Santa Clara County Declares State of Emergency for H1N1-Swine Flu
Saturday, October 03, 2009
Santa Clara County Declares State of Emergency for H1N1-Swine Flu
However, the trial vaccine tested by Novaris DID include MF59® , which is a squalene adjuvant. In case, you are looking for additional information about MF59®, click this link for further information about adjuvants that is quite interesting whether it is true or not (Source: the Prison Planet Forum).
The official Novaris press release is below.
Released as of: September 03, 2009 07:15 CET
Novartis MF59® adjuvanted cell culture-based vaccine shows strong immune response in A(H1N1) clinical trials
- First pilot trial of investigational A(H1N1) vaccine with 100 subjects indicates strong, potentially protective, immune response in 80% of subjects after one dose, more than 90% after two doses.
- MF59® adjuvanted cell culture-based A(H1N1) vaccine was well tolerated, pain at the injection site the most frequent adverse event.
- Larger pivotal trials with both cell culture and traditional egg based vaccines under way to include more than 6000 adults and children.
The trial evaluated the tolerability and immunogenicity of the vaccine. Different schedules and timing between vaccinations were tested. The vaccine schedule comprised one or two doses of 7.5µg MF-59® adjuvanted surface-antigen A/California/2009 vaccine derived from cell-culture. Results showed that the serum (note: serum is processed blood) antibody responses were highest among subjects who received two doses of vaccine, however a single vaccine dose also induced responses associated with protection against influenza. Hemagglutination-inhibition titres reached 1:40 or greater in 80 percent and more than 90 percent of those receiving one dose and two doses respectively. These would satisfy the immunogenicity criteria as set out by European and US regulators. The findings showed that it is possible to induce protective antibodies against A(H1N1) infection within two weeks of administration of a single low-dose adjuvanted vaccine. Non-adjuvanted formulations were not evaluated in the study.
The pilot trial was led by Dr. Stephenson of the Department of Infection, Immunity and Inflammation at the University of Leicester. He is a clinical senior lecturer at the University, and a consultant in infectious diseases at the University Hospitals of Leicester NHS Trust. Dr. Stephenson said "the aim of the trial was to find out how many doses and what type of vaccine is needed to give protection. These initial results should help to plan vaccination campaigns in the autumn, including doses and timings. We concluded that the MF59-adjuvanted A(H1N1) vaccine of low antigen content was well tolerated and generated antibody responses associated with protection against influenza, even after a single dose."
Novartis Vaccines and Diagnostics is a Novartis division focused on the development of preventive treatments. The division has two businesses: Novartis Vaccines and Chiron. Novartis Vaccines is the world's fifth-largest vaccines manufacturer and second-largest supplier of flu vaccines in the US. The division's products also include meningococcal, pediatric and travel vaccines. Chiron, the blood testing and molecular diagnostics business, is dedicated to preventing the spread of infectious diseases through the development of novel blood-screening tools that protect the world's blood supply.
Novartis provides healthcare solutions that address the evolving needs of patients and societies. Focused solely on healthcare, Novartis offers a diversified portfolio to best meet these needs: innovative medicines, cost-saving generic pharmaceuticals, preventive vaccines, diagnostic tools and consumer health products. Novartis is the only company with leading positions in each of these areas. In 2008, the Group's continuing operations achieved net sales of USD 41.5 billion and net income of USD 8.2 billion. Approximately USD 7.2 billion was invested in R&D activities throughout the Group. Headquartered in Basel, Switzerland, Novartis Group companies employ approximately 99,000 full-time-equivalent associates and operate in more than 140 countries around the world. For more information, please visit http://www.novartis.com
Central media line : +41 61 324 2200
Novartis Global Media Relations
+41 61 324 7999 (direct)
+41 79 593 4202 (mobile)
Novartis Vaccines and Diagnostics
+1 (617) 871 7931 (direct)
+1 (617) 710 8953 (mobile)
+41 61 324 7944
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+41 61 324 9980
+41 61 324 1065
+1 212 830 2433
+41 61 324 3018
+1 212 830 2445
+41 61 324 8425
+1 212 830 2456
+41 61 324 7188
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FDA Authorizes Use of Expired Tamiflu As Part of Federal Government's Response to H1N1 "Swine Flu" Health Emergency
Nevertheless, the FDA has approved the use of expired Tamiflu to combat the H1N1 "swine flu" virus. The FDA says it is safe, but once again, expired milk may not make you sick, but why would you want to drink it? Same thing here. If you are going to take to Tamiflu (which I would not), why would you want an expired batch?
