swine_flu

News1

http://www.euroinvestor.co.uk/news/story.aspx?id=10639073

Novartis A(H1N1) Pandemic Influenza vaccine Focetria® receives positive opinion from CHMPCorporate news announcement processed and transmitted by Hugin AS.The issuer is solely responsible for the content of this announcement. ------------------------------------------------------------------------------------

* Significant milestone in bringing pandemic influenza vaccines tomarket in Europe

* Novartis delivers first shipments of A(H1N1) vaccine togovernments in Europe just three months after the WHO declarationof the pandemic

* Focetria formulated with MF59® adjuvant which can boost thebody's immune response and increase protective antibody levelswith less antigen than needed with non-adjuvanted vaccines

Basel, September 25, 2009 - Novartis announced today that Focetria®,the Novartis Influenza A(H1N1) 2009 monovalent vaccine, has receiveda positive opinion from the Committee for Medicinal Products forHuman Use (CHMP) of the European Medicines Agency (EMEA). Thepositive opinion clears the way for European Union approval in all 27Member States as well as in Iceland and Norway. Today's announcementmarks a significant milestone in bringing a pandemic vaccine tomarket in Europe.

Focetria, the Novartis Influenza A(H1N1) 2009 monovalent vaccine isan inactivated influenza virus vaccine indicated for activeimmunization of persons of six months of age and older againstinfluenza disease caused by the novel pandemic A(H1N1) influenzavirus. The pandemic vaccine has been developed using traditionalinfluenza manufacturing processes in an egg-based formulation.Focetria contains MF59®, Novartis proprietary adjuvant, which hasbeen added to boost the immune response in individuals receiving thevaccine. MF59 can elicit protective antibody levels with a lowerdose, just 7.5 micrograms of viral antigen versus 15 micrograms innon-adjuvanted vaccines, potentially resulting in greater vaccinesupply.

Novartis has already started first deliveries of pandemic vaccinesunder quarantine to governments in Europe, despite the initially lowyields with the current production seed strain provided by the WorldHealth Organization (WHO). A new seed strain could provide highervolumes.

"Only three months after the declaration of the pandemic by the WHO,Novartis was able to ship the first batches of our pandemic vaccineunder quarantine to governments in Europe pending EU approval," saidAndrin Oswald, CEO of Novartis Vaccines and Diagnostics. "This CHMPpositive opinion paves the way for EU approval, which will allowgovernments to begin their vaccination campaigns with the goal ofreaching more patients before the rapidly spreading virus reachesthem. Several recent clinical trials suggest that just one dose ofpandemic vaccine can protect healthy adults, which means that now thevaccine can be provided to more people than if two doses wereneeded."

Focetria was previously approved by the EU in May 2007 as a mock-upfile to be used once the WHO declared a pandemic. This previousapproval was based on clinical studies involving the MF59 adjuvantand different influenza strains with pandemic potential, includingH5N1 and H9N2.

Novartis also plans to begin delivery of its Fluvirin® A(H1N1)monovalent vaccine to the US market by early October. The US Food andDrug Administration approved this vaccine on September 15, 2009. Dataderived from recent clinical trials of Fluvirin conducted in CostaRica indicate that a single-dose regimen is as effective as atwo-dose regime in healthy adults ages 18-64 suggesting the potentialto extend A(H1N1) vaccine supply further to support public healthefforts. The trial was conducted in 784 healthy adults.

About MF59®Novartis proprietary MF59 adjuvant has an established safety profile,supported by more than 12 years of clinical safety data and more than40 million doses of commercial use in Europe. The adjuvant has beenstudied in clinical trials involving more than 26,000 people,including children, and has been licensed for use in people 65 yearsof age and over in the seasonal influenza vaccine, Fluad®, since 1997in the European Union. Fluad is not licensed for sale in the U.S.

DisclaimerThe foregoing release contains forward-looking statements that can beidentified by terminology such as "can," "potentially," "could,""will," "suggest," "potential," "plans," "suggesting," or similarexpressions, or by express or implied discussions regarding potentialmarketing approvals for Novartis' A(H1N1) vaccines, potentialproduction timing and volumes for such vaccines or regardingpotential future revenues from such vaccines. You should not placeundue reliance on these statements. Such forward-looking statementsreflect the current views of management regarding future events, andinvolve known and unknown risks, uncertainties and other factors thatmay cause actual results to be materially different from any futureresults, performance or achievements expressed or implied by suchstatements. There can be no guarantee that A(H1N1) vaccines will be

approved for sale in any market. Nor can there be any guarantee thatA(H1N1) vaccines will be produced by any particular date, or in anyparticular volumes. Nor can there be any guarantee that A(H1N1)vaccines will achieve any particular levels of revenue in the future.In particular, management's expectations regarding A(H1N1) vaccinescould be affected by, among other things, unexpected regulatoryactions or delays or government regulation generally; unexpectedmanufacturing difficulties or delays, including unexpecteddifficulties with our flu cell culture manufacturing facility andprocesses; unexpected clinical trial results, including unexpectednew clinical data and unexpected additional analysis of existingclinical data; the company's ability to obtain or maintain patent orother proprietary intellectual property protection; competition ingeneral; government, industry and general public pricing pressures;the impact that the foregoing factors could have on the valuesattributed to the Novartis Group's assets and liabilities as recordedin the Group's consolidated balance sheet, and other risks andfactors referred to in Novartis AG's current Form 20-F on file withthe US Securities and Exchange Commission. Should one or more ofthese risks or uncertainties materialize, or should underlyingassumptions prove incorrect, actual results may vary materially fromthose anticipated, believed, estimated or expected. Novartis isproviding the information in this press release as of this date anddoes not undertake any obligation to update any forward-lookingstatements contained in this press release as a result of newinformation, future events or otherwise.

