Company Calls on FDA to Speed Authorization of Genetically Modified Mosquitoes to Fight Zika Virus

Regulatory NewsRegulatory News | 25 May 2016 |  By 

As the US Food and Drug Administration (FDA) continues to debate whether to allow Britain’s Oxitec to release genetically modified mosquitoes into Florida and other vulnerable areas as a means of controlling the spread of the Zika virus, the company’s CEO told a House committee Wednesday that time is running out.

Oxitec CEO Hadyn Parry, who testified before the House Committee on Science, Space and Technology, told the representatives that the company’s GM mosquito is safe for the environment and that the only factor holding up the approval of the new species, which FDA has classified as an investigational new animal drug, is “concern over the words ‘genetic modification.’”

Oxitec’s genetically engineered line of Aedes aegyptimosquitoes – which transmit potentially debilitating human viral diseases, including Zika, dengue, yellow fever and chikungunya – are intended to eliminate certain populations of the mosquito wherever the genetically tailored ones are released. Parry told the committee that 90% of the mosquito population could be dead within six months if the GM mosquitoes are released.

The mosquitoes are genetically altered to stop their offspring from breeding, and Parry said that even if the genetic alterations don’t work, the mosquitoes will continue to breed as they already would. And as far as the release of GM mosquitoes impacting other mosquitoes or ecosystems elsewhere, Parry said the average mosquito only flies about 200 yards in a lifetime, and Oxitec has the ability to track and trace where the genetically modified species travel.

Rep. Ralph Abraham (R-LA) said he supports the release of the genetically modified mosquitoes, adding, “We’ve got to kill these mosquitoes.”

FDA Review

FDA is still reviewing information on the Oxitec mosquito in consultation with government experts from other agencies, including the CDC and EPA.

The public comment period for the draft Environmental Assessment and preliminary finding of “No Significant Impact concerning investigational use of Oxitec OX513A mosquitoes” closed on 13 May. More than 2,000 comments have been submitted to FDA, many of which are from individuals concerned about the environmental impact of such a release.

FDA says it is thoroughly reviewing all public comments and information submitted before determining its next steps. Oxitec will not conduct the field trial of its OX513A mosquito until the agency has had the opportunity to review public comments and prepare an Environmental Impact Statement.

Open field trials of the genetically modified OX513A mosquito have already been conducted in Brazil, the Cayman Islands, Panama and Malaysia.


Also at the hearing, three physicians discussed the possibility and benefits of stricter travel warnings for pregnant women to areas where the Zika virus is prevalent, including Brazil and Colombia.

Dr. Steven Presley, professor at Texas Tech University, also warned that the types of mosquitoes carrying the Zika virus can breed in as small a container of water as a can of tuna or even a bottle cap. He added that they like to be inside homes and usually bite early in the morning or just after sunset.

Presley also said that estimates for infections could be well below what’s actually occurring, as patients with Zika may be asymptomatic.

The hearing comes as the House and Senate continue to fight over how much in emergency funds should be appropriated for Zika-related purposes.

The Senate has added an amendment to the combined FY 2017 Military Construction-Veterans Affairs and Transportation-Housing and Urban Development appropriations bills that provides $1.1 billion, most of which would be available until 30 September 2017. The House, meanwhile, has offered a standalone supplemental appropriations bill (H.R. 5243) to provide $622.1 million for Zika funding, which would be available until 30 September 2016. Rescissions are included in the House bill, meaning it would cut some HHS funding, though it is currently unclear how much would be offset. Nearly half of the House funds are designated as emergency funding. 

Full Committee Hearing - Science of Zika: The DNA of an Epidemic

FDA: Oxitec Mosquito


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