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Global Health Matters

September - October, 2009  |  Volume 8, Issue 5

 

New synthetic protein could speed flu vaccine

NIH scientists have developed a way to drastically cut the time needed to mass produce flu vaccines by cloning the protective antigen protein and growing it in bacteria instead of eggs.

The team of investigators from the National Institute of Child Health and Human Development and the National Institute of Allergy and Infectious Diseases—together with Fogarty's director of international epidemiology, Dr. Mark Miller—used the new technique on several strains of avian flu as well as the pandemic A/H1N1 strain.

Typically, development can take up to six months, but using recombinant hemagglutinin (rHA) antigens to create a flu vaccine could take only three or four weeks, Miller said.

"Influenza vaccine production has been using technology that's over 50 years old," he said, noting that recombinant protein synthesis is similar to the one that led to widespread use of hepatitis B vaccine now available worldwide for less than 50 cents a dose. That would make the technique attractive to large countries facing a shortage of vaccines now under production by the big drug companies.

"This is a vaccine construct that is not commercially available now," Miller said. The new method, tested in mice and ferrets is awaiting human clinical studies as required by the Food and Drug Administration prior to licensure. If successful, vaccine production could scale up quickly, Miller added. A number of international vaccine manufacturers have expressed interest to work further with this product.

"The ... methodology for producing a rHA vaccine is cheaper, safer and more productive than the available technology to meet urgent needs in a world health emergency," the researchers concluded in an article published in the journal Vaccine.

Specifically, they said, "Our protocol eliminates the handling of live virus and expensive egg propagation systems or insect cell cultures and facilitates the rapid production (weeks) of high yields of immunogen... compared to current methods requiring one to two eggs per vaccine dose and a minimum of six months after the circulating strain is isolated."

Experiments supported by NIH in extramural labs are pursuing similar means for expedited vaccine production, he said.

Other Fogarty scientists are also at the forefront of research into A/H1N1.

Dr. Martha Nelson and Dr. Eddie Holmes collaborated with researchers in Wisconsin, New York and at the J. Craig Venter Institute on a large-scale analysis of the evolutionary relationships of influenza viruses from the current A/H1N1 pandemic. Their work revealed that the virus has already diversified into multiple lineages that exhibit complex spatial patterns and rapid growth dynamics.

In addition, Dr. Gerardo Chowell has been analyzing historical pandemics and the current A/H1N1 outbreak in the U.S. Dr. Viggo Andreasen and Dr. Kimberly Bloom-Feshbach have been working on historical data from Scandinavian pandemics dating from 1890 and Dr. Colin Russell has been mapping how the flu virus fools the immune system.

Finally, Drs. Cecile Viboud, Lone Simonsen, Russell and Miller have published lessons from past influenza pandemics in the new PLOS Current, a moderated, but not peer-reviewed, online journal.

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Biesova Z, Miller MA, Schneerson R, Shiloach J, Green KY, Robbins JB, Keith JM. "Preparation, characterization, and immunogenicity in mice of a recombinant influenza H5 hemagglutinin vaccine against the avian H5N1 A/Vietnam/1203/2004 influenza virus." Vaccine. 2009 Aug 15

Miller, Mark; Viboud, Cécile; Simonsen, Lone; Olson, Donald R.; Russell, Colin. "Mortality and morbidity burden associated with A/H1N1pdm influenza virus: Who is likely to be infected, experience clinical symptoms, or die from the H1N1pdm 2009 pandemic virus?" PLoS Currents Influenza. 2009 Aug 26 [revised 2009 Sep 2]