About NovartisNovartis Vaccines and Diagnostics is a division of Novartis focusedon the development of preventive treatments. The division has twobusinesses: Novartis Vaccines and Novartis Diagnostics. NovartisVaccines is the world's fifth-largest vaccines manufacturer andsecond-largest supplier of flu vaccines in the US. The division'sproducts also include meningococcal, pediatric and travel vaccines.Novartis Diagnostics prevents the spread of infections through thedevelopment and marketing of innovative technologies that enableearly detection of pathogens to protect the world's blood supply andprevent the spread of infectious diseases.

Novartis provides healthcare solutions that address the evolvingneeds of patients and societies. Focused solely on healthcare,Novartis offers a diversified portfolio to best meet these needs:innovative medicines, cost-saving generic pharmaceuticals, preventivevaccines, diagnostic tools and consumer health products. Novartis isthe only company with leading positions in each of these areas. In2008, the Group's continuing operations achieved net sales of USD41.5 billion and net income of USD 8.2 billion. Approximately USD 7.2billion was invested in R&D activities throughout the Group.Headquartered in Basel, Switzerland, Novartis Group companies employapproximately 99,000 full-time-equivalent associates and operate inmore than 140 countries around the world. For more information,please visit http://www.novartis.com.

News2

http://www.emea.europa.eu/influenza/newsroom/newsroom.html#

swine_flu2.pdf

http://www.pharmabiz.com/article/detnews.asp?articleid=51901

http://www.mt-id.org/

News3

http://health.yahoo.com/news/afp/healthfludrugsemeaeu_20091023160327.html

EU agency urges two-dose swine flu jab

By AFP - Fri Oct 23, 9:01 AM PDT

LONDON (AFP) - Three swine flu vaccines authorised for use in the EU should still be taken in two doses, although a single injection could be enough for two of them, the European Medicines Agency (EMEA) said Friday.

A nurse vaccinates a medical worker, on October 20, 2009 at the Necker hospital in Paris as France begins vaccinating key medical workers against swine flu. Three swine flu vaccines authorised for use in the EU should still be taken in two doses, although a single injection could be enough for two of them, the European Medicines Agency (EMEA) said Friday.(AFP/File/Francois Guillot)

The EMEA's committee for medicinal products for human use has reiterated recommendations from September that the three vaccines -- Celvapan, Focetria and Pandemrix -- should be taken as two doses at least three weeks apart.

But according to the limited data available so far, one dose for Pandemrix and Focetria may be enough.

Celvapan is made by US drugmaker Baxte, Focetria by Novartis of Switzerland and Pandemrix by Britain's GlaxoSmithKline.

The World Health Organisation said Friday nearly 5,000 people have died from swine flu infections since the A(H1N1) virus was detected in April.

Many European Union member states are now starting vaccination programmes as winter approaches in the northern hemisphere.

News4

http://www.pharmabiz.com/article/detnews.asp?articleid=51901&sectionid=3&z=y

Novartis influenza A(H1N1) monovalent vaccine Focetria gets positive opinion from CHMP

Wednesday, September 30, 2009 12:00 IST Basel

Novartis announced that Focetria, the Novartis Influenza A(H1N1) 2009 monovalent vaccine, has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP)

News5

Israeli Health Ministry Challenged On Swine Flu Vaccines

Written by Daisy, J. Stern, MD

Friday, 06 November 2009 01:25

Dr Daisy J Stern MD writes to Professor Dan Engelhard of Hadassah University Hospital, Israel and says: I reminded you of the squalene and polysorbate 80 contained in these vaccines, and about the dangers of auto-immune reactions, neurotoxicity, and infertility that these vaccines present.

This is a letter addressed to Professor Engelhard of the Ministry of Health in Isreal. It will also be a petition; please sign too, specially if you are an MD, an RN, etc. Either they listen, or we do a Bagatz. LAWYERS WELCOME TOO!!

Professor Dan EngelhardHead, Department of Pediatrics, Infectious DiseasesHadassah University Hospital, Ein-KeremPOB 12000, Jerusalem 91120, IsraelFax: 02-6434579Tel: 02-6778960, 050-7874040

Jerusalem, Nov. 4th, 2009

Dear Professor Engelhard,

A few days ago I spoke to you on the phone, and expressed my serious concerns to you regarding the decision of the Ministry of Health in Israel to administer Focetria and PandemRix, the two adjuvanted H1N1 vaccines respectively from Novartis and GSK, to the unsuspecting population of Israel.

I reminded you of the squalene and polysorbate 80 contained in these vaccines, and about the dangers of auto-immune reactions, neurotoxicity, and infertility that these vaccines present. You responded to me that you were well aware of the dangers involved, but that you and your panel of physicians , specialists in their respective fields, had decided that benefits outweigh the risks, based on worldwide mortality statistics due to the H1N1 virus.

Professor Engelhard, please let me remind you of the following facts ( I have included one or two references for each topic, but there are many, many more, some peer- reviewed, some not. Time is of the essence and unfortunately I do not have time to include them all at present).

