setup of this meeting. Patricia Smith, President, Lyme […]