Van beleggers
voor beleggers
Uitgebreid zoeken

Beurscodes, betekenis en hulp bij zoeken

Europa

AEX
Euronext Amsterdam
BRU
Euronext Brussels
PSE
Euronext Paris
LIS
Euronext Lissabon
CHX
CBOE Europe, grote(re) EU aandelen
NAV
Investment Funds (NAV)

Noord-Amerika

NYS
New York Stock Exchange
OTC
CBOE BZX Exchange (US)
TSE
Toronto Stock Exchange

Kunt u een instrument niet vinden?

Zoek dan via de zogenaamde ISIN code. Elk instrument, aandeel etc. heeft een unieke code.

Kies vervolgens - wanneer er meerdere resultaten zijn - de notering op de beurs van uw keuze.

Waar vind ik die ISIN code?

Google de naam van het instrument, aandeel etc. met de toevoeging 'ISIN'.

Als zoeken op ISIN code geen resultaten oplevert hebben wij het instrument of aandeel niet in onze koersendatabase.

desktop iconMarkt Monitor
  • Word abonnee
  • Inloggen

    Inloggen

    • Geen account? Registreren

    Wachtwoord vergeten?
Home  /  Forum  /  Crucell  /  Avian Flu vaccine set for US production

Ontvang nu dagelijks onze kooptips!

word abonnee

Crucell« Terug naar discussie overzicht

Avian Flu vaccine set for US production

28 Posts
Pagina: «« 1 2 | Laatste | Omlaag ↓
  1. agi 9 augustus 2005 10:47
    en hier publicatie in New York Times:

    August 7, 2005
    Avian Flu Vaccine Called Effective in Human Testing
    By LAWRENCE K. ALTMAN
    WASHINGTON, Aug. 6 - Government scientists say they have successfully tested in people a vaccine that they believe can protect against the strain of avian influenza that is spreading in birds through Asia and Russia.

    Health officials have been racing to develop a vaccine because they worry that if that strain mutated and combined with a human influenza virus to create a new virus, it could spread rapidly through the world. (The vaccine cannot lead to such a situation because it is made from killed virus.)

    Tens of millions of birds have died from infection with the virus and culling to prevent the spread of the virus. About 100 people have been infected, and about 50 have died from this strain of the avian influenza virus, called A(H5N1). So far there has been no sustained human-to-human transmission, but that is what health officials fear, because it could cause a pandemic. And that fear has driven the intense research to develop a vaccine.

    The director of the National Institute of Allergy and Infectious Diseases, Dr. Anthony S. Fauci, said that although the vaccine that had undergone preliminary tests could be used on an emergency basis if a pandemic developed, it would still be several months before that vaccine was tested further and, if licensed, offered to the public.

    "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?"

    An earlier human vaccine against the A(H5N1) avian influenza virus was prepared after it first appeared in the world, in Hong Kong in 1997. That vaccine was never fully developed or used, and the strain has mutated since then.

    In interviews over recent days, Dr. Fauci has said that tests so far had shown that the new vaccine produced a strong immune response among the small group of healthy adults under age 65 who volunteered to receive it, although the doses needed were higher than in the standard influenza vaccine offered each year. The vaccine, developed with genetic engineering techniques, is intended to protect against infection, not to treat those who are sick.

    Further tests are expected to be conducted among two groups - people 65 and older, and children - over the next several months. Dr. Fauci expressed confidence that they would confirm the success of the first tests and answer remaining scientific questions.

    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.

    Only a small number of human cases of A(H5N1) influenza have been found. Although a few cases may have been transmitted from person to person in Asia, the A(H5N1) strain has not garnered enough strength to spread widely among humans anywhere.

    As of Friday night, according to the World Health Organization in Geneva, the avian strain has killed 57 of the 112 people it has been known to infect in four countries. They are Cambodia (4 cases), Indonesia (one case), Thailand (17 cases) and Vietnam (90 cases).

