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APHIS seeks comment on FMD vaccine production

Vaccine manufacturer seeks approval to produce modified FMD vaccine on U.S. mainland.

The U.S. Department of Agriculture’s Animal & Plant Health Inspection Service (APHIS) is seeking public comment on a petition from a vaccine manufacturer seeking approval to produce foot and mouth disease (FMD) vaccine consisting of a modified non-infectious and non-transmissible strain of the virus on the U.S. mainland.

According to APHIS, access to FMD vaccine is an important part of FMD preparedness efforts, but to protect against the introduction of this devastating livestock disease, the live virus of FMD is not allowed anywhere in the country except for the off-shore Plum Island Animal Disease Center, where it is held and worked with under very strict biocontainment procedures. (That exemption will also apply to its successor facility, the National Bio & Agro-Defense Facility, after the facility is completed, APHIS said).

The vaccine, which was developed jointly with USDA’s Agricultural Research Service, is non-infectious, non-transmissible and incapable of causing the disease because it has been modified in such a way that it is no longer able to produce infection, the agency said. The manufacturer asserts that because the FMD virus is no longer able to produce infection, it should not be considered a live virus of FMD and should be able to be produced on the U.S. mainland.

As part of the petition review process, APHIS is seeking comments from the public on two topics: (1) the manufacturer’s interpretation of live virus and (2) whether there is support for manufacturing the vaccine in the U.S.

Public comments will be accepted through Sept. 14, 2020, at the https://www.federalregister.gov/d/2020-15031. APHIS will thoroughly review all comments before making its determination.

FMD is a severe and highly contagious viral disease affecting cows, pigs, sheep, goats, deer and other animals with divided hooves. It was eradicated from the U.S. in 1929, but if it were to infect the U.S. livestock industry, it would cause devastating economic effects, APHIS said.

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