Login
 

Avian Flu vaccine set for US production

Volgen
 
Klik hier om dit forumtopic te volgen en automatisch op de hoogte gehouden te worden bij nieuwe berichten.
28 Posts, Pagina: 1 2 » | Laatste
Aantal posts per pagina:  20 50 100 | Omlaag ↓
[verwijderd]
7
Avian Flu Vaccine Set for U.S. Production


Sunday, August 7, 2005; 4:54 PM

WASHINGTON -- Mass production of a new vaccine that scientists believe can protect against an avian flu outbreak could begin as early as mid-September, the director of the National Institute of Allergy and Infectious Diseases said Sunday.

Dr. Anthony S. Fauci said the government is ready to move ahead with ordering significantly more than the 2 million doses it acquired from a French vaccine maker before testing began earlier this year to jump start the U.S. vaccine stockpile in case the tests were successful.


Preliminary data from the first 115 of the initial tests on 450 healthy adults showed an immune response that scientists believe is strong enough to protect against the avian influenza that's spreading among birds in Asia and Russia. Fauci said he expects analysis of data from the other 300 tests will show similar results.

"We're now, given these results, going to move ahead with ordering from the company additional dozes," Fauci said in a telephone interview. "I can't tell you exactly how many; that's going to depend on the production capability, but certainly it will be significantly more than the 2 million doses."

For the past year, government health officials have been hurrying to develop the vaccine because of fears that the avian influenza strain could change into one that could spread rapidly among humans throughout the world. While the strain has killed millions of birds, only about 50 humans have died from it and so far there has been no widespread transmission of the virus from one human to another.

Fauci predicted that the Food and Drug Administration could approve the new vaccine fairly quickly, since it's similar to prior seasonal flu vaccines the agency approves each year. The bigger problem is the lack of manufacturing capacity to produce the number of doses that may be needed.

An influenza pandemic similar to the one in 1918 that killed 50 million people would require hundreds of millions of doses of the vaccine, Fauci said, and the handful of companies that now make influenza vaccines cannot produce the new bird flu vaccine and the regular seasonal flu vaccine at the same time.

Production of next winter's seasonal flu vaccine will end later this month, meaning it will be mid-September at the earliest before mass production of the bird flu vaccine can get underway, he said.

"It's less a regulatory issue than a production capacity issue," Fauci said.

The next step in the testing process is to try out the vaccine on a group of volunteers over age 65, followed by tests on children. Fauci said trials on the over-65 volunteers will begin within a month, and will take four to six months to complete. Tests on children will follow immediately.

In each case, Fauci said, scientists will determine if there are safety issues associated with giving the vaccine to those more vulnerable groups and what the appropriate dosage level should be for each group.

The initial tests of the 450 healthy adults found that higher doses than normally given in the seasonal flu vaccine were needed to produce the required immune response. Even larger doses likely would be needed to induce a similar immune response in the elderly.

Fauci said more testing is needed to determine the optimal dosage level. Until that is done, the 2 million doses already purchased by the government in bulk form cannot be repackaged for use if there is an emergency.

Health and Human Services Secretary Mike Leavitt said last week the government wants to stockpile 20 million doses of the new vaccine. He estimated that it would take four to six months to mass produce the vaccine.

"We're in the process of doing aggressive contingency planning to determine how we can ratchet up production dramatically," Leavitt said.

www.washingtonpost.com/wp-dyn/content...
[verwijderd]
0
ik zou zeggen..probeer het eens met...juist ja...STAR*)>>:

[..."We're in the process of doing aggressive contingency planning to determine how we can ratchet up production dramatically," Leavitt said.]...



*) als STAR begint gaan de stralen alle kanten op...!!
bv.tanden
0
ordering significantly more than the 2 million doses it acquired from a French vaccine maker =

Le Groupe sanofi-aventis


Kassa ... en eerder dan verwacht. ( de E 60 kan snel komen )

we zullen maandag wel zien

(bedankt en aanbevolen)
barst
0
toch een merkwaardig bericht.
ze gaan het vaccin verder testen o.a. op kinderen en bejaarden om onder meer de juiste dosis vast te stellen.
en dan nu al besluiten om 20 miljoen ipv 2 miljoen dses te bestellen.
maar ja, het zou wel mooi nieuws zijn voor zowel sanofi als voor crucell
Alaskan Timber
0
The bigger problem is the lack of manufacturing capacity to produce the number of doses that may be needed.