    The additional tests are needed in part to determine the optimal dose of vaccine; how many shots people will need for protection; and whether adding another ingredient called an adjuvant to the vaccine could raise the potency of lower doses, stretching the number of people that could be protected. Even when these tests are completed, more time will be needed before the Food and Drug Administration can license the human vaccine and before policy makers determine when and how it should be administered.

    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.

    Although cautioning that the vaccine had not been fully tested, Dr. Fauci said that the initial test findings had given the federal government enough confidence to start the process of adding millions more doses of the vaccine to the 2 million it had bought. The present supply is stored in bulk form, and "we cannot put it in vials until we find out what the right dose is," Dr. Fauci said.

    The manufacturer needs to know the dose and regimen to determine how much more vaccine it can produce and make available to the United States and other customers.

    Scientists had to test the human avian influenza vaccine on volunteers because the A(H5N1) strain differed in significant ways from the conventional strains that cause human influenza.

    Also, the influenza shots that are offered each year are derived from the human strains that are circulating most widely at the time experts choose the components of the next vaccine. Human influenza viruses mutate enough each year to force changes in the standard vaccines. Such vaccines produce a broader and stronger immunity because recipients build up an immunity to influenza from repeated immunizations and exposure to the influenza virus.

    In a sense, the standard annual influenza shots are booster doses. But the A(H5N1) vaccine is a primary immunization because, having had no exposure to that virus, people lack any immunity to the avian strain.

    The United States is thought to be the only country that has produced a human vaccine against the A(H5N1) influenza strain. Australia, Canada, France and Japan are among countries where scientists are trying to develop human avian influenza vaccines, according to the World Health Organization.

    Dr. Fauci's institute also contracted with the Chiron Corporation, which is based in Emeryville, Calif. to make another A(H5N1) vaccine. But tests of the Chiron vaccine have not started because of delays related to prior contamination found in Chiron's plants.

    Dr. Fauci said his institute had 8,000 doses of the Chiron human A(H5N1) vaccine and hoped to start testing it in volunteers in late fall. The tests will follow the same steps taken with the Sanofi-Pasteur vaccine, he said.

    www.nytimes.com/2005/08/07/health/07v...

    agi
  3. [verwijderd] 9 augustus 2005 12:00

    In 2004 we began with the development of PER.C6®-based vaccines for epidemic and pandemic flu with Sanofi Pasteur.
    In 2005 we find ourselves in a fast-growing flu market where cell-based competition is taking shape.
    Our human-cell productionsystem appears to have a number of important advantages over other cell-based systems in terms of manufacturing characteristics.

    While risk is inherent in our industry, we believe we have reduced that risk by working together with the world leader in flu vaccines, as evidenced by the recent$97 million grant the Sanofi-Crucell collaboration received from the HHS in the US.

    Our emphasis on developing our production process has also set us apart from our competitors, and we have prepared ourselves carefully each step of the way.
    Now, together with our efforts on Ebola and West Nile virus, work on our flu program is entering a critical phase. We believe we are well prepared, and it promises tobe a challenging and rewarding year for Crucell.

    Ronald Brus President & CEO

    New vaccines that can be easily and quickly produced for all flu virus strains are urgently needed. Cell-based production could play an important role in meeting the demand that a pandemic will create – a demand that egg-based production cannot meet.

    For the Crucell-Sanofi Pasteur collaboration on PER.C6®-based epidemic and pandemic flu vaccines, 2005 promises to be a significant year, with clinical trials for our vaccine candidates set to begin in Q3.
    In furthering our programs, we aim to make a major contribution to the world’s defences against a possible flu pandemic.

    hugin.info/132631/R/997623/151799.pdf
  4. [verwijderd] 9 augustus 2005 12:07
    Toch worden ook hier veel vraagtekens gezet!

    Commentary
    .
    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.

    Media Resources

    bron:

    www.recombinomics.com/News/08080501/H...

    Dirk
  6. [verwijderd] 9 augustus 2005 12:30
    Questions and Answers
    H5N1 Avian Flu Vaccine Trials

    What is H5N1 avian influenza and why is it of concern to health officials?

