Yearly licensing studies from 1997 to 2007 of the inactivated whole virus seasonal influenza vaccine fluval - A useful approach to pandemic vaccine development even in less well developed countries?

Influenza and other Respiratory Viruses

Volumn 2, Issue 6, 2008, Pages 221-228

  Vajo, Zoltan ^a   Kosa, Lajos ^a   Szilvasy, Istvan ^d   Pauliny, Zsuzsanna ^b   Bartha, Kálmán ^b   Visontay, Ildiko ^b   Jankovics, Mate ^c   Kis, Agnes ^e   Jankovics, Istvan ^b  

^a National Center for Allergy and Immunology   (Hungary)

^b NATIONAL CENTER FOR EPIDEMIOLOGY   (Hungary)

^c SEMMELWEIS UNIVERSITY OF MEDICINE   (Hungary)

^d State Health Center   (Hungary)

^e Orszagos Gyogyszereszeti Intezet   (Hungary)

Author keywords

Influenza; Licensing; Seasonal; Vaccine

Indexed keywords

ALUMINUM PHOSPHATE; DISODIUM HYDROGEN PHOSPHATE; FLUVAL; IMMUNOLOGICAL ADJUVANT; INACTIVATED VIRUS VACCINE; INFLUENZA VACCINE; POTASSIUM CHLORIDE; POTASSIUM DIHYDROGEN PHOSPHATE; SODIUM CHLORIDE; THIOMERSAL; UNCLASSIFIED DRUG; ALUMINUM DERIVATIVE; INACTIVATED VACCINE; PHOSPHATE; VIRUS ANTIBODY;

ADULT; ANTIBODY BLOOD LEVEL; ANTIBODY TITER; ARTICLE; BLOOD SAMPLING; DEVELOPED COUNTRY; DRUG EFFICACY; DRUG FORMULATION; DRUG MANUFACTURE; DRUG SAFETY; FEMALE; GOOD MANUFACTURING PRACTICE; HEMAGGLUTINATION INHIBITION TEST; HUMAN; HUMAN EXPERIMENT; IMMUNOGENICITY; INFLUENZA; INFLUENZA VACCINATION; INJECTION SITE ERYTHEMA; INJECTION SITE PAIN; LICENSING; MALE; NORMAL HUMAN; PANDEMIC; PRIORITY JOURNAL; SEASONAL VARIATION; SEROCONVERSION; VACCINE PRODUCTION; VIRUS PURIFICATION; ADOLESCENT; AGED; BLOOD; CLINICAL TRIAL; DRUG APPROVAL; IMMUNOLOGY; INFLUENZA VIRUS A H5N1; MIDDLE AGED;

ADJUVANTS, IMMUNOLOGIC; ADOLESCENT; ADULT; AGED; AGED, 80 AND OVER; ALUMINUM COMPOUNDS; ANTIBODIES, VIRAL; DRUG APPROVAL; FEMALE; HEMAGGLUTINATION INHIBITION TESTS; HUMANS; INFLUENZA A VIRUS, H5N1 SUBTYPE; INFLUENZA VACCINES; INFLUENZA, HUMAN; MALE; MIDDLE AGED; PHOSPHATES; VACCINES, INACTIVATED; YOUNG ADULT;

EID: 66449109509     PISSN: 17502640     EISSN: 17502659     Source Type: Journal    
DOI: 10.1111/j.1750-2659.2008.00053.x     Document Type: Article

References (32)