Ook dit past in het plaatje (AVA).
[verwijderd]
0
In de herhaling:

flosz - 7-8-05, 00:30 | Reageer | Quote | Zoek | Aanbevolen: 0


"It's good news," Dr. Fauci said. "We have a vaccine."

But he cautioned: "We don't have all the vaccine we need to meet the possible demand. The critical issue now is, 'Can we make enough vaccine, given the well-known inability of the vaccine industry to make enough vaccine.' "

Because the vaccine is made in chicken eggs, "a potential major stumbling block" to successful mass production is the number of eggs farmers can supply manufacturers, Dr. Fauci said.

If manufacturers can overcome such hurdles, the new vaccine could go far in averting a possible pandemic of human influenza, Dr. Fauci said.

Government researchers and others developed the vaccine, which is produced by Sanofi-Pasteur, a French vaccine company that is now part of Aventis. The government could decide to release the product under emergency conditions if an A(H5N1) influenza pandemic struck before the testing process was completed.

***************************************************************************

Daar zij ze weer, de eieren: gelukkig is er meer :

cws.huginonline.com/C/132631/PR/20050...


Euronext, NASDAQ: CRXL) heeft vandaag bekendgemaakt dat zijn partner sanofi pasteur, het vaccinbedrijf van de sanofi-aventis Group, een contract van USD$97 miljoen van de Amerikaanse Health and Human Services Department (HHS (Amerikaanse Ministerie van Volksgezondheid)) heeft ontvangen. Het doel van het contract is het versnellen van registratie van een op PER.C6® gebaseerd griepvaccin en het ontwerp van de bijbehorende vaccinproductiefaciliteit.

Het project is onderdeel van de inspanningen van de Amerikaanse overheid om de productiecapaciteit voor griepvaccins te vergroten in het geval van een pandemische of andere bedreiging van griep voor de volksgezondheid.

Op basis van de overeenkomst heeft sanofi pasteur bekendgemaakt dat het zijn ontwikkeling van een op PER.C6® gebaseerd griepvaccin zal versnellen. Aan het eind van drie jaar zullen Fase 1 en 2 klinisch onderzoek zijn afgerond en zal Fase 3 starten. Daarnaast heeft sanofi pasteur bekendgemaakt dat het een uitgebreid haalbaarheidsplan aan de HHS zal geven voor het bouwen van een in Amerika gevestigde en goedgekeurde productiefaciliteit voor het PER.C6® griepvaccin. Deze productiefaciliteit zal jaarlijks 300 miljoen monovalente doses van het griepvaccin kunnen leveren. Op grond van het contract zal sanofi pasteur het bestaande project versnellen om ongeveer 2 jaar eerder dan gepland een compleet en gedetailleerd ontwerp voor de productiefaciliteit gereed te hebben. Lonza Biologics plc., een biotechnologie contractproducent en onderdeel van The Lonza Group, zal een bijdrage leveren met betrekking tot het opschalen tot zeer grote volumes van PER.C6® cel-cultuur en de bouwtekening van de productiefaciliteit. Het contract omvat niet de daadwerkelijke bouw van de fabriek.

"We zijn verheugd dat Crucell's PER.C6® cellijn het platform zal zijn voor het ontwikkelen van een nieuw griepvaccin," zei Crucell's CEO, Ronald Brus.

"Het produceren van voldoende griepvaccin in het geval van een grieppandemie vraagt om een flexibel, grootschalig productiesysteem dat alle griepvarianten kan produceren," voegde Jaap Goudsmit, Crucell's Chief Scientific Officer daaraan toe. "We zijn verheugd dat de Amerikaanse overheid de PER.C6® productietechnologie heeft geselecteerd en op waarde schat om aan deze eisen te voldoen."

