GlaxoSmithKline [NYSE: GSK], the international pharmaceutical giant, has said that the HHS [the department of Health and Human Services] had placed another bulk order for the H5N1 antigen to add to the nation's stockpile of vaccines in preparation for any pandemic.
It also announced that it has already started the first North American pre-pandemic vaccine trials in its global pre-pandemic influenza program. This vaccine is used for the prevention of the H5N1 flu strain, also referred to as 'avian flu' or 'bird flu'.
The British drug maker GlaxoSmithKline [NYSE: GSK] had initially been awarded a contract for 15 mcg H5N1 bulk vaccine. This, the second order, was for $22.5 million I doses of the antigen used to help combat the deadly flu or any other strain of the virus thus preventing a global flu pandemic, and follows the 5 million doses of the vaccine ordered in November 2006.
According to the contract, GlaxoSmithKline is to manufacture the vaccine to be used in the trials at its manufacturing site in Ste. Foy, Quebec, Canada and to store the bulk vaccine product at the GSK site in Marietta, PA.
The British drug maker claims to have already begun its Phase I/II clinical trials for its pre-pandemic vaccine. The vaccine will be tested both, alone, and along with one of Glaxo's adjuvant agents, which can boost the vaccine's strength and would consequently work out to less antigen per dose while still providing immunity. Results of the test are expected early 2008.
In the first two phases of the trial taking place in seven U.S. states and two provinces in Canada, 675 participants will be studied to test the safety and immunogenic validity of two consecutive doses of the H5N1 pre-pandemic vaccine.
The third phase of the trial, which is planned for later this year, is expected to be on a much larger scale, in various centers and will involve 4,400 participants.
To inoculate people against a specific strain of the H5N1 virus in the eventuality of a pandemic take up to six months. It is hoped that this pre-pandemic vaccine being tested by GSK would keep people healthy as they wait for the strain-specific vaccine.
In 2006 it had been widely reported that companies producing and testing H5N1 vaccines were not obtaining the desired quantities of an important ingredient. The World Health Organization (WHO) felt that this would result in the desired results not being realized resulting in the number of people being vaccinated in the first year of a pandemic very low. It therefore requested increased research to resolve the problem. GSK who had already acquired Canadian flu vaccine developer ID BioMedical in 2005, believe that they have done this.
GSK vice-president of clinical development for flu, Ripley Ballou, said, "The goal of our North American clinical development program is to establish GSK's second manufacturing facility (Quebec) as a source for H5N1 vaccine, further strengthening our efforts to support governments' pandemic preparedness strategies.”
The Office of Biomedical Advanced Research and Development Authority (BARDA) in the Assistant Secretary for Preparedness and Response (ASPR) is sponsoring the deal.
![GlaxoSmithKline [NYSE: GSK], the international pharmaceutical giant, has said that the HHS [the department of Health and Human Services] had placed another bulk order for the H5N1 antigen to add to the nation's stockpile of vaccines in preparation for any pandemic.](http://www.earthtimes.org/newsimage/vaccine_order_4087.jpg)