Main points:

1.The statistics presented by the CDC and other monitoring bodies are severely distorted: the proven number of deaths due to the actual H1N1 virus is much smaller than previously reported: most cases were of patients who died of underlying, concomitant conditions, yet were labeled as H1N1 related deaths. Furthermore, a large number of so-called H1N1 cases were never actually proven to be such, cases counted even including phone calls made to doctors by patients worried they might have the H1N1 virus.

http://www.cbsnews.com/stories/2009/10/21/cbsnews_investigates/main5404829.shtml

2. H1N1 is a mild influenza virus, much milder even than regular, yearly seasonal influenza. The number of deaths is relatively small, compared to yearly influenza mortality rates.

http://articles.mercola.com/sites/articles/archive/2009/11/03/What-We-Have-Learned-About-the-Great-Swine-Flu-Pandemic.aspx

3. The Southern Hemisphere winter season passed without any major catastrophe. The flu season already peaked in the USA.

http://articles.mercola.com/sites/articles/archive/2009/11/03/What-We-Have-Learned-About-the-Great-Swine-Flu-Pandemic.aspx

4. There IS vaccine available that does not contain either adjuvant or thimerosal. That vaccine is being used on 250,000 German soldiers.

http://www.fightbackh1n1.com/2009/10/german-soldiers-to-receive-different.html

5. Squalene is highly neurotoxic and causes severe auto-immune reactions, even deaths.

http://www.without-consent.com/media/SqualeneReferences-AnimalToxicology.pdf

6. The concentration of squalene in both Focetria and PandemRix is between half a million to a million times higher than the squalene contained in the anthrax vaccine administered to US soldiers in 1991, which was seriously implicated in the Gulf War Syndrome, and from which hundreds of thousands of soldiers suffered terribly, and many thousands died.

http://uncensored.co.nz/2009/08/26/million-times-more-squalene-in-h1n1%20-vax-than-caused-gwi/

Ongoing administration of unlisted vaccines in the US military caused severe reactions and even deaths in thousands of people. The IDF also recently participated in illegal anthrax vaccine experiments on 716 unsuspecting Israeli soldiers ; administration of toxic substances by the US and Israeli government is nothing new.

http://pubchem.ncbi.nlm.nih.gov/summary/summary.cgi?cid=638072

http://www.youtube.com/watch?v=Q7M_TZpQiIY

7. The unnecessary H1N1 vaccination campaign of 1976 caused many cases of Guillain-Barre, some of them permanent. Just as today, people were not informed of the potential dangers involved in taking these highly toxic substances.

http://www.personalgrowthcourses.net/video/swine_flu_vaccine_2

8.Pandemrix has barely been tested on children at all, and has been banned from use in Switzerland below the age of 18, because of lack of clinical data.

http://www.physorg.com/news176099207.html

http://www.emea.europa.eu/humandocs/PDFs/EPAR/pandemrix/emea-combined-h832en.pdf

9. The only studies done with Focetria, containing the MARKETABLE PRODUCT, were on a total of 132 people.

( http://www.emea.europa.eu/influenza/vaccines/focetria/focetria.html )

10. The combination of squalene and polysorbate 80 in a buffered solution has been shown to be an excellent anti-fertility combination, in anti-fertility research performed by scientists for the W.H.O., who were assigned the job of developing anti-fertility vaccines to reduce world population. Giving these vaccines to our young population is tantamount to sterilizing them.

(Fertility Impairing Vaccine And Methods of Use' This application claims the benefit of U. S. Provisional Application No. 60/070,375, filed January 2,1998, U. S. Provisional Application No. 60/071,406, filed January 15,1998).

11. Giving these vaccines to our population is equivalent to using them as guinea pigs for the rest of Europe, the world, and specially for pharmaceutical companies, as they have not yet been properly tested in children or adults in other countries.

See reference , article #8.

12. Because of the recombinant nature of the H1N1 antigen used in the manufacture of these vaccines, there is significant risk that the vaccine itself will lead to a much more serious pandemic, by reassorting itself with other viruses in the community.

http://clareswinney.wordpress.com/2009/10/28/obamas-h1n1-swine-flu-national-emergency-evidences-vaccine-market-building-for-mass-murder/

I understand that, in accordance with W.H.O. directives, and with Prime Minister Benjamin Netanyahu's agreement, the goal of the Ministry of Health is to inject the WHOLE POPULATION OF ISRAEL WITH THESE DEADLY VACCINES by December 31st.

I urge you to cancel the decision to use PandemRix in our children ages 3-10, and desist as well from using Focetria in the rest of our population. The orders of the Ministry of Health significantly and unnecessarily endanger our whole population; the current risk of H1N1 pandemic clearly does not warrant such a step at this time. And even if there was a real need for a vaccine, using an adjuvanted vaccine that contains thimerosal is totally unwarranted and contraindicated.

Yours sincerely,

Daisy, J. Stern, MDFamily and Preventive Medicine.

USA and Israel.

Israel Truth Times Blogspot

News6

http://www.flutrackers.com/forum/showthread.php?t=23582

EU approves Novartis's 'mock-up' pandemic vaccine

Robert Roos News Editor

May 9, 2007 (CIDRAP News) – The European Union (EU) this week approved a "mock-up" influenza vaccine made by Novartis to permit a faster start on vaccine production in the event of a flu pandemic. When the World Health Organization (WHO) declares a flu pandemic, the vaccine, called Focetria, will be adapted to contain the pandemic virus, the Swiss-based drug company announced yesterday. The vaccine will not be manufactured until a pandemic is declared. The European Medicines Agency's (EMEA's) Committee for Medicinal Products for Human Use (CHMP) recommended approval of Focetria on Feb 22. A CHMP statement on that date said the vaccine was based on a 2004 strain of H5N1 avian flu from Vietnam. The vaccine contains Novartis's proprietary adjuvant MF59, an immune-boosting chemical, which can reduce the amount of active ingredient needed in each dose, the company says. The dose used in the approved mock-up vaccine