Over pandemische griep
Een grieppandemie kan een grotere toename van doden en ziektegevallen veroorzaken dan bijna elke andere natuurlijke bedreiging van de gezondheid. Een pandemie doet zich voor als er een zodanige wijziging in het griepvirus is, die resulteert in een risico voor het overgrote deel van de bevolking. In de 20ste eeuw hebben zich drie pandemieën voorgedaan. De meeste ernstige, in 1918, heeft aan meer dan 500.000 Amerikanen en meer dan 20 miljoen mensen wereldwijd het leven gekost. Recente gevallen van ziekte en doden onder mensen veroorzaakt door het vogelgriepvirus in Thailand, Nederland en in andere delen van de wereld benadrukt het gevaar van nieuwe varianten die mensen infecteren. Recente productieproblemen bij Chiron's op eieren gebaseerde griepvaccinfabriek tijdens het 2004 griepseizoen geven de kwetsbaarheid van de huidige beschikbare producten en productiefaciliteiten aan.

++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++


cws.huginonline.com/C/132631/PR/20040...

"PER.C6(TM) technologie is in staat op een betere wijze jaarlijkse productie van grote hoeveelheden griepvaccin mogelijk te maken," zei Michel DeWilde, executive vice-president, research and development voor Aventis Pasteur. "In tegenstelling tot andere celproductietechnologieën, maakt PER.C6(TM) grootschalige productie tegen concurrerende kostprijs mogelijk. Tevens is PER.C6(TM) niet onderhevig aan bepaalde beperkingen van andere celproductietechnologieën. Andere technologieën vereisen veelal enorme schaalvergroting van fysieke productiecapaciteit ten opzichte van bestaande, op eieren gebaseerde, productiesystemen."

"Wij geloven dat Crucell's PER.C6(TM) productietechnologie gecombineerd met het marktleiderschap van Aventis Pasteur en hun kennis en ervaring op het gebied van vaccinontwikkeling, zal leiden tot een nieuwe generatie van op cellen geproduceerde griepvaccins. Deze vaccins hebben op termijn de potentie huidige op eieren geproduceerde vaccins te vervangen," zei Dinko Valerio, voorzitter en CEO van Crucell. "Dit is onze eerste strategische overeenkomst voor het ontwikkelen en commercialiseren van één van Crucell's vaccinprogramma's. Het stelt Crucell in staat een aanzienlijke speler te worden in de grote, groeiende griepmarkt. Daarnaast zal het de wereldwijde commerciële ontwikkeling van een op PER.C6(TM) geproduceerd product versnellen."
[verwijderd]
2


Van Yahoo:

Bird Flu Vaccine: Across ALL Wires
by: MOZGI99 (?/M/a desert island)
Long-Term Sentiment: Strong Buy 08/08/05 05:06 am
Msg: 18004 of 18004

Bird flu vaccine works on people

but....

US National Institute of Allergy and Infectious Diseases director Anthony Fauci said the findings were a step forward but did not overcome the major hurdle of producing enough vaccine to meet demand in the event of a flu pandemic

Now....

Though this vaccine may not be effective against a worldwide pandemice with the evolution of the virus, it is a step in controlling rapid confusion, and fear in society.

Within 3-6 Weeks Orders in The Hundreds of Millions will be put into place, and then the major hurdle of producing vaccine will be met...
with one company..
and one company alone..

crucell.

Larger firms see this in the current downgrades and are using current market manipulation schemes to load up on stock. The next phase can push crucell into the 50-80 dollar level if not higher, and with the low daily volume this is the only way in.

Don't trade on fear,
but on knowledge,
fear is how the market is manipulated,
knowledge is what creates future 20 baggers.

but,
just a joe schmoe,
what do i know?

Trade on knowledge, accumulate as much as possible, someone else is buying here, actually multiple buyers using multiple marketmakers to accumulate, its beneath the tape. The Sec sees.

mozgi
[verwijderd]
2
US Considers a Third H5N1 Bird Flu Pandemic Vaccine Dose

Recombinomics Commentary
August 8, 2005

Doctors at these centers drew blood from the volunteers to document that they had no antibody to A(H5N1) before they received the first of two injections of the vaccine. Then the doctors drew another blood sample four weeks later when the volunteers received a second injection of the vaccine.

Fauci said his team was considering drawing a fourth blood sample to measure the antibody response over a longer period. He also said that the team was considering adding a third dose of vaccine to determine the maximum response that the vaccine could elicit.

