New international guidelines for clearing flu virus for development by drugmakers might speed pandemic vaccine supplies by two weeks, officials said today.
The World Health Organization determined that a step in testing genetically engineered viruses used to make vaccines can be skipped during a pandemic, the health agency said today. The faster procedure will only be used if the risk of a pandemic is high, the group said. Pandemic vaccines stockpiled by countries increase people's immune defenses against the H5N1 bird flu spreading in Asia.
When a pandemic occurs, large supplies of vaccines targeted precisely against the version of the virus spreading in humans would be needed quickly, flu experts have said. „This makes perfectly good sense,” said David Fedson, a former vaccine developer for Aventis Pasteur, part of Sanofi-Aventis SA. „This gives vaccine makers more time to determine the optimal conditions for production, and that's important.”
WHO, part of the United Nations, annually distributes virus strains to drugmakers, including Sanofi, GlaxoSmithKline Plc, Novartis AG, and MedImmune Inc., which grow the viruses in eggs to make vaccines targeted against seasonal strains of flu. The process, which must be repeated annually for that year's new flu strains, usually takes about four to six months.
Quick response to an international outbreak of lethal flu might save millions of lives, health officials have said. A pandemic flu that spread around the world in 1918 killed an estimated 50 million people. International health officials have questioned the safety of new techniques that use genetic engineering to make viruses that contain protective proteins for vaccines, and can be grown in eggs, Fedson said.
Before the revision, WHO had required the engineered strains to be tested in chickens and ferrets. WHO's announcement today is a signal that health officials are now confident that those techniques are dependable, Fedson said. „Experience has indicated that early screening tests in eggs are a reliable indicator of the safety of using these engineered viruses,” he said today at a conference on seasonal and pandemic influenza in Washington. „Releasing these strains earlier will simplify the process of getting these viruses from the laboratory into the hands of companies.” (Bloomberg)