An Asian problem
Bird Flu (avian influenza) is an infectious disease caused by type A strains of the influenza virus. Avian influenza does not normally infect species other than birds and pigs; however in 1997 18 human cases of bird flu were reported in Hong Kong. The outbreak resulted in six deaths and heightened public awareness of the disease and the need to develop an effective vaccine. Genetic analysis revealed the troubling fact that the virus had jumped directly from birds to humans. Worldwide pressure forced Hong Kong to destroy its entire poultry population of over 1.5 million birds in three days in the hope of preventing a pandemic. Scientists have identified at least 15 avian influenza virus subtypes and it is H5N1 that causes the greatest concern. This was the strain that caused the six deaths in Hong Kong and since then an additional 60 deaths in Vietnam, Indonesia, Thailand and Cambodia.
Arrival in Europe
This month, the inevitable happen – bird flu made its way across international borders and arrived in Europe. The H5N1 strain was identified in Turkey and Romania forcing both countries to cull thousands of birds in an effort to prevent the spread of the disease. Several days later Greek officials made the announcement that that a turkey from the eastern Aegean island of Chios, near the Turkish coast, had tested positive for the illness. No human cases of the virus have yet been reported but many believe that it is only a matter of time. Across Europe, the public became jittery with fears that a bird flu pandemic was inevitable and perhaps even imminent.
European Union foreign ministers called an emergency meeting to discuss the potential threat and to ally fears of a human pandemic. European Health Commissioner Markos Kyprianou said that the presence of bird flu in southeastern Europe does not increase the risk of a human influenza pandemic. However, ministers did declared the spread of bird flu from Asia into Europe a "global threat" requiring broad international co-operation. The European Union also announced plans to intensify biosecurity measures and to install early detection systems along the migratory paths of birds to prevent contamination of domestic flocks.
Keep out of the United States
In the United States, bird flu was also making the headlines. Secretary for Health and Human Services Mike Leavitt recently made a tour of several countries affected by avian influenza including Thailand, Cambodia, Laos, Vietnam and Indonesia. These regions are considered as the most likely epicenter of any potential human epidemic. He commented that the disease has the potential to affect the world economically, socially, and politically and warned that the “world is a biologically dangerous place right now”. In an effort to prevent the spread of the H5N1 virus, the United States government committed $25 million to the Asian region. The money is earmarked towards creating an early warning system for surveillance and diagnosis, containing outbreaks, training rapid response teams, and financing public information campaigns.
A shot in the arm for vaccine manufacturers
What’s bad news for some provides opportunities for others. The risk of a pandemic has provided a financial boost to several vaccine manufacturers and researchers. At the end of September, MedImmune Inc., the maker of the nasal flu vaccine FluMist, announced a collaboration with the National Institutes of Health (NIH) to develop a library of vaccines for more than a dozen strains of avian flu. MedImmune and the NIH will make the new vaccines using reverse genetics. Researchers will take samples from 16 viral strains and then reproduce the key protein that attaches to nasal passages, causing infections. The engineered protein is essentially then attached to the FluMist vaccine, like changing wheels on a car.
Akzo Nobel’s Nobilon International business, has also announced that it is developing a human vaccine against the H5N1 strain of the avian flu virus. Development of the vaccine, which is still in its early stages, is taking place at Nobilon in conjunction with Akzo Nobel’s human healthcare business, Organon. The company’s animal health business, Intervet, already supplies an avian flu vaccine which is used to inoculate birds.
In Australia, vaccine manufacturer CSL has just received approval to start a clinical trial of a prototype avian influenza vaccine. The company has begun incubating hundreds of eggs with the H5N1 strain of bird flu under tight security at its facility in Melbourne in preparation for the clinical trial. The trial volunteers are all healthy adults and will receive two doses of the vaccine several weeks apart. They will then be tested to see whether their immune systems have recognized the presence of the viral fragments and responded by making antibodies.