is 15 micrograms (mcg), according to the CHMP. "Once the WHO declares a pandemic, Novartis will submit a revised application to the European Medicines Agency to incorporate the identified viral strain," Novartis officials said in a news release yesterday. "The Focetria mock-up file submitted for EU approval in early 2006 was based on clinical studies involving the MF59 adjuvant and different influenza strains with pandemic potential, including H5N1 and H9N2." A CHMP statement from December 2006 defines a mock-up vaccine as one "that mimics the future pandemic influenza vaccine in terms of its composition and manufacturing method" but contains a different flu strain. Novartis said it is also seeking EU approval for a prepandemic H5N1 vaccine that includes MF59 and is based on the same technology as Focetria. The vaccine is intended for use before a pandemic declaration to help "prime" the immune system to fight off H5N1 infections, the company says. Both Focetria and the prepandemic vaccine involve the conventional production method of growing the vaccine virus in eggs, according to Eric Althoff, a Novartis spokesman in Emeryville, Calif. Once a pandemic flu strain is identified, it will take at least 6 months to adapt the virus for production in eggs and start producing the vaccine in quantity, Althoff told CIDRAP News yesterday. "It'll be at least 6 months, just from the simple time of getting enough raw material, ie, eggs, to have full-scale production," he said. On Apr 26 the CHMP recommended EU approval of a Novartis seasonal flu vaccine grown in cell culture instead of in eggs. Althoff said the company also aims to make a cell culture–based pandemic flu vaccine, but development is in an early stage. Cell-culture production is described as somewhat faster and much more flexible than egg-based production. No cell-based flu vaccine has been marketed anywhere as yet, though the EU in 2001 approved a cell-based seasonal flu vaccine made by Solvay Pharmaceuticals for sale in the Netherlands. Althoff said Novartis is talking with US regulators about how to seek approval for both pandemic mock-up and prepandemic vaccines. European authorities provided guidance earlier than the US Food and Drug Administration (FDA) did on the steps needed to get approval for a mock-up vaccine, he said. "That pathway hadn't been mapped out by the FDA or how to handle the review and approval of such a vaccine," he said. But an FDA advisory committee recently prescribed the necessary steps, he added. "I think there's great progress now and more clarity about how to move forward." In April the FDA approved an H5N1 vaccine made by Sanofi Pasteur, despite only modest immunogenicity demonstrated in clinical trials. The Department of Health and Human Services has been stockpiling the vaccine for

use in a pandemic. http://www.cidrap.umn.edu/cidrap/con...7novartis.html

__________________

CSI:WORLD Counting dead children for the CDC, until they change school closing policy and start telling the truth about childrens deaths. They must make notification to the parents of school infections immediate and mandatory. To not require parents to be notified adds on average 35 dead children a week.

http://swineflumagazine.blogspot.com/

Re: EU approves Novartis's 'mock-up' pandemic vaccine

> It'll be at least 6 months, just from the simple time > of getting enough raw material, ie, eggs, to have > full-scale production

12 weeks according to:http://www.emea.europa.eu/pdfs/gener...50155706en.pdf

22 weeks, I had read last year at www.pei.de

here is a link (in German)

http://www.pei.de/cln_042/nn_434236...pfstoff/06.html

it basically says, that in worst case they need:edit:[10 weeks for producing the seedvirus]12 weeks for preparation10 weeks for producing the first 80 million doses10 weeks for producing the 2nd 80 million doses

in the best case, using a prepared "seed virus" (which they don't have yet, as I understand)they need :10 weeks for preparation6 weeks for producing the 1st 80 million doses6 weeks for producing another 80 million doses for the 2nd required shot.They would start delivering the first doses after 10 months.edit:[weeks,not nonths](But don't know yet, who would get them with what priority and won't tell you in advance,where in that priority chain you are...)

and, as I read elsewhere, one dose would cost approximately 5 Euros($7)

News7http://www.pharmiweb.com/PressReleases/pressrel.asp?ROW_ID=8056

Novartis A(H1N1) Pandemic Influenza vaccine Focetria® receives positive opinion from CHMPNovartisPosted on:28 Sep 09

More Novartis press releases View Jobs at Novartis

- Significant milestone in bringing pandemic influenza vaccines to market in Europe- Novartis delivers first shipments of A(H1N1) vaccine to governments in Europe just three months after the WHO declaration of the pandemic- Focetria formulated with MF59® adjuvant which can boost the body's immune response and increase protective antibody levels with less antigen than needed with non-adjuvanted vaccines  

Basel, September 25, 2009 - Novartis announced today that Focetria®, the Novartis Influenza A(H1N1) 2009 monovalent vaccine, has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA). The positive opinion clears the way for European Union approval in all 27 Member States as well as in Iceland and Norway. Today's announcement marks a significant milestone in bringing a pandemic vaccine to market in Europe.  

Focetria, the Novartis Influenza A(H1N1) 2009 monovalent vaccine is an inactivated influenza virus vaccine indicated for active immunization of persons of six months of age and older against influenza disease caused by the novel pandemic A(H1N1) influenza virus. The pandemic vaccine has been developed using traditional influenza manufacturing processes in an egg-based formulation. Focetria contains MF59®, Novartis proprietary adjuvant, which has been added to boost the immune response in individuals receiving the vaccine. MF59 can elicit protective antibody levels with a lower dose, just 7.5 micrograms of viral antigen versus 15 micrograms in non-adjuvanted vaccines, potentially resulting in greater vaccine supply.  

Novartis has already started first deliveries of pandemic vaccines under quarantine to governments in Europe, despite the initially low yields with the current production seed strain provided by the World Health Organization (WHO). A new seed strain could provide higher volumes.  

"Only three months after the declaration of the pandemic by the WHO, Novartis was able to ship the first batches of our pandemic vaccine under quarantine to governments in Europe pending EU approval," said Andrin Oswald, CEO of Novartis Vaccines and Diagnostics. "This CHMP positive opinion paves the way for EU approval, which will allow governments to begin their vaccination campaigns with the goal of reaching more patients before the rapidly spreading virus reaches them. Several recent clinical trials suggest that just one dose of pandemic vaccine can protect healthy adults, which means that now the vaccine can be provided to more people than if two doses were needed." 

