COLUMBUS, Ohio (CN) – The CEO of PhageVax complains that the U.S. Department of Health and Human Services has refused to test his production method for an H1N1 flu vaccine, using E. coli, which he claims is much faster than the standard vaccine production method, using eggs.
In his federal complaint, Clark Tibbs claims that his method to produce a single-dose swine flu vaccination using E. coli bacteria is superior to the 50-year old “egg-based technology” still being used, and that his vaccine can be produced in one quarter of the time.
Tibbs, whose company is based in Newark, Ohio, says that in June this year the World Health Organization declared a pandemic outbreak of swine flu, which Tibbs predicts will mutate and spread quickly, possibly mixing with the deadly avian flu virus.
Tibbs says the new flu strains are resistant to current vaccines and that it takes up to 6 months to create new vaccines, by which time the viruses will have mutated again.
Tibbs, who incorporated his company in November 2005, claims that from “30 to 50 percent of the U.S. population may be infected this winter season” and about “90,000 U.S. citizens may die from novel H1N1 infections.”
Tibbs estimates that only 22.5 million U.S. citizens will receive the vaccine, which typically requires two doses, and that HHS will be forced to use additives to extend the supply due to shortages.
Tibbs also claims the United States faces a shortage of mechanical ventilators, which will be needed to treat hospitalized swine flu patients, who would risk death without one.
Tibbs claims there is about “one mechanical ventilator for every 1,000 people in the United States.” He claims that HHS unlawfully intends to keep the actual number of mechanical ventilators confidential.
Tibbs says that while the old egg-based technology takes up to 6 months to develop a vaccine once a strand of the virus is identified, the PhageVax method could “produce 1 million doses in each of its 300 manufacturing facilities … resulting in 300 million doses in approximately four weeks,” at a fraction of the usual cost.
Tibbs says the PhageVax method “can be used for a wide spectrum of infectious diseases, such as malaria.” The method uses virus-eating bacteria and E. coli, which “allows for rapid generation of easily scalable vaccines,” according to the complaint.
Tibbs claims that the Department of Health and Human Services, the Centers for Disease Control and Prevention, the National Institute of Allergy and Infectious Disease and the National Institutes of Health ignored or denied his inquiries about government testing for the PhageVax method.
He claims the government agencies are endangering citizens’ lives by refusing to test his method. He wants the court to order HHS to test the PhageVax vaccine method, and to complete a survey of the United States’ mechanical ventilator supply.
Tibbs and PhageVax are represented by Neil Conley of Chandlersville.