BIO Submits Comments to FDA's Draft EA and Preliminary FONSI Regarding the Proposed Field Trial of the OX513A Strain of Aedes aegypti (Ae. aegypti)
May 18, 2016
Ae. aegypti, a non-native mosquito species that survives exceptionally well in urban environments, is the primary vector for yellow fever, a disease that is experiencing a resurgence in some tropical countries2. Ae. aegypti mosquitoes also carry and transmit other viruses – Zika, dengue, and chikungunya – that can lead to a number of devastating diseases, such as hemorrhagic fever, microcephaly in infants, Guillain-Barré syndrome, and other neurological disorders. Five field tests in three other countries have proven the release of OX513A mosquitoes is an effective method for decreasing the size of Ae. aegypti populations. These results are consistent with FDA’s preliminary FONSI. The FONSI is well-reasoned and fully supported by the analysis in the draft EA. BIO urges FDA to move forward expeditiously, given the global threat to public health3 posed by Ae. aegypti.
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On August 6, BIO submitted comments on the NMPA Draft Technical Guideline on Clinical Trials of Cellular Immunotherapy Products. In the comments, BIO thanks NMPA for the opportunity to submit comments but argues for a more robust commenting period…