U.S.D.A. speeds process to create H1N1 vaccine

by Bryan Salvage
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WASHINGTON — The U.S. Department of Agriculture plans to make the master seed virus (M.S.V.) for the novel H1N1 flu available to interested veterinary biologics manufacturers. Next week, U.S.D.A.’s Animal and Plant Health Inspection Service’s Center for Veterinary Biologics (C.V.B.) will issue a notice to manufacturers to alert them the M.S.V. will be available as soon as it is fully characterized and tested. A.P.H.I.S. estimates the M.S.V. will be ready in early to mid-July 2009.

The M.S.V. is being derived from a sample acquired from the Centers for Disease Control and Prevention through collaboration between Agricultural Research Service’s (A.R.S.) National Animal Disease Center (N.A.D.C.) and C.V.B.

Although C.V.B. has licensed swine influenza vaccine for several strains of swine influenza virus since 1993, preliminary results from work conducted at N.A.D.C. in response to the 2009 H1N1 situation appear to indicate current swine influenza vaccine products may not provide adequate protection against the new strain. A.P.H.I.S. and A.R.S. are continuing to run additional tests to determine if any vaccines currently available protect against the 2009 H1N1 strain.

By providing all interested manufacturers with the same approved H1N1 M.S.V., A.P.H.I.S. is eliminating the need for each manufacturer to focus resources on developing its own master seed that would then require C.V.B. confirmatory testing. As a result, while the "global" M.S.V. is undergoing tests at C.V.B., each interested manufacturer can begin working immediately on the next steps involved in novel vaccine production.

Should the virus ever appear to be an emerging disease in swine, producers will have a vaccine available much faster than they would under the normal production process, possibly as early as November or December 2009, U.S.D.A. stated.

Mexico first reported an increase in influenza-like illness in humans in March 2009; in April, the number of human cases steadily increased. On April 24, the World Health Organization stated the U.S. and Mexico had confirmed several cases of human influenza virus H1N1. The number of confirmed and suspect cases in people spread rapidly through the U.S., Canada and Europe. On May 2, the Canadian Food Inspection Agency reported the virus had been confirmed in a swine herd in Alberta, Canada; C.F.I.A. suspects the herd was likely exposed to an infected person. The virus strain causing the current outbreaks is a novel H1N1 virus that has not been seen previously in either humans or animals.

The C.V.B. notice will be available online at http://www.aphis.usda.gov/animal_health/vet_biologics/vb_notices_2009.shtml.

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