Saturday, October 16, 2010

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Squalene: from the first pages oblivion

For reasons easy to understand, influenza is a disease of travelers . The risk of exposure to influenza viruses differs depending on of the season and destination, and is substantially in the following situations: (a) in the temperate zones of the northern hemisphere between December and February, (b) in the temperate zones of the southern hemisphere between April and September, (c) in the temperate zones of both hemispheres during the summer, because of contacts with people from regions where there are cases of influenza and (d) in tropical countries, throughout the year. In addition, visiting relatives and friends and travel for more than 30 days is an independent risk factor.

Last year at this time we are preparing for pandemic vaccination campaign and all the attention was focused on squalene, the main constituent of ' adjuvant MF59 included in pandemic vaccine Focetria . One reason for the low acceptance of vaccination against pandemic dell'adiuvante was precisely the presence of which, there have been called into question the safety. Also, because data on the use of MF59 in children were scarce, there were those who feared health risks in this age group.

After one year, no longer speaks of squalene. The question is the bleak predictions have come true safety dell'adiuvante?
at all. First, the Italian Drug Agency has published online data on adverse events, which did not reveal any signals that can change the assessment on the safety of Focetria (1).

have also been published just in recent weeks, some studies regarding the administration of MF59-adjuvanted influenza vaccine in children: these are the results of clinical studies (2-4) and the analysis carried out on data obtained from five pediatric trial (5). The conclusions are all in favor of safety dell'adiuvante.

As is often the media, the news of the charges occupy the headlines, the denial of the allegations leading to the establishment of facts are relegated to inside pages. In the case of the 'affaire squalene was not even a widespread denial. We simply do not talk about it anymore.

Bibliography

(1) Italian Drug Agency. H1N1 - data on suspected adverse reactions

(2) Vesikari T, Karvonen A, Tilman D et al. Immunogenicity and safety of MF59-adjuvanted H5N1 influenza vaccine from infancy to adolescence. Pediatrics 2010; 126: e762-70.
doi: 10.1542/peds.2009-2628

(3) Esposito S, D'Angelo E, Daleno C et al. Immunogenicity, safety and tolerability of monovalent
2009 pandemic influenza A/H1N1 MF59-adjuvanted vaccine in patients with β -thalassemia major.
Vaccine [Article in Press, Uncorrected Proof ]  doi:10.1016/j.vaccine.2010.09.058

(4) Yasuda Y, Komatsu R, Matsushita K et al. Comparison of half and full doses of an MF59-adjuvanted cell culture-derived A/H1N1v vaccine in Japanese children. Advances in Therapy 2010;27:444-57. 
DOI: 10.1007/s12325-010-0043-4

(5) Black S, Della Cioppa G, Malfroot A et al. Safety of MF59-adjuvanted versus non-adjuvanted influenza vaccines in children and adolescents: an integrated analysis. Vaccine 2010;28: 7331-6.
doi:10.1016/j.vaccine.2010.08.075            



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