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Stephen M. Apatow
Director of Research and Development 
Humanitarian Resource Institute Biodefense Reference Library
Foreign Animal and Zoonotic Disease Center
Eastern USA: (203) 668-0282   Western USA: (775) 884-4680
Internet: http://www.humanitarian.net/biodefense/fazdc/
Email: s.m.apatow@humanitarian.net

PANDEMIC INFLUENZA AND VACCINE PRODUCTION

The discussion topic of pandemic influenza, opened on 27 November 2003, focused on a challenge presented by Robert G. Webster, Ph.D., a member of the Infectious Diseases department and holder of the Rose Marie Thomas Chair at St. Jude Children's Research Hospital (Nation unprepared for flu pandemic):

"If an influenza pandemic started tomorrow, we would not be able to head it off with vaccines because the production facilities available to produce them are grossly inadequate." 

The immediate response to this communication initiative, that outlined the need for input regarding the potential utilization of resources available to the veterinary biologics industry, including vaccine production technology, came within hours.

Dr. David Halvorson, Professor, Avian Health at the College of Veterinary Medicine, University of Minnesota, President of the American Association of Avian Pathologists, 1993–94 (PubMED: Peer Reviewed Papers), presented the following points [Edited]:

• It may escape the notice of emergency preparedness types that there is a vast source of incubated eggs available at a moments notice, in case it becomes necessary to prepare hundreds of millions of doses of influenza vaccine quickly.
• The broiler industry hatches over 8 billion chicks annually. That's about 160 million hatched weekly.  That's 160 million embryos available weekly.  (There are no special requirements for vaccine eggs for human use when the antigen is inactivated, in contrast to the requirements for avian vaccines.)
• What could be done?  Either by contract or eminent domain, whole hatcheries and their embryos could be diverted from broiler production to vaccine production.  There are hundreds if not thousands of technicians in the USA and other countries who could be enlisted to train additional egg inoculators, again on short notice.  Then the whole hatchery could be converted to a vaccine antigen production facility.
• All that would be needed is seed stock produced by CDC or WHO, designation of a "vaccine production specialist" at each hatchery, funding, etc.
• The production of huge quantities of influenza vaccine is technically possible in an emergency situation.

Please note: All discussion regarding vaccine development is in accordance with the WHO Vaccine Safety and Quality Standard, characterization of starting materials by supplier audits, cell banking, seed lot systems, compliance with the principles of good manufacturing practices, independent release of vaccines on a lot-by-lot basis by national regulatory authorities, enhanced pre and post-marketing surveillance for possible adverse events following immunization.

The veterinary profession and agricultural industry must be fully engaged in collaborative research, strategic planning and development of initiatives associated with emerging infectious diseases and the threat of bioterrorism (Veterinary Medicine: Bioterrorism and Emerging Infectious Diseases).  The importance of agricultural security and emergency preparedness to public health, cannot be overstated.

Influenza Virus Vaccine Formulation for 2003-2004

Discussion Topics

• Safety and immunogenicity of a mammalian cell culture derived vaccine: Potential contamination of A-Fujian-H3N2 strain grown successfully in Madin Darby Canine Kidney (MDCK) cells following unsuccessful attempts to harvest virus through inoculation of chorionallantoic tissue, has prompted discussion regarding the safety and immunogenicity of  mammalian cell culture derived vaccine. 

• Food and Drug Administration, Center for Biologics Evaluation and Research, Vaccines and Related Biological Products Advisory Committee, 94th Meeting:  Thursday, February 20, 2003. Word.
• Food and Drug Administration, Center for Biologics Evaluation and Research, Vaccines and Related Biological Products Advisory Committee, Meeting on Influenza Virus Vaccine Formulation for 2003-2004: Tuesday, March 18, 2003. Word.