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发帖数: 2056 | 1 Written by M.E.Garza
Tuesday, 01 September 2009 22:22
That certainly seems to be case after the company released big news on
Monday. According to the Maryland based company, Phase II clinical trials
of its seasonal influenza virus-like particle vaccine showed the vaccine was
well tolerated and worked well against three types of seasonal flu,
including H1N1.
There are several reasons why this is an important development for the
company, but there is a more daunting reason why this is big news for
mankind.
Simply put, without faster processes for producing influenza vaccines that
protect against new strains, pharmaceutical companies will be backed up and
unable to help slow a pandemic.
Just last month, the World Health Organization reported that the swine flu
viruses aren’t producing enough of a key vaccine ingredient, which has
limited the amount of vaccine that is available. Its laboratory network went
to work to produce a new set of viruses that it hoped would work better,
and while some drugmakers have said they are running behind schedule others
insist they will be able to start shipping the bigger batches of vaccine
soon. Meanwhile, world governments with bigger pockets have placed huge
orders with companies like Baxter International Inc. (NYSE:BAX),
GlaxoSmithKline PLC (NYSE: GSK), NOVARTIS (NYSE: NVS) and Sanofi-Aventis SA
(NYSE:SNY), moving them to the front of the line as other, less fortunate
countries are being left to fend for themselves.
As Science Progress points out- for decades, most experts have agreed that
the process of manufacturing influenza vaccine using hens’ eggs is archaic
and needed to be improved. But because biotech funding seems to follow the
trail of super drugs generated by big pharmaceutical companies, the standard
has remained.
So what happens the moment a deadlier strain hits?
Would this process suffice? No.
According to experts at the Department of Health and Human Services,
producing a vaccine to protect the entire U.S. population against a pandemic
would require an enormous supply of eggs: 900 million are necessary to
produce 300 million doses. If strains hit that are too virulent and deadly,
this process will fall way short.
Fortunately, Novavax appears to be blazing a path to faster production and
better quality of flu vaccines.
The company circumvents the slow boat approach of taking the actual
influenza virus, growing it, and then inactivating it. Instead, Novavax's
recombinant, cell culture based VLP technology makes a genetic match to the
flu strains of interest. It does not require live flu virus seed that has to
be adapted to grow in eggs to create the egg-based vaccine.
This attribute of recombinant virus-like particle (VLP) will lead to a more
efficacious vaccine against the flu strains that are circulating around the
globe.
The results released as part of this study provided Novavax's first human
data to support this hypothesis. Thus, this method could potentially meet
the demands of “surge capacity” in the face of a pandemic.
That’s not all.
When VPLs are injected into a patient, the immune system reacts as if it
were attacking a real virus, creating anti-bodies against it, and giving the
patient immunity when the real strain attacks. Unlike traditional vaccines,
these VLPs do not run the risk of becoming virulent again, making them
safer to use.
The study showed that Novavax's VLP vaccine was not only well tolerated, but
it also induced strong hemagglutination inhibition (HAI) antibody responses
against three influenza strains: H1N1, H3N2, and B strains. That
demonstrated the potential for VLP vaccines to be cross-protective against
flu viruses from different seasons without the addition of an adjuvant.
Furthermore, the responses met the seroconversion criteria for licensure as
outlined in the FDA guidance document for influenza vaccine development and
if it’s good enough for the FDA, it’s not implausible to think that the
door may have just been opened for other governments to fast-track the
testing and licensing of Novavax’s VLP vaccine technology.
It’s not unheard of. Even the European Medicines Agency, the EU’s top drug
regulatory body, has accelerated the approval process for the current swine
flu vaccine, and countries such as Britain, Greece, France and Sweden say
they’ll start using a working vaccine the moment it’s greenlighted.
In an interview with The Associated Press, Dr. Keiji Fukuda, the World
Health Organization’s flu chief, warned about the potential dangers of
untested vaccines, although he stopped short of criticizing Europe’s
approach outright.
“One of the things which cannot be compromised is the safety of vaccines,”
Fukuda said. “There are certain areas where you can make economies,
perhaps, but certain areas where you simply do not try to make any economies
.”
NVAX’s reach across the pond has already begun. In June, the company
announced an initial agreement to license its proprietary (VLP) vaccine
technology to ROVI Pharmaceuticals of Spain. ROVI will use it to create a
comprehensive influenza vaccine solution for the Spanish government under a
new 60 million-euro program sponsored and led by the Spanish Ministry of
Health and other government groups to develop pandemic and seasonal flu
vaccines and establish its only in-border facility. This program, which was
announced by Spanish health officials, is being launched to develop safe and
effective flu vaccines to serve the entire population of Spain.
Under separate agreements, ROVI will receive exclusive licenses to Novavax's
portable VLP vaccine technology to commercialize flu vaccines in Spain and
Portugal, and non-exclusive licenses in Europe, Latin America and Africa.
As part of the deal, Novavax is also set to receive royalties from ROVI's
sales of their products, and will retain exclusive rights to the vaccine in
North America, Asia and Australia.
In July, Cadila Pharmaceuticals announced the launch of a joint venture with
Novavax in India. Under that agreement, the two will launch a joint
venture, called CPL Biologicals Pvt. Ltd., which will develop and
manufacture vaccines, biological therapeutics and diagnostics in India.
Novavax told The Associated Press that the deals would “bring the company
development funding needed now and will be worth tens of millions of dollars
in future royalty and milestone payments once the vaccines are approved and
marketed.''
The safety of flu vaccines is a concern both here and abroad. Flu vaccines
have been used for 40 years, and many experts say extensive testing is
unnecessary, since the swine flu vaccine will simply contain a new
ingredient: the swine flu virus, but European officials won’t know if the
new vaccine causes any rare side effects until millions of people get the
shots. Still, they say the benefit of saving lives is worth the gamble.
Novavax’s safety results strongly support moving forward with larger head-
to-head trials of the VLP and egg-based vaccines, the first of which is
scheduled to start this autum in elderly adults, according to the company.
"The safety and immunogenicity results from this study give us confidence to
move our seasonal influenza VLP vaccine candidate forward into late phase
development," said Dr. Penny Heaton, Chief Medical Officer and Vice
President of Development of Novavax. "Given the immunogenicity results we
saw with our VLP vaccine candidate as compared with the egg-based vaccine,
we are now particularly excited to begin the larger head-to-head study in
elderly adults this Fall," Dr. Heaton said.
Make no mistake, NVAX’s ability to produce more powerful vaccines in a
little under two weeks and the study’s numerous other results have changed
the game. Some on Wall Street now feel that the company has painted a clear
"take-over bulls-eye" on their back, but that isn’t causing anyone to
become distracted at Novovax headquarters. Everyone is more strongly
committed and supportive of accelerated development of Novavax's pandemic
influenza vaccines, including the novel H1N1 2009 influenza VLP vaccine.
"We are working tirelessly with partners and governments worldwide to
potentially provide H1N1 vaccine to regions without an indigenous supply,"
said Dr. Rahul Singhvi, President and Chief Executive Officer of Novavax. "
The current influenza pandemic underscores the potential for Novavax's
advanced influenza vaccine technology to have significant public health
impact by providing vaccine in time to those in need," said Dr. Singhvi.
Expect more news from the company as new milestones are reached and other
study results are announced. I wouldn't be surprised to hear something
positive as early as as next week. |
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