Siegfried X
Well-known member
Last edited:
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First batch of H1N1 vaccine is ready to begin testing process. No vaccine for distribution before Fall 2009
- Thread starter Siegfried X
- Start date
Siegfried X
Well-known member
Novartis press release
Novartis press release
Novartis press release
Novartis H1N1 vaccine press release
Novartis press release
Novartis press release
Novartis H1N1 vaccine press release
Rush to produce H1N1 vx
Rush to produce H1N1 vx
Drugmakers rush to produce a swine flu vaccine
By MARIA CHENG, AP Medical Writer Maria Cheng, Ap Medical Writer ? 18 mins ago
LONDON ? With swine flu now an official pandemic, the race is on among drugmakers to produce a vaccine.
GlaxoSmithKline said Thursday after the World Health Organization declared a global flu epidemic that it would be ready within weeks to begin large-scale vaccine production. Sanofi-Aventis also said it had started working on its own version. On Friday, Swiss pharma giant Novartis announced it had created an experimental vaccine that has not been tested in people. Novartis' vaccine was made via a cell-based technology that may prove faster than the traditional way of making vaccines, which relies on chicken eggs.
Many rich countries like Britain, Canada and France signed contracts with pharmaceuticals long ago, guaranteeing them access to pandemic vaccine. WHO and others estimate that about 2.4 billion doses of pandemic vaccine could be available in about a year.
The likely scramble for vaccines will leave many people in poorer countries empty-handed.
So far, swine flu has been mostly detected in developed countries like the United States, Europe, Japan and Australia.
"We do not know how this virus will behave under conditions typically found in the developing world," WHO chief Dr. Margaret Chan said Thursday. She said the agency expects to see a "bleaker" picture as the virus makes its way to Africa and Asia. About 85 percent of the world's chronic diseases are found in poorer countries. More than 60 percent of the world's HIV cases are also in Africa.
WHO spokesman Gregory Hartl said officials were concerned people in poorer countries and those fighting other health problems like malaria, tuberculosis, malnutrition and pneumonia might be more susceptible to swine flu.
On Friday, WHO said that 74 countries had reported nearly 30,000 cases including 145 deaths. But so far, the virus appears to be mild. Most people don't need medical treatment to get better.
But the virus might have a more devastating effect in people with underlying health problems. About half of the people who have died from swine flu have had complications like asthma, diabetes, and obesity.
"Any population that has health challenges is potentially going to be at higher risk with H1N1 (swine flu)," Hartl said.
In May, officials led by Chan and U.N. Secretary General Ban Ki-moon asked vaccine makers to save a portion of their production for poor countries. Chan said she was aiming to get 10 percent of the global pandemic vaccine supply reserved for poor nations.
Only one large company, GlaxoSmithKline PLC, agreed to help. The drug giant offered to donate 50 million doses of pandemic vaccine to WHO for distribution to developing countries. Several smaller firms also made offers, but their production capacity is limited.
Because more than 95 percent of flu vaccines are still made in eggs, the Novartis announcement is unlikely to significantly boost the world's pandemic vaccine supply.
But the news pushed up Novartis shares by 4 percent to 44.82 Swiss francs ($41.56) on the Zurich exchange on Friday.
The WHO says drugmakers will likely have vaccines against swine flu approved and ready for sale after September.
WHO and nongovernment organizations like Oxfam are continuing to ask drugmakers to make some of their pandemic vaccines available for poorer countries at a cheaper price, as well as asking donor countries and organizations to pay for the doses.
But in a pandemic situation, WHO's attempts to secure vaccine for the poor and even the contracts countries have signed with drugmakers may make little difference to who actually gets the vaccine, some experts say.
In previous pandemics, vaccines have never left the country where they are made before all of that country's own needs have been met.
"WHO can say whatever it wishes, but pharmaceutical companies will take their marching orders from the politicians," said David Fedson, a vaccines expert and former professor of medicine at the University of Virginia.
"Do you think any doses of vaccine made in France, Germany, the Czech Republic or anywhere will be allowed out to go to other countries just because there's a contract?" Fedson said.
