Thursday, November 5, 2009

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Deutschland: Dritter Impfstoff zugelassen

05.11.2009
Deutschland hat einen weiteren Impfstoff der Schweizer Firma Novartis die Zulassung erteilt. Nach Focetria darf nun auch Celtura geimpft werden. An mehr als 1.850 Testpersonen wurde Celtura ausprobiert and largely considered to be compatibility. Were for Tests of local vaccination type discomfort at the injection site (redness, swelling and pain) and systemic symptoms such as mild fever, headache and fatigue. Celtura includes the effect enhancer (adjuvant) MF59 and is also suitable for children from 6 months. Yesterday, the President of the Professional Association of Child and Adolescent Physicians, Wolfram Hartmann, repeated his call, the children should be vaccinated. Am 19.10. Hartmann was still skeptical, which should be immunized with vaccine for children: "The vaccine is in them still have not tested, so the risk is too great, it now . Hesitation to use "- see News Archive In Switzerland, the Swiss vaccine Celtura not yet approved and Pandemrix got a ban for kids under 18 and people over 60 (Text: © Kiwi vision data: Blick.ch)

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On Wednesday 21 10, 2009 Jane wrote Mayor of http://www.theflucase.com
a letter to Novartis regarding the vaccine Celtura: excerpt from the original document (to download to
IVG DOWNLOAD
) e-mail from Mayor Jane;
http://www.theflucase.com
Wednesday, October 21, 2009 20:04 pavel.kucera @ novartis.com; presse@pei.de

Dear Pavel Kukera, Susanne Stocker,

I have a series of questions regarding Celtura, the vaccine of Novartis, which only in Germany and Switzerland to statement from a spokeswoman for EMEA used against "swine flu" should be. has

The "swine flu" vaccine "Aflunov" that had to be taken in 2008 from the market because it seems like the death of a number of homeless people in Krakow caused in Poland, after they underwent medical tests, containing the adjuvant "squalene "and now appears to Novartis under the name" CELTURA " be marketed as a new vaccine against swine flu "to.

Three Polish doctors and six nurses now see a prosecution against after she had 350 homeless people in Poland given the material, which seems like it was and Novartis' Aflunov "or Fluad called H5N1 vaccine.

The homeless were given the vaccination for about 2 € under the impression it would be a vaccination against normal seasonal flu.

http://www.telegraph.co.uk/news/worldnews/europe/poland/2235676/Ho Melesse-people-after-the-bird-flu-vaccine-trial-in-Poland.html

In a database of medical tests are medical tests for Novartis' Fluad H5N1/Aflunov listed, with location "Centrum Badań Farmakologii Klinicznej monipol, Kraków, Poland, 30-969.

http://clinicaltrials.gov/ct2/show/NCT00434733
Some of these experiments were apparently with 4,000 people at "home" made one of the homeless, where a large number of people eventually died. Aflunov / Fluad H5N1 containing the adjuvant MF59, squalene. The adjuvant MF59

is also a part of two vaccines against "swine flu" of Novartis, namely Focetria and Celtura (MF59C.1).

Aflunov had in June 2008 by Novartis for a Complaint by the Committee for Medicinal Products (Committee for Medicinal Products for Human Use, CHMP) will be removed from the market.

"The CHMP was concerned about the way the clinical trial was conducted. An inspection of some locations showed that the study, in accordance with "good clinical practice (clinical good practice, GCP) was performed. As a consequence, the study results could not be regarded as reliable and do not use them for evaluation of the vaccine. As a consequence, the clinical database for the assessment of vaccine safety has not been big enough to meet the requirements for guidelines EMEA (European Medicines Agency, EMEA) to meet for pandemic vaccines. Therefore, the CHMP was at the time of market withdrawal, no conclusion can make regarding the risk-benefit balance of Aflunov, "says the official report.

Michael Pfeiderer the Paul Ehrlich Institute, the Commissioner of the Government for the approval of drugs, had said in a report in a medical newspaper that he expected Aflunov received approval for marketing in the autumn of 2008 would

- just before it people killed in an incident that has exposed the Polish police.


http://www.pharmazeutische-zeitung.de/index.php?id=2754
According to a document from Novartis of 11 September 2007 (Novartis Vaccines & Diagnostics in growth and innovation), on 6 Aflunov November 2006 was submitted to the EMEA, had all three clinical trials existed and was about to be registered.


http://www.novartis.ch/downloads/investors/events/broker conferences/2007_09_Novartis_for_BS.pdf
is also significant that Aflunov is listed in the database on medical tests as the vaccine in July 2009 University Hospital Leicester has been tested.


http://clinicaltrials.gov/ct2/show/NCT00814385?term=aflunov&rank=1
Der Untersuchungsleiter ist derselbe Karl G. Nicholson, der auch zusammen mit Dr. Iain Stephenson diesen September im New England Journal of Medicine eine positive Studie über Celturà von Novartis publiziert hat.


http://content.nejm.org/cgi/content/short/NEJMoa0907650v1
Celturà soll den Menschen in Deutschland und der Schweiz verabreicht werden unter speziellen nationalen Lizenzvereinbarungen mit dem deutschen Paul Ehrlich Institut und der schweizerischen Organisation Swissmedic.

Eine Pressemitteilung von Novartis im April 2009 zeigt, dass Aflunov wieder zum Leben erweckt worden ist, nachdem man es im Juni 2008 vom Markt zurückziehen musste und Führungskräfte Novartis had suggested that it would have the potential for the treatment of the "swine flu".


http://insciences.org/article.php?article_id=4665
Novartis has now Aflunov as CELTURA repackaged and sought a national licensing arrangements Baring to avoid probems with the EMEA? Strangely, there is no information about CELTURA although this month for use in Germany by the Paul Ehrlich Institute was recommended.

The fact that the deadly Aflunov contained squalene must arouse fears in the face of the first use of squalene in a vaccine against "swine flu".

Adjuns The MF59 is not approved in the U.S. or the UK. MF59 contains squalene, which auto-immune diseases caused. People in USA and Great Britain, which was injected with a vaccine against anthrax MF59 reported a range of auto-immune diseases and other diseases.

The squalene adjuvant ASO3 is used in the vaccine "Pandemrix" by Glaxo Smith Kline.

vaccines, MF59 and ASO3 and which have not yet been certified for use in an emergency, but that may change.

Why did you Celtura selected as a vaccine? What was their criteria? Which stands for Information Swissmedic or to dispose of the PEI Celtura?

What clinical studies is available to you on Celtura? About Aflunov? Can you send me these studies list or more information?

is a repackaging of Celtura Aflunov? What are the differences?

When will likely Celtura approved? What clinical trials or other tests are carried out by you prior to admission?

Is there clinical data to Celtura and pregnant women? Small children?

What data?

What will conduct clinical trials Swissmedic or PEI after the administration of the vaccine? What studies are set erförderlich? What information will

They gather about the side effects of Celtura? How? What mechanisms do you have for the termination of vaccination, it should also become clear that people are being harmed by the vaccine? What is their criteria? [...] was




So far no satisfactory response from Novartis or PEI.
Ledigtlich one for information and would in due course inform the public of the approval.


"[...] We have noted your concerns As you can imagine, we are currently receiving increased with questions or comments relating to the approval of pandemic vaccines. We are therefore not possible in detail to her question taking. Swiss Medic will inform the public in due course on the approval of the used vaccine. We are happy to refer you to these communications today .[...] "


you download the whole Schrifwechsel download in PDF format that you find in the download section IVG


Source:..
http:// www.schweinegrippe-h1n1.seuchen-info.de/
, theflucase
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