During the 2009 swine flu epidemic, vaccine manufacturers raced to produce a vaccine, yet by the time inoculations were ready months later, the pandemic had done most of its damage for the season.
But the next time a severe flu hits, doctors may be ready with a vaccine within days, thanks to pathbreaking work by researchers at the Cambridge campus of the drug giant Novartis that was published Wednesday.
Earlier this year, Novartis scientists were able to design a vaccine in less than a week for a new strain of flu that had appeared in China. After receiving details of its genetic code on Easter Sunday, the researchers were able to synthesize the virus by the following Tuesday and determine the best design for a vaccine by that Saturday.
Details of the innovation were published in a scientific journal, Science Translational Medicine. The research follows another important advance in vaccines, a new and potentially faster manufacturing system, and together the two accelerated methods could prevent the spread of a dangerous flu strain.
“It’s a big deal if it works on a large scale,” said Marc Lipsitch, an epidemiologist and director of the Center for Communicable Disease Dynamics at the Harvard School of Public Health. “Anything that can allow us to speed up the production of vaccines by several weeks or more has the potential to really improve the response to a pandemic.”
‘To my knowledge, this is the first real-world product from synthetic biology.’
The new process is much faster, in part, because researchers can now use the genetic code of a virus to design its vaccine, instead of having to wait weeks for the actual flu strain to be shipped from wherever it has broken out.
Using techniques developed by the decade-old field of synthetic biology, the scientists made a copy of the virus using only the chemicals in its genetic recipe. Essentially, they transformed digital code into a biologically active virus in a matter of hours.
Though they made a few more innovations, the rest of the process of designing a vaccine is largely familiar. The vaccine, a similar but benign form of the virus, helps stimulate the body’s immune system to fight off the illness before it can take hold.
The vaccine cannot give the patient the flu, because it does not contain a live form of the virus.
Beyond its benefits for vaccine production, the Novartis work marks a major advance in the field of synthetic biology, which engineers new biological forms with new functions not found in their natural version.
“To my knowledge, this is the first real-world product from synthetic biology,” said J. Craig Venter, who cowrote the Novartis paper and is famous for being among the first scientists to map the human genome.
“I think it is just a tiny hint of the future of what’s to come,” said Venter, the chief executive of Synthetic Genomics in San Diego.
Until now, synthesizing a gene has been a cumbersome and repetitive process, requiring rounds of cloning and sequencing to improve accuracy. With the new paper, researchers showed they can manufacture an influenza gene quickly and accurately, said Philip Dormitzer, head of US vaccine research at Novartis.
Scientists chemically synthesized short bits of the flu strain’s genetic code, and then knitted those together to form a complete version.
In a second innovation in the paper, researchers showed they can use a library of pieces of flu genes found in previous strains, rather than having to start each synthesis from scratch, Dormitzer said.
While the sequencing technology is not groundbreaking, the way the researchers have used it is powerful and innovative, said Robert Finberg, chairman of the department of medicine at UMass Medical School and UMass Memorial Healthcare.
“It’s a technical advance, it isn’t a conceptual advance,” said Finberg, also a flu researcher. But “I think it does have great potential for more rapidly preparing vaccines for new strains as they evolve.”
So far, the new approach isn’t applicable for other viruses beside flu, though it may be eventually.
Dormitzer said the process still isn’t fast enough for viruses such as HIV that mutate quickly, nor is it necessary for those that evolve slowly, such as rabies.
The next step, he said, is to shave even more time off the flu vaccine development process by speeding up the testing and approval of a new vaccine.