Ultimately, Fedson said health officials and politicians will have to deal with a limited amount of vaccine for the billions worldwide who want it. "There's a lot of dirtiness in vaccine politics," he said. "We may try our best, but we won't succeed in doing what's necessary."
Rush to produce H1N1 vx
Drugmakers rush to produce a swine flu vaccine
By MARIA CHENG, AP Medical Writer Maria Cheng, Ap Medical Writer ? 18 mins ago
LONDON ? With swine flu now an official pandemic, the race is on among drugmakers to produce a vaccine.
GlaxoSmithKline said Thursday after the World Health Organization declared a global flu epidemic that it would be ready within weeks to begin large-scale vaccine production. Sanofi-Aventis also said it had started working on its own version. On Friday, Swiss pharma giant Novartis announced it had created an experimental vaccine that has not been tested in people. Novartis' vaccine was made via a cell-based technology that may prove faster than the traditional way of making vaccines, which relies on chicken eggs.
Many rich countries like Britain, Canada and France signed contracts with pharmaceuticals long ago, guaranteeing them access to pandemic vaccine. WHO and others estimate that about 2.4 billion doses of pandemic vaccine could be available in about a year.
The likely scramble for vaccines will leave many people in poorer countries empty-handed.
So far, swine flu has been mostly detected in developed countries like the United States, Europe, Japan and Australia.
"We do not know how this virus will behave under conditions typically found in the developing world," WHO chief Dr. Margaret Chan said Thursday. She said the agency expects to see a "bleaker" picture as the virus makes its way to Africa and Asia. About 85 percent of the world's chronic diseases are found in poorer countries. More than 60 percent of the world's HIV cases are also in Africa.
WHO spokesman Gregory Hartl said officials were concerned people in poorer countries and those fighting other health problems like malaria, tuberculosis, malnutrition and pneumonia might be more susceptible to swine flu.
On Friday, WHO said that 74 countries had reported nearly 30,000 cases including 145 deaths. But so far, the virus appears to be mild. Most people don't need medical treatment to get better.
But the virus might have a more devastating effect in people with underlying health problems. About half of the people who have died from swine flu have had complications like asthma, diabetes, and obesity.
"Any population that has health challenges is potentially going to be at higher risk with H1N1 (swine flu)," Hartl said.
In May, officials led by Chan and U.N. Secretary General Ban Ki-moon asked vaccine makers to save a portion of their production for poor countries. Chan said she was aiming to get 10 percent of the global pandemic vaccine supply reserved for poor nations.
Only one large company, GlaxoSmithKline PLC, agreed to help. The drug giant offered to donate 50 million doses of pandemic vaccine to WHO for distribution to developing countries. Several smaller firms also made offers, but their production capacity is limited.
Because more than 95 percent of flu vaccines are still made in eggs, the Novartis announcement is unlikely to significantly boost the world's pandemic vaccine supply.
But the news pushed up Novartis shares by 4 percent to 44.82 Swiss francs ($41.56) on the Zurich exchange on Friday.
The WHO says drugmakers will likely have vaccines against swine flu approved and ready for sale after September.
WHO and nongovernment organizations like Oxfam are continuing to ask drugmakers to make some of their pandemic vaccines available for poorer countries at a cheaper price, as well as asking donor countries and organizations to pay for the doses.
But in a pandemic situation, WHO's attempts to secure vaccine for the poor and even the contracts countries have signed with drugmakers may make little difference to who actually gets the vaccine, some experts say.
In previous pandemics, vaccines have never left the country where they are made before all of that country's own needs have been met.
"WHO can say whatever it wishes, but pharmaceutical companies will take their marching orders from the politicians," said David Fedson, a vaccines expert and former professor of medicine at the University of Virginia.
"Do you think any doses of vaccine made in France, Germany, the Czech Republic or anywhere will be allowed out to go to other countries just because there's a contract?" Fedson said.
Ultimately, Fedson said health officials and politicians will have to deal with a limited amount of vaccine for the billions worldwide who want it. "There's a lot of dirtiness in vaccine politics," he said. "We may try our best, but we won't succeed in doing what's necessary."