Focetria was previously approved by the EU in May 2007 as a mock-up file to be used once the WHO declared a pandemic. This previous approval was based on clinical studies involving the MF59 adjuvant and different influenza strains with pandemic potential, including H5N1 and H9N2.  

Novartis also plans to begin delivery of its Fluvirin® A(H1N1) monovalent vaccine to the US market by early October. The US Food and Drug Administration approved this vaccine on September 15, 2009. Data derived from recent clinical trials of Fluvirin conducted in Costa Rica indicate that a single-dose regimen is as effective as a two-dose regime in healthy adults ages 18-64 suggesting the potential to extend A(H1N1) vaccine supply further to support public health efforts. The trial was conducted in 784 healthy adults.  

About MF59®Novartis proprietary MF59 adjuvant has an established safety profile, supported by more than 12 years of clinical safety data and more than 40 million doses of commercial use in Europe. The adjuvant has been studied in clinical trials involving more than 26,000 people, including children, and has been licensed for use in people 65 years of age and over in the seasonal influenza vaccine, Fluad®, since 1997 in the European Union. Fluad is not licensed for sale in the U.S.

For more information:http://www.novartis.com/newsroom/media-releases/en/2009/1343650.shtml

Editor's Details

PharmiWeb EditorPharmiWeb.comhttp://www.pharmiweb.com

Read more: http://www.pharmiweb.com/PressReleases/pressrel.asp?ROW_ID=8056#ixzz0X7b78sQd

News8

http://www.theflucase.com/index.php?option=com_content&view=article&id=1098%3Amystery-over-qcelturaq-jab-planned-for-germany-and-switzerland&catid=1%3Alatest-news&Itemid=64&lang=en

MYSTERY OVER "CELTURA" JAB PLANNED FOR GERMANY AND SWITZERLAND

Last Updated on Thursday, 15 October 2009 17:11 Thursday, 15 October 2009 14:42

News - Latest News

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The decision by Germany’s national vaccine committee to use the „swine flu“ jab Celtura from Novartis, and not Focetria, is adding to confusion in the country over the mass vaccination campaign.

Switzerland is also to get Celtura and not Focetria.

Little is known about Celtura. The vaccine is to be made using a new cell culture method and contains the MF59(R) adjuvant, squalene, which has been linked to autoimmune diseases.

A pilot study run by the University of Leicester and Leicester Hospitals, involved 100 healthy volunteers, aged between 18 and 50.

The study was led by Dr Iain Stephenson , who has reported financial links with Novartis in other studies.

The results of this pilot study were published in September in   the New England Journal of Medicine .

Novartis issued a press release on Celtura.

The Novartis investor relations consultant listed for Celtura is Ruth Metzler-Arnold, a former Swiss Justice Minister, underlining the close links between pharma industry and government.

Novartis is packed with executives associated with the Rockefeller Foundation and the Bilderbergs, including CEO Daniel Vassella and Ann Fudge.

Vassella also attended this years Bilderberg meeting with David Rockefeller where the former Swedish PM Carl Bildt is reported to have floated the idea of turning the WHO into a global health department.

The WHO/UN and Bilderberg founders, the Rockefellers, have gone on record saying that they believe a massive reduction of the population is desirable.

Sen. Jay Rockefeller steered through Senate Bill 666, which allocating tax funds to pharma companies for the development of bioweapons, into law in 2003.

Vaccines containing the squalene adjuvants MF59 and ASO3 are illegal in the USA

However, the Public Readiness and Emergency Preparedness Act 0f 2006 may pave the way for the authorisation of the adjuvants ASO3 and MF59 for use in swine flu shots.

The US government is reported ot have stockpiled over 300 million doses of adjuvants.

A study funded by Novartis, published in Clinical and Vaccine Immunology, claims, “antisqualene antibodies are not increased by immunization with vaccines with the MF59 adjuvant. These data extend the safety profile of the MF59 emulsion adjuvant."

However, there is a significant body of scientific evidence that squalene was responsible for the autoimmune diseases, afflicting about 25 per cent of the veterans of Iraq with the Gulf War Syndrome, and a US federal judge prohibited the use of these vaccines in 2004.

Novartis had to withdraw ist Aflunov/Fluad H5N1 bird flu vaccine containg the MF59 squalene adjuvant in 2008 because it caused death and injury to many people in Poland.

Fears over the "Celtura“ jab are heightened by the fact that the vaccine is to be approved by the national German and Swiss regulators – the Paul Ehrlich Institute and Swissmedic – highly secretive bodies that are linked with the pharmaceutical industry.

The other type of "swine flu" vaccine earmarked for Germany and Switzerland is Pandemrix, a mock up vaccine manufactured by GlaxoSmithKline, which was approved in 2008, and which contains the squalene adjuvant ASO3 and is classified as a bioweapon by EU and US regulators.

There is no information on Celtura available from the Paul Ehrlich Institute or the EMEA.

News9 http://www.marketwatch.com/story/novartis-smaller-flu-vaccine-doses-suffice-2009-11-17

TEL AVIV (MarketWatch) -- Novartis AG, /quotes/comstock/13*!nvs/quotes/nls/nvs (NVS 53.43, -0.61, -1.13%) /quotes/comstock/06p!novn (CH:NOVN 54.35, -0.15, -0.28%) the Basel health-care giant, on Tuesday reported progress from clinical trials of its influenza A (H1N1) vaccine. In clinical trials, a single dose of the vaccine, which is half the currently approved U.S. dose, "fulfilled immune-response criteria associated with protection in adults and the elderly," those who are age 65 and older, the company said in a statement. The data "suggest that many more people could potentially be vaccinated with our current vaccines supply, protecting more people earlier against the current pandemic," said Andrin Oswald, chief executive of Novartis Vaccines & Diagnostics.

