In response to concerns raised in different emails vaccine against H1N1 us informs:
Although the current influenza pandemic A (H1N1) / 2009 is considered moderate in terms of severity, the pandemic influenza virus has caused deaths on average 6-14 per 1,000,000 inhabitants (1) . Until April 9, 2010, the Americas reported at least 8.271 deaths among confirmed cases in 28 countries in the region (2) . A safe and effective vaccine is certainly a powerful tool to minimize the damage caused by this virus, complementing the pharmacologic and nonpharmacologic measures.
The vaccine available in Colombia was acquired by an international bidding process in advance in the second half of 2009 by the Pan American Health Organization (PAHO) for the countries of the Region of the Americas, ensuring not only the best price but the highest quality and biological safety. This bid was made under exactly the same conditions producing laboratories that year after year is the acquisition of thousands of millions of vaccines for the expanded program on immunization in the countries of the region.
The Expert Group on Strategic Advice on Immunization (SAGE) held a special meeting in Geneva to discuss various issues and make recommendations about the vaccine against pandemic influenza A (H1N1) 2009. The experts identified three goals that countries should be established as part of the strategy for pandemic vaccination:
• Protect the integrity of the health care system and essential infrastructure of the country
• Reduce morbidity and mortality;
• Reduce the transmission of the pandemic in communities.
The group forwarded the following recommendations to the Director General of WHO:
As a first step to protect essential health infrastructure, countries should vaccinate staff assisting. As initially will not be enough vaccine can be considered the appropriateness of adopting a gradual approach to vaccinating certain groups. SAGE suggested the following groups, but not before noted that countries need to determine the order of priority based on specific conditions: pregnant women, children older than 6 months of age with a chronic disorder, healthy young adults 15 to 49 years of age, healthy children, healthy adults 50 to 64 years and adults from age 65.
As some pandemic influenza vaccines are produced by new technologies and their safety has not been extensively evaluated in certain populations, it is very important to implement mechanisms of pharmacovigilance in the highest possible quality. In addition, it is essential that the results of studies of immunogenicity and safety and effectiveness made after the entry into the market share rapidly in the international community to enable countries to make adjustments to their rules of vaccination.
Since it is predicted that there will be enough vaccine worldwide and the need for protection against virus strains that undergo the so-called "drift gene, SAGE recommended encouraging the production and use of vaccines containing adjuvants oil and water and prepared with live attenuated virus.
whereas almost has ended production of the seasonal vaccine 2009-2010 influenza season in the northern hemisphere and therefore not likely to affect the production of pandemic vaccine, SAGE was not necessary to recommend the discontinuation of the seasonal vaccine development to focus on vaccine production pandemic.
Given this, the National Committee on Immunization Practices NCIP, was based on recommendations the World Health Organization with regard to vaccines against influenza A (H1N1) Pandemic Influenza (H1N1) 2009 to define the priority population to be vaccinated in the country.
As for vaccine safety:
• Since September 2009 till date, more than 350 million doses of vaccine against pandemic influenza (H1N1) have been administered in the world health workers, high risk groups and general population (3) .
• In the Americas, and until April 9, 2010, have been applied 34.1 million doses 22 countries of the Region : Anguilla, Argentina, Bahamas, Barbados, Belize, Bermuda, Brazil, Colombia, Costa Rica, Ecuador, El Salvador, Guatemala, Honduras, Mexico, Montserrat, Nicaragua, Panama, Peru, Suriname, Trinidad and Tobago and Uruguay (4) .
• The pandemic vaccine that countries in the region are using is inactivated, with and without adjuvant. Today there is also the trivalent vaccine, which includes the pandemic strain (H1N1) and seasonal strains (H3N2) and B. This formulation is similar to the northern and southern hemispheres. Its availability is limited.
