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Draadje vogelgriep - Deel 2

1. flosz 4 juli 2008 10:10

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   Sneller vaccin pandemie ontwikkelen
   zondag, 08 juni 2008
   Een wereldwijde uitbraak van een nieuw griepvirus, is de grootste bedreiging voor Nederland. Om te zorgen dat we dan zo snel mogelijk beschikken over een goed vaccin, werken deskundigen Europa nu al twee jaar volop samen in het project FluSecure, dat wordt geleid door het Nederlands Vaccin Instituut (NVI). Het NVI werkt ook samen met de WHO aan de beschikbaarheid van vaccins voor ontwikkelingslanden.
   Een pandemie is een wereldwijde epidemie die wordt veroorzaakt door een nieuw virus subtype.Volgens wetenschappers duikt er eens in de 10 tot 50 jaar een nieuw griepvirus op, waartegen de mens nog geen bescherming heeft. In de vorige eeuw gebeurde dit drie keer: in 1918, 1957 en 1968. Tijdens de Spaanse griep in 1918, de meest dodelijke variant, vielen wereldwijd tussen de twintig en veertig miljoen doden. Een kwart van de wereldbevolking raakte met het virus besmet. In Nederland stierven bijna dertigduizend mensen. 'Dat er een grieppandemie komt is zeker, de vraag is alleen: wanneer?', zei minister van Binnenlandse Zaken Guusje ter Horst (PvdA) onlangs bij de presentatie van de risicoanalyse van het ministerie van Binnenlandse Zaken, waarin de grieppandemie als grootste risico voor Nederland uit de bus kwam.
   
   Tijd inkorten
   Een vaccin is de beste remedie tegen een pandemie. Aan nieuwe vaccins wordt volop gewerkt, maar de benodigde tijd om ze na een pandemie-uitbraak te produceren is nog steeds lang, te lang. Mocht er vandaag een grieppandemie uitbreken, dan duurt het in het gunstigste geval zes maanden voordat een goed werkend vaccin klaar is voor gebruik. Hoofdprobleem is dat er geen vaccin vooruit kan worden geproduceerd, omdat de exacte aard van het virus pas bekend is na uitbraak van een pandemie. Om de ontwikkeling van een vaccin dan te bespoedigen, gebeurt er nu al het nodige voorwerk in het EU-project FluSecure, waarin een tiental Europese 'Public health' organisaties samenwerken met de vaccinindustrie. Het NVI is de coördinator van het project.
   
   Ed Schmidt, griepexpert bij het NVI en projectmanager van FluSecure legt uit: 'Het gaat erom de tijd tussen een uitbraak en preventieve vaccinatie te bekorten. Met de deelnemende instituten zijn we op meerdere fronten bezig om zo snel mogelijk na een uitbraak een vaccin beschikbaar te hebben. Dat gebeurt bijvoorbeeld door voor nieuwe ontstane gevaarlijke griepstammen 'vaccinvoorlopers' te maken, maar ook door adjuvantia (hulpstoffen die vaccins beter doen werken) onderling met elkaar te vergelijken en door nieuwe adjuvantia verder te ontwikkelen.'
   
   Ei-tekort
   Het is niet alleen belangrijk om bij een pandemie snel een vaccin te kunnen ontwikkelen, het vaccin moet ook nog op grote schaal gemaakt worden. Ed Schmidt: 'Bij een pandemie moet je zo snel mogelijk vaccin hebben voor de 711 miljoen inwoners die Europa op dit moment telt. Dat is lastig, vooral omdat we bijna alle griepvaccins produceren op bebroede kippeneieren, een 'grondstof' die na een uitbraak van vogelgriep waarschijnlijk zeer schaars wordt. Daarom zoeken we naarstig naar innovatieve verbeteringen.'
   Verschillende biotech-bedrijven zijn bijvoorbeeld bezig met de ontwikkeling van nieuwe productiesystemen op basis van recombinante vaccins. Schmidt: 'Daarbij wordt een (stukje) viruseiwit in plaats van het hele virus geproduceerd. In onder andere planten blijkt het mogelijk om in korte tijd zeer grote hoeveelheden vaccin te produceren, zonder dat daarbij eieren nodig zijn. FluSecure heeft met zulke bedrijven samenwerkingsverbanden opgezet. Deze nieuwe productiesystemen zouden in principe genoeg zijn om de hele Europese bevolking van vaccin te kunnen voorzien. Inmiddels worden afspraken vastgelegd om binnen het FluSecure-project deze recombinante producten in trial studies te gaan testen en te vergelijken met bestaande pandemische vaccins van de gevestigde vaccinproducenten.'
   
   Universeel vaccin
   Een andere mogelijke oplossing om een pandemie in de kiem te smoren, is een universeel vaccin. Schmidt: 'Een dergelijk vaccin biedt bescherming tegen zeer veel verschillende griepstammen, en zou dus de beste oplossing zijn. Iedereen één keer vaccineren en dan ben je klaar. De grondlegger van dit experimentele product is prof. Wolter Fiers van de Universiteit van Gent. Ook hier gaat het om een recombinant vaccin (zonder eieren als grondstof) op basis van geconserveerd eiwit - M2. FluSecure kan helpen bij de verdere ontwikkeling van dit vaccin.'
   
