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Swine Flu Scare – Where’s Vical?

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In the chicken, egg and pig story what is the delay in the Navy’s support for Vical’s (VICL) DNA based H1N1 swine flu vaccine?

Bloomberg’s “Swine Flu Vaccine Delays Won’t Slow October Timetable” and “First Trials of Swine Flu Vaccine Begin in Australia” report that the US has contracted with five pharmaceutical companies to stockpile swine flu (H1N1) vaccines: Novartis (NVS) 45%, Sanofi Aventis (SNY) 26%, CSL (CSL:AU) 19%, and AstraZeneca (AZN) and GlaxoSmithKline (GSK) the remainder. Of these suppliers, only Australian based CSL is ready to start clinical trials. The others are incurring delays caused by production inefficiencies.

All these companies say they will be ready to start shipping in October, but that conflicts with regular network news reports showing the virus stubbornly replicating too slowly on conveyor belts of chicken eggs. Maybe a real swine flu pandemic will force the government to finally break their addiction to traditional vaccine development and crack the egg for good.

The Wall Street Journal’s “Swine Flu Prevention Takes on New Urgency” reports that Sanofi, Novartis, Glaxo and CSL are only yielding 30% of the active ingredient typically produced with seasonal flu.

Vical’s DNA-based vaccine produced 100% protection in preclinical trials with 2 doses and 75% protection with 1 dose. Vical developed its vaccine within weeks of receiving samples and the genetic coding from the government under a Cooperative Research and Development Agreement (CRADA) with the U.S. Naval Medical Research Center (NMRC). Vical is now waiting for funding from the Navy to begin clinical trials.

The key Vical difference is its vaccine is a DNA plasmid rather than a killed or weakened virus. Production cycles are measured in weeks rather than months, and Vical already has large scale cGMP manufacturing capability.

The Vical advantage seems to have been lost in the big money politics of vaccine stockpiling. But I believe that Vical could emerge a winner if a real swine flu pandemic emerges. No other company could develop inventory as quickly.

I also believe that Navy funding will be forthcoming. Just imagine a swine flu outbreak on an aircraft carrier. In Vical’s favor is that the NIH is already funding development of their RapidResponse(tm) DNA vaccine manufacturing platform.

Disclosure: Author is long VICL.

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