Information for Healthcare Professionals - Authorization of Use of Expired Tamiflu for Oral Suspension
FDA is authorizing the use of certain lots of expired Tamiflu for Oral Suspension as part of the federal government’s response to the 2009 H1N1 Influenza public health emergency.
In July 2009, FDA authorized 4 lots of Tamiflu for Oral Suspension for use beyond their labeled expiration dates. FDA is now authorizing additional lots in an effort to ensure that Tamiflu for Oral Suspension is available for patients during this public health emergency. The lots of Tamiflu for Oral Suspension that are being authorized are part of the Strategic National Stockpile and have been tested through the federal government’s Shelf-Life Extension Program (SLEP).
Under SLEP, FDA conducts scientific testing and analysis to determine if certain drugs are acceptable for use beyond their expiration date. During testing, FDA comprehensively evaluates each lot to assure the quality and stability of the product. Through the SLEP testing process, FDA has determined that data support the use of these lots of Tamiflu for Oral Suspension beyond their expiration dates.
The lots of Tamiflu for Oral Suspension now authorized by FDA for use beyond their expiration dates are not required to be relabeled with information about the use of the products beyond their expiration dates. Therefore, healthcare professionals and patients might receive Tamiflu for Oral Suspension that is beyond its expiration date. In addition, fact sheets for both patients and healthcare professionals will be made available by public health officials. These fact sheets will contain information about the authorized use of these products beyond their expiration dates.
These decisions to authorize the use of certain lots of Tamiflu for Oral Suspension beyond their expiration dates are based on rigorous scientific testing and analysis. Healthcare professionals may wish to discuss this information with patients to inform them that the medication they have been given is authorized for use based on scientific testing and analysis.
Considerations for Healthcare Professionals:
- Be aware that specific lots of Tamiflu for Oral Suspension have been authorized for use beyond their expiration dates
- Understand that FDA has determined that data support the use of certain lots of Tamiflu for Oral Suspension beyond their expiration dates
- Consider discussing this information with patients to help them understand this information and address any concerns they may have about these products
- For any Tamiflu that is beyond its expiration date, you may verify if it has been authorized for use through the following website: http://www.fda.gov/NewsEvents/PublicHealthFocus/ucm154962.htm
- Consider discussing with patients, families, and caregivers the benefits of taking antiviral medications in relation to the potential risks of untreated illness
Information for Patients, Families, and Caregivers:
- FDA has determined that certain lots of Tamiflu for Oral Suspension are authorized for use beyond their expiration dates based on scientific testing and analysis
- Discuss any concerns you have about using Tamiflu for Oral Suspension with your healthcare professional
- Make sure to follow all directions given by your healthcare professional when using Tamiflu for Oral Suspension
- If you want to look up the lot number for your Tamiflu to see if it is authorized for use beyond its expiration date, go to http://www.fda.gov/NewsEvents/PublicHealthFocus/ucm154962.htm and look for your lot number in the table under “Tamiflu Lots Whose Expiration Date Has Been Extended”
Mr. Smith, if you or your minions are on this site, here's a link to the vaccine ingredients. If you don't believe that information, you can view the ingredients listed in Section 11 of the four (4) vaccine package inserts on the FDA website. Do your own research Shepard!
