Aug 7 2007
The Department of Health and Human Services in the United States has ordered more doses of the avian flu vaccine from the international pharmaceutical giant GlaxoSmithKline (GSK).
The Department of Health and Human Services has placed another order for more doses of GSK's vaccine against the H5N1 strain of the bird flu virus.
The order for 22.5 million doses of the bird flu vaccine is in addition to the 5 million doses the government has already ordered as part of it's huge stockpile of the vaccine to be used in the event of bird flu pandemic.
The vaccine will be manufactured by Glaxo in Canada and the company has now begun Phase I/II of the first North American clinical trials for their pre-pandemic vaccine.
Experts say inoculating people against a specific strain of the H5N1 virus could take up to six months, and the pre-pandemic vaccine being tested by GSK would keep people healthy as they wait for the strain-specific vaccine.
The trials will test the vaccine alone, and with one of Glaxo's adjuvant agents, which can boost its strength; results are expected by early 2008.
The first two phases of the trial are taking place in seven U.S. states and two provinces in Canada, involving 675 participants.
They will be examined 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.
Reports in 2006 that companies producing and testing H5N1 vaccines were not obtaining the desired quantities of an important ingredient which would result in too few people being vaccinated in the first year of a pandemic, prompted the World Health Organization (WHO) to request 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.