(Repeating story first sent on Aug 9 to additional subscribers)
By Sharon Begley and Toni Clarke
NEW YORK/WASHINGTON Aug 9 All three U.S.
facilities established to quickly make vaccines and therapeutics
in the event of a major public health threat say they are
standing by to support any U.S. government effort to scale up a
treatment for Ebola.
The facilities, called Centers for Innovation in Advanced
Development and Manufacturing (ADM), were set up by the U.S.
Department of Health and Human Services in partnership with
private industry, to respond to pandemics or chemical,
biological, radiological, or nuclear threats.
They have the expertise to quickly switch production lines
to manufacture, for example, a smallpox vaccine if that scourge
were to re-emerge, or an anthrax vaccine, and other life-saving
compounds against both natural outbreaks and bioterrorism.
"They know our number and they can call us 24 hours a day,"
said Brett Giroir, chief executive of Texas A&M Health Science
Center, site of one of the facilities. "We are prepared."
Global health agencies are only starting to consider whether
to make experimental drugs, most of which have only been tested
on monkeys, available to patients in West Africa, which is
suffering the worst Ebola outbreak in history.
The World Health Organization is convening a group of
bioethicists to consider such as issues as who decides which
patients would receive the treatments or vaccines. U.S.
officials have repeatedly emphasized the importance of public
health measures such as quarantines to stop the spread of the
Among the Ebola treatments that have shown promising results
in lab animals is an antibody cocktail from Mapp
Biopharmaceutical, a tiny biotechnology company in San Diego; a
vaccine from Profectus in Tarrytown, New York; and an
RNA-interference drug being developed by Vancouver-based,
Tekmira Pharmaceuticals, which late last week got
approval from the U.S. Food and Drug Administration to resume
safety trials in human volunteers.
The decision to order any of the three advanced labs to
begin making Ebola treatments would be made at the highest
levels of the Obama administration.
BUS-LENGTH CLEAN ROOMS
The Texas facility consists of a dozen bus-length mobile
clean rooms, each supplied with sterile air, nutrient media for
growing cells, and other clean-manufacturing requirements.
"We are prepared to make any kind of vaccine," Giroir said,
from the traditional kind grown in chicken eggs to newer
varieties grown in mammalian or bacterial cells. "The whole idea
is to take a process that may exist only on sticky notes at a
small biotech company and scale it up as fast as possible"
The three centers are required to have the ability to
produce vaccines against pandemic flu but must also dedicate at
least six months a year to developing products against other
threats, and at sufficient volume to meet a sudden spike in U.S.
demand, Giroir said.
The Texas facility collaborates with British drugmaker
GlaxoSmithKline Plc. A center led by Emergent
Biosolutions in Baltimore, Maryland, collaborates with various
universities as does the third center, in Holly Springs, North
Carolina, led by Swiss drug company Novartis AG.
Their operations are funded with $400 million from HHS and
are overseen by the Biomedical Advanced Research and Development
Authority (BARDA), part of HHS's Office of the Assistant
Secretary for Preparedness and Response.
Combined, the centers have the capacity to produce and
deliver at least 50 million doses of vaccine against pandemic
influenza, the most likely source of a health emergency, within
Any Ebola order would be for much fewer doses, said Giroir.
"Even if Ebola were spreading here, it's not an airborne
transmissible disease like influenza so you wouldn't need 50
million doses. At most you'd need a few thousand, maybe a
The centers are not set up to invent drugs. They are
designed to take what Giroir calls "the scientific substrate" or
recipe for the product, either an existing one or, as in the
case of Ebola treatments, an experimental one and develop a
process for making it.
Of the three, only the Texas lab said it can produce
proteins such as human antibodies in plant-based systems, which
is how Mapp's Ebola drug has been made in limited quantities, so
the government may sub-contract with a company that has
additional plant technology.
One candidate is Bryan, Texas-based Caliber Biotherapeutics
LLC. Mapp currently works with Kentucky BioProcessing, a unit of
tobacco giant Reynolds American to produce its drug.
More capacity would be needed to scale up.
Emergent Biosolutions' facility does not have the recipe to
develop an Ebola treatment, but Adam Havey, president of the
company's biodefense division, said that if the government asked
it to produce something against the virus "we would absolutely
respond to that."
Novartis said its facility also "stands ready, as with
previous public health emergencies, to provide scientific
support aimed at halting the current outbreak."
Even with dedicated facilities to hand, getting medicines to
Africa quickly and in sufficient quantities will be a challenge.
BARDA does have a network of distributors, including Baxter
International Inc, Cook Pharmica LLC and JHP
Pharmaceuticals, who would be obliged, if requested, to fill
vials and package a BARDA-designated product.
While U.S. legislation intended such production to be for
U.S. use, there are provisions for products to be provided to
allies and other countries if it is in the interest of national
(Reporting by Sharon Begley and Toni Clarke; Editing by Michele
Gershberg and Martin Howell)