Friday, October 02, 2009
|Southern Colorado National Bank||Pueblo||CO||57263||October 2, 2009||October 2, 2009|
|Jennings State Bank||Spring Grove||MN||11416||October 2, 2009||October 2, 2009|
|Warren Bank||Warren||MI||34824||October 2, 2009||October 2, 2009|
Warren Bank will cost $275 million against the FDIC insurance fund. Jennings State Bank will cost $11.7 million against the FDIC insurance fund. Southern Colorado National Bank will cost $6.6 million against the FDIC insurance fund.
The total amount charged against the FDIC insurance fund today is $293.3 million! I will update this list as more bank closings, if any, come in today.
NORTHCOM Issues Domestic Terrorism Force Protection Directive to DoD Personnel (Says Complaceny is a Top Concern)
In response to the handful of thwarted domestic jihadist bombing plots in recent weeks - which included schemes against US military installations - the US Northern Command’s (NORTHCOM) Joint Operations Center issued a “Force Protection Directive” that cautioned domestic Defense Department personnel against becoming complacent to staying alert to terrorism threats.
Source: Homeland Security Today
Thursday, October 01, 2009
13,000 Fort Jackson South Carolina Soldiers Exhibit "Swine Flu" Symptoms (Army Suffers First H1N1 Soldier Death)
This is the Army's first death from H1N1 "swine flu" pandemic and hopefully, there are not any more. However, at Fort Jackson, South Carolina, 13,000 soldiers have exhibited H1N1 "swine flu" symptoms. Let's hope that this is merely the regular flu or cold and not something even more sinister.
Fort Jackson spokeswoman Karen Soule said as of Wednesday night, 51 of Fort Jackson's 13,000 soldiers had flu-like symptoms.
In 1976, most of the swine flu outbreaks occurred at military bases. In this pandemic, there will likely be some similar numbers, because the military has a mandatory vaccination program. These vaccines contain ingredients that have been shown to negatively affect human health. I believe that these mandatory vaccinations help spread the outbreak. Therefore, it is to be expected that we will see more deaths at the domestic military bases where the vaccination rates are highest.
The Army has programs for preventing and treating illnesses, and efforts were stepped up when swine flu surfaced in the spring. Measures include mandatory vaccinations, rearranging bunks head-to-toe, scrubbing quarters daily with bleach and laundering bedding every three weeks, May said.
Source: The News-Journal (Daytona Beach)
Well, the FDIC is now admitting what Remixx World! disclosed. In a recent FDIC memo, the FDIC says that the fund is negative as of September 30, 2009. Actually, it should have said that the FDIC insurance fund was negative as of the Colonial Bank failing on August 14, 2009, and the FDIC had to charge an emergency $5.6 billion fee to stay afloat.
Pursuant to these requirements, staff estimates that both the Fund balance and the reserve ratio as of September 30, 2009, will be negative. This reflects, in part, an increase in provisioning for anticipated failures. In contrast, cash and marketable securities available to resolve failed institutions remain positive.
You can read the rest of the FDIC memo by clicking HERE or checking the embedded document below.
Wednesday, September 30, 2009
Take this information for what it is worth considering the source. Using the previous years' flu numbers as a reference, the graph reveals that we should expect the H1N1 "swine flu" infection numbers to increase many times over the next several months.
Click here or on the map above for the official CDC flu trends chart as reported by Google Flu Trends | United States
Imposing martial law is certainly not the answer! I would not vote for this Andy Martin character if I lived in Illinois, because he is anti-Constitution.
2009-09-30 10:13:42 - Andy Martin says emergency measures are needed to stem the tide of violence in Chicago.
(CHICAGO)(September 30, 2009) Republican U. S. Senate candidate and insurgent “Internet Powerhouse” Andy Martin will hold a Chicago news conference Wednesday, September 30th to call for the imposition of martial law on the city of Chicago.
“The latest slaying of an innocent African-America child should be a wake-up call to the Chicago Mayor and Illinois Governor. If the city and state cannot provide African-Americans with basic personal safety—the ultimate human right—why are these officials in power?
