Newport Laboratories has been researching swine influenza
virus (SIV) for many years. Members of our team have licensed commercial SIV
vaccines in the past, and we are currently recognized as the industry leader with our
PINPOINT Evidence-Based (autogenous) SIV vaccines.
Over the years, Newport has advanced our technology from
subtyping (H1 or H3, N1 or N2) to sequencing important epitopes, to developing in-vitro (such as our high-throughput serum neutralization assay) and in-vivo
(animal models) methods of identifying and selecting the correct strains and
formulations.
When the novel H1N1 (nH1N1) first appeared in the spring of
2009, we immediately turned to our SIV isolate database, to determine if we had
ever isolated this particular strain from pigs. We found no evidence that we had, and we quickly communicated this to our customers.
We then began to look at contemporary swine SIV strains to search for any that
might neutralize the nH1N1 if included in a swine vaccine. We found
several. The next step was to build a vaccine containing these cross-neutralizing strains.
We submitted the resulting experimental product, as well as sera
resulting from vaccination with these strains, to the USDA for testing. Both
the sera and the vaccine showed a positive result against the nH1N1.
Click Here to download the informational bulletin
explaining the USDA’s testing process and our results, as well as an
explanation of our two-step isolate selection process.
At the same time that we were working to identify cross-neutralizing swine strains,
the USDA began allowing manufacturers to develop a conditionally-licensed
product containing nH1N1. Although Newport also
started down this path, we are no longer pursuing it. It is our
belief that the USDA should not allow this conditional product into the U.S.
market until it has been proven that vaccination with the nH1N1 sequence would
not potentially interfere with differential diagnostic screening based on
specific genes seen in nH1N1 that have not been seen in domestic pigs to date.
In addition, we believe that the government should assist in
subsidizing swine producers as they use the vaccine containing swine-origin
strains that will neutralize nH1N1. This is a human disease that can be
transmitted to pigs. The purpose of vaccinating is to minimize the potential
spread of nH1N1 in pigs, where it could recombine and re-infect humans in a
more virulent form.
We have been in contact with elected government officials asking for
their support of and investigation into such a subsidy program. Several that we
have spoken with have indicated that they support our position and will
take action.
We are asking the USDA to consider the other regulations
that they have available to them besides a conditionally licensed product. We
are asking that they allow this SIV vaccine, composed of swine strains that
have been shown to neutralize nH1N1, to be used in a broader manner across our
domestic swineherd.
Click here to read a press release prepared by Newport
explaining our progress in developing a swine vaccine for nH1N1.
Click here to read a story about our nH1N1 work that
appeared in the October 21, 2009, issue of the Worthington Daily Globe
newspaper.
Click here to read/view a brief that appeared on Sioux
Falls, SD television station KSFY (ABC) on October 28, 2009, spotlighting our
nH1N1 development.