1. Vaccine Manufacturing Capacity – 120 million doses required for UK alone

 

Current global capacity is to manufacture around 300 million doses of standard human influenza vaccine per year. But, recent data from the US National Institutes for Health and Sanofi Pasteur, suggested that Sanofi’s H5 vaccine (which has applications for avian flu) requires two doses of 90 micro grams of HA (180 micrograms per person). This means that there is only sufficient global manufacturing capacity for 75 million people  ... thus drastically short for even the UK requirement. If it were possible to make a pandemic vaccine with only 15 micrograms of H5 HA per dose but then given as two doses (prime and boost) ... that would mean a capacity of 450 million doses. PowderMed’s DNA vaccines requires only 2 micrograms per dose, thus 240 grams for 120 million doses - enough to vaccinate the whole of the UK (prime and boost).

 

Answer: Investment is required NOW in manufacturing capacity so that this can be brought on-line in the event of a pandemic. It will take 18 months to 2 years to commission and fully validate new manufacturing capacity, irrespective of the vaccine technology chosen.

2. Speed to Respond  - current technology too old and too narrow and far too slow
 

Current vaccine manufacturing is dependent upon an egg-based process. In the face of a pandemic this process would take at the absolute minimum six months before the first vaccine is produced. Many experts believe that this could be as much as 12 to 18 months. In the past pandemics have killed most of their victims in the first 3 to 6 months. Thus an egg-based vaccine will have virtually no impact upon the spread and devastation of a pandemic. Additionally, the egg-based process is dependent upon live fertilised chicken eggs; an avian flu epidemic may totally devastate the egg-laying hen population, resulting in no eggs and no vaccines at all. In addition, current vaccines require a “cold chain” of distribution and trained medical personnel to administer the injection.

 

Answer: Governments need to invest in new technologies that can be scaled up within the critical first three months. Whilst there is some investment going into flu vaccines produced in mammalian cell lines, which will avoid some of the issues of egg-based vaccines it will have virtually no impact upon the time to manufacture vaccines. Only DNA-based vaccines offer the potential to be produced within three months of a new flu virus being confirmed, taken together with a simple needle free delivery system without the need for cold storage and no need for administration by medical personnel vaccine distribution could be extremely rapid using supermarket distribution networks.

 

Expert Commentary Available - PowderMed

 

Dr. Clive Dix, Ph.D., CEO and co-founder of PowderMed Ltd. (www.powdermed.com), an Oxford UK based developer and manufacturer of DNA-based vaccines for viral diseases and cancer. PowderMed has produced an H5N1 Avian Influenza vaccine that is delivered by a fully developed and patented system, called Particle Mediated Epidermal Delivery (PMED™), whereby gold particles coated in the vaccine DNA are propelled into the immunologically active antigen presenting cells (APCs) of the epidermis (skin) using high-pressure helium. The new DNA-based avian flu vaccine in development would offer a rapid response (six weeks) to the potential global health emergency during the first six months of a pandemic, when the majority of mortalities would occur. It requires no cold storage and, being needle-free, is simple to administer. PowderMeds H5N1 vaccine is now being manufactured ready to enter the clinic in 2006. By 2007 it is expected that this, and PowderMeds “annual flu” vaccine will have completed phase II clinical Trials. 

 

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