    The H5N1 virus is one of 16 different known subtypes of avian influenza (bird flu) viruses. All influenza viruses(human and avian) are of significant concern to health officials because of their ability to mutate rapidly and their propensity for acquiring genes from viruses that infect other animal species. Some H5N1 viruses are highly pathogenic, meaning they can cause severe disease and death in humans.

    H5N1 viruses have been found in birds around the world. As the spread of H5N1 infection among birds increases, so, too, does the opportunity for H5N1 to be transmitted directly from birds to humans. Recently, human H5N1 infection has occurred in Cambodia, Thailand, and Vietnam during large H5N1 outbreaks among poultry, causing great concern among health officials.

    If cases of human infections increase, people simultaneously infected with human and avian influenza strains could become a “mixing vessel” for the disease. The result could be the emergence of a lethal H5N1 influenza virus that is easily transmitted from person to person. Such an easily transmissible virus could trigger a worldwide influenza pandemic.

    What companies received contracts from NIAID to develop H5N1 vaccines for the NIAID-sponsored clinical trials?

    Both sanofi pasteur (Swiftwater, PA) and Chiron (Emeryville, CA) are developing vaccines to be tested in NIAID-conducted clinical trials. Under these contracts, sanofi pasteur has delivered more than 8,000 doses to NIAID and Chiron will produce 10,000 doses.

    Where and how was the seed strain developed?

    The H5N1 “seed strain” (the strain used to produce the trial vaccines) was developed by researchers at St. Jude Children’s Research Hospital, Memphis, TN, using a technique known as reverse genetics. NIAID provided this H5N1 reference virus to sanofi pasteur and Chiron in spring 2004 for vaccine production.

    When will NIAID begin testing the H5N1 vaccines, and where will clinical trials be held?

    The first clinical trial is recruiting volunteers and began start vaccinations on April 4, 2005. This first trial will investigate the sanofi pasteur vaccine’s safety and ability to generate an immune response (immunogenicity). The trial will take place at three NIAID-sponsored Vaccine and Treatment Evaluation Units (VTEUs).

    It is anticipated that all seven of the following VTEUs will participate in one or more planned H5N1 vaccine studies. (The three sites participating in the first adult trial are marked with an asterisk below.)

    Baylor College of Medicine (Houston, TX)
    Cincinnati University Children's Hospital Medical Center (Cinncinnati, OH)
    University of California, Los Angeles*
    Saint Louis University Health Sciences Center (St. Louis, MO)
    University of Maryland School of Medicine* (Baltimore, MD)
    University of Rochester School of Medicine and Dentistry* (Rochester, NY)
    Vanderbilt University Medical Center (Nashville, TN)

    Who will be enrolled in the clinical trials?

    The first study will test the vaccine in approximately 450 healthy adults between the ages of 18 and 64. If data from this study indicate the vaccine is generally safe and able to stimulate a certain immune response, NIAID plans to test the vaccine in other populations, such as the elderly and children. Additional details of the studies will be announced by the participating clinical sites at a later date.

    What vaccine formulations will be tested?

    Because the current H5N1 virus circulating in Asia has never previously infected humans on a large scale, humans have no prior immunity against it. Therefore, NIAID is testing a range of concentrations or “dose levels” of the vaccine in healthy adults to evaluate the vaccine’s safety and its ability to generate an immune response.

    Is NIAID planning to test the vaccine with adjuvants?

    NIAID may in the future test the vaccine with an adjuvant, a substance intended to improve the immune response to the vaccine. NIAID is in discussions with manufacturers concerning production of an H5N1 vaccine that uses alum as an adjuvant.

    If the H5N1 virus currently circulating mutates considerably before the vaccine is ready for the public, will it still be effective?

    We know that flu viruses change over time (a process known as “antigenic drift”). However, in response to the increasing number of H5 cases reported in early 2004, public health officials deemed it critical to move ahead quickly and select one of the available human H5 viruses for vaccine production. If a distinct H5N1 virus should suddenly emerge, an additional new vaccine against that strain may be needed. Ultimately, the experience gained by manufacturers in preparing the current vaccine should make us better prepared for the next time.

    Are antiviral drugs effective in treating avian influenza in humans?

