Fear of Global Flu Pandemic Spurs Expansion of Vaccine Development and Production

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Researched by Industrialinfo.com (Industrial Information Resources, Incorporated; Houston, Texas). It has been a rough year for planet earth. Mother Nature has unleashed an unrelenting barrage of calamities across the world in the form of devastating earthquakes and lethal hurricanes. Now, having evolved from discussions in the lab among scientists and academics, the fear of a possible global avian flu pandemic is suddenly on everyone’s minds.

The danger lies in the possibility of the current bird flu in Asia mutating into a potent human-to-human influenza strain. It would be one that the population has never before been exposed to, making it all the more dangerous for the lack of natural immunities. The flu has spread to birds in sixteen countries, infected 121 people and killed 62, according to the World Health Organization (WHO). While it is currently almost impossible to determine if, when or how the avian virus, known as H5N1, will transform into a deadly human strain, government officials across the world are taking action.

Discussions with the drug companies are going beyond trying to secure adequate supplies of flu vaccines for the estimated 25% of the population that could be at risk of contracting the virus. Estimates for the possible number of U.S. casualties of an avian flu outbreak vary wildly, with some groups placing it at 500,000 lives lost to another claiming nearly two million. It is impossible to calculate with any kind of certainty, as there is truly no standard measurement to determine something that may or may not happen and what effect an unknown virus will have on the population. Officials are basing most projections on a "worst case scenario."

The last catastrophic influenza outbreak was in late 1918, the final year of World War I. The flu virus swept across the world and killed an estimated 50 million to 100 million people, a toll higher than the black plague of the Middle Ages. Many of those killed were young, healthy individuals between 20 and 40 years old, felled by a virus that was 25 times stronger than the "typical" flu.

But the fact is that nearly 40,000 people in the U.S. die every year from "typical" influenza. Annual vaccines are traditionally encouraged for people most typically at risk, those with weakened or immature immune systems, which includes infants, the elderly and people with AIDS. This year, in addition to the traditional high-risk group, health officials are now beginning to recommend that school-age children also receive a flu vaccine. And of course, anyone of any age is free to seek a dose from their physician or at one of the "flu vaccine clinics" that pop up every year at drugstores and pharmacies.

Roche (Basel, Switzerland), owner of Tamiflu, the most promising flu vaccine (against the possible avian strain) currently on the market, has been asked by world leaders to release its patent-protected drug to be manufactured generically by others years before this would traditionally be allowed. While working on these arrangements, Roche has indicated that in addition to ramping up production to full capacity at existing plants, they will construct a completely new vaccine production unit in the U.S., although the site has not yet been determined. Roche has donated three million packs of Tamiflu to the WHO for use as a rapid response stockpile in the event of an outbreak of a pandemic strain. The company currently produces Tamiflu in several locations, including its Roche Carolina operation in Florence, South Carolina and Roche Colorado in Boulder.

Swiss drugmaker Novartis has agreed to purchase vaccine manufacturer Chiron (NASDAQ:CHIR) (Emeryville, California) for over $5 billion. Chiron’s global vaccines business is the fifth largest in the world and one of the largest suppliers of influenza vaccines. The company was recently given the "all clear" from the FDA after making the news last year when it ran into production problems with its flu vaccine. With the Chiron purchase, Novartis will create a fourth business unit comprised of vaccines and diagnostics, joining their other three life science divisions: pharmaceuticals, consumer health and its generics business Sandoz.

GlaxoSmithKline (GSK) (NYSE:GSK ) (Middlesex, England) has been busy ramping up its vaccine sector. The company recently purchased the former Wyeth (NYSE:WYE ) (Madison, New Jersey) vaccine manufacturing plant in Marietta, Pennsylvania (See GlaxoSmithKline Continues Power Play in Hot Global Vaccine Market with $1.4 Billion Buyout Offer for Canada’s ID Biomedical). GSK will invest over $100 million in upgrading and expanding the plant, where it will develop and research vaccines.

Sanofi-Pasteur, the vaccine division of the Sanofi Aventis Group (NYSE:SAN ) (Paris, France), has recently begun construction of yet another vaccine production unit to expand their site in Swiftwater, Pennsylvania (See Sanofi Pasteur Gives E&C Firm Greenlight for Construction of $150 Million Vaccine Plant in Pennsylvania). The $150 million project follows a series of expansions at the site over the past few years.

Earlier this week, President Bush revealed the administration’s pandemic flu plan, which includes a $7.1 billion emergency appropriation. From that amount, $100 million would be given to state and local health departments to help them complete their own flu plans.

The administration's plan provides funding for early detection, containment and treatment of an outbreak. It also seeks $2.8 billion from Congress to fund a "crash program" to accelerate the development of new vaccine production technology, moving beyond the current method that uses chicken eggs to produce the antibodies. While no current drug would be the perfect solution for H5N1, as it is necessary for the virus to emerge prior to developing the proper vaccine, it is believed that the available vaccines would afford some protection.

It is important to remember in 1918 the world was a very different place from the world today with its medical wonders. There was no penicillin, no antiviral drugs, no antibiotics to treat secondary infections and no respirators to keep patients with pulmonary diseases alive. The medical profession didn’t even know exactly what a virus was.

Today, literally billions of dollars, both private and public, have been spent and will continue to be invested to thwarting this latest threat and others that pose medical dangers. As reported in the Pharmaceutical Tracker - Online Database, laboratories that can cost up to $1,000 per square foot are filled with scientists and the latest equipment developing new drugs and pharmaceutical- biotech engineers are constantly seeking swifter production processes to get these new drugs to market as quickly as possible. This is a global effort bringing together some of the greatest scientific minds of our time with supreme technology, all which would have seemed like so-much science fiction back in 1918.

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