1. Barker WH. Excess pneumonia and influenza associated hospitalizations during influenza epidemics in the United States. Am J Public Health 1986; 76: 761-765.
2. Nichol KL, Lind A, Margolis KL et.al. The effectiveness of vaccination against influenza in healthy, working adults. N Engl J Med 1995; 333: 889-893.
3. Fedson DS. Vaccine development for an imminent pandemic: Why we should worry, what we must do. Hum Vaccin 2006; 2: 38-42.
4. Dennis C. Flu-vaccine makers toil to boost supply. Nature 2006; 440: 1099.
5. Fauci AS. Seasonal and pandemic influenza preparedness: Science and countermeasures. J Infect Dis 2006; 194 (Suppl 2): S73-S76.
6. Vajo Z, Kosa L, Visontai I, Jankovics M, Jankovics I. Inactivated whole virus influenza A (H5N1) vaccine. Emerg Infect Dis 2007; 13: 807-808. Available from http://www.cdc.gov/eid/content/13/5/06-1248.html
7. License number: OGYI-T-8998/01, National Institute of Pharmacology, Budapest, Hungary, 1995.
8. Wood JM, Schild GC, Newman RW, Seagroatt V. An improved single-radial-immunodiffusion technique for the assay of influenza haemagglutinin antigen: Application for potency determinations of inactivated whole virus and subunit vaccines. J Biol Stand 1977; 5: 237-247.
9. European Directoriate for the Quality Medicines. European Pharmacopia, 5.8 CD, 7/2007, Strasbourg, France: European Directoriate for the Quality Medicines pp. 3406-3407.
10. European Committee for Proprietary Medicinal Products. Guideline on Dossier Structure and Content for Pandemic Influenza Vaccine Marketing Authorisation Application (CPMP/VEG/4717/03). Brussels: European Agency for the Evaluation of Medicinal Products, April 5, 2004.
11. European Committee for Proprietary Medicinal Products. Note for Guidance on Harmonization of Requirements for Influenza Vaccines, March 1997 (CPMP/BWP/214/96). Brussels: European Agency for the Evaluation of Medicinal Products, March 12, 1997.
12. Kendal AP, Pereira MS, Skehel JJ, (eds). Concepts and Procedures for Laboratory Based Influenza Surveillance. Atlanta: Centers for Disease Control, 1982.
13. Klimov A, Cox N. Serologic Diagnosis of Influenza Virus Infections by Hemagglutination Inhibition. Influenza Laboratory Course, Atlanta: Centers for Disease Control, 7.1-5, 2003.
14. Giesecke J, Sellwood C, Van-Tam J. Expert Advisory Groups on Human H5N1 Vaccines. Brussels: European Centre for Disease Control and Prevention. 2007, p. 47.
15. US Food and Drug Administration. Draft Guidance on Clinical Data Needed to Support the Licensure of Pandemic Influenza Vaccines. http://www.fda.gov/cber/gdlns/panfluvac.htm
16. Stephenson I, Nicholson KG, Wood JM, Zambon MC, Katz JM. Confronting the avian influenza threat: Vaccine development for a potential pandemic. Lancet Infect Dis 2004; 4: 499-509.
17. Jankovics I. The influenza viruses: Past, present and future. Lege Artis Med 1996; 6: 62-68.
18. Meiklejohn G. Viral respiratory disease at Lowry Air Force Base in Denver, 1952-1982. J Infect Dis 1983; 148: 775-783.
19. Fazekas G, Martosne-Mendi R, Zimonyi F et al. 3rd. Cross-reactive Immunity Induced by Fluval H5N1, a Reverse Genetic-derived A/Vietnam/ 1194/04 (NIBRG-14) Influenza Vaccine WHO Meeting on Influenza Vaccines with Broad Spectrum and Long Lasting Immune Responses. Geneva, Switzerland: WHO, 2007.
20. Department of Viral Vaccine Control. Yearly Reaction Reports. Budapest, Hungary: National Center for Epidemiology.
21. Nichol KL, Treanor JJ. Vaccines for seasonal and pandemic influenza. J Infect Dis 2006; 194 (Suppl 2): S111-S118.
22. Treanor JJ, Campbell JD, Zangwill KM, Rowe T, Wolff M. Safety and immungenicity of an inactivated subvirion influenza A (H5N1) vaccine. N Engl J Med 2006; 354: 1343-1351.
23. Bresson JL, Perronne C, Launay O et.al. Safety and immunogenicity of an inactivated split-virion influenza A/Vietnam/1194/2004 (H5N1) vaccine: phase I randomised trial. Lancet 2006; 367: 1657-1664.
24. Lin J, Zhang J, Dong X et.al. Safety and immunogenicity of an inactivated adjuvanted whole-virion influenza A (H5N1) vaccine: A phase I randomised controlled trial. Lancet 2006; 368: 991-997.
25. Leroux-Roels I, Borkowski A, Vanwolleghem T et.al. Antigen sparing and cross-reactive immunity with an adjuvanted rH5N1 prototype pandemic influenza vaccine: A randomised controlled trial. Lancet 2007; 18: 370.
26. Yearly Statistic Reports. Budapest, Hungary: National Center for Epidemiology.
27. Takatsy G. Purified precipitated virus obtained by a new simple method. Acta Med Acad Sci Hung 1952; 3: 185-191.
28. Vajo Z, Kosa L, Szilvasy I et.al. Safety and immunogenicity of a prepandemic influenza A (H5N1) vaccine in children. Pediatr Infect Dis J (In press).
29. WHO Announcement, July 13th, 2007: http://www.who.int/mediacentre/news/ statements/2007/s14/en/index.html
30. Wood JM. Developing vaccines against pandemic influenza. Philos Trans R Soc Lond B Biol Sci 2001; 356: 1953-1960.
31. Guideline on Adjuvants in Vaccines for Human Use (CHMP/VEG/134716/2004), p. 8. http://www.emea.europa.eu/pdfs/human/vwp/13471604en.pdf.
32. EC Guide to Good Manufacturing Practice (GMP), Volume 4, basing upon the Directive 2001/83/EC of the European Parliment and the Council of 6 November 2001 relating to medicinal product for human use. Official Journal; L 311: 67-128.