The Public Health Impact of the So-Called "Fluad Effect" on the 2014/2015 Influenza Vaccination Campaign in Italy: Ethical Implications for Health-Care Workers and Health Communication Practitioners

Seasonal influenza, causing complications, hospitalizations and deaths, generates a serious socio-economic burden, especially among elderly and high-risk subjects, as well as among adult individuals. Despite the availability and active free-of charge offer of influenza vaccines, vaccine coverage rates remain low and far from the target established by the Ministry of Health. Notwithstanding their effectiveness, vaccines are victims of prejudices and false myths, that contribute to the increasing phenomenon of vaccine hesitancy and loss of confidence. Media and, in particular, new media and information and communication technologies (ICTs) play a major role in disseminating health-related information. They are extremely promising devices for delivering health education and promoting disease prevention, including immunization. However, they can also have a negative impact on population\ue2\u80\u99s health attitudes and behaviors when channeling wrong, misleading information. During the 2014/2015 influenza vaccination campaign, the report of four deaths allegedly caused by administration of an adjuvanted influenza vaccine, Fluad the so-called \ue2\u80\u9cFluad case\ue2\u80\u9d received an important media coverage, which contributed to the failure of the vaccination campaign, dramatically reducing the influenza vaccine uptake. In the extant literature, there is a dearth of information concerning the effect of the \ue2\u80\u9cFluad case\ue2\u80\u9d. The current study aims at quantifying the impact of the \ue2\u80\u9cFluad effect\ue2\u80\u9d at the level of the Local Health Unit 3 (LHU3) ASL3 Genovese, Genoa, Italy. Ethical implications for health-care workers and health communication practitioners are also envisaged

Abnormal megakaryopoiesis and platelet function in cyclooxygenase-2-deficient mice

Previous studies suggest that cyclooxygenase-2 (COX-2) might influence megakaryocyte (MK) maturation and platelet production in vitro. Using a gene deletion model, we analysed the effect of COX-2 deficiency on megakaryopoiesis and platelet function. COX-2-/- mice (10-12 weeks old) have hyper-responsive platelets as suggested by their enhanced aggregation, TXA2 biosynthesis, CD62P and CD41/CD61 expression, platelet-fibrinogen binding, and increased thromboembolic death after collagen/epinephrine injection compared to wild-type (WT). Moreover, increased platelet COX-1 expression and reticulated platelet fraction were observed in COX-2-/- mice while platelet count was similar to WT. MKs were significantly reduced in COX-2-/- bone marrows (BMs), with high nuclear/cytoplasmic ratios, low ploidy and poor expression of lineage markers of maturation (CD42d, CD49b). However, MKs were significantly increased in COX-2-/- spleens, with features of MK maturation markers which were not observed in MKs of WT spleens. Interestingly, the expression of COX-1, prostacyclin and PGE2 synthases and prostanoid pattern were modified in BMs and spleens of COX-2-/- mice. Moreover, COX-2 ablation reduced the percentage of CD49b+ cells, the platelet formation and the haematopoietic stem cells in bone marrow and increased their accumulation in the spleen. Splenectomy decreased peripheral platelet number, reverted their hyper-responsive phenotype and protected COX-2-/- mice from thromboembolism. Interestingly, fibrosis was observed in spleens of old COX-2-/- mice (28 weeks old). In conclusion, COX-2 deletion delays BM megakaryopoiesis promoting a compensatory splenic MK hyperplasia, with a release of hyper-responsive platelets and increased thrombogenicity in vivo. COX-2 seems to contribute to physiological MK maturation and pro-platelet formation

Safety and tolerability of 13-valent pneumococcal conjugate vaccine in the elderly: An observational study in Liguria Region, Italy

Background: In September 2011 the European Medical Agency authorized the use of 13-valent pneumococcal conjugate vaccine (PCV13) in adults aged \ue2\u89\ua550 years. The same occurred in the US in December 2011 when the Food and Drug Administration approved the use of PCV13 in the same target age-group with indication for the prevention of invasive pneumococcal diseases and community acquired pneumonia sustained by the serotypes contained in the vaccine. The Liguria Region, in Italy, implemented in 2013 an active and free of charge immunization strategy with PCV13 among adults affected by specific risk conditions and the elderly aged \ue2\u89\ua570 years. Methods: An observational study was performed in order to assess the safety and tolerability of PCV13 among elderly dwelling in the metropolitan area of Genoa, the capital city of Liguria Region. Eligible subjects, who received PCV13 following the public health immunization campaign at the Local Health Unit 3 of Genoa, provided a written informed consent to take part in the study. Eight-hundred-seventy-one subjects were enrolled between October 2013 and May 2014: all were monitored by qualified healthcare personnel for at least 30 min after vaccination at the outpatient clinics, in order to assess any possible sudden reaction. The occurrence of a series of local and systemic solicited reactions and of any unsolicited Adverse Events (AEs) was monitored using a self-administered clinical diary and by regular phone contacts up to 14 and 21 d following immunization, respectively. Moreover, a 6-months follow-up following vaccination was planned in order to monitor Severe Adverse Events (SAEs). Results: No sudden reaction occurred in vaccinees at the outpatient clinics. Pain (27.4%) was the most frequent reaction reported by subjects at the injection site, while new muscle pain (13.6%), fatigue (10.7%), and headache (9.9%) resulted the most common systemic reactions. Rates of the main reactions reported in this on-field study resulted generally lower than those registered in clinical trials performed in the elderly. The incidence of fever (2.2%) following vaccination was low at values superimposable to that reported in previous studies. Conclusion: This observational study showed a good safety and tolerability of PCV13 among the elderly in routine clinical practice further confirming the evidence coming from clinical trials in the same age-group