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DoD Influenza Surveillance for VRBPAC PowerPoint PPT Presentation
DoD Influenza Surveillance for VRBPAC - Title: DoD Influenza Surveillance for VRBPAC Author: James Neville Last modified by: brownj Created Date: 4/3/2003 7:10:59 PM Document presentation format
Title: DoD Influenza Surveillance for VRBPAC Author: James Neville Last modified by: brownj Created Date: 4/3/2003 7:10:59 PM Document presentation format
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FDA/CBER VRBPAC Meeting PowerPoint PPT Presentation
FDA/CBER VRBPAC Meeting - Demonstrate use of reverse genetics to generate H5 vaccine reference viruses and ... Reverse cumulative distribution of MN antibody at day 56 (28 days after dose 2) ...
Demonstrate use of reverse genetics to generate H5 vaccine reference viruses and ... Reverse cumulative distribution of MN antibody at day 56 (28 days after dose 2) ...
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VRBPAC March 15, 2005 PowerPoint PPT Presentation
VRBPAC March 15, 2005 - Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, Adsorbed ... that the different age groups respond to the vaccine in equivalent manners? ...
Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, Adsorbed ... that the different age groups respond to the vaccine in equivalent manners? ...
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VRBPAC Topic PowerPoint PPT Presentation
VRBPAC Topic - The current situation with Influenza A/H5N1 highlights the need for ... 'Swine Flu Vaccine' experience in 1976. GBS 1 case per 100,000 persons vaccinated ...
The current situation with Influenza A/H5N1 highlights the need for ... 'Swine Flu Vaccine' experience in 1976. GBS 1 case per 100,000 persons vaccinated ...
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Use of MDCK Cells for Manufacture of Inactivated Influenza Virus Vaccines VRBPAC – 16 Nov 05 PowerPoint PPT Presentation
Use of MDCK Cells for Manufacture of Inactivated Influenza Virus Vaccines VRBPAC – 16 Nov 05 - Use of MDCK Cells for Manufacture of Inactivated Influenza Virus Vaccines VRBPAC 16 Nov 05 Influenza Disease impact Annual winter epidemics 10-20% of world ...
Use of MDCK Cells for Manufacture of Inactivated Influenza Virus Vaccines VRBPAC 16 Nov 05 Influenza Disease impact Annual winter epidemics 10-20% of world ...
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Vaccines and Related Biological Products Advisory Committee VRBPAC May 21, 2002 Prevnar, Pneumococca PowerPoint PPT Presentation
Vaccines and Related Biological Products Advisory Committee VRBPAC May 21, 2002 Prevnar, Pneumococca - Finnish OM Study. Primary Objective ... Finnish OM study. Case surveillance and ascertainment. Free access to study clinics 7 days/week ...
Finnish OM Study. Primary Objective ... Finnish OM study. Case surveillance and ascertainment. Free access to study clinics 7 days/week ...
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Use of Madin-Darby Canine Kidney (MDCK) Cells for Manufacture of Inactivated Influenza Vaccines: Introduction PowerPoint PPT Presentation
Use of Madin-Darby Canine Kidney (MDCK) Cells for Manufacture of Inactivated Influenza Vaccines: Introduction - Use of Madin-Darby Canine Kidney (MDCK) Cells for Manufacture of Inactivated Influenza Vaccines: Introduction Philip R. Krause, M.D. Outline Definitions and brief ...
Use of Madin-Darby Canine Kidney (MDCK) Cells for Manufacture of Inactivated Influenza Vaccines: Introduction Philip R. Krause, M.D. Outline Definitions and brief ...
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FluMist? Influenza Virus Vaccine, Live, Intranasal (Cold Adapted, Trivalent) MedImmune Inc. PowerPoint PPT Presentation
FluMist? Influenza Virus Vaccine, Live, Intranasal (Cold Adapted, Trivalent) MedImmune Inc. - ... design and endpoints for the clinical study performed in adults for the ... If the data are adequate to support safety and efficacy, please discuss what ...
... design and endpoints for the clinical study performed in adults for the ... If the data are adequate to support safety and efficacy, please discuss what ...
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Use of MDCK Cells for Manufacture of Inactivated Influenza Vaccines: Introduction PowerPoint PPT Presentation
Use of MDCK Cells for Manufacture of Inactivated Influenza Vaccines: Introduction - ... yellow fever vaccines Chicken embryo cell culture for measles, mumps vaccines Mouse brain for inactivated JEV vaccine Human diploid cells ...
... yellow fever vaccines Chicken embryo cell culture for measles, mumps vaccines Mouse brain for inactivated JEV vaccine Human diploid cells ...