    Data from the World Health Organization’s Global Influenza Surveillance Network indicate that the recently circulating H5N1 strains are susceptible to oseltamivir (sold as Tamiflu), one of two kinds of antiviral drugs approved for use in the United States to treat human influenza infections.

    ###

    Media inquires can be directed to the NIAID OCPL media group at 301-402-1663.

    Prepared by:
    Office of Communications and Public Liaison
    National Institute of Allergy and Infectious Diseases
    National Institutes of Health
    Bethesda, MD 20892

    U.S. Department of Health and Human Services

    www3.niaid.nih.gov/news/newsreleases/...
  7. [verwijderd] 9 augustus 2005 15:00
    US bird flu vaccine passes human test


    The first bird flu vaccine for human use developed by US scientists has passed human test. Scientists say the vaccine can prevent H5N1 virus from infecting human.

    According to a New York Times report dated Aug 6th, the vaccine was developed by the National Institute of Allergy and Infectious Diseases. It can protect healthy people from infection, although it is not able to cure the infected.

    By People's Daily Online

    bron:
    english.people.com.cn/200508/09/eng20...
  8. [verwijderd] 9 augustus 2005 16:24
    quote:

    Alex-j79ux schreef:

    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
    De Telegraaf, dinsdag 9 augustus 2005

    Vaccin in de maak tegen vogelgriep

    Van onze medische redactie


    RIJSWIJK, dinsdag
    Een wereldwijde epidemie van vogelgriep kan mogelijk worden voorkomen door een nieuw vaccin, dat inmiddels succesvol op mensen is getest.
    De hoopvolle geluiden komen van dr. Anthony Fauci van het Nationale Instituut voor Allergieën en Infectieziekten in de Verenigde Staten. Het vaccin wordt door het Franse bedrijf Sanofi-Aventis ontwikkeld in kippeneieren.

    Slachtoffers
    Een probleem is echter nog dat de productie maanden duurt en er bij een dreigende wereldepidemie ongelooflijke hoeveelheden nodig zijn.
    De menselijke variant van het vogelgriepvirus heeft in Azië al meer dan vijftig slachtoffers geëist. Gevreesd wordt dat het virus in de toekomst niet alleen van vogels op mensen overgaat, maar ook van mens op mens. Dan doemt het scenario op van de Spaanse griep van 1918, waar miljoenen mensen aan zijn bezweken.
    Viroloog Ab Osterhaus, van het Erasmus Medisch Centrum in Rotterdam, noemt het positief dat nu is aangetoond dat een mens antistoffen kan aanmaken tegen vogelgriep. Volgens hem moet er nu gezocht worden naar een type vaccin dat op grotere schaal geproduceerd kan worden, bijvoorbeeld een dat gemaakt kan worden met een celkweek.

    De viroloog wijst erop dat momenteel de aanpak van vogelgriep op diverse plaatsen in de wereld wordt onderzocht. Volgens Osterhaus is het de bedoeling om volgende maand tijdens een Europees congres over influenza op Malta de verschillende benaderingswijzen van onderzoekers te bespreken.



28 Posts
Pagina: «« 1 2 | Laatste |Omhoog ↑

Meedoen aan de discussie?

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

Direct naar Forum

Indices

AEX 878,83 -0,39%
EUR/USD 1,0718 +0,07%
FTSE 100 8.121,24 -0,28%
Germany40^ 17.905,20 -0,15%
Gold spot 2.324,99 +1,72%
NY-Nasdaq Composite 15.605,48 -0,33%

Stijgers

Corbion
+2,70%
B&S Gr...
+1,20%
Ahold ...
+1,17%
ForFar...
+1,04%
OCI
+1,00%

Dalers

VIVORY...
-13,94%
EBUSCO...
-5,50%
ACOMO
-4,69%
Air Fr...
-4,29%
Arcadis
-3,88%

Lees verder op het IEX netwerk Let op: Artikelen linken naar andere sites

Gesponsorde links

Meld u aan voor de dagelijkse Beursupdate

Dagelijks een update van het laatste beursnieuws en beleggingskansen in uw mailbox!