Global landscape analysis of no-fault compensation programmes for vaccine injuries: A review and survey of implementing countries.

To update the landscape analysis of vaccine injuries no-fault compensation programmes, we conducted a scoping review and a survey of World Health Organization Member States. We describe the characteristics of existing no-fault compensation systems during 2018 based on six common programme elements. No-fault compensation systems for vaccine injuries have been developed in a few high-income countries for more than 50 years. Twenty-five jurisdictions were identified with no-fault compensation programmes, of which two were recently implemented in a low- and a lower-middle-income country. The no-fault compensation programmes in most jurisdictions are implemented at the central or federal government level and are government funded. Eligibility criteria for vaccine injury compensation vary considerably across the evaluated programmes. Notably, most programmes cover injuries arising from vaccines that are registered in the country and are recommended by authorities for routine use in children, pregnant women, adults (e.g. influenza vaccines) and for special indications. A claim process is initiated once the injured party or their legal representative files for compensation with a special administrative body in most programmes. All no-fault compensation programmes reviewed require standard of proof showing a causal association between vaccination and injury. Once a final decision has been reached, claimants are compensated with either: lump-sums; amounts calculated based on medical care costs and expenses, loss of earnings or earning capacity; or monetary compensation calculated based on pain and suffering, emotional distress, permanent impairment or loss of function; or combination of those. In most jurisdictions, vaccine injury claimants have the right to seek damages either through civil litigation or from a compensation scheme but not both simultaneously. Data from this report provide an empirical basis on which global guidance for implementing such schemes could be developed.

Truncated Class 1 Integron Gene Cassette Arrays Contribute to Antimicrobial Resistance of Diarrheagenic Escherichia coli.

Class 1 integrons (c1-integrons) are associated with multidrug resistance in diarrheagenic Escherichia coli (DEC). However, little is known about gene cassettes located within these c1-integrons, particularly truncated c1-integrons, in DEC strains. Therefore, the aims of the present study were to reveal the relationship between antimicrobial resistance and the presence of truncated c1-integrons in DEC isolates derived from human stool samples in Japan. A total of 162 human stool-derived DEC isolates from Japan were examined by antimicrobial susceptibility testing, PCR-based gene detection, and next-generation sequencing analyses. Results showed that 44.4% (12/27) of c1-integrons identified in the DEC isolates harbored only intI1 (an element of c1-integrons) and were truncated by IS26, Tn3, or IS1-group insertion sequences. No difference in the frequency of antimicrobial resistance was recorded between intact and truncated c1-integron-positive DEC isolates. Isolates containing intact/truncated c1-integrons, particularly enteroaggregative E. coli isolates, were resistant to a greater number of antimicrobials than isolates without c1-integrons. aadA and dfrA were the most prevalent antimicrobial resistance genes in the intact/truncated c1-integrons examined in this study. Therefore, gene cassettes located within these intact/truncated c1-integrons may only play a limited role in conferring antimicrobial resistance among DEC. However, DEC harboring truncated c1-integrons may be resistant to a greater number of antimicrobials than c1-integron-negative DEC, similar to strains harboring intact c1-integrons.

Regulatory aspects of quality and safety for live recombinant viral vaccines against infectious diseases in Japan.

Recombinant viral vaccines expressing antigens of pathogenic microbes (e.g., HIV, Ebola virus, and malaria) have been designed to overcome the insufficient immune responses induced by the conventional vaccines. Our knowledge of and clinical experience with the new recombinant viral vaccines are insufficient, and a clear regulatory pathway is needed for the further development and evaluation of recombinant viral vaccines. In 2018, the research group supported by the Ministry of Health, Labour and Welfare, Japan (MHLW) published a concept paper to address the development of recombinant viral vaccines against infectious diseases. Herein we summarize the concept paper-which explains the Japanese regulatory concerns about recombinant viral vaccines-and provide a focus of discussion about the development of recombinant viral vaccines.

Association between first airborne cedar pollen level peak and pollinosis symptom onset: a web-based survey.

Cedar pollinosis in Japan affects nearly 25 % of Japanese citizens. To develop a treatment for cedar pollinosis, it is necessary to understand the relationship between the time of its occurrence and the amount of airborne cedar pollen. In the spring of 2009, we conducted daily Internet-based epidemiologic surveys, which included 1453 individuals. We examined the relationship between initial date of onset of pollinosis symptoms and daily amount of airborne cedar pollen to which subjects were exposed. Approximately 35.2 % of the subjects experienced the onset of pollinosis during a one-week interval in which the middle day coincided with the peak pollen count. The odds ratio for this one-week time interval was 4.03 (95 % confidence interval: 3.34-4.86). The predicted date of the cedar pollen peak can be used to determine the appropriate date for initiation of self-medication with anti-allergy drugs and thus avoid development of sustained and severe pollinosis.

Early therapy with neuraminidase inhibitors for influenza A (H1N1) pdm 2009 infection.

BACKGROUND: Neuraminidase inhibitors have been reported to decrease mortality in patients infected with influenza A (H1N1) pdm 2009 (H1N1 pdm09), but it is not clear whether they are effective against H1N1pdm09 in apparently healthy children. METHODS: The effect of early treatment with neuraminidase inhibitors on 70 otherwise healthy children with possible H1N1 pdm09 (pH1N1pdm09) infection was investigated. The children were simultaneously treated with a neuraminidase inhibitor (oseltamivir or zanamivir) and maoto, a Japanese traditional herbal medicine, which had been reported to be effective against seasonal influenza. Clinical severity was assessed using patient history, namely the worst values for clinical vital signs and laboratory data on admission. After refining these parameters with univariate, decision tree and multiple regression analysis, mean covariance structure equation analysis was used to investigate the association of estimated clinical severity to the selected parameters. RESULTS: Total path analysis using a Bayesian method indicated that the estimated clinical severity of pH1N1pdm09 was positively associated with maximum body temperature, pulse rate, respiration rate, duration necessary for defervescence, admission duration and log urinary ß2-microglobulin/creatinine level, and negatively associated with age and the presence and duration of treatment with the neuraminidase inhibitor in the outpatient clinic. CONCLUSIONS: This study provides the first clinical evidence that early treatment with neuraminidase inhibitors in outpatient clinic decreased the estimated clinical severity of pH1N1pdm09 in apparently otherwise healthy pediatric inpatients.

[Outpatient antimicrobial drug use and antimicrobial resistance frequency in Suwa area, Nagano, Japan].

A cross-sectional study was conducted to determine antimicrobial use and to analyze the correlation to resistant bacteria. Records on antimicrobial prescriptions in Suwa area, Nagano prefecture, were collected from December 2009 to May 2010 from a national health insurance database system. Records on antimicrobial-resistant bacteria during the same period were collected from area hospitals. Data was then compared to data published in Europe. The target population was 31,505, or 27.1% of the total area population. More antimicrobials were prescribed in an outpatient setting rather for inpatients. Total outpatient antimicrobial use was 9.34 defined daily dose (DDD) per 1,000 subject days. Macrolides, lincosamides, and streptogramins (MLS) was the most prescribed drug group, followed by beta-lactams other than penicillin and quinolone. The quinolone-resistance rate among Escherichia coli in this area was within a predictable range based on European data, although that of macrolide-resistance among Streptococcus pneumoniae exceeded the predictable range. The health insurance system electronic database proved useful in collecting data on antimicrobial use for curbing action against antimicrobial resistance, including antimicrobial stewardship.