“If necessary, President Barack Obama should send federal troops to protect the right to life of every Chicago child. There cannot be two standards of life, one for minority neighborhoods and another for non-minority neighborhoods.
“I find it incongruous that on a day when Illinois National Guard soldiers were returning from Afghanistan, we needed our Guard personnel in Chicago to restore order here at home.
“With due respect to Superintendent Jody Weis, he has to ratchet up the war on crime and wage relentless war on the gangs and predators who are preying on Chicago’s African-American children. Weis has to take personal ownership of this war, and start leading from the streets, not the safety of his office.
“If newspaper reporter Mark Brown can see where the gangs are lurking, why are not attacking these encampments and arresting these gangsters?
“If the City cannot protect existing citizens, how are we going to guarantee the safety and of millions of Olympic visitors?
“I propose that the mayor, governor and president adopt a five-point program to return safety to Chicago’s streets:
“First, I want Superintend Weis out on the streets, personally supervising field operations. He needs to lead from the front, not his headquarters office.
“Second, I want the CPD to put every sworn officer on the streets, and replace desk officers with temps if necessary. Any officer who is authorized to carry a gun should be working outside, on the streets. We need to regain control of this city.
“Third, Cook County needs to hire an emergency allotment of prosecutors and prison guards, and create space for thousands of new prisoners, as well courtrooms for prosecution of these predators. We need to disrupt, disable and destroy the gang elements and criminal elements in minority neighborhoods.
“Fifty years of anti-gang efforts have failed. Failure is no longer an acceptable option.
“Maybe Tod Stronger should fire some of his relatives, and well as other Daley Machine payrollers, and replace them with prosecutors and jail guards. State Attorney Alvarez needs to become more proactive; she has been much too passive.
“Fourth, Governor Quinn should mobilize the Illinois State Police and the Illinois National Guard, and have these forces start patrolling the streets of any neighborhood with excessive crime.
“Fifth, President Obama should order the deployment of part of our ready reserve forces to duty in Chicago. It was a Republican President, Dwight Eisenhower, who sent the 101st Airborne Division to Little Rock, Arkansas to enforce the constitutional rights of African-American students. Republicans were in the forefront of protecting African-Americans then. Republicans should lead again.
“The Daley Machine’s failure to protect minority children is a disgrace to humanity. If the City refuses to do its job, federal troops should be used to protect Chicago’s minority neighborhoods. Republicans need to start raising hell about the hellish conditions in minority neighborhoods. Children living in these areas have a right to life and a right to live. Their lives should not be snuffed out by gangsters operating in plain sight of a Sun-Times reporter.
“As for Barack Obama, the latest tragedy took place in the Altgeld Gardens area, where he was a so-called ‘community organizer’ 25 years ago. Obviously, Obama’s efforts left no lasting impression in the neighborhood. It is time for America’s first African-American president to start taking the protection of Chicago’s African-American children seriously Martin will state. “Daley and Obama should be flying to Chicago, not Copenhagen.
”The bottom line: we need martial law in Chicago until the safety and security of every schoolchild is ensured. I realize that these endless, random killings are an emergency situation; they are intolerable. Why can’t Chicago’s and Illinois’s leaders do the same and respond to this unacceptable reality
September 30th news conference details:
U. S. Senate candidate and Internet Powerhouse Andy Martin
Sidewalk news conference, SE corner of Huron and Wabash,
Wednesday, September 30, 2009 1:00 P.M.
Internet Powerhouse and U. S. Senate candidate Andy Martin calls for martial law in Chicago to end the violence in African-American neighborhoods.
(866) 706-2639; Cell (917) 664-9329 (not always turned on)
Tuesday, September 29, 2009
Foreign Mercenary American Police Force Security Firm Takes Over Hardin Montana Police Department and Jail? (Is This Red Dawn?)
