Even as US 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 US 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 scratch.
Slowed delivery of
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 the new 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 BARDA."We'll take it," said Robinson, whose agency
handles pandemic preparedness as part of the US Department of Health and Human
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
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 urgently
Bird flu global
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 US flu vaccine manufacturing
After the 2009 H1N1 pandemic, US 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 to
Test drive for the
new flu technology
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 recalls.
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 US 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, US 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, director of
the US 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 several months.