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A/H1N1 virus vaccine in an experimental phase
The vaccine is applied in 3 thousand volunteers give healthy results of their safety and efficacy in early November. The cost will be $ 8 per dose.
Sun, 23/08/2009 - 16:06
Mexico City .- The A/H1N1 virus vaccine from Sanofi-Aventis to acquire the government of Mexico about $ 8 each, and applied experimentally in 3 thousand volunteers give healthy results of their safety and efficacy in early November.
In parallel, the governments of Mexico and the United States requested the Sanofi-Aventis part of the clinical lot of vaccine to conduct their own research on safety and efficacy based on the peculiar characteristics of its own population.
"You asked for clinical doses of vaccine to conduct their own research protocols on the performance of the antigen in its people," said Cesar Mascarenas, public health director for Latin America at Sanofi Pasteur, after ensuring that the vaccine will be ready in December.
In an interview, explained that the laboratory Mascarene-global investing 370 million euros annually in research and developed the vaccine in terms of clinical batches and currently makes his human trials will thus determine the exact amount of antigen required each dose and adjuvant to enhance immune response.
"Clinical studies of phase three began on 6 August in the U.S. producing plants and France, with people of different ages, babies from six months to five years, infants aged 5 to 17 years, adults 18 to 59 years , aged over 60 years, "said Mascarenas to Milenio Diario.
For the manager of the leading manufacturer of vaccines in the world, the process of research and manufacturing of the vaccine at all were altered just before the discovery of 60 thousand turkeys infected with influenza virus in Chile.
"At the moment did not alter the composition of the vaccine," which has a seed virus and swine influenza, he said, after overtaking already began to set the world price of the vaccine, ranging in $ 8 per unit and which may lose money, according to the volume of purchases. No laboratory will make special discounts.
Influence on how the genetic factor in the response and effectiveness of immunization against H1N1, the manager of one of the leading laboratories worldwide that manufacture vaccines noted that based on the characteristics of the strain, which has component and swine influenza, "We do not believe that there would be no severe adverse reaction.
Clinical trials with 3 thousand humans elected in France and America "for reasons of time," consists in taking blood before and after the shot, and the procedure is repeated twice every three or four weeks evening. All tests were run at the same time to ensure the good practice of medical studies.
The analysis population is not exposed to the virus to determine if they are immune, through such tests have determined whether the antibodies needed to obtain the required threshold of protection. "We will determine if penalties seroprotected stay or increased antibody only their initials, then the vaccine will be tested on people with threats such as diabetes."
In an interview, Cesar Mascarenas also acknowledged that this is the first time in the history of the pharmaceutical industry that will deliver significant economic benefits for the global manufacture of a vaccine, percent, did not require large investments.
This is a production, he said, already appropriated by countries with greater economic solvency, such as U.S., France, England and Germany.
Currently, he announced, efforts are being made in Latin America for consolidated purchases to be made of the vaccine, at a fair price, through the Revolving Fund of the Pan American Health Organization.
"While it will not be the same number of doses that are in developed countries, if an amount sufficient to cover the population at risk," he said after mentioning that Sanofi-Aventis will donate to the World Health 10 per cent of production to give to less developed countries.
Claves
The U.S. government made contracts with 5 laboratories antigen and adjuvant, a substance that causes a lower concentration of antigen was able to get the same answer.
"It's like a modulator of the immune response favoring, so that less amount of antigen is having the same response, so we do not know how many doses will be U.S. or formulation to be used," he said.
Blanca Valadez