   Vaccinvoorlopers
   Een onderdeel van het FluSecure-project dat al langer loopt, is het maken van 'vaccinvoorlopers'. Dat gebeurt in Engeland, Duitsland en Denemarken. Schmidt: 'We hebben nu al negen zaaistammen voor mogelijke pandemisch gevaarlijke griepstammen gesynthetiseerd. Met deze zogenoemde zaaistammen zouden vaccins gemaakt kunnen worden. De stammen zijn niet alleen gericht tegen H5N1 (het vogelgriepvirus), maar ook tegen de subtypen H7 en H9. FluSecure ontwikkelt in Duitsland en in Denemarken momenteel ook een nieuwe zaaistam tegen H2N2 (een subtype van het vogelgriepvirus) waarmee vervolgens op het NVI veiligheidstesten worden uitgevoerd. We hebben trouwens ook al H5N1-stammen gemaakt die een veel hogere vaccinopbrengst mogelijk maken dan de bestaande zaaistammen.'
   
   Ontwikkelingslanden
   Als er een grieppandemie uitbreekt, loopt de hele wereldbevolking gevaar. Probleem is dat de huidige wereldwijde productiecapaciteit ophoudt bij zo'n 400 miljoen doses, die vooral bestemd zijn voor de westerse wereld. De WHO vreest dat bij een uitbraak van een grieppandemie veel ontwikkelingslanden zonder griepvaccin zullen blijven zitten. Daarom wil de WHO dat er in een aantal van deze landen productiefaciliteiten komen, zodat als het nodig is, ook daar pandemisch griepvaccin gemaakt kan worden. Op verzoek van de WHO is het NVI gestart om een makkelijk opschaalbaar en overdraagbaar productieproces te ontwikkelen voor (pandemisch) griepvaccin voor vaccinproducenten in ontwikkelingslanden.
   
   www.nvi-vaccin.nl/?id=67&bid=944
   
   FluSecure, incl. Sanofi:
   ec.europa.eu/research/health/poverty-...
   P.36.
   
2. flosz 4 juli 2008 10:12

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   Acronym: PANFLUVAC
   EC contribution: €3 334 798
   Duration: 48 months
   Starting date: 01/01/2007
   Instrument: STREP
   Key words: Pandemic H5N1 influenza, intranasal
   delivery, virosomal vaccine, lipopeptide adjuvants,
   dendritic cell targeting, pre-clinical to clinical
   evaluation strategy
   
   Influenza epidemics remain a burden for
   both human health and national economies,
   as witnessed by the recent advance of the
   pathogenic avian H5N1 influenza virus. While the
   numbers of human deaths in Europe has remained
   relatively low, the presence of such cases in Turkey
   demonstrates the danger posed by this virus. The
   avian H5N1 virus has now been detected in wild
   birds in numerous European countries, and the
   PANFLUVAC consortium is committed to creating
   an efficacious vaccine against this virus, to
   provide strong protection in a pandemic situation.
   The overall aim of PANFLUVAC is to construct
   vaccine delivery systems for intranasal and
   parenteral vaccines. New H5N1 vaccines are to be
   based on well-established virosome technology
   — proven its worth for efficacious interpandemic
   vaccines — as well as whole virus vaccines. This
   will permit comparison of the intranasal virosomal
   vaccine with the whole virus vaccine. The vaccine
   potency will be enhanced by novel adjuvants
   targeting dendritic cells, offering both antigensparing
   potential and immunopotentiation
   characteristics. Both ISCOMs and lipopeptide
   adjuvants are already proven immunopotentiators,
   biosafe for humans. Certain of these have been
   employed with experimental influenza vaccines
   which allow the new H5N1 vaccines to be
   fast-tracked in their development. Accordingly,
   PANFLUVAC will generate the first H5N1 vaccine
   within the first 18 months of the project.
   The PANFLUVAC project is also designed to
   facilitate rapid modification of the vaccine in
   the face of virus drift. Within the preclinical
   evaluation, the new vaccines will be tested for the
   degree of heterotypic cross protection they offer.
   PANFLUVAC offers a generic vaccine development
   system to provide safe and efficacious vaccines
   against influenza, fitting in with the European
   Commission’s Working Paper on Community
   Influenza Pandemic Preparedness and Response
   Planning.
   
