Published Date: 1998-02-05 23:50:00
Subject: PRO/AH> Influenza H5N1, new vaccine development - USA
Archive Number: 19980205.0225
INFLUENZA H5N1, NEW VACCINE DEVELOPMENT - USA
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A ProMED-mail post
See Also
Influenza vaccines, new technology needed (02) 980124222659Influenza vaccines, new technology needed: opinion 980110002759
Influenza H5N1, human - China (Hong Kong) 980110230837
Influenza H5N1, human - China (Hong Kong) (03) 980115235952
Influenza H5N1, human - China (Hong Kong) (04) 980116000038
Date: Wed, 04 Feb 1998 22:41:37 -0500
From: Robert A. LaBudde <ral@lcfltd.com>
Source: ANIMALNET (D. Powell, Univ. Guelph) and Press Release, 3 Feb 98
EMERGENCY HUMAN VACCINE AGAINST HONG KONG H5N1 INFLUENZA "BIRD FLU"
DEVELOPED BY CONNECTICUT BIOTECHNOLOGY COMPANY
MERIDEN, Connecticut -- Protein Sciences Corporation has successfully
developed the first experimental human vaccine against the H5N1 "Bird Flu"
strain of influenza that recently infected people in Hong Kong and caused
significant economic loss in Asia. The Company understands that the vaccine
will be used by the United States National Institute of Allergy and
Infectious Diseases, National Institutes of Health (NIH) in clinical trials
involving laboratory and healthcare workers who are "at risk" from exposure
to the new virus in the United States and other countries.
The Company has delivered more than 1,000 doses of the new vaccine to the
NIH for use in trials with "at risk" people, and the NIH will be conducting
these trials in collaboration with Protein Sciences. The firm has already
supplied purified H5 hemagglutinin to Government laboratories to help in
surveillance and testing of the H5N1 virus.
When recent cases of H5N1 influenza infections in humans were reported from
Hong Kong, officials from the NIH requested that Protein Sciences escalate
its efforts to produce a vaccine. Dr. Gale Smith, Protein Sciences' Senior
Vice President and Chief Scientific Officer, said, "In an urgent call on
Sunday, December 7, an NIH official informed us of two new cases of H5N1
influenza in Hong Kong. We immediately began an all-out effort to produce a
vaccine."
Protein Sciences' genetically engineered vaccine is based on highly
purified hemagglutinin protein from the H5 subtype produced using the
Company's proprietary vaccine technology. The firm cloned the gene for the
H5 hemagglutinin from genetic material prepared by the Centers for Disease
Control and Prevention in Atlanta from an influenza virus that infected a
three-year-old boy in Hong Kong on May 21, 1997. The boy subsequently died.
The cloned H5 gene was then engineered into a Protein Sciences' proprietary
production process that uses baculovirus and insect cell fermentation
(BEVS).
Daniel D. Adams, Chief Executive Officer of Protein Sciences, said, "Using
our unique technology for development and production, we have the ability
to make new flu vaccines very quickly, in a matter of weeks instead of
months or years, as has been the case in the past. Therefore, it is now
feasible to respond in a timely fashion to emerging new influenza virus
strains and to decide on which strains to include in the annual flu vaccine
much closer to the time the vaccine is needed."
Unlike the current method of making influenza vaccine by infecting chicken
eggs with a live virus, Protein Sciences' production process does not
involve use of a live virus, is not dependent upon growth of a virus in
eggs, uses no animal products and requires only a few weeks to produce a
vaccine. Commenting on his Company's vaccine production system, Adams
noted, "This is an important milestone in changing the way many vaccines
are manufactured."
Using its BEVS technology, Protein Sciences has previously developed
vaccines against some of the more common strains of influenza virus and
conducted several Phase I/II clinical trials in collaboration with the NIH.
These vaccines were safe in humans and effective at producing immunity
against the target influenza virus strains. Protein Sciences' Dr. Gale
Smith stated, "The Company believes that based on these results, our new
H5N1 vaccine will be safe for use in humans, will entail no risk of
infection and will be the fastest approach to producing a vaccine against
this emerging strain of influenza virus."
The NIH awarded the Meriden, Connecticut company the vaccine contract in
December, 1997 because of Protein Sciences' expertise in influenza
vaccines, its unique technology that allowed the firm to deliver the
vaccine within eight weeks from when it was first contacted and the NIH's
previous experience in clinically evaluating other influenza vaccines
produced by the Company.
While the newest vaccine has not yet been used in humans, an H5N1 vaccine
developed by Protein Sciences was shown to be safe and completely
protective in chickens challenged with a lethal dose of the virus by the
United States Department of Agriculture. Protein Sciences is taking steps
to license H5N1 for veterinary use in the United States and similar H5 and
H7 vaccines in Mexico and other countries where avian influenza infections
have reached epidemic proportions.
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