News10

http://www.emea.europa.eu/influenza/vaccines/focetria/focetria.html

FocetriaSummary information

This EPAR summary reflects the Commission's decision of 11 November 2009.

What is Focetria?

Focetria is a vaccine. It is a suspension for injection that contains parts (‘surface antigens’) of the influenza (flu) virus. It contains a flu strain called A/California/7/2009 (H1N1)v like strain (X-181).

What is Focetria used for?

Focetria is a vaccine to protect against ‘pandemic’ flu. It should only be used for the influenza A (H1N1) pandemic that was officially declared by the World Health Organization on 11 June 2009. A flu pandemic happens when a new strain of flu virus emerges that can spread easily from person to person because people have no immunity (protection) against it. A pandemic can affect most countries and regions around the world. Focetria is given according to official recommendations.

The vaccine can only be obtained with a prescription.

How is Focetria used?

Focetria is given as one dose, injected into the upper arm muscle, with a second dose preferably being given after an interval of at least three weeks.

How does Focetria work?

Focetria is a vaccine. Vaccines work by ‘teaching’ the immune system (the body’s natural defences) how to defend itself against a disease. When a person is given the vaccine, the immune system recognises the virus as ‘foreign’ and makes antibodies against it. The immune system will then be able to produce antibodies more quickly when it is exposed to the virus again. This helps to protect against the disease.

Focetria contains small amounts of ‘surface antigens’ (proteins on the outer membrane of the virus that the body recognises as foreign) of a virus called A(H1N1)v that is causing the current pandemic. The virus has been first inactivated so that it does not cause any disease. The outer membranes that contain the surface antigens have then been extracted and purified. The vaccine also contains an ‘adjuvant’ (a compound containing oil) to enhance the immune response.

How has Focetria been studied?

Focetria was first developed as a ‘mock-up’ vaccine that contained an H5N1 strain of the flu virus called A/Vietnam/1194/2004. The company studied the ability of this mock-up vaccine to trigger the production of antibodies (immunogenicity) against this strain of flu virus in advance of the pandemic.

Following the start of the H1N1 pandemic, the company replaced the virus strain in Focetria with the H1N1 strain causing the pandemic, and presented data relating to this change to the Committee for Medicinal Products for Human Use (CHMP).

An ongoing study in 661 healthy adults (including 251 elderly subjects over 60 years of age) is comparing the ability of Focetria H1N1 (as a two-dose schedule) to trigger an immune response with that of experimental vaccines containing either half as much virus material and adjuvant, or twice as much virus material and no adjuvant.

What benefit has Focetria shown during the studies?

The mock-up vaccine was shown to bring about protective levels of antibodies in at least 70% of people in which it was studied. In line with the criteria laid down by the CHMP, this demonstrated that the vaccine brought about an appropriate level of protection. The CHMP was also satisfied that the change of strain did not affect the characteristics of the vaccine.

In the 132 adult subjects aged between 18 and 60 years who received the marketed formulation of Focetria H1N1, the vaccine was shown after the first dose to trigger immunity to a satisfactory level. The percentage

of subjects who had a level of antibodies in their blood that was high enough to neutralise the H1N1 virus (seroprotection rate) was 96%.

What is the risk associated with Focetria?

The most common side effects with Focetria (seen in more than 1 patient in 10) are headache, myalgia (muscle pain), reactions at the site of the injection (swelling, pain, hardening and redness), malaise (feeling unwell), sweating, fatigue (tiredness) and shivering. For the full list of all side effects reported with Focetria, see the Package Leaflet.

Focetria should not be given to patients who have had an anaphylactic reaction (severe allergic reaction) to any of the components of the vaccine, or to any substances found at very low levels in the vaccine, such as egg or chicken protein, ovalbumin (a protein in egg white), kanamycin or neomycin sulphate (antibiotics), formaldehyde and cetyltrimethylammonium bromide. However, it may be appropriate to give the vaccine to these patients during a pandemic, as long as facilities for resuscitation are available.

Why has Focetria been approved?

The CHMP decided that, based on the information obtained with the mock-up vaccine and the information provided on the strain change, the benefits of Focetria are greater than its risks for the prophylaxis of influenza in the officially declared H1N1 pandemic situation. The Committee recommended that Focetria be given marketing authorisation.

Focetria has been authorised under ‘Exceptional Circumstances’. This means that it has not yet been possible to obtain full information about the pandemic vaccine. Every year, the European Medicines Agency will review any new information that may become available and this summary will be updated as necessary.

What information is still awaited for Focetria?

The company that makes Focetria will collect information on the safety and effectiveness of the vaccine, and submit this to the CHMP for evaluation.

Which measures are being taken to ensure the safe use of Focetria?

The company that makes Focetria will collect information on the safety of the vaccine while it is being used. This will include information on its side effects and its safety in children, the elderly, pregnant women, patients with severe conditions and people who have problems with their immune systems.

Other information about Focetria:

The European Commission granted a marketing authorisation valid throughout the European Union for the H5N1 mock-up vaccine for Focetria to Novartis Vaccines and Diagnostics S.r.l. on 2 May 2007. The marketing authorisation for the H1N1 vaccine was granted on 29 September 2009.

News11http://clareswinney.wordpress.com/2009/10/28/obamas-h1n1-swine-flu-national-emergency-evidences-vaccine-market-building-for-mass-murder/

Obama’s H1N1 Swine Flu National Emergency Evidences Vaccine “Market-Building” for Mass Murder

10/28/2009 · 7 Comments

By Dr Leonard Horowitz and Sherri Kane, 27 October 2009

Los Angeles–President Obama’s declared H1N1 emergency cannot be reconciled by either vaccine shortages or flu cases; only by medical “market-building,” vaccination intoxications, and mass murder for population reduction says common sense and mounting evidence.