   The challenge
   The avian H5N1 influenza virus is now spreading
   among the wild bird population in Europe, and
   infection of humans has already reached the borders
   of continental Europe. For a truly efficacious vaccine,
   one must consider the route of virus entry into the
   host (the respiratory tract), and host requirements
   for protective immune defences. That is, an ideal
   vaccine should induce both local (mucosal) and
   systemic (serum) immunity.
   Currently, parenterally administered inactivated
   influenza vaccine is the best prophylactic control
   measure. However, parenteral vaccination does
   not ensure induction of local immunity in the
   respiratory tract — the route by which the virus
   infects humans — and from where it transmits
   to other individuals. Inducing mucosal immunity
   by vaccination would enhance control of both
   disease and transmission. Although mucosal
   immunisation has been studied, no acceptable
   intranasal vaccine against influenza is yet
   available. A major problem for the intranasal
   vaccine has been the adjuvant, which is required
   for efficient induction of immunity.
   WHO recommendations
   The WHO assessment of the risk to human
   health from the H5N1 avian influenza virus
   states: 'The disease in humans has no vaccine
   to confer protection and no specific treatment
   once illness becomes severe.' The WHO warning
   that 'outbreaks in birds pose a significant threat
   to human health', and that H5N1 'has the
   potential to ignite a global influenza pandemic
   in humans', has led to an urgent requirement for
   H5N1 pandemic influenza virus vaccines. The
   PANFLUVAC vaccines fit this requirement and
   allow for a rapid response to the entry of H5N1
   into Europe, enforcing the WHO recommendation
   that 'trials of experimental influenza pandemic
   vaccines for humans be accelerated'.
   Antigen-sparing strategies and effects
   of immunomodulatory molecules
   PANFLUVAC is designed to construct a vaccine delivery and formulation to meet current and
   future influenza pandemics. The proposed H5N1
   vaccine will be prepared with regard to the
   immediate needs, as identified above by the
   WHO. In addition, the project will generate the
   'mock-up' library of vaccine reagents to meet
   the permanent threat from pandemic influenza.
   The overall aim is to construct the efficacious
   H5N1 vaccine, enhancing the capacity to protect
   the people of Europe both now and in the
   future, rather than just in the short term. The
   rapidly ageing European population, which is
   particularly vulnerable to influenza complications
   and influenza-related deaths, is a clear reminder
   of the need for better interpandemic as well as
   pandemic vaccines.
   The project allows for ‘robust scale-up of
   vaccine production’, being coordinated by the
   leading group in virosomal technology – Crucell
   (partner 2 CRU). CRU holds the intellectual
   property rights for the application of ISCOMs
   for influenza vaccines. To this end, the project
   employs the latest advances in reverse genetics
   (partner 3 - National Biological Standards Board)
   — referred to in the Commission Working
   Paper (COM(2004)201 final). This allows for
   novel vaccines to be provided within a short
   time. Vaccine efficacy will be enhanced through
   application of novel formulations and adjuvants,
   in response to the requirement in the call for
   antigen-sparing strategies and the application of
   novel immunopotentiating agents. The proposed
   adjuvants, both current and under development,
   will provide the formulated vaccine with a potent
   immunogenicity. Moreover, these selected
   adjuvants target the dendritic cells, which are
   critically important for the activation of an
   efficacious immune response. This allows for the
   development of more efficacious vaccination and
   better usage of the vaccine available.
   By promoting the vaccine to reach the target
   organs and cells more efficiently, lower doses of
   vaccine are required to maintain immunogenic
   concentrations. This increases the likelihood
   of manufacturing potential r eaching demand, and reduces the risk of adverse side effects
   due to incorrect interaction with organs. It also
   responds to the Commission Working Paper
   (COM(2004)201 final), on development of a safe
   vaccine.
   The proposed solution
   PANFLUVAC will create an efficacious vaccine
   inducing potent local and systemic immune
   responses to protect the host and prevent
   viral transmission. This is based on virosomal
   technology, together with a novel lipopeptide
   adjuvant targeting the critical cells of the
   immune system – dendritic cells. Consequently,
   PANFLUVAC will provide a particularly efficacious
   and safe vaccine against influenza virus (H5N1).
   In addition, the basis for efficacious intranasal
   and parenteral vaccines will be established, for
   future demands.
   
   
3. flosz 4 juli 2008 10:13

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   Vervolg.
   
   Aim :
   Considering the evolution of the avian H5N1
   influenza virus and the threat it poses for initiating
   a human pandemic, an efficacious vaccine against
   this virus is urgently required. Accordingly, the
   PANFLUVAC project will construct an efficacious
   vaccine formulation to meet immediate and
   future needs for controlling influenza epidemics
   and pandemics. PANFLUVAC will deliver both
   an efficacious H5N1 vaccine and an inactivated
   whole virus vaccine within the first 18 months of
   the project. The vaccine is based on well-proven
   virosomal technology, together with a novel
   promising ISCOM and lipopeptide adjuvants. By
   investigating novel adjuvants, PANFLUVAC will
   provide the basis for the generation of efficacious
   and safe vaccines to combat both interpandemic
   seasonal influenza and influenza pandemics.
   
   ec.europa.eu/research/health/poverty-...
   p.10.
   
4. [verwijderd] 4 juli 2008 14:07

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   Novartis zou wel eens een probleem kunnen hebben met hun FLUAD-H5N1 Influenza Vaccine.
   
   clinicaltrials.gov/ct2/show/NCT00434733
   
   De trials zijn gedaan in een Poolse kliniek:
   
   clinicaltrials.gov/ct2/show/locn/NCT0...
   
   Naar het nu blijkt zijn een aantal daklozen van de straat geplukt om te participeren in de trial.
   
   Drie artsen en zes verpleegkundigen worden aangeklaagd:
   
   Poland Charges Doctors for Misleading Patients in Drug Test
   
   By Marta Waldoch
   
   July 3 (Bloomberg) --
   
   Poland's regional prosecutor's office charged three doctors and six nurses for misleading volunteers in a drug test by not telling them the vaccine they were testing was against avian influenza and not regular flu.
   
   More than 300 people, including a number of homeless, took part in the trials, which were approved by medical authorities and the country's health minister, prosecutor Agnieszka Reniecka said in an interview today.
   
   All the procedures were followed, except getting the patient's ``conscious agreement'' for the test, the Grudziadz, northern Poland-based prosecutors' office said in a statement yesterday.
   
   Gazeta Pomorska and Polish private television channel TVN24 yesterday reported as many as 21 people might have died in relation to the tests.
   
   They cited Mieczyslaw Waclawski, an executive in a homeless shelter in Grudziadz, who connected the deaths of 21 of his tenants last year with the bird flu vaccine trial.
   
   Although six people who'd been in the tests died, there was no evidence the deaths were linked to the study, Reniecka said.
   
   www.bloomberg.com/apps/news?pid=newsa...
   
   Geen goede zaak, je gaat je meteen afvragen hoe betrouwbaar alle trials eigenlijk zijn.
   
   Recentelijk ook het bericht, dat er eigenlijk geen standaard is om de effectiviteit van vaccins te meten. Iedereen verzint zelf wat. Bevordert ook niet het vertrouwen in vaccins:
   
   Bird flu vaccine strength could be under-or overestimated due to test variability
   
   A study comparing the tests being used by vaccine manufacturers to gauge the effectiveness of their H5N1 avian flu vaccines shows there is a lot of variation in the sensitivity of the tests, the British scientist leading the effort says.
   
