Vaccine Development

The influenza vaccine is developed each year in response to the best guesses by researchers and doctors about what this year's most volatile flu strains will be. The problem with this method is that it can take months for a vaccine to be identified, developed, and deployed to clinics and doctors' offices. And in that time, thousands of people can fall ill.

The cure, so to speak, for this gap in vaccine development is online communication. Researchers at Novartis Vaccine and Diagnostics (NV&D), in partnership with the Centers for Disease Control and Prevention (CDC) and the World Health Organization (WHO), have found that by using an online DNA library they can generate a vaccine in a matter of days, not months, after receiving viral RNA from the flu strains that are currently in the air.

It took six months to develop vaccines in 2009, but they can now be created in as little as three days. By keeping information about vaccines online and at the ready, researchers at an outbreak site can send out genome segments that can be used to produce an effective vaccine locally. The researchers recently demonstrated this rapid vaccine development technique on pieces of the H7N9 virus currently infecting humans and animals in China.

“The degree to which we could increase the accuracy of rapid gene synthesis was surprising,” said study author Philip Dormitzer, M.D., the global head of virology and head of research at NV&D. At the beginning of the study, using even the most advanced gene synthesis technology, only about three percent of the synthetic vaccines researchers created had the correct genetic sequences. “Now, we have protocols that result in 80 to 90 percent of the...genes having the correct sequence,” Dormitzer said.

Time Saved, Lives Saved

While most vaccines are widely and readily available in the U.S., in the developing world, it’s not quite so simple.

In 2009, the H1N1 flu pandemic spurred one of the fastest global response and vaccine development efforts in history. Just six months after the vaccine strains were identified, companies had developed and distributed hundreds of millions of doses, the CDC reports.

Unfortunately, that’s not fast enough. For the populations influenza hits hardest—the elderly and young children—a faster vaccine development and deployment schedule isn’t just ideal: It’s necessary.

“Faster influenza virus vaccine development and distribution can decrease the morbidity and mortality from an influenza pandemic. During the 2009 H1N1 influenza pandemic, because of the time needed for vaccine development, substantial quantities of vaccine were not distributed until after the peak of illness,” Dormitzer said.

The CDC report indicates that every week of acceleration in vaccine development during the 2009 pandemic would have prevented 300,000 to 400,000 illnesses in the U.S. alone. And we were lucky in 2009, Dormitzer says, because the the H1N1 virus strain was not highly pathogenic, or infectious.

“For a pandemic with a highly pathogenic strain, this decreased illness with an accelerated vaccine supply would correspond to at least tens of thousands of lives saved with each week of time saved,” he said. 

New Gene Synthesis Techniques

The Internet has been around since 1996, but synthetic genomic techniques have advanced greatly only in recent years.

“During the 2009 influenza pandemic, we and at least one other company attempted to make a vaccine virus using synthetic genes but did not succeed in time for the results to be useful for the pandemic response," Dormitzer said. "The ability to synthesize genes both rapidly and accurately is new.”

Researchers begin by using instantaneous data exchange, facilitated by the Internet, to update vaccine production and development in real-time. The synthetic vaccine building blocks are really just packets of information, and because that information can be transmitted around the globe and updated instantly, the production schedule for an effective vaccine has been greatly shortened.

Influenza, because it already has an established vaccination system within the public health and regulatory domains, is one of the first pathogens researchers have targeted.

“For vaccines against other viruses, even if you could make a vaccine virus against a new strain in the laboratory very quickly, there would be higher barriers to using that vaccine to protect humans,” Dormitzer said, although the potential for this kind of rapid synthesis is there.

Currently, researchers are using this process in response to the H7N9 influenza outbreak in China, and the process is performing as expected. “The early availability of these genes could enable more rapid and effective public health responses worldwide,” Dormitzer said.

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