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Influenza Virus Vaccine 20082009 Strain Selection PowerPoint PPT Presentation
Influenza Virus Vaccine 20082009 Strain Selection - No candidate virus for manufacture was available that gave more complete ... the availability of suitable vaccine candidate strains. Options for Strain Composition for ...
No candidate virus for manufacture was available that gave more complete ... the availability of suitable vaccine candidate strains. Options for Strain Composition for ...
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Center for Biologics Evaluation and Research, FDA PowerPoint PPT Presentation
Center for Biologics Evaluation and Research, FDA - 'The Researcher/Reviewer Model is essential to providing CBER with top-level ... Milan Blake, Ph.D.-Acting Director. Jay Slater, M.D.- Acting Deputy Director ...
'The Researcher/Reviewer Model is essential to providing CBER with top-level ... Milan Blake, Ph.D.-Acting Director. Jay Slater, M.D.- Acting Deputy Director ...
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Design of Trials for Licensure of New Adult Pneumococcal Vaccine Indications An FDA Reviewers Perspe PowerPoint PPT Presentation
Design of Trials for Licensure of New Adult Pneumococcal Vaccine Indications An FDA Reviewers Perspe - Design of Trials for Licensure of New Adult Pneumococcal Vaccine Indications ... Effectiveness Trials ... data can be obtained in efficacy/effectiveness trials ...
Design of Trials for Licensure of New Adult Pneumococcal Vaccine Indications ... Effectiveness Trials ... data can be obtained in efficacy/effectiveness trials ...
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Topics Covered PowerPoint PPT Presentation
Topics Covered - History of cell-substrate DNA in biological products Methods used to quantify DNA Perceived safety issues associated with DNA Review of assays and ...
History of cell-substrate DNA in biological products Methods used to quantify DNA Perceived safety issues associated with DNA Review of assays and ...
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Pandemic Influenza Vaccine Safety and Effectiveness Monitoring and Comments on sanofi pasteur PowerPoint PPT Presentation
Pandemic Influenza Vaccine Safety and Effectiveness Monitoring and Comments on sanofi pasteur - ... may be severe (e.g. Guillain Barr Syndrome after 1976-77 swine influenza pandemic) Alleviate unwarranted fears to strengthen confidence in vaccine ...
... may be severe (e.g. Guillain Barr Syndrome after 1976-77 swine influenza pandemic) Alleviate unwarranted fears to strengthen confidence in vaccine ...
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Considerations in the Pre- and Early Pandemic Use of Influenza Vaccine PowerPoint PPT Presentation
Considerations in the Pre- and Early Pandemic Use of Influenza Vaccine - Inactivated vaccine provides some protection beyond one flu season and against ... Surrogates for protection are also not well defined (unknown for LAIV), and HAI ...
Inactivated vaccine provides some protection beyond one flu season and against ... Surrogates for protection are also not well defined (unknown for LAIV), and HAI ...
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Pandemic Influenza Vaccines: FDA Preparedness Activities PowerPoint PPT Presentation
Pandemic Influenza Vaccines: FDA Preparedness Activities - ... pre-clinical data, to support the initiation of clinical ... identification of product, pre-clinical and clinical study priorities for pandemic vaccines ...
... pre-clinical data, to support the initiation of clinical ... identification of product, pre-clinical and clinical study priorities for pandemic vaccines ...
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Influenza Virus Vaccine Composition 20052006 PowerPoint PPT Presentation
Influenza Virus Vaccine Composition 20052006 - B/Shanghai/361/2002-like strains predominant in Asia, Europe and North America ... B/Shanghai like strains not inhibited by vaccine but B/Hong Kong-like strains ...
B/Shanghai/361/2002-like strains predominant in Asia, Europe and North America ... B/Shanghai like strains not inhibited by vaccine but B/Hong Kong-like strains ...
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VACCINES AND RELATED BIOLOGICAL PRODUCTS ADVISORY COMMITTEE Topic 1: Discussion of BLA for Sanofi Pa PowerPoint PPT Presentation
VACCINES AND RELATED BIOLOGICAL PRODUCTS ADVISORY COMMITTEE Topic 1: Discussion of BLA for Sanofi Pa - ... licensed in the U.S. for avian influenza viruses such as H5N1. ... Cumulative Number of Confirmed Human Cases of Avian Influenza A/(H5N1) Reported to WHO ...
... licensed in the U.S. for avian influenza viruses such as H5N1. ... Cumulative Number of Confirmed Human Cases of Avian Influenza A/(H5N1) Reported to WHO ...