   Differences in the sensitivity of the tests mean companies could be underestimating or overestimating the power of their vaccines as they try to work out what is the smallest protective dose, experts admit.
   
   As things stand now, there is no way to usefully compare the results of one company's clinical trials for their vaccine with a competitor's findings.
   
   Hele artikel:
   
   www.canadaeast.com/wellness/article/3...
   
   
5. [verwijderd] 12 juli 2008 18:37

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   Recente studie naar anti-lichamen H5N1:
   
   Short report
   
   Epitope characterization of the protective monoclonal antibody VN04-2 shows broadly neutralizing activity against highly pathogenic H5N1
   
   Angeline PC. Lim , Steven KK. Wong , Annie HY. Chan , Conrad EZ. Chan , Eng Eong Ooi and Brendon J. Hanson
   
   Virology Journal 2008, 5:80doi:10.1186/1743-422X-5-80
   
   
   Published: 11 July 2008
   
   Abstract (provisional)
   
   The monoclonal antibody VN04-2 was previously shown to protect mice against lethal A/Vietnam/1203/04 H5N1 virus challenge when administered pre- and post-infection.
   
   In this study, we characterized the binding requirements of this antibody using direct binding to hemagglutinin and neutralization assays with H5N1 virus-like particles (H5N1-VLP) of eight recent H5N1 strains representing the major mutations within the 140s antigenic loop.
   
   Binding was clade independent and 3 mutations within this antigenic region are required before escape is possible, suggesting that apart from the H5N1 viruses circulating in Indonesia, VN04-2 may provide protection against H5N1 viruses from all other regions.
   
   The complete article is available as a provisional PDF. The fully formatted PDF and HTML versions are in production.
   
   www.virologyj.com/content/5/1/80/abst...
   
   PDF: www.virologyj.com/content/pdf/1743-42...
6. flosz 14 oktober 2008 09:40

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   To save on labor cost and expand vaccination usage in China, the company(Sanofi) is also building a 70 million euro ($95.2 million) manufacturing base in southern China's Shenzhen, in addition to its filling and packaging facility already in operation.
   The new site, to start operation by 2012, will focus on making influenza vaccines with an initial annual capacity of 25 million doses.
   Pisano also said the Shenzhen production facility could be turned into producing pandemic vaccines, such as one for human infections of the often deadly bird flu virus H5N1, "in a matter of weeks."
   search.japantimes.co.jp/cgi-bin/nn200...
   
7. [verwijderd] 14 oktober 2008 10:24

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   In enkele weken zoveel vaccin produceren.
   Op PERC.6 cellijn?
   
   Grootoorvleermuis.
8. flosz 14 oktober 2008 10:28

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   quote:

   Dr. acula schreef:

   In enkele weken zoveel vaccin produceren.
   Op PERC.6 cellijn?
   
   Grootoorvleermuis.
   

   Voorlopig eieren.
   
   Maar er staat ook iets heel anders:
   
   1.: The new site, to start operation by 2012, will focus on making influenza vaccines with an initial annual capacity of 25 million doses.
   
   2. The Shenzhen production facility could be turned into producing pandemic vaccines, such as one for human infections of the often deadly bird flu virus H5N1, "in a matter of weeks."
   
   Ombouwen fabr. van prod. griep vaccin naar pan.griep vaccin is binnen enkele weken mogelijk, er staat niets over prod. aantal. pan.griep vac.
9. [verwijderd] 14 oktober 2008 10:34

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   Ik begrijp het.
   
10. flosz 24 oktober 2008 17:25

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    Responses to Avian Influenza and State of Pandemic Readiness
    Fourth Global Progress Report, October 2008.
    UN System Influenza Coordinator & The World Bank
    un-influenza.org/files/ProgressReport...
    
11. [verwijderd] 27 oktober 2008 09:41

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    Bericht met een steek onderwater ?
    -------------------------------------------------
    
    Vaxart Demonstrates Efficacy of Oral Avian Flu Vaccine in Preclinical Studies
    
    - Using proprietary platform, company develops first orally-administered
    
    vaccine to protect against avian influenza in a large-animal model -
    
    SAN FRANCISCO, Oct. 24 /PRNewswire/ -- Vaxart Inc., a biotechnology
    company focused on the development of oral vaccines, today announced
    positive efficacy results from preclinical studies of the company's oral
    avian flu vaccine.
    
    Sean Tucker, PhD, Vaxart founder and vice president of research, presented data from animal models demonstrating that an orally administered flu vaccine was protective against lethal exposure to H5N1 influenza. Tucker presented the data this morning at the Modern Mucosal Vaccines, Adjuvants & Microbicides (MMVAM) international conference in Porto, Portugal.
    
    Delivery of flu vaccine via a capsule rather than an injection offers
    critical advantages, particularly in the case of a pandemic.
    
    The Vaxart vaccine formulation can withstand ambient temperatures, enabling emergency distribution methods that avoid the transmission risks associated with centralized vaccination clinics.
    
    In the developing world, where medical providers and supplies are scarce, oral vaccination will reduce costs, as well as needle reuse and consequent cross-infection.
    
    The data presented today are from studies measuring the effectiveness
    of an orally-administered avian flu vaccine designed by Vaxart scientists
    using the company's proprietary modular platform.
    
    The Vaxart vaccine (ND1)comprises a non-replicating chimeric adenovirus-5 vector, or delivery vehicle, engineered to express avian flu hemaggluttinin (HA) and a TLR3 ligand as a vaccine adjuvant.
    
