(In 20th paragraph, corrects title of Mike Shaw to make clear
he runs a CDC laboratory instead of being director of the CDC)
* Faster DNA method shaved 2 weeks off vaccine process
* Chinese researchers say counter measures 'urgently needed'
By Julie Steenhuysen
CHICAGO, April 11 Even as U.S. officials this
week awaited the arrival of a sample of the new bird flu virus
from China - typically the first step in making a flu vaccine -
government-backed researchers had already begun testing a "seed"
strain of the virus made from the genetic code posted on the
This new, faster approach is the result of a collaboration
among the U.S. government, vaccine maker Novartis and
a unit of the J. Craig Venter Institute, which is using
synthetic biology - in which scientists take the genetic code of
the virus and use it as a recipe to build the virus from
It was an idea born in the aftermath of the 2009 H1N1
pandemic, in which production delays and poor-quality seed
strain slowed delivery of the vaccine until October, late enough
that people were already sick with swine flu.
The new method has shaved two weeks off the vaccine-making
process. It will take five to six months to ramp up production,
but even weeks could make a difference in the case of a
potentially deadly flu pandemic, said Robin Robinson, director
of the Biomedical Advanced Research and Development Authority or
"We'll take it," said Robinson, whose agency handles
pandemic preparedness as part of the U.S. Department of Health
and Human Services. "If the virus turns out to be a tough one,
that could be very important."
At least 33 people have been infected and 10 have died from
the strain of bird flu known as avian influenza A (H7N9) first
found in humans last month. So far, the strain does not appear
capable of being passed from person to person.
But Chinese researchers, in a report published online on
Thursday in the New England Journal of Medicine, warned that the
sudden emergence of this strain of flu "may pose a serious human
health risk" and said "appropriate counter measures were
An especially deadly strain of bird flu in 2003 known as
H5N1 had already raised the threat of a global pandemic,
spurring more than $2 billion in government contracts to shore
up U.S. flu vaccine manufacturing capabilities.
After the 2009 H1N1 pandemic, U.S. health agencies gathered
to do some soul searching. Representatives from BARDA, the Food
and Drug Administration, the Centers for Disease Control and
Prevention and the National Institutes of Health looked for ways
to expedite the process of making flu vaccines, Robinson said.
These advances would need to apply to all vaccine makers,
whether they used the traditional method of growing the virus in
live chicken eggs, or the newer methods of growing it in cells
or vaccines made from genetically engineered proteins.
Robinson, who formerly headed the vaccines division at
Novavax Inc, had seen firsthand the speed at which a
vaccine could be made using synthetic biology during the 2003
outbreak of Severe Acute Respiratory Syndrome or SARS, when
companies and governments rushed to make a vaccine.
So, in 2010, BARDA tapped Novartis, one of its vaccine
partners, along with a company owned by Dr. J. Craig Venter, the
flamboyant scientist who took part in the race to map the human
genome and caused a stir in 2010 when he used synthetic genes to
create a custom microbe and bring it life.
As a test drive for the new flu technology, in 2011 the
government gave its partners the genetic sequence for a North
American strain of H7N9, a similar virus to the one making
people sick in China. "It was just a coincidence," Robinson
In less than two weeks, Novartis and Venter's group were
ready to make virus seed. The next year, they sequenced an H5N1
virus and produced a synthetic virus in six days.
Then came a live test. The United States asked its partners
to make a real vaccine for a variant of swine flu known as H3N2
that had been infecting children in the U.S. Midwest last year.
Once again, they produced virus seed in less than a week.
So, when Chinese health authorities released the genetic
sequence for the H7N9 bird flu on March 30, U.S. health
officials decided to try the new technique.
Novartis and Venter's company, Synthetic Genomics Vaccines
Inc, went to work and by April 4, they had synthetic DNA ready
and had started to grow the virus in cells, long before samples
of the actual virus arrived from China on April 11.
Normally, getting a sample would be the starting point for
making a seed virus, which would then be grown and tested to
ensure it would grow well in chicken eggs or cells.
That involves a certain amount of guesswork, however. The
new process of building the virus based on its genetic code
allows "almost guaranteed success," said Mike Shaw, who directs
the influenza laboratory for the U.S. Centers for Disease
Control and Prevention.
"That is because you're creating a virus that is almost
tailor-made," he said.
Shaw said the CDC plans to take a vaccine candidate at least
to the stage of human safety trials, a process that will take
(Reporting by Julie Steenhuysen; Editing by Douglas Royalty and