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... Human Papillomavirus Vaccines HPV Strains 16, 18, (70 PowerPoint PPT Presentation
... Human Papillomavirus Vaccines HPV Strains 16, 18, (70 - ... Human Papillomavirus Vaccines HPV Strains 16, 18, (70% cervical other anogenital cancers) 6, 11 (90% genital warts) 16, 18 (70% cervical cancers) ...
... Human Papillomavirus Vaccines HPV Strains 16, 18, (70% cervical other anogenital cancers) 6, 11 (90% genital warts) 16, 18 (70% cervical cancers) ...
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IMMUNE CORRELATES OF PROTECTION AGAINST INFLUENZA A VIRUSES IN SUPPORT OF PANDEMIC VACCINE DEVELOPME PowerPoint PPT Presentation
IMMUNE CORRELATES OF PROTECTION AGAINST INFLUENZA A VIRUSES IN SUPPORT OF PANDEMIC VACCINE DEVELOPME - Current State of Efficacy Evaluation of Pandemic Influenza Vaccines ... Therefore, evaluation of pandemic influenza vaccines is relying on immunological ...
Current State of Efficacy Evaluation of Pandemic Influenza Vaccines ... Therefore, evaluation of pandemic influenza vaccines is relying on immunological ...
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Importance of Influenza Vaccination in Children PowerPoint PPT Presentation
Importance of Influenza Vaccination in Children - Seasonal Occurence of Influenza, RSV and Parainfluenza U.S. 1996-99 ... RSV and parainfluenza data collected through National Respiratory Enteric ...
Seasonal Occurence of Influenza, RSV and Parainfluenza U.S. 1996-99 ... RSV and parainfluenza data collected through National Respiratory Enteric ...
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Influenza Vaccine Production PowerPoint PPT Presentation
Influenza Vaccine Production - Trivalent (influenza A H1N1, influenza H3N2, and influenza B) ... First evidence of reduced vaccine effectiveness because of ... 20/99 (H1N1)-like ...
Trivalent (influenza A H1N1, influenza H3N2, and influenza B) ... First evidence of reduced vaccine effectiveness because of ... 20/99 (H1N1)-like ...
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The transmissible spongiform encephalopathies and allergen vaccines PowerPoint PPT Presentation
The transmissible spongiform encephalopathies and allergen vaccines - most allergen extracts are produced without any bovine components ... Estimating the infectivity of the mold allergen extract. medium LD50/mL ...
most allergen extracts are produced without any bovine components ... Estimating the infectivity of the mold allergen extract. medium LD50/mL ...
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Classical Vaccines PowerPoint PPT Presentation
Classical Vaccines - The word vaccination, which is derived from vacca, the Latin word for cow. Edward Jenner. ... The arm of Sarah Nelmes, a dairy maid, who had contracted cowpox. ...
The word vaccination, which is derived from vacca, the Latin word for cow. Edward Jenner. ... The arm of Sarah Nelmes, a dairy maid, who had contracted cowpox. ...
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Approaches to Vaccine Development PowerPoint PPT Presentation
Approaches to Vaccine Development - Clinical endpoint ... Guidance for Industry Providing Clinical Evidence of Effectiveness for Human ... effect of change(s) on product's clinical performance ...
Clinical endpoint ... Guidance for Industry Providing Clinical Evidence of Effectiveness for Human ... effect of change(s) on product's clinical performance ...
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NVAC Pandemic Influenza Working Group PowerPoint PPT Presentation
NVAC Pandemic Influenza Working Group - ... of Pandemic Planning & Preparedness ... perspectives on pandemic planning and preparedness ... groups for a pandemic joint group with ACIP ...
... of Pandemic Planning & Preparedness ... perspectives on pandemic planning and preparedness ... groups for a pandemic joint group with ACIP ...
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Issues Associated With Residual PowerPoint PPT Presentation
Issues Associated With Residual - 0.2 g (1.9 x 1010 molecules) of polyoma virus DNA is oncogenic in newborn hamsters ... From BPL treatment, safety factor: 3 x 107(not shown) ...
0.2 g (1.9 x 1010 molecules) of polyoma virus DNA is oncogenic in newborn hamsters ... From BPL treatment, safety factor: 3 x 107(not shown) ...
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This is a background with safe frame and cdc logo PowerPoint PPT Presentation
This is a background with safe frame and cdc logo - NEW IN ADDITION TO ABOVE: Children less than 9 years old who received only 1 ... communities might not see any influenza transmission until after the New Year ...
NEW IN ADDITION TO ABOVE: Children less than 9 years old who received only 1 ... communities might not see any influenza transmission until after the New Year ...