Actually, the jail will more than likely house individuals deemed terrorists by the United States of America, including Guantanamo detainees and Hardin has been mentioned as a possible site. If you don't trust Al-Jazeera as site, the Huffington Post also linked to this article in case you trust Ms. Arianna Huffington.
I wonder if this is related to the recent Montana FEMA Vigilant Guard exercise with foreign troops from Kyrgyzstan.
Why does the APF company crest and symbol incorporate the Serbian flag? Here's a good discussion board thread from Above Top Secret on this Hardin, Montana issue in case I am not updating this page fast enough for your liking.
One of the worst people I have seen in this entire matter so far is APF's publicity director Becky Shay (see below) who left her job as a local reporter to go work for the large, secretive corporation that she regularly wrote about in the Billings Gazette. You have to love those reporter ethics! I guess that $60,000 and patio are worth it to sell out your local compatriots.
I shouldn't be too mad, because her local compatriots would likely do the same thing in her position. In fact, job seekers recently crashed the American Police Force website seeking employment and a possible patio just like Ms. Shay. Therefore, I guess birds of a feather do flock together.
Source: KULR-8 ; Above Top Secret (Image Source)
by Chuck Paone
66th Air Base Wing Public Affairs
9/29/2009 - LEDYARD, Conn. (AFNS) -- Addressing the Air Force Command and Control, Intelligence, Surveillance and Reconnaissance Symposium here Sept. 29, the leader of the Air Force Space community said space and cyberspace are integrally connected.
"Think of space and cyber as circles on a Venn diagram," said Gen. C. Robert Kehler, commander of Air Force Space Command. Those circles, he noted, clearly overlap.
"In that overlap is access and persistence," he said.
The general said he doesn't think anyone fully understands the connection between space and cyber just yet, but he's sure it's a powerful one.
One key connection is that cyber capabilities help enable the utility of space systems.
"Space allows us to operate in small groups in distributed ways," the general said. "In near-peer conflict, space allows us to complete the kill chain. In global assessment, it's the unblinking, or almost unblinking, eye. In crisis management, it allows us to see what we'd otherwise miss. ...
"It allows us to navigate with accuracy, to communicate with certainty, strike with precision and see with clarity. Those are enormous war fighting advantages."
General Kehler said it was important for him to address this conference, in part because of the presence of its co-sponsor, the Electronic Systems Center, headquartered at Hanscom Air Force Base, Mass.
"We rely heavily on ESC," he said, calling AFSPC "a demanding customer." He labeled the center the main provider to the Joint Space Operations Center, and said it would be the same for cyber.
He noted that the acquisition community is still under the gun to find ways to deliver capabilities faster.
"Our acquisition systems are not keeping pace with the speed of need," General Kehler said.
Those needs vary, he said. In some cases, the need is for a new capability in five years, which generally can be handled.
"In other cases, the need is in five minutes, and we don't have too many acquisition programs that can do that," he said. "Yet that is exactly where we're headed; we're certainly headed that way in cyberspace, in some cases, with space too."
The general said he understood that the acquisition community is constrained within a certain box. But leaders of both ESC and the Space and Missile Center at Los Angles Air Force Base understand that "within that box there's a lot of running room and we need to start running."
General Kehler also echoed a theme offered up by retired former Air Force Chief of Staff Gen. John P. Jumper at the conference opening Sept. 28. Talking about the concept of "operationally responsive space," General Kehler said, it's about "using the things you already have, better and faster."
The general covered many other subjects during his speech, including the intense focus on maintaining inter-continental ballistic missiles.
"Perfection is the standard again," he said.
The general also discussed the Air Force's nearly 10-year streak of successful satellite launches, acknowledging that, statistically, a failure may be due.
"But not this time," he said, repeating the words and attitude his operators apply to each and every launch.
He also talked about his two near-term goals for the newly created 24th Air Force, the operational cyber arm located in San Antonio.
"The first is to stabilize the patient," he said. "We need to get our arms around the Air Force network and provide mission assurance even under duress," he said.
