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http://diario.latercera.com/2011/03...mil-dosis-de-vacuna-contra-la-influenza.shtml
Spanish to English translation
Fault detected in 140 thousand doses of flu vaccine
Break in cold chain affected part of the units for children aged six months to two years. Firm should submit a new plan.
by Ana Maria Morales
With two weeks to launch the vaccination campaign against influenza, has detected a problem with a product line for children.
On 8 March, the lab was awarded the purchase of vaccines, Sanofi Pasteur, told the Ministry of Health that there was a problem in moving the product, by interrupting the cold chain during the journey to the country.
This is serious, because if you change the temperature levels in which vaccines are stored can affect immunities in them.
The laboratory confirmed the existence of the problem, but noted that it took the option of discarding the use of this product.
"It is true that a small proportion of pediatric vaccines that came to our country, scheduled for this season, showed deviations in temperature during transport. Our parent company, through its Quality Department, determined as a measure of extreme caution, that these doses are not used and our laboratory is already managing their replacement, "he told La Tercera the medical director of Sanofi Pasteur, Alejandra Massoc.
This failure occurred in 140 000 units of vaccines, of the 550 thousand who purchased the ministry through the direct purchase system.
In the Health Ministry say that this situation will involve a delay of vaccination, because the dose should correspond to those intended to replace the second phase of the campaign.
This is because children, unlike adults, they receive two doses of vaccine antiinfluenza, which must be placed four weeks apart.
The laboratory said the "replacement of the vaccines will be made in a timely manner so that the ministerial campaign will not be affected," said Dr. Massoc.
However, industry sources say it is very difficult that they could comply with the times since the laboratory, along with importing a new game, you are obligated to hospital again, and technical certification of the vaccine, which takes at least 14 days in the Institute of Public Health (ISP).
Tuberculosis
That is not the only problem with vaccines. In January it reported three cases of children who reported side effects after they were vaccinated against tuberculosis (BCG) in Valparaiso raise and Coquimbo. Because of this fact ordered an investigation to identify the causes of this problem.
As reported yesterday by the Health SEREMI Valparaiso, Jaime Jamett, a report by the Institute of Public Health and was handed over to authorities last week ruled that the vaccine provided to children has had problems in their manufacture, so that is discarded as a result.
The other thesis it is investigated is whether the techniques applied at the time of inoculation to correspond to the appropriate children. Regarding this issue, Jamett said that a committee of experts in the field Minsal evaluated practices used, and whether staff had the appropriate training. While staff had found that experience, "that line is kept open," he said.
Are only concerned with immunological studies of children, to determine if they had a problem that caused this reaction to the vaccine. Jamett said that each year there are eight to 10 cases of this type. The study was commissioned to France
Spanish to English translation
Fault detected in 140 thousand doses of flu vaccine
Break in cold chain affected part of the units for children aged six months to two years. Firm should submit a new plan.
by Ana Maria Morales
With two weeks to launch the vaccination campaign against influenza, has detected a problem with a product line for children.
On 8 March, the lab was awarded the purchase of vaccines, Sanofi Pasteur, told the Ministry of Health that there was a problem in moving the product, by interrupting the cold chain during the journey to the country.
This is serious, because if you change the temperature levels in which vaccines are stored can affect immunities in them.
The laboratory confirmed the existence of the problem, but noted that it took the option of discarding the use of this product.
"It is true that a small proportion of pediatric vaccines that came to our country, scheduled for this season, showed deviations in temperature during transport. Our parent company, through its Quality Department, determined as a measure of extreme caution, that these doses are not used and our laboratory is already managing their replacement, "he told La Tercera the medical director of Sanofi Pasteur, Alejandra Massoc.
This failure occurred in 140 000 units of vaccines, of the 550 thousand who purchased the ministry through the direct purchase system.
In the Health Ministry say that this situation will involve a delay of vaccination, because the dose should correspond to those intended to replace the second phase of the campaign.
This is because children, unlike adults, they receive two doses of vaccine antiinfluenza, which must be placed four weeks apart.
The laboratory said the "replacement of the vaccines will be made in a timely manner so that the ministerial campaign will not be affected," said Dr. Massoc.
However, industry sources say it is very difficult that they could comply with the times since the laboratory, along with importing a new game, you are obligated to hospital again, and technical certification of the vaccine, which takes at least 14 days in the Institute of Public Health (ISP).
Tuberculosis
That is not the only problem with vaccines. In January it reported three cases of children who reported side effects after they were vaccinated against tuberculosis (BCG) in Valparaiso raise and Coquimbo. Because of this fact ordered an investigation to identify the causes of this problem.
As reported yesterday by the Health SEREMI Valparaiso, Jaime Jamett, a report by the Institute of Public Health and was handed over to authorities last week ruled that the vaccine provided to children has had problems in their manufacture, so that is discarded as a result.
The other thesis it is investigated is whether the techniques applied at the time of inoculation to correspond to the appropriate children. Regarding this issue, Jamett said that a committee of experts in the field Minsal evaluated practices used, and whether staff had the appropriate training. While staff had found that experience, "that line is kept open," he said.
Are only concerned with immunological studies of children, to determine if they had a problem that caused this reaction to the vaccine. Jamett said that each year there are eight to 10 cases of this type. The study was commissioned to France