• El perfil de seguridad de la vacuna contra la influenza pandémica (H1N1) 2009 es similar al de la vacuna contra la influenza estacional. Desde que empezó la vacunación (más de 350 millones de dosis administradas a la fecha), no se ha producido ningún evento que cuestione la seguridad de la vacuna contra la influenza pandémica .
o No se ha observado ningún incremento en las tasas de aborto y de muerte intrauterina fetal en las mujeres embarazadas vacunadas contra la influenza pandémica (H1N1), en comparación con las embarazadas no vacunadas (3) .
o La tasa de anafilaxis reportada currently continues to oscillate between the expected (0.1-1.0 cases/100, 000 doses) (6) . It has placed particular emphasis on the recognition, proper diagnosis and treatment of anaphylaxis to avoid fatal outcomes. For this, the Brighton Collaboration Group (Brighton Collaboration) established definitions and levels of certain diagnoses, which were included in the Guide for Monitoring ESAVI of pandemic influenza vaccine (H1N1) (2009) of the OPS.
or have reported only two deaths (Canada and the Netherlands) whose causes are associated with programmatic errors (3) . In the case of Canada, not provided adequate and timely medical treatment to the person who submitted anaphylaxis, which triggered his demise, in the case of Holland, instead of the vaccine was applied insulin.
or regulatory authorities of several countries jointly evaluated the adverse effects identified pandemic vaccine in clinical trials, and compared these results with those existing seasonal influenza. In conclusion, the safety profile of both vaccines coincide, ie, the adverse effects of the pandemic vaccine observed in clinical trials are similar to those of the vaccine seasonal influenza (1) .
o In addition, after analyzing the data reported by the system (VAERS reporting system for adverse events allegedly attributable to vaccination - USA) in October-November 2009, concluded that pandemic influenza vaccine (H1N1) remains secure because there was no increase of ESAVIs reported to compare the frequency of reporting with estacional7 influenza vaccine.
or are available the results of three clinical trials recently conducted in China (12.691 people between 3 and 87 years / different vaccine formulations) 8, United States (children and adults without adjuvant vaccine) 9 and Hungary (355 persons aged 18-60 years and without adjuvant 60/vacuna) 10 on the safety of pandemic vaccine. In summary, these studies conclude:
a) The adverse events reported were mild and limited; ESAVI most frequently reported were pain at the injection site, cough, runny nose and nasal congestion, the severe and more frequent event was fever.
b) The frequency of systemic reactions was similar in all age groups in the multicenter, randomized, double-blind against placebo made in China. By increasing the amount of antigen (7.5-30 mg) increased the number of adverse events, on the contrary, with increasing age, decreased the number of adverse events.
c) The range of occurrence of local reactions was between 12% and 50%, whereas systemic reactions was between 16-49% in all age groups (U.S. study). Systemic reactions reported most frequently in adults are headache, myalgia and malaise; for children was frequent crying, irritability, loss of appetite and drowsiness.
d) Increased number of events when administered simultaneously non-adjuvanted pandemic vaccine and the vaccine against seasonal influenza (18% vs. 10%). The difference is due to moderate pain at the injection site reported by subjects who received both vaccines (study from Hungary).
or Al April 9, 2010, in the Americas has been reported ESAVIs 1.135, of which 65 have been classified as serious events [*] .
In conclusion, this pandemic is an event well documented from the scientific point of view, in which the emergence and spread of a new influenza virus has caused an unusual pattern of disease worldwide. No is an arbitrary matter of inventing words, definitions or controversial. Rate pandemic "false" is to ignore history and recent scientific data and trivialize the deaths of more than 14 000 people and many cases of serious illness who have suffered much more.
As we move forward, the world will face many health problems full of difficulties. The resources we have to solve them are limited, especially in developing countries, and find ways to make the best possible way is the joint responsibility of Member States and organizations, including the Parliamentary Assembly of the Council Europe and the WHO.
advised to check references, reliable as those published in journals where publication and peer review is done as follows:
1. Pfeifer D, Alfonso C, Wood D. Defining the safety profile of pandemic influenza vaccines. Lancet (2009). Published online December 16. DOI: 10.1016/S0140-6736 (09) 62133-4.