Over the weekend, initial reports from Reuters News Service and Fox News stated that the President’s declaration was intended to prepare the country in case of “a rapid increase in illness that may overburden health care resources.” The media quoted an unidentified administration official saying, “It’s important to note that this is a proactive measure — not a response to a new development.” This action was “similar to disaster declarations issued before hurricanes hit coastal areas,” Reuters reported.Why would the Obama administration anticipate an H1N1 “hurricane” to hit when Purdue researchers concluded last week the epidemic was expected to peak this week? In fact, too soon for vaccines to be helpful.

Thus, most people getting vaccinated now risk side effects for NOTHING–no benefit what-so-ever!

Furthermore, CBS News determined last week the CDC’s reported H1N1 cases had been overblown up to 97 percent. Only about 1,000 people have died of H1N1 since April’s Mexican outbreak. That is merely 1/18th, or less than 6%, of expected deaths from a normal seasonal flu during the same time period.

It is highly suspicious that David A. Paterson, New York State’s Governor, suddenly suspended “mandatory” H1N1 shots for health professionals citing vaccine shortages, not litigation exposures, as cause for the policy change.

Neglecting notice that more than 60 percent of nurses in New York State refused to take the H1N1 vaccines according to polls, and unions had filed lawsuits against New York and Washington State to gain injunctions against mandated injections, Paterson’s yellow press blamed “limited vaccine supplies” as reason to inject pregnant women and children exclusively. Only two weeks earlier, New York State officials posted their first priority, “as established by the CDC,” to vaccinate health care workers and emergency medical services personnel.

Oddly, all this talk about sudden vaccine shortages being the cause of a federal emergency grossly contradicts what many health officials were saying merely three weeks ago. United Press International (UPI) reported, for instance, Dr. Judy Monroe, Indiana’s state health commissioner, said that an ample supply of the vaccine would be available for everyone by mid-October. Now, suddenly, there is an alleged shortage that compels mixed messages and general confusion.

“Shortage Marketing” Disease and Death

“This is called “shortage marketing,” Dr. Leonard Horowitz explains. “It is an increasing trend in the industrial world to get consumers to purchase products that are unappealing,  over-inventoried, or scarce.”

For weeks preceding Obama’s declaration of national emergency polls showed the vast majority of Americans, including health care workers, rejecting the seasonal and H1N1 flu vaccines. So with stockpiles high, despite allegations of manufacturing delays, the government’s promotions and policy changes simply reflect “shortage marketing.”

But this is a “superficial concern” according to Dr. Horowitz, who references neurobehavioral and neurocognitive disorders demonstrated in vaccine recipients who were normal before getting vaccinated. He credits the brilliant work of Andrew Moulden, MD, PhD, photographically detailing tremendous physical damage occurring following vaccinations. These previously unknown and unseen subtle changes in nerve function and physical appearance is now demonstrated in pictures by Dr. Moulden that are irrefutable in courts and the scientific world.

Dr. Horowitz, a Harvard-trained expert in behavioral science, media persuasion and public health education, has spent 20 years documenting drug industrialists’ and health officials’  criminal actions.

“The only way to reconcile President Obama’s declaration of emergency, given the increasing risks of vaccine injuries, post-peak diminishing risks of H1N1, and the anticipated public health nightmare caused by live viruses “shedding” from those vaccinated to unvaccinated persons, is to follow the flow of money,” Dr. Horowitz says. “In the process of shedding vaccination H1N1, the highly unstable shed virus is expected to pick up more lethal genes from other circulating viruses, including possibly H5N1 that kills nearly 60 percent of those infected.”

Dr. Horowitz notes that authorities have been mum on the triple recombinant H1N1 produced in labs for use in the “active” vaccine. Experts know this is highly unstable, because it is a man-made laboratory creation that did not evolve naturally over the millennia. This unstable mutant more readily recombines with other circulating viruses when it is shed for up to 3 weeks, thus exposing non-vaccinated people who are infected with other viruses.

This is the best explanation for Obama’s anticipated “hurricane,” explains Dr. Horowitz, who criticizes the mainstream media for completely neglecting this greatest risk while falsely reporting vaccine “shortages.” Something else is obviously happening behind the scenes that only seasoned investigators can discern, he says.

He diagnoses the alleged vaccine shortage as a profitable ploy used by those “who have outrageously obvious connections to the Population Council, the preeminent organization directing global depopulation, as encouraged by Obama’s science czar, John Holdren.

Dr. Holdren is the co-author of the 1977 book, Ecoscience, which calls for massive global depopulation using sterilizing vaccinations.

Dr. Horowitz points to the fact that Nonoxynol-9, a spermicidal drug causing spontaneous abortions in pregnant women, and birth defects in infants, is one of the many new “adjuvants” banned in the United States, but used by the American-based Baxter Company in their H1N1 flu vaccines stockpiled by European nations.

(Click here to view Part 1 of 3 YouTube segments that you should share with others!)

Outrageous Conflicting Interests

Dr. Horowitz also suggests discerning conflicting interests between vaccine makers and the news sources that break the federal government’s announcements, in this case Reuters and FOX news.

Reuters is directed by Thomas H. Glocer, a Merck & Co. director making money from H1N1 vaccine sales through Merck’s subsidiary, CSL, Inc. Merck also sells Pneumovax, a vaccine suggested for use at the time influenza vaccines are given, yet contraindicated in people with active influenza infections.*

A “live” H1N1 vaccine infects those vaccinated with “active” viruses. Thus, Merck’s suggested Pneumovax usage is contraindicated according to their own package insert!

