* Several experts discussed the vaccine is in development.
* Specialists are confident with the virus.
* 400 Spanish children become part of clinical studies.
* Trinidad Jimenez said the Internet on influenza A.
* Differences between common cold and influenza A | Ten myths about influenza A.
* TIMELINE: Victims of influenza A in Spain
* POLL: Would you let your child try out the vaccine?
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* Influenza A
DAVID YAGÜE. 10/09/2009 - 15:15
Experts and institutions agree: we must be calm before the evolution of influenza A and its vaccine. That's how he expressed strong Fernando Rodríguez Artalejo, Professor of Public Health of the Autonomous University of Madrid (UAM), when 20minutos.es assured that, although the process has accelerated, "nobody will get the vaccine until it is sure it is safe and effective ". Here we have everything you need to know about the flu vaccine to arrive, expected before year end.
Who makes the vaccine?
Although there are several pharmaceutical developing vaccines against influenza A virus, Spain, currently, only vaccines buy two of them, Novartis and GlaxoSmithKline (GSK).
Can vaccines of these manufacturers will be different?
Although vaccines for both companies may have some slight differences, protect against the virus in the same way, effectively and safely, as both will, when reaching the public, with the approval of international and national agencies. Signing agreements with two pharmaceutical answers the need of production: having such a demand for several manufacturers dose needed to take the shortest time as much.
What is the normal process for developing a flu vaccine?
Once a vaccine is discovered, its development has two phases: a pre-clinic and other clinics. In the first, says Fernando Rodriguez Artalejo, Professor of Public Health of the Autonomous University of Madrid (UAM), is carried out technological development and it is proved "by creating antibodies to the virus in animals." It is proved, therefore, their level of safety and efficacy.
In the second phase human trial. First, in small groups of healthy adults. Here and measured doses to be provided and side effects, even in these early tests are only the most frequent. After trials are conducted in larger groups of people, first in adults and then children, because it is assumed that their immune system is not as mature.
With the results of these tests in hand, the European Medicines Agency will make technical recommendations. Above them, the European Commission will decide whether to authorize its distribution and use.
How many people will be tested before reaching the public?
GSK will make 16 trials, distributed in Europe, Canada and the U.S., which will involve 9,000 people. Of these, 8 studies would be in adults, 5 children (babies included) and three in older people, according to sources from the company 20minutos.es. His first adult trials began in Germany in mid August.
Meanwhile, Novartis began its first trial in July and announced its results in early September. Currently continuing their tests with the participation of more than 6,000 adults and children worldwide.
Are you going to carry out tests of the process in Spain?
Yes, the Minister of Health, Trinidad Jimenez, announced this week that were to start trials with vaccines "immediately" in our country.
Who are these patients who are tested?
These 400 children between 6 months and 17 years, Madrid, Andalusia and the Basque Country. These subjects will receive two doses separated by a period of 21 days. According to the Health Department Basque Government, the children of this community will be divided into two groups: the first will receive their first dose between 21 and 27 September and the second between 5 and 11 October. The results are not available until six months.
All are volunteers, meaning that they have the informed consent of their parents (and his own, if they are over 12 years) and not charge for it. They are also entitled to leave the trial at any time.
Why precisely in Spain?
Because our country has good facilities and specialists in the field of vaccines, sources with the pharmaceutical industry. Since GSK ensure that all its "marketed vaccines and developing countries has been Spanish intervention.
From their results do not depend on its use in Spain, but will join other similar studies being conducted worldwide.
Why are we talking about a vaccine against the virus a few months after the onset of the virus?
For two reasons. First, this vaccine is not particularly "innovative", according to Professor Rodriguez Artalejo, which says its technology is very similar to other influenza vaccines. Another professor in Preventive Medicine and Public Health, Rafael Rodríguez-Contreras Pelayo, explains that "each year are prepared by laboratories need to include some new mutation of the virus and include in the vaccine."
In a specific case of the influenza vaccine, GSK sources explain that the previous work prepared to find a vaccine for avian flu known as possible that we have done so as quickly as it only had to be applied to this strain a model already adopted.
Secondly, drug companies are making while they test doses, so if all goes well, the tests are positive and the vaccine is approved, almost immediately available.
Is it reasonable from a medical standpoint accelerate the process?
All the experts consulted by 20minutos.es believe so. In addition, ensure that accelerate the process does not "have abandoned basic safety measures" that vaccines have to meet to be authorized.
Do not pose risks?
"We must not fear the vaccine more than others from the flu, which have unwanted effects in rare cases," said Rodriguez-Contreras. "No one will receive the vaccine until they are sure is safe and effective" categorical claims another professor, Rodriguez Artalejo, which continues: "There is a rush, but not so much because the virus has not mutated and disease, for now, is essentially benign."
What did he mean when the Health Minister stated that it would begin distributing the vaccine before having the results of clinical trials?
He was referring only to tests performed with children in Spain and it will take about six months to get results. For drug approval and will take many trials, conducted by various countries with developed healthcare system, with adults and children.
What are the deadlines that are handled with this vaccine?
According to the minister of industry, the authorization would be in late September, early October to begin the vaccination strategy of early November. Similarly, he insisted that for the month of December, the vaccine could be available on the private channel, so "people can buy it in pharmacies as needed" although qualified, the National Health System (NHS) "vaccines will have to spare."
How do you provide?
The vaccine consists of two doses to be administered with a gap of 21 days. The first will be at-risk groups, but remember that once approved, with contraindications hand, some of these people can be vaccinated later. This is because the first approvals will be in the healthy adult group, with whom they are tested before, and perhaps, and to do so with the utmost security, no results yet available from other populations at risk.
In this process there may be "understandable paradox" in the words of Professor Rodríguez Artalejo, as a group of risk such as pregnant women can not be vaccinated immediately, since usually clinical trials are done after this group than with adults and children.
How many doses of vaccine has commissioned the Spanish Government?
The health ministry has purchased 37 million doses to the two aforementioned pharmaceutical. This means that, when necessary two doses, 18 million Spanish people could be vaccinated.
What if the vaccine is there on time?
While it appears that this will be the case, nor would it occur to dramatize the situation. "In Latin America are finishing the winter and more flu season and has not been a disaster, even in the absence of vaccine," explains Rodríguez Artalejo.
What if the virus mutates?
If this happens, vaccines would not be made effective. However, all experts and international organizations agree on little worried about this aspect. The virus appears to have stabilized, so that this possibility is remote.
Will I have the flu vaccine is also normal if I do this it?
He said it very clear 20minutos.es Trinidad Jimenez: "The flu vaccine does not work against influenza. So you have to be vaccinated twice. The influenza vaccine does not immunize against seasonal or vice versa.
Experts differ on the possibility of having supplied the vaccine together with influenza A together with the common flu to be similar processes. For Rodriguez Artalejo, besides some differences between them (for example, that of influenza A requires two doses), would be a timing issue because, to be ready for the fishing year are preparing vaccines and manufacturing since before the appearance of influenza virus A.
Instead, Rodriguez-Contreras believes "it would be possible to" unite the two vaccines. The professor blamed the decision to "awe" that has caused unwarranted virus, "we seem to plague the XIV century and it is not" because "other interests", commercial or other types.
If I've had the flu to me I have to vaccinate?
No, having spent the disease would have been immunized.
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