The tests involved 240 healthy volunteers, separated into two groups numbering 120 men and women each. All of them received insurance policies and benefits in line with international standards.
Mikrogen general director Dr. Anton Katlinsky said the tests had produced encouraging results. "We used the World Health Organization's recommendations in our work, as well as our own unique methods and patented technologies," Professor Katlinsky said.
Dr. Vitaly Zverev, director of the Mechnikov Vaccine and Serum Research Institute, said a study of post-vaccination side effects showed the preparation was well tolerated, safe, and did not produce any serious negative effects.
Vaccine developers now have to conduct augmented tests and to officially register the new medication.
Several hundred million rubles have already been spent on this high-priority medical project. This is seen as the only course of action since a possible bird flu pandemic is likely to kill an estimated one-third of the world's population.
Due to efforts by the WHO and numerous national medical and sanitary services, including Russian agencies, no new bird flu outbreaks have been registered to date. But this does not mean that the disease has been eradicated.
Russian authorities have not yet registered any bird flu cases, but this ominous virus killed six people in Baku, the capital of Azerbaijan, this April.
Wavering global interest in bird flu is directly linked with the manifestations of this disease. A series of bird flu outbreaks, which began in 1997 and lasted until 2006, convinced everyone that the virus was a threat to humans and could cause serious complications and even death.
A major outbreak terrified mankind in December 2003 and fanned rumors of a possible epidemic and even a global pandemic. Many countries, including Russia, rushed to develop prototype bird flu preparations capable of dealing with this new menace.
Of the 15 known bird flu virus strains, H5N1 is the most active and dangerous one. The World Health Organization is worried that there may not be sufficient quantities of the vaccine for everyone if a pandemic breaks out.
At present 360 million flu vaccines are produced annually. What makes the situation grave is that the whole of mankind, or over six billion people, would have to be vaccinated under the worst scenario.
Marie-Paule Kieny, director of the WHO Initiative for Vaccine Research, told journalists she was satisfied with the completion of initial clinical vaccine tests in Russia, a well-known and generally recognized producer of such preparations. She stressed the latest Russian achievements were encouraging, and the WHO will look forward to augmented clinical tests and final results.
Many scientists believe that the H5N1 virus cannot cause a major epidemic in the near future. "I see no reason to agree with assertions that bird flu will wipe out mankind," said Vladimir Ivanitsky, PhD, a lecturer at Moscow State University. He said the bird flu virus had been known for a long time, birds had always contracted this disease, which sometimes affected humans. "Nothing has changed in the nature of the virus and birds," he said.
Globalization and enhanced medical control make it possible to more effectively diagnose and treat various diseases than before. Mankind is now better prepared to deal with a possible bird flu epidemic.
Vitaly Zverev said migrating birds would once again spread the active H5N1 virus all over the world the following spring.
Scientists believe the extremely mutagenous bird flu virus is bound to change within the next few years, and new viruses are a major threat.
The new Mikrogen vaccine is vital because its initial strain can be modified and used against a new strain, say, of the H7N2 virus.
Experts said it would take Russia seven to eight weeks to obtain the first several million vaccines after singling out the initial strain. In short, this country will receive enough anti-flu vaccines in 45 to 60 days.