The consideration of a third dose strongly suggests that two doses of 90 micrograms each, generated a response that was far from ideal. This is of concern for a number of reasons.

The above data was generated using younger adults injected with a 2004 reverse engineered version of H5N1 from Vietnam. The group tested will likely generate the best response, so the response in the over 65 group or children may be weaker. Since this is a pandemic vaccine, requiring three shots over an extended time period is also less than ideal, especially if the vaccine has to be used under pandemic conditions.

The borderline response is also of concern with regard to supply. The amount of an individual virus required in the human flu vaccine is 15 micrograms. At the highest doses tested, 180 micrograms were used, which is 12X the amount used for a human virus. A third shot would raise that total to 18X per person. Since the FDA approved method of antigen preparation involves growing the reverse engineered virus in chicken eggs, the number of eggs currently limits supply. This limitation may be exacerbated by poor growth of the virus, which has a tendency to kill the chicken embryo.

A borderline response also raises concerns about utility of the vaccine against an evolving H5N1. Sequences from early 2005 isolates from Vietnam show that HA has 4 amino acid differences with the vaccine prototype strain and NA has 3 differences. Although these differences are modest, they could be enough to make the border line pandemic vaccine ineffective.

Of even greater concern, however, is the H5N1 traveling and transmitting in Russia, Kazakhstan, and Mongolia. These strains almost certainly are linked to the Qinghai Lake outbreak. Isolates from Qinghai Lake have been sequenced and they differ from the pandemic strain at 18 amino acid positions in HA and 13 positions in NA. These changes a similar to differences between the 1997 H5N1 from Hong Kong and 2004 H5N1 from Vietnam. Because of these large numbers of changes, the 1997 pandemic vaccine was not considered a candidate for development against the 2004 H5N1 outbreak.

Thus, the pandemic vaccine results are similar to the results from treating mice with oseltamivir (Tamiflu). The treatment did generate a dose response curve, but even though the amount of Tamiflu used was 5X the FDA approved amount for treatment (and 10X the amount approved fro prevention, 50% of the mice died, even though they were infected after the Tamiflu flu treatment had been initiated.

Therefore, both pandemic vaccine and H5N1 anti-viral data indicate significantly more work is required and the existing treatments will do little to blunt a raging pandemic.

As H5N1 approaches Europe and the summering migratory birds in northern China and southern Russia prepare to head south to recombine with endemic H5N1 in areas like southeast Asia and probably China and India, there is considerable cause for concern.

www.recombinomics.com/News/08080501/H...
[verwijderd]
1
quote:

flosz schreef:




The consideration of a third dose strongly suggests that two doses of 90 micrograms each, generated a response that was far from ideal. This is of concern for a number of reasons.

The above data was generated using younger adults injected with a 2004 reverse engineered version of H5N1 from Vietnam. The group tested will likely generate the best response, so the response in the over 65 group or children may be weaker. Since this is a pandemic vaccine, requiring three shots over an extended time period is also less than ideal, especially if the vaccine has to be used under pandemic conditions.

The borderline response is also of concern with regard to supply. The amount of an individual virus required in the human flu vaccine is 15 micrograms. At the highest doses tested, 180 micrograms were used, which is 12X the amount used for a human virus. A third shot would raise that total to 18X per person. Since the FDA approved method of antigen preparation involves growing the reverse engineered virus in chicken eggs, the number of eggs currently limits supply. This limitation may be exacerbated by poor growth of the virus, which has a tendency to kill the chicken embryo.

A borderline response also raises concerns about utility of the vaccine against an evolving H5N1. Sequences from early 2005 isolates from Vietnam show that HA has 4 amino acid differences with the vaccine prototype strain and NA has 3 differences. Although these differences are modest, they could be enough to make the border line pandemic vaccine ineffective.



Thus, the pandemic vaccine results are similar to the results from treating mice with oseltamivir (Tamiflu). The treatment did generate a dose response curve, but even though the amount of Tamiflu used was 5X the FDA approved amount for treatment (and 10X the amount approved fro prevention, 50% of the mice died, even though they were infected after the Tamiflu flu treatment had been initiated.