    "Injected vector-based vaccines that deliver a target pathogen protein
    have shown excellent potency in animal models, but their application has
    been limited in humans because the immune system typically responds to the
    vector rather than the target," said Dr. Tucker.
    
    "By using oral delivery of a non- replicating vector with a potent adjuvant, we achieve a robust immune response that is focused on the targeted pathogen rather than the delivery vehicle.
    
    This approach addresses the problems that have plagued vector-based vaccination and also allows us to create different vaccines simply by switching out the antigen."
    
    Meer:
    
    www.prnewswire.com/cgi-bin/stories.pl...
12. [verwijderd] 23 december 2008 09:26

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    di 23 dec 2008, 08:54
    
    CDA vreest griepzwanen
    Van onze parlementaire redactie
    
    Den Haag - Het CDA maakt zich grote zorgen om een onderzoek waarbij zwanen met vogelgriep worden besmet en vervolgens worden vrijgelaten. Kamerlid Henk Jan Ormel heeft de ministers Verburg (Landbouw) en Klink (Volksgezondheid) gevraagd dit onderzoek te verbieden, omdat het volgens hem levensgevaarlijk kan zijn.
    
    Het Erasmus Medisch Centrum in Rotterdam wil met het experiment de verspreiding van het virus volgen, maar dat kan volgens Ormel ook zonder besmette zwanen vrij te laten. "In het Duitse Nedersaksen, vlak bij de grens met Nederland, heerst al vogelgriep. Laat ze het daar gaan bestuderen'', zegt hij.
    
    De onderzoekers willen een laagpathogeen, ongevaarlijk virus gebruiken dat in elk geval in laboratoriumomstandigheden veilig is. Ormel, die van huis uit dierenarts is, vreest dat het toch misgaat.
    
    Bron: dft
13. [verwijderd] 23 december 2008 17:25

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    Vogelgriep vlak bij Nederlandse grens
    
    BRUSSEL - In een pluimveebedrijf in het Belgische Bocholt, enkele kilometers van Weert, is vogelgriep vastgesteld. Bij een controle bleken enkele eenden en ganzen besmet met het virus.
    
    De vijfduizend ganzen, eenden, kippen, kalkoenen en ander gevogelte worden uit voorzorg gedood, meldde de Belgische dienst voor veilig voedsel FAVV dinsdag. Ook bij een bedrijf Buggenhout (in Oost-Vlaanderen) is het virus ontdekt en worden dieren preventief gedood.
    
    Het gaat volgens de FAVV niet om de gevaarlijke variant H5N1, maar om een minder besmettelijk type. De dienst zegt dit zo’n tien keer per jaar aan te treffen bij controles.
    
    Het Nederlandse ministerie van Landbouw laat weten dat vooralsnog alleen monsters worden genomen van het pluimvee dat recentelijk met een vijftigtal transporten uit België naar Nederland is vervoerd. Voor extra maatregelen als het extra reinigen van de wagens waarmee de dieren worden vervoerd, is nog geen aanleiding, meldt een woordvoerder.
    
    Medio december werd extra reiniging wel ingesteld voor pluimveetransporten van en naar Nedersaksen (Duitsland) toen daar een milde vorm van vogelgriep bleek te heersen. Nu vindt het ministerie dat niet nodig aangezien er beduidend minder pluimveedrijven zijn in de streek waar de vogelpest nu is opgedoken waardoor het risico kleiner is dat de ziekte zich verspreidt.
    
    bron: telegraaf
14. flosz 24 december 2008 16:54

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    Evolutie van griep: een ‘besmettelijke’ manifestatie
    
    Het Erasmus MC en het Natuurhistorisch Museum Rotterdam organiseren in het kader van het Darwinjaar 2009 de wetenschapsmanifestatie 'H5N1 - De evolutie van een griepvirus'. Deze 'besmettelijke manifestatie' duurt van 12 februari tot en met 25 oktober 2009.
    
    De manifestatie bestaat uit een tentoonstelling, een on-line game en een luister-CD over de voortdurende strijd van wetenschappers met griepvirussen, die zichzelf steeds veranderen en daardoor een gevaar blijven voor de volksgezondheid.
    
    Pandemie
    't Is maar een griepje', zijn de geruststellende woorden bij een gevoel van malaise, dat we maar al te goed kennen. Om de jaarlijkse wintergriep te overwinnen, is een weekje uitzieken gelukkig meestal genoeg. Wie er helemaal geen last van wil hebben, haalt op tijd de 'griepprik', een vaccin dat is gebaseerd op het griepvirus van het jaar ervoor.
    Toch was in de twintigste eeuw drie keer sprake van een grieppandemie: een wereldwijde griepepidemie die miljoenen dodelijke slachtoffers kan maken. Een pandemie kan ontstaan doordat virussen evolueren en dus nieuwe varianten voortbrengen. Bij de grieppandemieën van de vorige eeuw ging het om vogelgriepvirussen, die een voor mensen besmettelijke en ziekmakende nieuwe variant voortbrachten.
    
    Schade
    Onderzoekers, onder andere van de afdeling Virologie van het Erasmus MC, en de overheid kunnen zich op het risico van een grieppandemie voorbereiden en daarmee schade voor individuele burgers en de samenleving beperken. Over griepvirussen, vogelgriep, globale verspreiding, beleidsmaatregelen, vaccins en virusremmers gaat de 'besmettelijke' wetenschapsmanifestatie 'H5N1 - De evolutie van een griepvirus'.
    
