According to an update on the environmental review, the FDA considered thousands of comments from the public prior to publishing its final environmental assessment.
*Updated on 8/5/2016 at 5:16 PM EST
On August 5, 2016, the FDA announced its approval of a field trial in which genetically modified Aedes aegypti would be released in Florida to target the population of the Zika-carrying mosquitos in the area, as Puerto Rico reported its second Zika-related death.
Infection with the Zika virus is confirmed to cause several neurological complications in developing fetuses, including microcephaly. Recently, the World Health Organization (WHO) reported that 68 countries and territories around the world are currently experiencing ongoing Zika transmission. Furthermore, the Centers for Disease Control and Prevention (CDC), the Florida Department of Health, and WHO have all confirmed active Zika transmission in Miami, Florida, with 17 individuals infected locally, the most recent of which resides in Palm Beach County, but is confirmed to have acquired infection in Miami. In addition, Puerto Rico has been experiencing a rapid increase in the number of Zika case, with more than 5,000 reported infections, many of whom are pregnant women. Recently, the CDC confirmed with Contagion that on Friday, August 5, 2016, a Puerto Rican individual infected with the Zika virus died, making this the island’s second Zika-related death.
In response to the Zika epidemic, the British company, Oxitec Ltd., genetically engineered an Aedes aegypti mosquito (OX513A) that would transmit a modified gene to its offspring to cause their premature death. In March 2016, the US Food and Drug Administration (FDA) started reviewing the possible environmental impacts of conducting a field trial in which the OX513A would be released in Key Haven, Florida. Since male mosquitos do not spread Zika, the company believes that OX513A will not pose additional harm to the trial area.
Nonetheless, the trial earned much backlash from Key Haven residents; that is not to say that the FDA did not take public opinion into consideration. In March, when the FDA announced that it was reviewing the field trial proposal, it also opened the doors for public commentary. In addition, in an exclusive interview with Contagion, FDA spokesperson Siobhan DeLancey addressed concerns regarding the release of OX513A.
According to an update on the environmental review, the FDA considered thousands of comments from the public prior to publishing its final environmental assessment (EA). In the EA, the FDA announced the “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.” Nonetheless, the FDA clearly states that the decision to approve the field trial does not denote approval for commercial use of OX513A.
The FDA has published a final Finding of No Significant Impact and Environmental Assessment on our mosquito https://t.co/BeCo4t0btn
— Oxitec Ltd (@Oxitec) August 5, 2016
Furthermore, the FDA notes that Oxitec must follow local, state, and federal requirements while conducting the field trial, and must work “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.”
The OX513A trial has the potential to reduce the prevalence of Ae. aegypti in Key Haven, joining the limited arsenal currently available to combat active Zika transmission.