Archive for the ‘FDA’ Category
FDA approves field trial on the release of Oxitec’s genetically engineered (GE) mosquitoes (OX513A) to suppress the local Aedes aegypti mosquito populationSunday, August 7th, 2016
August 5, 2016
The FDA has completed the environmental review for a proposed field trial to determine whether the release of Oxitec Ltd.’s genetically engineered (GE) mosquitoes (OX513A) will suppress the local Aedes aegypti mosquito population in the release area at Key Haven, Florida. After considering thousands of public comments, the FDA has published a final environmental assessment (EA) and finding of no significant impact (FONSI) that agrees with the EA’s conclusion that the proposed field trial will not have significant impacts on the environment.
FDA’s finalization of the EA and FONSI does not mean that Oxitec’s GE mosquitos are approved for commercial use. Oxitec is responsible for ensuring all other local, state, and federal requirements are met before conducting the proposed field trial, and, together with its local partner, the Florida Keys Mosquito Control District, to determine whether and when to begin the proposed field trial in Key Haven, Florida.
CDC’s Zika MAC test has been cleared by FDA (Emergency Use Authorization) for detecting evidence of the virus in human sera or CSFSaturday, February 27th, 2016
** the Zika MAC test is used to gauge recent infection and can detect the virus as early as 4 days after symptoms begin.
“….. the Food and Drug Administration (FDA) issue an Emergency Use Authorization (EUA) for emergency use of the Centers for Disease Control and Prevention’s (CDC) Zika Immunoglobulin M (IgM) Antibody Capture Enzyme-Linked Immunosorbent Assay (Zika MAC-ELISA) for the presumptive detection of Zika virusspecific IgM in human sera or cerebrospinal fluid (CSF)……”
FDA: A new indication for BioThrax (Anthrax Vaccine Adsorbed) to prevent disease following suspected or confirmed exposure to Bacillus anthracis for people 18 through 65 years of age in conjunction with recommended antibiotic treatment.Wednesday, November 25th, 2015
The U.S. Food and Drug Administration today approved a new indication for BioThrax (Anthrax Vaccine Adsorbed) to prevent disease following suspected or confirmed exposure to Bacillus anthracis, the bacterium that causes anthrax disease. The vaccine’s new use is approved for people 18 through 65 years of age in conjunction with recommended antibiotic treatment. BioThrax was initially approved by the FDA in 1970 for the prevention of anthrax disease in persons at high risk of exposure.
Anthrax disease, especially the inhalation form, is often fatal if not promptly treated. Anthrax is considered one of the more likely agents to be used in a biological attack, primarily because its spores are very stable and easy to disperse. Although it is rare, people may contract anthrax disease through natural exposures, such as contact with infected animals or contaminated animal products.
“With today’s approval of BioThrax, we now have a vaccine that can be used, together with antibiotic treatment, to prevent disease after exposure to anthrax spores,” said Karen Midthun, M.D., director of the FDA’s Center for Biologics Evaluation and Research.
BioThrax is the first vaccine to receive approval based on the Animal Rule. The Animal Rule allows animal efficacy data to be used as a basis for approval when human efficacy studies are not ethical or feasible.
Protective antibody levels, which were determined in rabbit and monkey studies, were used to predict efficacy in humans based on an assessment of the extent of antibody response achieved in human study participants. A 70 percent probability of survival in animal models from inhalational anthrax disease was deemed a reasonable level of protection and likely to provide reasonable benefit in humans.
The ability of BioThrax to increase the probability of survival after stopping post-exposure antibiotic treatment was assessed in rabbits. Rabbits treated with both antibiotics and BioThrax had a survival rate of 70 to 100 percent, depending on the vaccine dose administered. In contrast, in two studies of rabbits that received only antibiotic treatment, survival rates were 44 and 23 percent respectively.
The safety and antibody responses to BioThrax in humans were evaluated in a multi-center study conducted in the United States. Subcutaneous (under the skin) injections were given to 200 healthy adults in three doses at zero, two, and four weeks. The majority of study participants generated antibody responses that correlated to a 70 percent probability of survival that was observed in animal models.
The observed adverse reactions were comparable with those observed when BioThrax is used for pre-exposure disease prevention. The safety profile for BioThrax is well-established, with the majority of localized adverse events reported as tenderness, pain, swelling, and redness at the injection site, as well as limited movement of the injected arm. The most common systemic adverse reactions were muscle aches, headache, and fatigue.
BioThrax is manufactured by Emergent BioDefense Operations Lansing LLC, based in Lansing, Michigan.