    Data en links
    • Tentoonstelling 'H5N1 - De evolutie van een griepvirus' van 12 februari tot en met 25 oktober 2009 te zien in het Natuurhistorisch Museum Rotterdam, Westzeedijk 345 (Museumpark), Rotterdam, website: www.nmr.nl
    • De on-line game 'The Great Flu' is vanaf 12 februari 2009 te spelen via de websites van www.erasmusmc.nl en het www.nmr.nl
    • De luister-cd ''t is maar een griepje' ingesproken door prof.dr. Ab Osterhaus, verschijnt in januari 2009 bij uitgeverij Luisterwijs, Amsterdam.
    
    Uit Monitor okt./nov.: Ab’s lab.
    www.erasmusmc.nl/5663/177341/211028/3...
    
    Uit Crucell-PPP 2005: Ab, en R. Fouchier, Thijs KUIKEN, Guus RimmelZWAAN.
    www.crucell.com/page/downloads/Goudsm...
    
    2005:Crucell has recently partnered with Dr Ab Osterhaus of Rotterdam's Erasmus University to investigate starting an antibody discovery program against avian flu. This program potentially complements Crucell's involvement in influenza vaccine development and production, where it has joined forces with sanofi pasteur.
    
15. ved 24 december 2008 18:04

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    Baxter Receives EMEA Positive Opinion for CELVAPAN, The First Cell Culture-Based Pandemic Flu Vaccine
    
    Posted December 23, 2008
    
    Baxter Receives EMEA Positive Opinion for CELVAPAN, The First Cell Culture-Based Pandemic Flu Vaccine
    
    Clinical data from a Phase III and subsequent booster study demonstrate safety, immune response and cross-protective memory
    
    DEERFIELD, Ill.--(BUSINESS WIRE)--Baxter International Inc. (NYSE: BAX) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA) has issued a positive opinion for the marketing authorization of CELVAPAN, the first cell culture-based H5N1 (avian flu) pandemic vaccine, in the European Union.
    
    The positive opinion precedes the licensure of the "mock-up" vaccine, which allows CELVAPAN to be used if the World Health Organization (WHO) officially declares a pandemic. The positive opinion was based on results from a comprehensive clinical development program, including a Phase III clinical trial that demonstrated vaccines for two different H5N1 virus strains were well tolerated and generated a functional immune response.
    
    "We are very pleased to receive the EMEA's positive opinion for CELVAPAN," said Hartmut Ehrlich, M.D., vice president, BioScience global research and development. "This is another step towards our goal of supplying a safe and effective vaccine to protect the population against a possible influenza pandemic."
    
    A "mock up" vaccine is identical to the future pandemic vaccine in composition and manufacturing; however, since the actual pandemic strain is not known, the vaccine contains another influenza strain not yet exposed to the general population. Once a pandemic is declared, this licensure allows for a fast track approval of the vaccine containing the actual pandemic strain.
    
    CELVAPAN is made using Baxter's proprietary Vero cell technology, which offers advantages against conventional egg-based vaccine technology. Baxter's Vero cell manufacturing process is more rapid due to its ability to use the "native" virus that does not need to be modified in order to grow in chicken eggs. The shorter time for vaccine production is critical in accelerating vaccine supply in response to an influenza pandemic.
    
    CELVAPAN is produced in Bohumil, Czech Republic, at one of the largest cell culture vaccine production facilities in the world. Vero cell technology uses a well-established continuous mammalian cell line to produce the pandemic vaccine.
    
    Baxter's candidate avian flu vaccine is derived from the H5N1 strain A/Vietnam/1203/2004. Its antigen composition and structure are identical to the actual virus circulating in nature. This vaccine formulation alleviates the need to enhance the immune response by including adjuvants (additives) that may cause side effects. In the Phase III study, CELVAPAN induced an immune response that is similar to the body's defense against a natural influenza virus infection.
    
    Phase III Clinical Trial Results
    
    The purpose of the randomized Phase III study was to evaluate safety and immune responses to 7.5 µg of the Vietnam strain vaccine in two age groups (adults 18-59 and elderly, i.e., older than 60). The antibody persistence and immune response to a booster with either the same or a different strain was also measured. The study also investigated the ability of the vaccine to induce cross-immunity against divergent H5N1 strains.
    
    Overall, the vaccine was well tolerated after the first and second vaccination as well as after the booster, with a safety profile similar to currently licensed seasonal influenza vaccines. The most common side effects were injection site pain and headache, fatigue or malaise.
    
    A positive immune response was induced even after only one immunization as determined by measurement of functional antibodies using a microneutralization assay (50.7 percent in the adult group; 54.4 percent in the elderly group). Following the second immunization, 73 percent of subjects in the adult and 74 percent in the elderly age group demonstrated seroneutralizing levels of antibody, meaning the vaccine was found to be at least equally immunogenic in the elderly as in the adult age group. A six-month booster vaccination with either A/Vietnam/1203/2004 or A/Indonesia/05/2005 strain vaccines induced a substantial booster response. A booster vaccination using a different strain resulted in high levels of antibodies against the initial and the booster strain, which is indicative of cross-protective immunological memory.
    
    Last June, The New England Journal of Medicine published data demonstrating CELVAPAN met Phase I/II trial endpoints for safety and immunogenicity (generating a functional immune response). This was the first peer-reviewed publication of study results for CELVAPAN, the first cell culture-derived avian influenza vaccine to undergo clinical evaluation.
    
    About Pandemic Flu
    
    A pandemic is a global disease outbreak caused by an agent for which there is little or no immunity in the human population and which can spread easily from person-to-person worldwide causing serious illness and death. Most cases of avian flu infection in humans have so far resulted from direct or close contact with infected poultry (e.g., domesticated chicken, ducks, and turkeys) or surfaces possibly contaminated from feces of infected birds. Avian influenza infection follows an unusually aggressive clinical course, with rapid deterioration and a high fatality rate.
    
