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Conditional Licensure of Vaccines (General Info)

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  • Pamela Alley
    ***MODERATORS NOTE: I thought this might be intriguing in re a possible vaccine for VHD in future. God forbid we ever need it!--PA ****** Ed Curlett
    Message 1 of 1 , Jan 5, 2001
      ***MODERATORS NOTE: I thought this might be intriguing in re a possible vaccine for VHD in future.  God forbid we ever need it!--PA
      ******
       
       
      Ed Curlett        (301) 734-3256
                                                       ed.c.curlett@...
                                         Jerry Redding  (202) 720-6959
                                                    jerry.redding@...


      USDA ISSUES CONDITIONAL LICENCE FOR HORSE VACCINE

           WASHINGTON, Dec. 18, 2000 The U.S. Department of Agriculture announced today
      that it has issued a conditional license to Fort Dodge Laboratories, Inc. of Fort Dodge, Iowa, a
      division of American Home Products, Inc. for a vaccine intended to aid in the prevention of
      equine protozoal myeloencephalitis.

           The Animal and Plant Health Inspection Service issues conditional product licenses
      under its regulatory authority to meet an emergency condition, limited market, local situation, or
      other special circumstances.
       
           "Under these regulations, a product that is shown to be pure and safe and demonstrates a
      reasonable expectation of efficacy may be licensed while data to establish efficacy and potency
      are obtained," said Alfonso Torres, deputy administrator for APHIS' veterinary services
      program.  The center for veterinary biologics, licensing and policy development staff of
      veterinary services issued the license.

           EPM is a debilitating and sometimes fatal neurologic disease of horses linked to infection
      by a protozoal parasite most often identified as Sarcosystis neurona.  Opossums and birds are the
      normal hosts for S. neurona; horses may become infected by ingesting the organism in food
      contaminated by opossum fecal material.  In some cases, infection by the parasite may result in
      damage to the central nervous system, particularly the spinal cord.

           Diagnostic procedures currently available for use on living animals are difficult and often
      unreliable.  Treatment regimes for EPM are costly, often of limited effectiveness, and in a small
      number of treated animals symptoms recur when therapy is discontinued.
       
           Nationwide, exposure of horses to S. neurona has been estimated to be as high as 50
      percent based on the presence of antibodies to the organism in tested horses, with higher rates
      reported in certain areas.  Evidence of exposure and subsequent development of disease,
      however, are not well correlated and most estimates of the incidence of EPM disease are less
      than 1 percent.

            Conditional licenses are generally issued with restrictions and for a limited period of
      time.  At the end of the conditional licensure period, data obtained in support of the product’s
      efficacy, potency, and product performance are evaluated to determine if the conditional license
      should be renewed or if a regular product license may be issued.

           In keeping with these regulations, the product described above has been issued a
      conditional license for six months.  The product is restricted to use by a veterinarian, in those
      states where use of the product has been approved by the appropriate state regulatory authorities.

           Any adverse reactions made known to the manufacturer that may be linked to use of the
      product are to be reported immediately to USDA by the manufacturer.  Promotion, advertising,
      and marketing materials to be used in conjunction with the product are subject to prior review by
      USDA.

           At the conclusion of the six-month conditional licensure period, the manufacturer is to
      provide all data collected relevant to product performance in support of any request for
      reissuance of a product license.
       
                                     #

      NOTE: USDA news releases, program announcements, and media advisories are available on
      the Internet.  Access the APHIS Home Page by pointing your web browser to
      http://www.aphis.usda.gov and clicking on "APHIS Press Releases."  Also, anyone with an
      e-mail address can sign up to receive APHIS press releases automatically.  Send an e-mail
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