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Postmarketing Adverse Event Reporting for Medical Products and Dietary Supplements During an Influenza Pandemic

Drug Safety
Source: FDA Center for Drug Evaluation and Research - What's New - Category: Drugs & Pharmacology Source Type: news

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Publication date: Available online 18 April 2018 Source:Microbes and Infection Author(s): Jeffrey Downey, Erwan Pernet, François Coulombe, Maziar Divangahi Influenza A virus (IAV) is a pulmonary pathogen, responsible for significant yearly morbidity and mortality. Due to the absence of highly effective antiviral therapies and vaccine, as well as the constant threat of an emerging pandemic strain, there is considerable need to better understand the host-pathogen interactions and the factors that dictate a protective versus detrimental immune response to IAV. Even though evidence of IAV-induced cell death in human pu...
Source: Microbes and Infection - Category: Infectious Diseases Source Type: research
We continue to see a remarkable stream of people transiting therevolving door from high-level positions in health care corporations to high-level positions in health care policy or regulation for the Trump administration.  Lately, though, these transitions have not been without missteps. The most recent cases we have found, in the order of their public appearance, appear below.John Bardis, Who Went from MedAssets to Assistant Secretary of Health and Human Services for Administration, Resigned Under FireWe first discussed the appointment of Mr Bardis in May, 2017,here.  We noted then that most recently Mr Bar...
Source: Health Care Renewal - Category: Health Management Tags: conflicts of interest CVS Donald Trump finance health care corruption Pfizer revolving doors Source Type: blogs
One-fifth of the patients with CVID vaccinated against pandemic influenza A(H1N1) converted to a ≥ 1:40 titer of specific antibodies against the antigen and selected clinical and immunological predictive markers were identified in this subgroup.
Source: Journal of Allergy and Clinical Immunology - Category: Allergy & Immunology Authors: Source Type: research
Conclusion The present study demonstrates that catechin might be a safe reagent for long-term use to prevent influenza A (H1N1) virus infection; whereas gallic acid might be a sensitive reagent to inhibit influenza virus infection. We conclude that these two phyto-chemicals in TSL-1 are responsible for exerting anti-pandemic influenza A (H1N1) virus effects.
Source: Journal of the Chinese Medical Association - Category: General Medicine Source Type: research
In this study, we developed several new influenza nucleoprotein (NP)-specific monoclonal antibodies (mAbs) and compared their sensitivity and specificity with those of commercially available anti-NP mAbs. Three mAbs, designated M24.11, M34.3 and M34.33, exhibited higher reactivities to recombinant NP proteins and A/Puerto Rico/8/1934 (H1N1) viral lysates compared with the commercial mAbs, as assessed using enzyme-linked immunosorbent assays. M34.3 and M34.33 showed higher reactivities with A/California/04/09 (pandemic H1N1) and A/Philippines/2/82 (H3N2) viral lysates than the commercial mAbs. In contrast, M24.11 had marked...
Source: Journal of Microbiology and Biotechnology - Category: Biotechnology Authors: Tags: J Microbiol Biotechnol Source Type: research
In this study, we attempted to generate a high growth influenza vaccine strain in MDCK cells using an A/Puerto/8/1934 (H1N1) vaccine seed strain. Following 48 serial passages with four rounds of virus plaque purification in MDCK cells, we were able to select several MDCK-adapted plaques that could grow over 108 PFU/ml. Genetic characterization revealed that these viruses mainly had amino acid substitutions in internal genes and exhibited higher polymerase activities. By using of a series of Rg viruses, we demonstrated the essential residues of each gene and identified a set of high-growth strains in MDCK cells (PB1D153N, M...
Source: Journal of Microbiology and Biotechnology - Category: Biotechnology Authors: Tags: J Microbiol Biotechnol Source Type: research
In an influenza pandemic, arrival times of cases are a proxy of the epidemic size and disease transmissibility. Because of intense surveillance of travelers from infected countries, detection is more rapid and complete than on local surveillance. Travel information can provide a more reliable estimation of transmission parameters.
Source: Travel Medicine and Infectious Disease - Category: Infectious Diseases Authors: Source Type: research
Current influenza vaccines are mainly strain-specific and have limited efficacy in preventing new, potentially pandemic, influenza strains. Efficient control of influenza A infection can potentially be achieve...
Source: Journal of Biomedical Science - Category: Biomedical Science Authors: Tags: Research Source Type: research
Baik Seong Glycosylation of the hemagglutinin (HA) and neuraminidase (NA) of the influenza provides crucial means for immune evasion and viral fitness in a host population. However, the time-dependent dynamics of each glycosylation sites have not been addressed. We monitored the potential N-linked glycosylation (NLG) sites of over 10,000 HA and NA of H1N1 subtype isolated from human, avian, and swine species over the past century. The results show a shift in glycosylation sites as a hallmark of 1918 and 2009 pandemics, and also for the 1976 “abortive pandemic”. Co-segregation of particular glycosylation si...
Source: Viruses - Category: Virology Authors: Tags: Article Source Type: research
Publication date: 5 April 2018 Source:Cell, Volume 173, Issue 2 Author(s): Yao-Qing Chen, Teddy John Wohlbold, Nai-Ying Zheng, Min Huang, Yunping Huang, Karlynn E. Neu, Jiwon Lee, Hongquan Wan, Karla Thatcher Rojas, Ericka Kirkpatrick, Carole Henry, Anna-Karin E. Palm, Christopher T. Stamper, Linda Yu-Ling Lan, David J. Topham, John Treanor, Jens Wrammert, Rafi Ahmed, Maryna C. Eichelberger, George Georgiou, Florian Krammer, Patrick C. Wilson Antibodies to the hemagglutinin (HA) and neuraminidase (NA) glycoproteins are the major mediators of protection against influenza virus infection. Here, we report that current i...
Source: Cell - Category: Cytology Source Type: research
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