Just take the flu shot
Although no vaccine is currently available to immunize people against avian influenza, some health authorities have recommended people get regular flu shots in the hope that this might help prevent bird flu from combining with the easily spread human flu. Key international research groups have also demonstrated, in animal models that the existing flu shot Tamiflu (oseltamivir) is effective against the avian H5N1 strain. This has thrown Roche, the company who makes Tamiflu into the center of the avian influenza debate and placed enormous pressure to increase production. The company has just received Food and Drug Administration (FDA) approval for an additional capsule manufacturing site in the United States for supply of the drug, expanding its already significantly increased worldwide production capacity. Until recently, in most markets, sales of Tamiflu, were well below the company's expectations. But that changed last year, when WHO recommended governments stockpile antiviral drugs, such as Tamiflu. Since then, sales of Tamiflu from January to June 30, 2005, were nearly double the number in 2004. Experts expect revenue from the drug to reach at least $620 million this year.
Roche's monopoly over production and marketing of Tamiflu, and the lack of production capacity amid mounting, urgent demand, has drawn comparisons with the row over the availability of anti-AIDS drugs in Third World countries. That controversy led to new rules in the World Trade Organisation that allow governments to cope with a public health emergency by waiving the patent rights of a private company and allowing generic copies of a drug to be made. While not wanting to give up patent rights, Roche has indicated that it is willing to discuss all available options, including granting sub-licenses, with any government or private company to manufacture Tamiflu.
Although the use of Tamiflu may help assist in preventing the spread of avian influenza, it can not be relied on as the only solution. Already at least one case of bird flu has shown resistance to the drug highlighting the need to have more than one drug on the market to treat any future pandemic.
A European race
In Europe, several companies including Sanofi-Aventis, GlaxoSmithKline and Chiron are racing to develop a bird flu vaccine, but they cannot complete the work until the final humanized strain of the virus emerges. In a bid to speed up the process, the European Agency for the Evaluation of Medicinal Products (EMEA) has drawn up rules allowing firms to submit "core dossiers" before they formulate vaccines with the precise strain circulating.
In France, the government has ordered 2.5 million doses of an experimental vaccine from Sanofi-Aventis to ensure the French pharmaceutical company can mass produce the proposed medication at home. "We will probably never need to use them," said Didier Houssin, coordinator of a government bird-flu task force. "It's a way to support Sanofi's research on the vaccine."
The United States government is also helping in the push for the development of an avian influenza vaccine in Europe. President George W. Bush met recently with executives from several pharmaceutical companies including Richard Clark, president and CEO of Merck & Co. Inc.; Robert Essner, chairman, president and CEO of Wyeth; Jean-Pierre Garnier, CEO of GlaxoSmithKline; David Mott, president and CEO of MedImmune; Howard Pien, chairman, president and CEO of Chiron Corp.; and David Williams, CEO of Sanofi Pasteur, the vaccine unit of Sanofi-Aventis. Bush urged them to increase their companies manufacturing capacity and develop an effective bird flu vaccine.
Europe's largest drugmaker, GlaxoSmithKline Plc., has announced that it will start producing their antiviral flu medicine Relenza in Australia complementing existing production in France. Research has shown the drug to be useful in treating bird flu.
Chiron is also working to develop a vaccine against bird flu, but the earliest that vaccine could be on the market would be mid-2007. The company is manufacturing the vaccine in England and thousands of doses are expected to be shipped to the US in the next few weeks when scientists will begin testing it on humans.
Immunity from vaccine economics
It’s ironic and unfortunate for pharmaceutical companies that the more successful an anti-viral medication is, the less profitable it will be. The development of vaccines is also an extremely risky business and doesn’t come with the high potential for profit that other areas of drug development have. Lobbyists from pharmaceutical companies are therefore calling for immunity from lawsuits if a vaccination results in harm. Without effective legal safeguards, some pharmaceutical companies are unlikely to research or produce vaccines stressing that the business offers little reward but a lot of risk. This economic dilemma necessitates the need for Governments worldwide to enter into partnerships with industry to ensure that an appropriate level of anti-viral research and production is achieved with the interests of society and not just profit in mind.