Novartis, Novavax whip up new bird flu vaccines as pandemic fears flourish

Winter's coming, and with it there's a surge of dire warnings that new cases of H7N9 bird flu in China warrant a global pandemic alert. While the most recent pandemic alarms have fizzled out without any major outbreaks of a lethal virus, the federal government has been supporting work on new vaccine technologies. And today two prominent vaccine developers--Novartis ($NVS) and Novavax ($NVAX)--grabbed the R&D spotlight with news that they were able to successfully develop new vaccines within months that could be used against H7N9, demonstrating their broad effectiveness in spurring an immune response in human studies. 

Shares of Novavax popped 9% this morning on the news that its virus-like particle technology platform spawned a vaccine that triggered a significant immune response against H7N9 in 81% of the 284 adults in the study. And the Rockville, MD-based company was able to develop and test the vaccine/adjuvant combo in less than four months after the virus was identified and sequenced.

"These are very preliminary results, but it appears for the first time that we may have a vaccine that would work against an outbreak" of avian flu, Robin Robinson, director of the Biomedical Advanced Research and Development Authority (BARDA), tells Reuters. "This is a very important milestone. We have a promising vaccine where before we had none."

Novartis, meanwhile, says it was able to track an 85% response rate among the 400 adults it tested its adjuvanted H7N9 vaccine on. The pharma giant did it using its cell-culture manufacturing technology, which has been developed to rapidly produce mass quantities of vaccines--a vast improvement over the slow egg-based vaccine production system that has been used for generations.

Novartis and partners at the Craig Venter Institute in San Diego were able to launch a clinical trial in August after the virus was identified in March. The project was funded by BARDA.

The H1N1 scare back in 2009 spurred a global, multibillion-dollar effort to stockpile vaccines. The campaign highlighted just how long it took to develop and manufacture new vaccines and then spurred a backlash after governments around the globe rushed to buy stockpiles only to see the threat evaporate. In Europe some health officials accused pharma companies of capitalizing on the fear of a lethal pandemic, and memories of the controversy will likely influence any new moves to guard against a new outbreak. This winter's alarm may also fizzle, but these companies have demonstrated that new vaccines can be developed in record time.

"This rapid response underscores our leadership position in pandemic preparedness," said Andrin Oswald, division head of Novartis Vaccines. "Thanks to our investments into innovative production technologies and adjuvants, we are now able to offer a protective solution for a potentially deadly pandemic virus within a few months after the emergence of the H7N9 virus."

"The performance of our vaccine candidate is particularly important in light of the speed with which pandemic outbreaks can unfold," says Dr. Lou Fries, Novavax's vice president of clinical and medical affairs. "Often, an initial outbreak of a novel influenza virus is followed by a more severe and widespread outbreak at the onset of the next fall and winter respiratory virus season, as seen in 2009 with H1N1. Unfortunately, vaccine makers in 2009 were unable to produce vaccine in advance of the second wave and there was little impact of vaccine upon H1N1 disease in the first year. Past H7-based vaccine candidates have been poorly immunogenic and thus could not be advanced as viable vaccine candidates. This risk appears to have been overcome by our H7N9 adjuvanted VLP vaccine."

- here's the release from Novavax
- and the release from Novartis
- read the report from Reuters

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