That doesn't mean the Air Force can or should try to protect everything, though, the general said.
Cyberspace is like a densely populated urban area, he said, with people doing all the same things online they'd do on city streets. In that environment, vandals, criminals, spies and determined nation states also are lurking. But just as a person doesn't call the Air Force when his or her wallet is stolen, the Air Force is not responsible for all hostile Web-related actions.
The second charge for 24th AF officials is to posture Air Force Cyber Command to be the Air Force component for U.S. Cyber Command.
"I don't want to duplicate what the other services are doing," he said.
A full lineup of speakers from government and industry are still on tap here, including a dinner speech by Air Force Secretary Michael B. Donley.
Sept. 30 events will feature more discussions and key presentations. Featured speakers include Gen. Kevin Chilton, commander of U.S. Strategic Command, and Air Force Chief of Staff Gen. Norton Schwartz.
Along with ESC, the Air Force C2ISR Symposium is being sponsored by the Paul Revere Chapter of the Air Force Association.
Source: United States Air Force
Here are some interesting points that Mr. Jim Rickards made in this CNBC video:
1. The dollar will lose 50% of its current value. There is $60 trillion in the marketplace and the U.S. has no feasible combination of growth and taxes that can fund this liability. The country can fund $30 trillion, so the dollar must be reduced by 50%. That means you! Unless you keep your financial holdings in other currencies aside from the dollar, you will lose 50% of your net worth.
2. The U.S. is close to going broke and will need to depreciate the dollar to solve the country's debt problems.
3. Unannounced at the G20 is the fact that the IMF was anointed as the new global central bank. The IMF is now printing money, issuing debt for the first time ever and holding a balance sheet.
4. He recommends gold as a possible alternative.
5. The U.S. no longer has the privilege of printing money to the world.
6. The end game is to displace the U.S. dollar as the global reserve currency with SDRs (which are Special Drawing Rights). There is no asset or commodity backing these SDRs.
Commerce Department: NIST Framework and Roadmap for Smart Electrical Grid Interoperability Standards Release 1.0 (Draft)
One of the biggest challenges confronting the move toward a cleaner, more efficient electrical grid in the U.S. is that all of the devices, meters, wireless networks and software platforms created by an endless array of companies need to be able to communicate seamlessly with one another. This list is the first major attempt by the government to make sure this happens fast.
You can download the report NIST Framework and Roadmap for Smart Grid Interoperability Standards Release 1.0 (Draft) by clicking here.
Once this smart grid is in place, then complete control over various segment populations can be achieved with the flip of a switch. Further, each device on the smart grid will have a unique identification number that will be logged each time the device is used on the grid. Processing the log will allow anyone to determine when these devices were used.
For example, once the smart grid is in place, a household's usage of electricity and appliance will be able to be monitored and itemized to a very specific detail. The grid will be able to tell that you used your microwave oven for four (4) minutes at 6:45pm based on your home's power draw at that time. This information would then be analyzed, resulting in the the conclusion that Brand X microwave oven has this same unique power draw. Now the grid knows you own a Brand X microwave oven. However, if this Brand X microwave has been recalled or is no longer legal, then the grid will not power this appliance. It will simply shut the electricity off to the Brand X microwave. Instead it will notify you that the appliance is not compliant and what your penalty will be.
Source: Venture Beat
Monday, September 28, 2009
The water in Australia's biggest river is running so low and is so salty that the nation's fifth-largest city, Adelaide, is at risk of having to ship water in to its residents, politicians have warned.
Adelaide's water crisis follows similar problems in cities around the world, as the combination of growing population, increasing agricultural use and global warming stretches resources to the limit. Experts are warning of permanent drought in many regions.
Source: The London Guardian
This documentary is newsworthy due to the continuing 9/11 issues and revelations that these movies help foster. The previous Loose Change editions were great and helped wake up a large group of people to the inconsistencies of the official 9/11 story. Hopefully, this video does the same or more.