    About Baxter
    
    Baxter International Inc. develops, manufactures and markets products that save and sustain the lives of people with hemophilia, immune disorders, infectious diseases, kidney disease, trauma, and other chronic and acute medical conditions. As a global, diversified healthcare company, Baxter applies a unique combination of expertise in medical devices, pharmaceuticals and biotechnology to create products that advance patient care worldwide.
    
    www.fiercebiotech.com/press-releases/...
    
16. [verwijderd] 16 januari 2009 11:45

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    De overheid in de VS gaat door, zoals verwacht, met Novartis, cell based vaccine:
    
    HHS Awards $487 Million Contract to Build First U.S. Manufacturing Facility for Cell-Based Influenza Vaccine
    
    The U.S. Department of Health and Human Services (HHS) today announced a $487 million multiple year contract with Novartis Vaccines and Diagnostics, Inc., to build the first U.S. facility to manufacture cell-based vaccine for seasonal and pandemic flu. Because cell-based influenza vaccine can be made faster and in greater quantities than traditional vaccine, the new facility is expected to increase the U.S. capacity to make pandemic influenza vaccine by at least 25 percent.
    
    Cell-based vaccine production could more easily meet surge capacity needs because cells could be frozen and stored in advance of an epidemic or developed rapidly in response to an epidemic. Cell-based vaccine production also dramatically reduces the possibility for contamination and promises to be more reliable, flexible, and expandable than egg-based methods.
    
    Currently, influenza vaccines licensed by the U.S. Food and Drug Administration (FDA) are made in specialized chicken eggs using a process that has changed little in over 50 years. In place of eggs, cell-based vaccine production uses laboratory-grown cells that are capable of hosting a growing virus. The virus is injected into the cells where it multiplies. The cells’ outer walls are removed, harvested, purified, and inactivated. Using this technology, a vaccine can be produced in a matter of weeks.
    
    “Today we are taking an important step in our ongoing commitment to pandemic preparedness,” said Dr. Robin Robinson, director of the HHS Biomedical Advanced Research and Development Authority (BARDA), which will oversee the contract. “In a pandemic we would need vaccine ready within six months. That’s why the National Strategy for Pandemic Influenza set domestic surge capacity as a goal in preparing the nation for a pandemic. That goal could not be accomplished using the traditional egg-based method of producing flu vaccine.”
    
    New cell-based influenza vaccines provides an option for people who are allergic to eggs and, therefore, unable to receive current flu vaccines. Cell-based production avoids other problems that egg-based production has, such as a potential shortage of eggs due to poultry-based diseases.
    
    The cell-based vaccine technology can also be used to make vaccines for seasonal influenza and other major emerging infectious diseases.
    
    Under the contract, Novartis and HHS share the cost of the new cell-based influenza vaccine manufacturing facility in Holly Springs, N.C., with the HHS contract covering 40 percent of the cost and Novartis bearing 60 percent.
    
    Also under the contract, Novartis will provide two new flu vaccines for seasonal flu or for pre-pandemic use. The contract builds on progress made through a previous HHS contract award to Novartis to accelerate the development of cell-based influenza vaccine.
    
    The new contract also will fund scientific studies, called clinical bridging studies, to compare existing Novartis vaccines to new ones, including those developed in the new facility, to show that these new ones are also safe and effective. By comparing new and existing vaccines, the company can provide information quickly to the FDA to request licenses for the new vaccines.
    
    If licensed by the FDA, the new cell-based vaccines made in the United States could be purchased for by the federal government for vaccine stockpiles.
    
    www.hhs.gov/news/press/2009pres/01/20...
    
    Blijkbaar ziet men geen onoverkomenlijke bezwaren voor wat betreft het aspect tumor gevoeligheid van MDCK cellijn. Zie bijvoorbeeld:
    
    74.125.77.132/search?q=cache:Ub_LSkun...
17. [verwijderd] 16 januari 2009 12:01

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    dat de overheid id VS heeft geen verstand heeft van verstandig omgaan met financien, weten we inmiddels...maar dat ze, net als de technologie van hun autoindustrie, vertrouwen op ouderwetse biotechnologie is een teken ad wand!
    
    is dit het land van avontuur, ondernemingszin en innovatie?
18. gogogoo 16 januari 2009 14:29

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    Report shows U.S. only half ready for flu pandemic
    
    – Thu Jan 15, 11:18 pm ET
    
    WASHINGTON (Reuters) – U.S. states have made progress in stockpiling drugs and preparing to vaccinate people in case of a flu pandemic but are far behind in plans for the ensuing months of disruption, the government said on Thursday.
    
    The report from the U.S. Health and Human Services department showed most states responsible for maintaining food supply in an emergency were ready, but transportation plans had a long way to go. Experts said the economic crisis would only make things worse.
    
    "It's mixed. I see the glass half full in the sense that the important issues are being addressed seriously by serious people," William Raub, who has been helping organize pandemic preparedness for HHS, told Reuters.
    
    Most health experts agree that a pandemic of something, probably influenza, is inevitable and the U.S. government has been pushing states to develop preparedness plans.
    
    No one can say when or what disease will strike, but the No. 1 suspect now is H5N1 avian influenza, or bird flu, which has infected 394 people and killed 248 of them since 2003.
    
    The virus does not infect people easily now but continues to pop up in flocks of birds in Asia, Europe, the Middle East and Africa and could mutate into a form that people pass easily to one another.
    