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Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, Adsorbed Tdap, ADACEL Ave PowerPoint PPT Presentation
Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, Adsorbed Tdap, ADACEL Ave - 99.9% had documented 5 previous doses of dip, tet and pertussis-containing vaccine ... Dip and tet 2-sided 95% CI of difference in seroprotection rates and booster ...
99.9% had documented 5 previous doses of dip, tet and pertussis-containing vaccine ... Dip and tet 2-sided 95% CI of difference in seroprotection rates and booster ...
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FluMist for children 5 years of age STATISTICAL DISCUSSION of SAFETY based on MICP111 PowerPoint PPT Presentation
FluMist for children 5 years of age STATISTICAL DISCUSSION of SAFETY based on MICP111 - Children with medically-diagnosed or treated wheezing within 42 days before ... Medically significant wheezing (MSW) related hospitalizations comprise ...
Children with medically-diagnosed or treated wheezing within 42 days before ... Medically significant wheezing (MSW) related hospitalizations comprise ...
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AVIRON COLDADAPTED LIVE ATTENUATED INFLUENZA VIRUS VACCINE, TRIVALENT FLUMIST PowerPoint PPT Presentation
AVIRON COLDADAPTED LIVE ATTENUATED INFLUENZA VIRUS VACCINE, TRIVALENT FLUMIST - A/Wuhan/359/95 (H3N2) - both years. B/Harbin/7/94-like - both years ... H3N2 strain (A/Sydney) was a variant from the vaccine strain (A/Wuhan) ...
A/Wuhan/359/95 (H3N2) - both years. B/Harbin/7/94-like - both years ... H3N2 strain (A/Sydney) was a variant from the vaccine strain (A/Wuhan) ...
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GardasilTM : Quadrivalent Human Papillomavirus 6, 11, 16, 18 L1 VLP Vaccine Applicant: Merck PowerPoint PPT Presentation
GardasilTM : Quadrivalent Human Papillomavirus 6, 11, 16, 18 L1 VLP Vaccine Applicant: Merck - Vaccines and Related Biological Products Advisory Committee ... Loris McVittie, Ph.D. Jerry Weir, Ph.D. Non-Clinical: Sally Hargus, Ph.D. Marion Gruber, Ph.D. ...
Vaccines and Related Biological Products Advisory Committee ... Loris McVittie, Ph.D. Jerry Weir, Ph.D. Non-Clinical: Sally Hargus, Ph.D. Marion Gruber, Ph.D. ...
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FDAs Role in Facilitating the Availability of Influenza Vaccine PowerPoint PPT Presentation
FDAs Role in Facilitating the Availability of Influenza Vaccine - FDA has utilized an accelerated pathway for influenza vaccines resulting in the ... FDA is also providing technical input and regulatory guidance, as well as ...
FDA has utilized an accelerated pathway for influenza vaccines resulting in the ... FDA is also providing technical input and regulatory guidance, as well as ...
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Clinical Evaluation of Vaccines PowerPoint PPT Presentation
Clinical Evaluation of Vaccines - Clinical evaluation alone can involve a dozen interlocking trials of different ... Goal is to provide 'robust and compelling evidence' for net clinical benefit ...
Clinical evaluation alone can involve a dozen interlocking trials of different ... Goal is to provide 'robust and compelling evidence' for net clinical benefit ...
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The Reduction of Animal Use in the Critical Path to Vaccines PowerPoint PPT Presentation
The Reduction of Animal Use in the Critical Path to Vaccines - Deleted guinea pig test for diphtheria (residual toxin and irreversibility of diphtheria toxoid) ... Vaccination serological test in mice or guinea pigs ...
Deleted guinea pig test for diphtheria (residual toxin and irreversibility of diphtheria toxoid) ... Vaccination serological test in mice or guinea pigs ...
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Monitoring the Effectiveness of Pandemic Influenza Vaccines PowerPoint PPT Presentation
Monitoring the Effectiveness of Pandemic Influenza Vaccines - Data concerning clinical effectiveness of pandemic vaccines will be essential ... Project with Marshfield Clinic was funded to provide rapid, within season ...
Data concerning clinical effectiveness of pandemic vaccines will be essential ... Project with Marshfield Clinic was funded to provide rapid, within season ...
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New Vaccines for Pneumococcal Disease Prevention in Adults A Regulatory viewpoint on Laboratory Endp PowerPoint PPT Presentation
New Vaccines for Pneumococcal Disease Prevention in Adults A Regulatory viewpoint on Laboratory Endp - response trials comparing a new pneumococcal conjugate ... immunization in comparison with licensed product ... Comparisons between vaccines based upon their ...
response trials comparing a new pneumococcal conjugate ... immunization in comparison with licensed product ... Comparisons between vaccines based upon their ...
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