Source: Veracity Videos
I hope that our country is not headed down this destructive path, but it appears it may be imminent at this point. I am praying that both sides will pull back from the brink. Nevertheless, people have to be informed and prepared no matter what happens.
The USA is suffering the most severe ammunition famine in living memory. Gun fanciers, fearing a Democrat crackdown on every American's right to pack heat, are clearing shelves at ammo shops and hoarding cartridges...
The shortages are so bad that retail globocorp Wal-Mart has been forced to introduce rationing at the ammo counter in many of its stores. Depending on calibre, customers may be limited to purchases of just 50 rounds at a time.
Source: The Register
Sunday, September 27, 2009
Martial law has been declared in Honduras, according to a correspondent currently visiting the country.
The reporter, whose identity is being kept anonymous for his safety, is currently traveling for work and was informed in one of their factories, which was immediately shut down.
He informed me, "Curfew starts at 5:30pm till 7 am. Streets are packed. The ex prez showed up today- current prez is missing- presumed kidnapped."
Source: Ground Report
FLASHBACK: Baxter BioScience Completes Production of First Commercial Batches of CELVAPAN A/H1N1 "Swine Flu" Pandemic Vaccine
If you want to check out the ingredients and the package leaflet for the CELVAPAN, click this sentence. The vaccine contains inactivated swine flu vaccine, trometamol and polysorbate 80.
Baxter Completes Production of First Commercial Batches of A/H1N1 Pandemic Vaccine | Business Wire
DEERFIELD, Ill. -- August 05, 2009
Baxter International Inc. (NYSE: BAX) today announced that it completed production of its first commercial batches of CELVAPAN A/H1N1 pandemic vaccine in late July and is discussing plans for distribution with national health authorities, subject to obtaining appropriate authorizations. CELVAPAN, the brand name for the company’s A/H1N1 pandemic influenza vaccine, is made using Baxter’s proprietary Vero cell culture technology.
Baxter plans to deliver initial quantities of CELVAPAN to national public health authorities that have pandemic agreements with the company. These health authorities placed orders for the vaccine following the World Health Organization’s (WHO) elevation of the pandemic alert level to phase 6 and declaration of a pandemic.
Baxter’s proprietary Vero cell production technology is meeting the company’s expectations to rapidly produce a vaccine in response to a pandemic. CELVAPAN was developed and commercially produced using this process within 12 weeks of receiving the A/H1N1 virus strain, which represents an innovation in vaccine production.
“We are pleased with our company’s ability to meet its expected timelines in developing and producing CELVAPAN,” said Joy Amundson, corporate vice president and president of Baxter BioScience. “This is an encouraging validation of our science, our Vero cell vaccine technology and the teamwork at Baxter in meeting this important milestone to help address an urgent public health issue.”
Baxter is collaborating with regulatory authorities to ensure the company is in accordance with all requirements needed to support approval and use of CELVAPAN. “To make CELVAPAN A/H1N1 vaccine, we applied the same development, qualification and manufacturing processes used in gaining European Medicines Agency (EMEA) licensure of a mock-up pandemic vaccine,” said Hartmut J. Ehrlich, M.D., vice president of global research and development for Baxter BioScience. “The mock-up vaccine made with a different pandemic strain was tested in five clinical trials worldwide in more than 1,300 people. In addition, more than 3,500 people have been vaccinated during an ongoing phase III study.”
Confirmatory clinical trials to evaluate safety and immunogenicity of CELVAPAN A/H1N1 in adults, the elderly and children are scheduled to begin in August. Baxter has initiated its license application for CELVAPAN A/H1N1 based on the EMEA published guidelines for pandemic vaccine marketing authorization and will supplement its application post-approval with the appropriate safety and immunogenicity data from the confirmatory clinical trials. Once national vaccination programs are initiated, Baxter will also conduct a large-scale observational study in people receiving CELVAPAN. In all countries, decisions to administer the vaccine will be determined by local public health authorities.
