If the highly pathogenic strain of avian influenza ever comes to Kansas, diagnosticians at Kansas State University’s Veterinary Diagnostic Laboratory will be the first to know.

The lab, which is part of K-State’s College of Veterinary Medicine, is the first place samples would be tested if there were a suspected case of avian influenza in Kansas.

Dr. Gary Anderson, director of the lab and professor of diagnostic medicine and pathobiology, says that the lab has been certified by the U.S. Department of Agriculture to perform avian flu testing. The lab also tests for swine, equine, and canine versions of influenza.

“K-State’s Veterinary Diagnostic Laboratory is known for thorough and timely diagnostic services,” Anderson said. “And in the case of bird flu, were it to make it to Kansas, time would be of the essence. We presently have five employees who are certified by the National Animal Health Laboratory Network to perform avian influenza testing, which allows handling of a large number of samples and reporting the results within a short time frame.”

Avian influenza was recently in the news because of two pre-Thanksgiving outbreaks in Britain. To date, the pathogenic strain of avian influenza — also referred to as H5:N1 — has been reported in Southeast Asia and a handful of European countries, but not in the U.S. It affects poultry — chickens, turkeys, ducks, etc. — and is particularly contagious among domestic flocks, although the disease is thought to originate with migratory fowl.

“From a poultry standpoint, our biggest concern is that migratory birds from the North will mix in the summer breeding grounds and spread avian flu when they fly south for the winter,” said Scott Beyer, a K-State poultry expert and associate professor of animal sciences and industry. “However, this has not yet happened in North America, which is somewhat of a surprise.”

According to Beyer, if the bird flu does make it to the United States, poultry producers are prepared and have been taking precautions against the disease for some time.

“The chicken and turkey industries screen all flocks for avian influenza prior to sending them to the processing plant,” Beyer said. “For many years, the U.S. policy has been never to allow any form of avian influenza to persist in the birds. So, even the most benign form is not allowed to exist in flocks. If we do have an H5:N1 outbreak, which is the highly contagious kind, our system would pick it up very quickly.”

Typically, a single dead bird should not cause significant concern, Anderson said. “We start to worry when there is a large group of dead birds or migratory waterfowl in a relatively small area,” he said.

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In recent years, the bird flu virus has caught the attention of all of Western Europe. In 2006 in particular, there was a lot of speculation about a wide-scale flu outbreak, in other words a pandemic. The Dutch government was worried about running short of vaccine, mainly because it has a very short shelf-life. All that could change, says PhD student Jean-Pierre Amorij of the University of Groningen. In his thesis he describes a way of storing flu vaccine in powder form. It can then be stored for at least a year more than enough time to build up national stocks.

Amorij will be awarded his PhD on 4 January 2008. During the past four years he has examined all kinds of methods for long-term storage of the flu vaccine. The answer lay in what is known as freeze drying a protein molecule, such as a vaccine, is extremely quickly frozen between millions of sugar molecules. These molecules bunch together like miniscule balls around the vaccine, so that it can be stored stably in a dried form.

Sugars

Amorij did not use ordinary sugars for the freeze-drying process but special types like inulin and trehalose. It took Amorij eighteen months to find a freeze-drying process that was exactly right. That is painstaking but important work because the vaccine still has to work even after freeze drying. ‘The biggest problem was choosing the right freezing speed and the right sugar’, says Amorij. But he managed it. The result looks like icing sugar.

No need for a flu jab

Freeze-dried flu vaccine not only has a longer shelf-life, it’s also easier to use. You don’t need injection needles any more as the powdered vaccine can be swallowed or inhaled. That will save a lot of time if the government has to vaccinate a lot of people very fast during a pandemic. You don’t need medical personnel to be present when swallowing or inhaling. Amorij also conducted tests on mice to see whether inhaling or swallowing worked best. ‘Inhaling was by far the most effective with the mice,’ he says. ‘The immune reaction was even more powerful than with an injection.’ According to Amorij, the powder is particularly suited to inhalation. It is very light and stays suspended so it can penetrate deep into the lungs. That makes absorption even more efficient.

Application

When the time comes, it thus looks as if all of the Netherlands will be immunised during a pandemic via inhalers. However, according to Amorij the application will take some time yet. ‘So far we’ve only tested it on mice. The tests on people still have to take place. If everything goes well, then that could happen within five years. If there are a few setbacks it could take ten years. One thing is certain, though, it’s on its way.’

Curriculum Vitae

Jean-Pierre Amorij (Zaanstad, 1978) studied Pharmacy and Pharmaceutical Engineering at the University of Groningen and was awarded his Pharmacist’s diploma in 2003. His PhD thesis at the Faculty of Mathematics and Natural Sciences of the University of Groningen was supervised by Prof. H.W. Frijlink. He conducted his research at the Department of Pharmaceutical Engineering and Biopharmaceutics of the University of Groningen in close cooperation with the Department of Medical Microbiology, Molecular Virology section (Prof. J.C. Wilschut) of the University Medical Center Groningen and the University of Groningen. His thesis is entitled The Development Of Stable Influenza Vaccine Powder Formulations For New Needle Free Dosage Forms.