Therefore, both pandemic vaccine and H5N1 anti-viral data indicate significantly more work is required and the existing treatments will do little to blunt a raging pandemic.





Crucell= Alive and Kicking!

"PER.C6(TM) technologie is in staat op een betere wijze jaarlijkse productie van grote hoeveelheden griepvaccin mogelijk te maken," zei Michel DeWilde, executive vice-president, research and development voor Aventis Pasteur. "In tegenstelling tot andere celproductietechnologieën, maakt PER.C6(TM) grootschalige productie tegen concurrerende kostprijs mogelijk. Tevens is PER.C6(TM) niet onderhevig aan bepaalde beperkingen van andere celproductietechnologieën. Andere technologieën vereisen veelal enorme schaalvergroting van fysieke productiecapaciteit ten opzichte van bestaande, op eieren gebaseerde, productiesystemen."

"We zijn verheugd dat Crucell's PER.C6® cellijn het platform zal zijn voor het ontwikkelen van een nieuw griepvaccin," zei Crucell's CEO, Ronald Brus.

"Het produceren van voldoende griepvaccin in het geval van een grieppandemie vraagt om een flexibel, grootschalig productiesysteem dat alle griepvarianten kan produceren," voegde Jaap Goudsmit, Crucell's Chief Scientific Officer daaraan toe. "We zijn verheugd dat de Amerikaanse overheid de PER.C6® productietechnologie heeft geselecteerd en op waarde schat om aan deze eisen te voldoen."
Alex-j79ux
1
Ab Osterhaus meldt heden in de telegraaf :

Succesvolle tests op mensen van vogelgriepvaccin van Sanofi geproduceerd op basis van kippeneieren.

“Er moet nu gezocht worden naar een type vaccin dat op grotere schaal geproduceerd kan worden, bijvoorbeeld een die gemaakt kan worden met een celkweek”.

“De aanpak van vogelgriep wordt op diverse plaatsen in de wereld onderzocht”.

“Het is de bedoeling, volgende maand tijdens een Europees congres over influenza op Malta de verschillende benaderingswijzen van onderzoekers te bespreken.

Vr.gr

Louis
1955
0
osterhaus is al decennia erg op de hand van solvay, die zijn ook met celkweek bezig zoals bekend hier.
Wij prefereren Crucell (niets verrassend) dat via Sanofi-Aventis een beter process heeft (beat them)
[verwijderd]
0
[verwijderd]
0
WHO: New bird flu vaccine "good beginning, not silver bullet"

The new human bird flu vaccine being tested in the United States is a good step toward preventing a potential pandemic, but it shouldn't be mistaken for a "silver bullet," the World Health Organisation said Monday.

But he also said the vaccine is difficult to produce and is only effective if given in large doses.

Other scientists say the development of any bird flu vaccine must be accompanied by international programs to distribute it in countries where a pandemic is likely to originate - most likely in Asia where many poor countries will not be able to afford it.

The promising results were based on a study involving healthy adults and did not include testing on children, the elderly and people with chronic illnesses - the most vulnerable groups to flu - raising questions about the vaccine's overall effectiveness, said Dick Thompson, a WHO spokesman in Geneva.

"This is a good beginning," Thompson said of the results. "Is it perfect to produce? Is it the silver bullet? No, it's not, but it's a good start."

www.eitb24.com/noticia_en.php?id=81345
28 Posts, Pagina: 1 2 » | Laatste
Aantal posts per pagina:  20 50 100 | Omhoog ↑

Plaats een reactie

Meedoen aan de discussie?

Word nu gratis lid of log in met je emailadres en wachtwoord

Direct naar Forum

Meer »

Koers 0,000   Verschil 0,00 (0,00%)
Laag 0,000   Volume 0
Hoog 0,000   Gem. Volume 0
01-jan-01 00:00

Meer »

Teamleider Logistiek (Venlo)

Als Teamleider Logistiek ben je verantwoordelijk voor jouw processen binnen de vestiging. 27 mrt - XPO Logistics

27 mrt Klantgerichte manager Wonen (Lisse)
27 mrt Manager Accounting (Huizen)
27 mrt Schipper dagtochten (m/v, fulltime of partti...