    "The pandemic threat is real and continuing, irrespective of how much the perception of the threat may wax or wane over time. Therefore, if we are to counter the next pandemic effectively, we must prepare now," said Raub.
    
    TRYING TO SURVIVE
    
    The 50 U.S. states, five territories and Washington, D.C., got good marks on getting ready to distribute antiviral drugs and vaccines. More difficulties turned up in preparing areas such as 'surge capacity" -- the ability of a hospital to care for a sudden influx of sick or injured patients.
    
    "The vast majority of hospitals are like the vast majority of other elements -- they are in the private sector," said Dr. Til Jolly, deputy chief medical officer at the Department of Homeland Security.
    
    "And economic times are tough," Jolly added.
    
    Mike Osterholm, director of the Centers for Infectious Disease Research and Policy at the University of Minnesota, said the economic recession was already damaging preparedness efforts.
    
    "People are just trying to survive and asking 'Is this the time to be preparing for a catastrophe?'," Osterholm said in a telephone interview.
    
    Association of State and Territorial Health Officials executive director Dr. Paul Jarris said any progress was being jeopardized by reductions in federal funding.
    
    "Federal funding for state and territorial pandemic preparedness ended in August 2008," Jarris said in a statement. In addition, overall federal funding for preparedness activities has been cut by 25 percent since 2005."
    
    Raub said the report had been sent to all states and was meant as guidance.
    
    Many states were still thinking in terms of "an incident", he said, instead of planning for months of disruption that would affect the whole country and the world.
    
    The report said areas funded by the U.S. Centers for Disease Control and Prevention had done their best, including in disease surveillance and laboratory preparation.
    
    But community outreach was still weak. "Most states have not begun to work with businesses, school districts, spiritual leaders or with other non-governmental organizations in planning. These are critical partners that need to be included in pandemic influenza planning," the report said. (Editing by Philip Barbara)
    news.yahoo.com/s/nm/20090116/us_nm/us...
19. aossa 19 januari 2009 14:50

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    In volgend bericht:
    
    www.in-pharmatechnologist.com/Industr...
    
    "Novartis is at the forefront of cell-culture vaccines through its partnership with Dutch firm Crucell and access to the latter’s popular PER.C6 cell line."
    
    ???
    
    Edit: Optaflu waarschijnlijk
20. gogogoo 19 januari 2009 14:53

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    quote:

    aossa schreef:

    In volgend bericht:
    
    www.in-pharmatechnologist.com/Industr...
    
    "Novartis is at the forefront of cell-culture vaccines through its partnership with Dutch firm Crucell and access to the latter’s popular PER.C6 cell line."
    
    ???
    

    Ik zat 'm net ook te plakken.
    
    Hallo, Novartis maakt Optaflu cell-culture flu vaccine ook obv van Per.c6. Zou wel leuk zijn, maar ik denk dat Sanofi het er niet mee eens is.
    
    Novartis gets $487m for US cell culture flu vac plant
    By Gareth Macdonald, 19-Jan-2009
    Related topics: Industry Drivers
    
    Novartis will receive a further $487m (€366m) from the US HHS for its cell-culture flu vaccine plant in Holly Springs, North Carolina.
    
    The facility, which will boost US vaccine production 25 per cent when fully operational in 2012, has been under construction since 2007 when Novartis won its original Department of Health and Human Services (HHS) contract.
    
    The new deal calls for Novartis to develop two new vaccines, for either seasonal or pandemic use, and provides funding for clinical bridging studies designed to compare the firm’s vaccines to existing products in terms of safety and efficacy, potentially expediting their approval by the US Food and Drug Administration.
    
    As Robin Robinson of the HHS’ Biomedical Advanced Research and Development Authority (BARDA) said, the plant and the flexibility it provides are vital to the country’s pandemic plans.
    
    “In a pandemic we would need vaccine ready within six months,” Robinson explained, adding that this goal could not be accomplished using traditional egg-based manufacturing methods.
    
    Andrin Oswald, CEO of Novartis Vaccines and Diagnostics commented that: "The site will provide jobs for more than 300 highly skilled people with the capability to produce cell-based seasonal flu vaccine, pre-pandemic vaccine and 150m doses of pandemic vaccine within six months of the declaration of an influenza pandemic."
    
    The ability to freeze cell cultures means that they can be made available for large scale production in a fraction of the time taken to procure the millions of hens eggs needed to make vaccine using the traditional approach, significantly reducing manufacturing lag.
    
    Such flexability and speed means production can be delayed until the specific virus strain responsible for an epidemic, or pandemic, has been properly identified. This avoids the best -guess, blanket approach of combining several likely strains in a vaccine that is necessitated by the longer manufacturing times needed for egg-based production.
    
    Novartis is at the forefront of cell-culture vaccines through its partnership with Dutch firm Crucell and access to the latter’s popular PER.C6 cell line. In 2007, Novartis’ Optaflu, production of which is due to be switched from the firm’s plant in Marburg, Germany to Holly Springs, became the first cell culture-derived vaccine to be cleared by European regulators.
    
    Joerg Reinhardt, Novartis COO said: "We believe that this contract award underscores the US Government's commitment to ensure pandemic vaccine supply, and reflects their confidence in Novartis.”
    
    The announcement of the new contract coincides with the release of a HHS report highlighting “major gaps” in the country’s strategy for coping with the predicted influenza pandemic.
    
    The authors said that although progress has been made, the protection of government workers as a way of maintaining vital infrastructure was not being given sufficient thought, commenting that “even the best plans can fail if managers cannot accommodate significant absenteeism.”
    
    www.in-pharmatechnologist.com/Industr...