Vaccination remains the principal way to control seasonal infections and is the most effective method of reducing influenza-associated morbidity and mortality. Since the 1940s, the main method of producing influenza vaccines has been an egg-based production process. However, in the event of a pandemic, this method has a significant limitation, as the time lag from strain isolation to final dose formulation and validation is six months. Indeed, production in eggs is a relatively slow process and production yields are both unpredictable and highly variable from strain to strain. In particular, if the next influenza pandemic were to arise from an avian influenza virus, and thus reduce the egg-laying hen population, there would be a shortage of embryonated eggs available for vaccine manufacturing. Although the production of egg-derived vaccines will continue, new technological developments have generated a cell-culture-based influenza vaccine and other more recent platforms, such as synthetic influenza vaccines.

Conventional egg-based manufacturing technology for seasonal influenza vaccines has several drawbacks, including its inflexibility, reliance on egg supplies, risk of contamination, absence of growth of some isolates and egg-adaptive viral mutations that threaten vaccine matching. To overcome these limitations, cell culture-derived vaccines have been designed, including the trivalent inactivated vaccine Flucelvax®/Optaflu® (brand names in the US/EU, respectively). Flucelvax®/Optaflu® has gained wide regulatory approval and is currently implemented in several countries. Non-clinical studies have assuaged hypothetical concerns regarding oncogenicity and use in persons allergic to dogs. Ample clinical data suggest the non-inferiority of Flucelvax®/Optaflu® to egg-based vaccines in terms of immunogenicity, safety and tolerability, and it has fulfilled American and European mandatory requirements. Although Flucelvax®/Optaflu® is currently indicated only for adults and the elderly, pediatric data indicate its good immunogenicity and safety. This paper provides an update on the clinical development of Flucelvax®/Optaflu®, its seasonal trials and available post-marketing surveillance data.

A study was conducted on a new acid peroxygen system based disinfectant (Virkon), in order to assess its in vitro efficacy. The chemical was tested on different bacteria (Staphylococcus aureus, Pseudomonas aeruginosa, Escherichia coli), spores (Bacillus subtilis) and on the Hepatitis B surface antigen (HBsAg), and compared in its activity with phenol and glutaraldehyde (calculation of the 'phenol coefficient' and the 'glutaraldehyde coefficient'). The constancy of speed of disinfection, the coefficient of concentration, the minimal inhibitory concentration (MIC) were also determined, and the destruction of the HBsAg antigenic activity was studied using an ELISA kit. The sporicidal efficacy of Virkon was assessed by cultivating spores in agar nutrient after contact with different dilutions of the disinfectant. The results of the tests showed that Virkon has a high concentration coefficient (mean value of k: 0.374/min) and a wide range of action. The low MIC demonstrates how little concentrations of Virkon can inactivate all studied bacteria. The disinfectant was also able to destroy the hepatitis B surface antigen, and it demonstrated good activity against spores, especially if used in physiologic solution. These characteristics, coupled with the absence of initiation or toxic effects on animals showed by other studies, make wide fields of application for the new disinfectant foreseeable.

This paper reports the results of a study conducted by the Italian Association for Immune-Prophylaxis Promotion (AIP.I) with the aim of surveying the attitudes and perceptions of Italian health care workers regarding the use and efficacy of influenza vaccine. The results clearly show that a high proportion of the questioned health care workers showed a general lack of concern about the severity of the disease. Doubts about vaccine efficacy and fear of post-vaccination side effects were also observed to have an important influence on the vaccination acceptance rates. These data underline the need for a systematic education program to provide influenza vaccination within the public and private health-care sectors in Italy.

Three-hundred and eight outpatient elderly subjects (> or = 65 years) were randomly assigned to receive the MF59-adjuvanted influenza vaccine (FLU-AD; n = 204) or a conventional subunit influenza vaccine (AGRIPPAL S1; n = 104) in order to compare the safety and immunogenicity of the two vaccines. Although mild pain at the injection site was reported more frequently by subjects immunised with the adjuvanted vaccine, both vaccines were shown to be safe and well tolerated. The adjuvanted vaccine was more immunogenic as indicated by higher post-immunisation geometric mean titres (GMTs) and by higher proportions of subjects with post-immunisation > or = four fold increases of antibody titres or subjects with > or = 1/160 post-immunisation HI titres. These differences, statistically significant for all three strains after immunisation, indicated that, by addition of the MF59 adjuvant emulsion, conventional subunit influenza antigens acquire an enhanced immunogenicity without any clinically significant increase of their reactogenicity.