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In light of the importance of virus monitoring for pandemic influenza preparedness and response, Indonesia’s refusal to share samples of avian flu (H5N1) virus with the WHO for most of 2007 is “distressing and potentially dangerous for global public health,” say two leading global health experts in an essay in this week’s PLoS Medicine.

Laurie Garrett (Senior Fellow for Global Health at the Council on Foreign Relations, New York) and David Fidler (Professor of Law and Director of the Center on American and Global Security at Indiana University) say that Indonesia repeatedly refused to share H5N1 samples unless significant changes were made to allow it greater access to vaccine derived from samples it shared with WHO.

Typically some 250-300 million influenza vaccine doses are made each year, based primarily on samples of flu viruses circulating in Asia, yet most of those vaccinated are residents of rich countries. Some developing countries, say the authors, have challenged this strategy by asking “”What’s in it for us? We share virus samples, and pharmaceutical companies make vaccines from them that primarily benefit rich countries. Without better access to vaccine, why should we share virus samples?”

Garrett and Fidler offer a novel proposal to overcome the virus sharing impasse. They propose that annually updated supplies of more than 500 million doses of highly specific influenza vaccine, plus antiviral medicines, protective masks and gloves, and germicide washes be stockpiled in Hong Kong. They select Hong Kong, they say, because it has shown “absolute transparency regarding disease emergences going back several decades,” it is a dynamic center of virus research and response, and it sits in the middle of the ecological zone that has spawned the bulk of all flu strains known to have emerged over the last three decades.

“We advocate that the strategic stockpile be fed continuously and its specificity updated based on circulating forms of viruses,” say the authors. “These objectives would be accomplished through an Advance Market Commitment (AMC) mechanism in which the G-8 nations and Asian powerhouses China, India, Singapore, South Korea, and Japan set aside a fund to guarantee purchase of stockpiled products. The Asia-Pacific Economic Cooperation forum (APEC) should manage the AMC fund and the stockpiled materials in Hong Kong. APEC has proven to be one of the most dynamic and effective of the world’s regional organizations.”

The PLoS Medicine essay is being published to coincide with the intergovernmental negotiations in Geneva (see http://www.who.int/gb/pip/) on setting up a new international standard of sharing information about influenza and samples of influenza viruses.

Citation: Garrett L, Fidler DP (2007) Sharing H5N viruses to stop a global influenza pandemic. PLoS Med 4(11): e330. Click here.

About PLoS Medicine

PLoS Medicine is an open access, freely available international medical journal. It publishes original research that enhances our understanding of human health and disease, together with commentary and analysis of important global health issues.

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About the Public Library of Science

The Public Library of Science (PLoS) is a non-profit organization of scientists and physicians committed to making the world’s scientific and medical literature a freely available public resource.

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Sinovac Biotech Ltd. (Amex: SVA), a leading provider of biopharmaceutical products in China, announced an update on the clinical trials for its pandemic influenza vaccines. Sinovac received approval in April 2007 from the China State Food and Drug Administration (SFDA) to commence Phase Ib and II trials of its pandemic influenza (H5N1) whole viron inactivated vaccine and Phase I and II trials of its pandemic influenza (H5N1) split vaccine.

In the pandemic influenza whole viron vaccine Phase II trial, a total of 402 enrolled volunteers from 18 to 60 years old were vaccinated with doses of 5ug, 10ug or 15ug. In accordance with the Phase II trial protocol, all of the volunteers were vaccinated with two doses and followed for an observation period. There were no serious adverse events.

In the Phase I and Phase II trials for the split pandemic influenza vaccine, 160 volunteers from 3 to 70 years old, sorted into four different age groups, were enrolled. The volunteers received doses of 5ug, 10ug, 15ug or 30ug and were followed for an observation period. There were no serious adverse events.

Separately, Sinovac’s external auditors are currently reviewing the Company’s third quarter financial results, which the Company plans to disclose thereafter. Pertaining to the Annual General Meeting of Shareholders originally scheduled for August 2007, the Company did not receive at that time sufficient shareholder votes, given the geographical nature of its shareholders, to achieve a quorum, as per its corporate by-laws. Sinovac is diligently working to reschedule its Annual General Meeting.

About Sinovac

Sinovac Biotech Ltd. is a China-based biopharmaceutical company that focuses on the research, development, manufacture and commercialization of vaccines that protect against human infectious diseases. Sinovac’s vaccines include Healive(TM) (hepatitis A), Bilive(TM) (combined hepatitis A and B) and Anflu(TM) (influenza). Sinovac is currently developing human vaccines against the H5N1 strain of pandemic influenza, and Japanese encephalitis.

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