ABOUT BAXTER’S PANDEMIC VACCINE DEVELOPMENT
Baxter received the A/H1N1 strain for testing and evaluation from the U.S. Centers for Disease Control and Prevention (a WHO Collaborating Center) in early May. The company then undertook pre-production testing and evaluation of the virus strain to assess its growth characteristics and ability to work in the company’s proprietary Vero cell culture. Based on the virus’ ability to grow in Vero cell culture, Baxter initiated commercial production on June 3, 2009. Bulk CELVAPAN vaccine is produced at its large-scale commercial facility in Bohumil, Czech Republic, and is sent to Vienna, Austria for the final formulation, fill and finish before distribution.
Mock-up licensure is a regulatory pathway for pandemic vaccines that was created by the European Medicines Agency (EMEA) in 2004. This pathway allows for the development, evaluation and testing of a company’s vaccine production capabilities using an available influenza strain that has the potential to cause a pandemic. Once a pandemic is declared and the influenza virus strain causing the pandemic is identified, the mock-up licensure allows for fast track approval of a pandemic vaccine containing the actual pandemic strain. Other countries may choose to evaluate the company’s EMEA submission and use that information as the basis for their national health authority’s authorization for use of the vaccine.
ABOUT BAXTER INTERNATIONAL INC.
Baxter International Inc., through its subsidiaries, develops, manufactures and markets products that save and sustain the lives of people with hemophilia, immune disorders, infectious diseases, kidney disease, trauma, and other chronic and acute medical conditions. As a global, diversified healthcare company, Baxter applies a unique combination of expertise in medical devices, pharmaceuticals and biotechnology to create products that advance patient care worldwide.
This release includes forward-looking statements concerning the company’s vaccines products, including with respect to potential timelines. The statements are based on assumptions about many important factors, including the following, which could cause actual results to differ materially from those in the forward-looking statements: continued success in advancing a new technology through full-scale production, including with respect to steps required for finishing, release, shipment, and customer acceptance; remaining regulatory approvals; governments’ continuing decisions with respect to orders; and other risks identified in the company’s most recent filing on Form 10-K and other Securities and Exchange Commission filings, all of which are available on the company's website. The company does not undertake to update its forward-looking statements.
Baxter International Inc.
Kym White, (847) 948-2304
Deborah Spak, (847) 948-2349
Mary Kay Ladone, (847) 948-3371
Clare Trachtman, (847) 948-3085
Local Centura Health Hospital Says Up to 200 People May Die From H1N1 "Swine Flu" in Colorado Springs
But now you can start thinking about as many as 200 people in Colorado Springs dying from the H1N1 virus, according to Centura Health, Colorado's largest hospital and health care system, which runs Penrose-St. Francis Health Services locally.
Centura's worst-case fatality estimate was part of a meeting of Penrose-St. Francis medical staff Sept. 10, where an infection control expert from St. Paul, Minn., spoke to a couple hundred physicians and staff.
Source: Colorado Springs Independent
MUGABE: I will never, never, never, never surrender. Zimbabwe is mine. I am an Zimbabwean. Zimbabwe for Zimbabweans. Zimbabwe never for the British. Britain for the British.
AMANPOUR: Is that just political rally rhetoric or -- or did you mean that? What did you mean?
MUGABE: That Zimbabwe belongs to the Zimbabwean people.
AMANPOUR: Right. Do you consider...
MUGABE: Pure and simple.
AMANPOUR: ... and everybody believes that?
MUGABE: Yes. All people believe it.
AMANPOUR: So do you consider white Zimbabweans to be Zimbabweans?
MUGABE: Those who are naturalized and have citizenship, yes.
AMANPOUR: Those who've been living there for years and years and years?
MUGABE: But historically...
MUGABE: ... historically, they have a debt.
AMANPOUR: The people who -- contributing to farming -- historically they have a debt to pay?
MUGABE: Yes, yes, their land. They -- they occupied the land illegally. They seized the land from our people.