2. Pan American Health Organization (PAHO). Updated Regional Pandemic (H1N1) 2009 (website). Retrieved April 9:
http://new.paho.org/hq/index.php?option=com_content&task=view&id=2597&Itemid=569
http://new.paho.org/hq/index.php?option=com_content&task=view&id=2597&Itemid=569
3. Personal communication with Dina Pfeifer, Quality, Safety and Standards Team, World Health Organization.
4. Country reports to the Pan American Health Organization.
5. Pan American Health Organization (PAHO). Rubella: How to face the events supposedly attributable to vaccination or immunization? PAHO: 2002.
6. World Health Organization. Global Advisory Committee on Vaccine Safety. December 3-4, 2009. Wkly Epidemiol Rec 2009; 5 (85) 1929-1931
7. Centers for Disease Control and Prevention (CDC). Safety of Influenza A (H1N1) 2009 Monovalent Vaccines – United States, October 1 – November 24, 2009. MMWR Vol. 58 / No 48.
8. X-F Liang, H-Q Wang and J-Z Wang et al. Safety and immunogenicity of 2009 pandemic influenza A H1N1 vaccines in China: a multicentre, double-blind, randomized, placebo-controlled trial. Lancet (2009). Published online December 16. DOI: 10.1016/S0140-6736(09)62003-1.
9. E Plennevaux, E Sheldon, M Blatter, M-K Reeves-Hoché and M Denis. Immune response after a single vaccination against 2009 influenza A H1N1 in USA: a preliminary report of two randomized controlled phase 2 trials. Lancet (2009) Published online December 16. DOI 10.1016/S0140-6736(09)62026-2
10. Z Vajo, F Tamas, L Sinka and I Jankovics. Safety and immunogenicity of a 2009 pandemic influenza A H1N1 vaccine when administered alone or simultaneously with the seasonal influenza vaccine for the 2009–10 influenza season: a multicentre, randomized controlled trial. Lancet (2009). Published online December 16. DOI 10.1016/S0140-6736(09)62039-0.
11. Australian Government. Department of Health and Aging. Therapeutic Goods Administration (sitio en Interent). Consultado el 5 de abril del 2010 en: http://www.tga.gov.au/alerts/medicines/h1n1vaccine1.htm
12. Public Health Agency of Canada (website) Retrieved on April 5 in: http://www.phac-aspc.gc.ca/alert-alerte/h1n1/surveillance-archive/addeve20100203-eng.php
13. Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (website). Retrieved on April 5 in: http://vaers.hhs.gov/resources/2010H1N1Summary_Apr01.pdf
14. European Medicines Agency. Retrieved on April 5 in: http://www.ema.europa.eu/
15. Huang W, Chuang J, Hsu-Suong Kuo, S. Monitoring the safety of pandemic H1N1 vaccine. Lancet 2009. Published online October 31. DOI: 10.106/S0140-6736 (09) 61917-6
16. Black S, Eskola J, Siegrist CA, et al. Importance of background rates of disease in vaccine safety DURING Assessment of mass immunization with H1N1 pandemic influenza vaccines. Lancet 2009. Published online October 31. DOI: 10.1016/s0140-6736 (09) 62133-8
17. DeStefano F, Tokars J. H1N1 vaccine safety monitoring: beyond background rates. Lancet 2009. Published online October 31. DOI: 10.106/S0140-6736 (09) 61917-6
18. Pan American Health Organization. Monitoring events supposedly attributable to vaccination or immunization (ESAVI) of Vaccine for Pandemic Influenza (H1N1) 2009 and Crisis Prevention. A Practical Guide (website). Retrieved on April 6 in http://new.paho.org/hq/index.php?option=com_content&task=view&id=2500&Itemid=2009&lang=en
[*] An event is serious if it causes death, hospitalization, prolonged hospitalization, persistent disability and / or constitutes a threat for life. Serio is not synonymous with severe (Intensity / severity). Source: International Drug Monitoring, 1991 - WHO.
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