Oxitec: FDA Publishes Preliminary Finding of No Significant Impact
March 21, 2016
FDA Publishes Preliminary Finding of No Significant Impact on Oxitec’s Self-limiting Mosquito
The US Food and Drug Administration’s Center for Veterinary Medicine (FDA-CVM) today released in the Federal Register a preliminary finding of no significant impact (FONSI) on Oxitec’s self-limiting OX513A Aedes aegypti mosquito for an investigational trial in the Florida Keys. The finding agrees with the draft environmental assessment (EA) submitted by Oxitec, Ltd., that concludes a field trial of the Company’s genetically engineered (GE) OX513A mosquitoes in Key Haven, Florida, will not result in a significant impact on the environment. This follows an FDA-led evaluation of potential impacts on health and the environment of the proposed trial.
Oxitec’s Chief Executive Officer Hadyn Parry said, “We are pleased that the FDA-led team has released this preliminary FONSI. The Aedes aegypti mosquito represents a significant threat to human health, and in many countries has been spreading Zika, dengue and chikungunya viruses. This mosquito is non-native to the US and difficult to control, with the best available methods only able to reduce the population by up to 50%, which is simply not enough. We look forward to this proposed trial and the potential to protect people from Aedes aegypti and the diseases it spreads.”
The purpose of the proposed trial is to determine the efficacy of Oxitec’s self-limiting mosquitoes for the control of the local population of Aedes aegypti in Key Haven, Monroe County, Florida.
Oxitec’s self-limiting mosquitoes have been genetically engineered so that their offspring die before reaching adulthood. Male Oxitec mosquitoes, which do not bite or spread disease, are released to mate with wild female Aedes aegypti so that their offspring die, reducing the population. Efficacy trials in Brazil, Panama, and the Cayman Islands have tested this approach, and in these trials the population of Aedes aegypti was reduced by more than 90% – an exceptional level of control compared to conventional methods, such as insecticides.
The FDA review team consisted of experts from the Center for Veterinary Medicine (CVM), the Centers for Disease Control and Prevention (CDC), and the Environmental Protection Agency (EPA). The FDA led an extensive review of evidence from trials in urban environments performed in Brazil, Panama and the Cayman Islands since 2009, and data from numerous safety studies, site inspections and independent experts.
For more information:
Oxitec Florida Keys Project FAQ: http://www.oxitec.com/health/florida-keys-project/
Florida Keys Mosquito Control District: http://keysmosquito.org/latest-gm-information/