TORONTO, Feb. 8 /CNW/ - Microbix Biosystems Inc. (TSX: MBX), a biotechnology company commercializing novel biological technologies for human healthcare, which has the financing and senior management in place to build and operate the largest vaccine production facility in China and the third largest in the world, responded today to a media report that has fueled unfounded speculation that a universal influenza vaccine is a near-term possibility. Microbix CEO, William J. Gastle, made the following statements:
Commenting on the universal vaccine:
“According to the CDC, FDA and NIH experts who spoke on this subject at the World Vaccine Congress Meeting which we attended in November 2010 in Washington D.C., any universal vaccine, however effective, will likely require annual boosts with seasonal products. The idea is that the universal vaccine is to provide a base-line protection, but the strength of that protection will vary with each new strain that emerges. According to these experts there will always be a demand for egg-based seasonal vaccine. We have seen the data. There is a lot of variation between target populations which may likely mean the development of a universal flu vaccine will, in the end, be an academic exercise.Lead time for these sorts of products has historically been significant. For example, despite the fact that recombinant flu vaccines have been available for clinical testing since 1985, not a single one has yet been approved.
Such approvals are dependent on a myriad of questions that need to be clearly answered before such products would even be considered for further clinical trials or potential approval. For example, even if it is possible for a “universal” vaccine to elicit a protective immune response — what percentage of vaccinated people will be protected (current flu vaccine have a better than 80% protection rate), will children less than 3 years of age respond the same way as adults over 60? Will the immune response decrease the efficacy of necessary pandemic or seasonal shots?
Equally at issue, is at what cost these new vaccines come to market. To be commercially viable, the cost for these vaccines must also be in line with what the market has seen over the past 10 years, i.e. from $5 to $8 per dose. Recombinant vaccines always carry a much higher price tag. For example, recombinant hepatitis B vaccine is over $100 per dose and recombinant flu vaccines have yet to receive regulatory approval in the US despite clinical testing since 1989.”
Commenting on the Hunan/Microbix Influenza Vaccine Facility:
“The strong foundation for the Hunan/Microbix facility rests on the backing that a facility of this type has among senior health officials in China and the demand of its population. For instance, the central government of China has mandated that vaccine supply be increased from the current 30 million doses (covering 2% of the population) to approximately 300 million doses within five years. When measured against the World Health Organization’s criteria, the total need for flu vaccine supply in China becomes nearly 600 million doses. Making good medical and business sense, our plans in China are based on known and proven technology that will enjoy 20 plus years in the market place.”
About Microbix Biosystems
Microbix Biosystems Inc. specializes in the development of the most advanced vaccine production technology and markets virology and biological products worldwide. Microbix, in partnership with the Hunan government in China, is building Asia’s largest and most advanced vaccine facility. In addition, the Company has intellectual property in a large market biotherapeutic drug, a vaccine technology and an animal reproduction technology. Microbix supplies customers in the U.S., Europe, and Asia. Established in 1988, Microbix is headquartered in Toronto.
