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The Emerging Risks of Live Virus & Virus Vectored Vaccines

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<strong>The</strong> <strong>Emerging</strong> <strong>Risks</strong> <strong>of</strong> <strong>Live</strong> <strong>Virus</strong> & <strong>Virus</strong> <strong>Vectored</strong> <strong>Vaccines</strong>:<br />

Vaccine Strain <strong>Virus</strong> Infection, Shedding & Transmission<br />

61 Brandler S, Tangy F. <strong>Vaccines</strong> in Development against West Nile <strong>Virus</strong>. <strong>Virus</strong>es 2013;<br />

5(1): 2384-2384-2409.<br />

62 Zust R, Dong H, Li ZF et al. Rational Design <strong>of</strong> a <strong>Live</strong> Attenuated Dengue Vaccine: 2’-O-<br />

Methyltransferase Mutants Are Highly Attenuated and Immunogenic in Mice and<br />

Macaques. PLOS Pathogens 2013; 9((9).<br />

63 Rui H, Ritchie JM, Bronson RT et al. Reactogenicity <strong>of</strong> live attenuated Vibrio cholera<br />

vaccines is dependent on flagellins. PNAS 2010; 107(9): 4359-4364.<br />

64 Bartlett EJ, Castano A, Surman ER et al. Attenuation and efficacy <strong>of</strong> human parainfluenza<br />

virus type 1 (HPIV1) vaccine candidates containing stabilized mutations in the P/C and L<br />

genes. Virology Journal 2007; 4:67.<br />

65 Larionova N, Kiselva I, Isakova-Sivak I et al. <strong>Live</strong> Attenuated Influenza <strong>Vaccines</strong> Against<br />

Highly Pathogenic H5N1 avian Influenza: Development and Preclinical Characterization. J<br />

<strong>Vaccines</strong> Vaccin 2013; 4(8).<br />

66 European Medicines Society. Guideline on quality, non-clinical and clinical aspects <strong>of</strong><br />

live recombinant viral vectored vaccines. June 24, 2010.<br />

67 FDA. Guidance for Industry: Characterization and Qualification <strong>of</strong> Cell Substrates and<br />

other Biological Material used in the Production <strong>of</strong> Viral <strong>Vaccines</strong> for Infectious Diseases.<br />

FDA Center for Biologics Evaluation & Research (CBER) February 2010.<br />

68 Sandvik T, Tryland M, Hansen H et al. Naturally Occurring Orthopoxviruses: Potential for<br />

Recombination with Vaccine Vectors. J Clin Microbiol 1998; 36((): 2542-2547.<br />

69 Schaller B, Sandu N. Clinical medicine, public health and ecological health: a new basis<br />

for education and prevention? Arch Med Sci 2011; 7(4): 541-545.<br />

70 Myhr AI, Traavik T. Genetically Engineered <strong>Virus</strong>-<strong>Vectored</strong> <strong>Vaccines</strong> – Environmental<br />

Risk Assessment and Management Challenges. In: Genetic Engineering – Basics, New<br />

Applications and Responsibilities. In Tech 2012.<br />

71 Ibid.<br />

72 Souza APD, Haut L, Reyes-Sandoval A, Pinto AR. Recombinant viruses as vaccines<br />

against viral diseases. Braz J Med Biol Res 2005; 38: 509-522.<br />

73 Lauring AS, Jones JO, Andino R. Rationalizing the development <strong>of</strong> live attenuated virus<br />

vaccines. Nature Biotech 2010; 28: 573-579.<br />

74 Saxena M, Van TTH, Baird FJ et al. Pre-existing immunity against vaccine vector: friend<br />

or foe? Microbiol 2013; 159: 1-11.<br />

NVIC Referenced Report – Nov. 2014, Page 46

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