If that’s not bad enough, CSL, Inc. did its H1N1 vaccine safety testing on pregnant women, infants, and children at facilities financed by Rupert Murdoch and his family–the Royal Victoria Women’s Hospital directed by Elisabeth Murdoch, and the Murdoch Children’s Research Institute overseen by Rupert’s daughter-in-law Susan Murdoch. So much for FOX News’s impartiality.

The Wall Street Journal that announced “New York Ends Flu Shot Mandate for Health Care Workers” on October 23rd,  is disqualified by way of its links to Merck also. . . . WSJ CEO Councilman, David Brennan, directs the AstraZeneca’s Flumist manufacturer, Medimmune, Inc. AstraZeneca drafted Brennan from Merck & Company, and appointed him CEO in 2006.

This pattern of gross conflicting interests, and coordinated multi-media genocidal counterintelligence, expands with reading Thomas Glocer’s article wherein Reuters plugs “an experimental new drug called peramivir, made by Biocryst Pharmaceuticals Inc.”**

Peramivir is produced by Jon P. Stonehouse’s BioCryst Pharmaceuticals, Inc. President and Chief Executive Officer, Stonehouse recently served as Senior Vice President of Corporate Development at (surprise, surprise) Merck. At Merck, Stonehouse was responsible for “leading strategic developments . . . [that] significantly changed the company,” according to BioCryst’s website.

The Partnership for New York City and Council for Depopulation

It is obvious that our H1N1 “intelligence” is being gathered and broadcast from the highest levels of the medical-media’s mafia. As previously reported in Dr. Horowitz’s “AFFIDAVIT,” submitted to the FBI earlier this month, and filed last week in a lawsuit against federal officials in Washington State, David Rockefeller, Rupert Murdoch, Thomas Glocer, and other media moguls are partnered in the world’s most powerful drug ring and biotechnology consortium. Its members

include the government of New York State as well as the US Federal Government. Proof of these facts are available for inspection online at The Partnership for New York City (PFNYC). The site provides its members list and related pharmaceutical industry activities.

The Founder of PFNYC, David Rockefeller, wields tremendous influence over many of the foundations and institutions that direct the US Federal Government’s policies and practices. American “health care reform” is currently directed, on behalf of the Democratic party, by Sen. Jay Rockefeller.

The Rockefeller Brothers Fund granted millions of dollars to the Population Council of the City of New York during its formative years. Rockefeller family members founded this Population Council, according to The Rockefeller Archive Center. The organization currently advances globally as the world’s premier depopulation advocacy group. The US Federal Government and private institutions fund the Population Council at this time.

Summary and Conclusion

“Biopreparedness” for the 2009 H1N1 Swine Flu is all about mind manipulation and vaccination for population reduction.

In the past week, the swine flu situation went from near ending to causing a “National Emergency.” People, aware of the dangers of H1N1 vaccinations, opted out and gained precedent-setting federal court prohibitions on mandatory vaccinations.  CBS declared the numbers of H1N1 cases fraudulently overstated by the CDC, and additional lawsuits were filed exposing State and Federal officials for genocidal malfeasance.

Rather than admitting disgrace, government spin doctors integrated vaccine “shortage marketing” as a distraction for public consumption. New York State Health Commissioner, Richard F. Daines, who said only a week ago that health workers must be vaccinated for the seasonal flu and the H1N1 virus, or risk discipline, said that scarce vaccines would be given exclusively to pregnant women and children.

Ironically, US Health and Human Services Secretary, Kathleen Sebelius, pledged 10 percent of vaccines would be donated to other countries.

All of this preceded Barack Obama’s declaration of “National Emergency,” thus, exercising Executive power to implement The Model State Emergency Health Powers Act affecting most of the 50 States.

Obviously, none of this makes much sense unless you examine the fundamental and overriding intoxication and depopulation agendas, and what the media moguls know that few commoners learn: the H1N1 vaccines contain “live” viruses that are highly unstable. As laboratory “reverse engineered” genetically spliced germs, they are expected to recombine with more deadly viruses, possibly H5N1, by January, 2010.  These new strains, circulating the globe, are projected to kill nearly 3 billion people. This Lex Lutheresque evil is obviously orchestrated by David Rockefeller’s family and friends that control vaccine manufacturing, “health care reform,” mass media persuasion, and global depopulation industries.

Like it or not, you are advised to prepare for the worst.

-end -

*Thus, “live” H1N1 vaccinated viruses causing influenza-like symptoms in people simultaneously injected with Pneumovax is arguably medical malpractice.

**This article came out the same day as the Wall Street Journal article, synchronous with Obama’s emergency declaration, on Friday, Oct. 23rd. Then the U.S. Food and Drug Administration (FDA) issued an emergency use authorization for peramivir encouraging intravenous used in patients who cannot take pills, Tamiflu, or Relenza.

NOTE TO JOURNALISTS: Dr. Horowitz is asking why silver hydrosols are being completely neglected by mainstream media when these simple revolutionary mineral waters safely and effectively terminate infectious diseases caused by pathogenic viruses, bacteria, fungi, and parasites. He invites everyone to research OxySilver for its proven benefits online at www.OxySilver.net.Investigative journalist and co-author, Sherri Kane, is working with Dr. Horowitz to advance Healthy World Organization (HWO), a natural alternative to David Rockefeller et. al.’s, World Health Organization. Information about HWO is available at: HealthyWorldOrganization.org.

To prepare for serious flus, see Dr. Horowitz’s comprehensive website FLUscam.com. Herein he endorses natural alternatives to vaccines including vitamin C and vitamin D. See his “FLU To Dos” page.

Dr. Horowitz and Ms. Kane have co-authored a terrific newsletter to wake people up about what is really happening with H1N1 2009 Swine Flu. Download that pdf file for free from FLUscam.com, take it to your local printer, and distribute these newsletters throughout your community.

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