Ricercatori tedeschi: possibili rischi cardiovascolari da vaccino anti H1N1 posted on 19-11-2009
Riporto parte dell' abstract di un recente articolo di ricercatori dell' Univervsità di Mainz (Germania). [1] Il grassetto è del curatore

 

"We draw attention to unappreciated hazards of using adjuvanted vaccine in Europe. Evidence from animal experiments in conjunction with clinical epidemiological data indicates that, quite irrespective of cause, stimulation of the immune system may accelerate atherogenesis. Application of adjuvanted flu vaccines to individuals at risk may therefore aggravate the course of underlying atherosclerotic vessel disease with all the clinical consequences."

 

Per una migliore comprensione dell'articolo che solleva importanti domande, riporto alcuni passi significativi  dell' articolo completo

Dottor Andrea Valeri, coordinatore SIMO influenza working group                    mail: avaleri55@yahoo.it


...MF59, a squalene oil-in-water emulsion with yet poorly delineated mechanism of action, appears to target monocytes, macrophages and dendritic cells via mechanisms distinct from those mediated from danger signals. MF59 induces macrophage recruitment to the injection site and appears to promote uptake of antigen by macrophages and dendritic cells.....


However, injection of adjuvanted flu vaccine frequently causes local pain and occasionally fever [7], an indication that proinflammatory cytokines are generated in appreciable amounts. MF59-adjuvanted flu-vaccines have been applied in young children but there is little experience with their use in pregnant women...


This is particularly relevant in the present context because it highlights the fact that macrophage stimulation accelerates atherogenesis in the absence of any infection

 

...These few examples should suffice to transmit that if, at any stage, vaccination drives macrophages into their inflammatory state, the effects on atherosclerosis will hardly be unpredictable and acute clinical events could be precipitated. Causes might be the adjuvant or another ingredient, a combination of both, or any other inflammatory events provoked by intramuscular injection of the vaccine.


Against this background, the discomforting question arises whether any clinical data exist that would relieve us of these concerns. The simple answer is no. Although millions of individuals have been vaccinated with the adjuvanted flu vaccine, data relating to any of the previous questions have not been systematically acquired. Trials conducted with H1N1 vaccines also do not and cannot address these questions. Such trials would have to be conducted in individuals with identified risk factors, and observations would have to be made over extended periods of time. The latter also holds for healthy young individuals who are to repeatedly receive adjuvanted vaccines over years or decades. That unknown dangers may also be lurking here should be self-evident. To top matters, the GSK flu vaccine with its novel combination of adjuvant and additives has not ever been applied to a large number of recipients. The adjuvant included in the GSK vaccine is AS03 in the same or similar formulation previously employed in the adjuvanted H5N1 influenza vaccine [9]. The safety of that vaccine was assessed in 400 volunteers... 


The possible connection between vaccination of individuals at risk and triggering of life-threatening cardiac events might have just been on the verge of discovery in 2003. During January 24 to May 2, 2003, smallpox vaccin was administered to 36.000 civilians in the USA. Five myocardial infarctions (MI) occurred within 3 weeks, the time frame empirically chosen to define possible side effects, following vaccination in individuals aged 46–65. Five MI were higher than the two that would have been expected in this age group, and approached but did not exceed the upper 95% predictive interval of 5.4 [17].


Foremost, the question to be answered is whether the hazards of conducting mass vaccinations at the present stage might outweigh the expected benefits.


If, in retrospect, vaccination should turn out to have been unnecessary because a virulent H1N1-virus never emerged, consequences for the responsible parties can be foreseen, and public faith in preventive medicine will be shaken to the roots.


Or, if the vaccination program is implemented, would it not be prudent to use non-adjuvanted vaccine in individuals at risk? We have focused on cardiovascular disorders but the arguments would extend to other diseases that harbor immunopathological components. Finally, if the decision is still made to uniformly employ adjuvanted vaccines, careful survey systems should be implemented to clearly establish that the concerns expressed here, in particular the potential of adjuvanted vaccines to precipitate cardiovascular events, are nothing more than theory.

 
[1]
Bhakdi S, Lackner K, Doerr HW. Possible hidden hazards of mass vaccination against new influenza A/H1N1: have the cardiovascular risks been adequately weighed? Med Microbiol Immunol. 2009 Oct 23

PubMed Abstract
PMID: 19851782

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