The Mountains Voice
Retired
Re: Rush to produce H1N1 vx - Don't miss this!
Re: Rush to produce H1N1 vx - Don't miss this!
Full Story on "SUCCESFUL" vaccine can be found here.....
http://news.yahoo.com/s/ap/20090612/ap_on_he_me/eu_switzerland_novartis_flu_vaccine
Excerpt...
The vaccine was produced at a Novartis plant in Marburg, Germany. Novartis said the facility could potentially produce millions of doses of vaccine a week.
A second plant is being built in Holly Springs, North Carolina, the company said.
Re: Rush to produce H1N1 vx - Don't miss this!
Full Story on "SUCCESFUL" vaccine can be found here.....
http://news.yahoo.com/s/ap/20090612/ap_on_he_me/eu_switzerland_novartis_flu_vaccine
Excerpt...
The vaccine was produced at a Novartis plant in Marburg, Germany. Novartis said the facility could potentially produce millions of doses of vaccine a week.
A second plant is being built in Holly Springs, North Carolina, the company said.
Desolation_anonymous
Well-known member
Re: Rush to produce H1N1 vx - Don't miss this!
Re: Rush to produce H1N1 vx - Don't miss this!
Awesome! Amazing news!
Question- is this the Marburg the Marburg Hemorrhagic Fever is named after? (named after the location of the first outbreak in 1967 in Marburg, Germany.)?
Re: Rush to produce H1N1 vx - Don't miss this!
Awesome! Amazing news!
Question- is this the Marburg the Marburg Hemorrhagic Fever is named after? (named after the location of the first outbreak in 1967 in Marburg, Germany.)?
bubstubbler
Member
Re: Rush to produce H1N1 vx - Don't miss this!
Re: Rush to produce H1N1 vx - Don't miss this!
Hope the new plant comes on line soon...
Re: Rush to produce H1N1 vx - Don't miss this!
Hope the new plant comes on line soon...
Gert van der Hoek
In Memoriam - Editor, Senior Moderator
Re: First batch of H1N1 vaccine is ready
Re: First batch of H1N1 vaccine is ready
Novartis is using a MDCK cell line for production if I am not mistaken.
Testing in mice showed MDCK stimulates or generates, not sure about that, tumors more, much more, than other cell lines. (MDCK are sort of cancer cells, which are tamed?)
They were working to solve that problem, I don´t know if it is solved now.
Re: First batch of H1N1 vaccine is ready
Novartis is using a MDCK cell line for production if I am not mistaken.
Testing in mice showed MDCK stimulates or generates, not sure about that, tumors more, much more, than other cell lines. (MDCK are sort of cancer cells, which are tamed?)
They were working to solve that problem, I don´t know if it is solved now.
AlaskaDenise
In Memoriam
Re: Rush to produce H1N1 vx - Don't miss this!
Re: Rush to produce H1N1 vx - Don't miss this!
Latest news article about plant status that I can find:
Novartis flu vaccine plant boosts Holly Springs' economy
By Erin Coleman
Posted: Apr. 24, 2009
Holly Springs, N.C. ? Construction of a flu vaccine-production plant by Swiss pharmaceutical giant Novartis AG has been giving Holly Springs some welcome protection against the recession.
Nonstop work for 20 months had brought the 430,000-square-foot facility halfway to completion, and installation of the reactors to grow the flu vaccine was under way when WRAL toured the site Wednesday.
"We currently have 700 people on site, so it's a substantially large construction project not just for Novartis but for the entire industry," Novartis site manager Chris McDonald said.
The $600 million facility is the largest bio-manufacturing project under construction in the United States, the site manager said.
The project is on budget and ahead of schedule, in part, because of the struggling economy, said McDonald.
"Two years ago, thing were booming here in N.C., so it was a little more difficult to attract tradesfolk to your project. And now the cost of raw materials has decreased, so overall it's probably helped us from a schedule prospective, as well as from a cost perspective," he said.
Approximately 100 local companies from drywall specialists to electricians have worked on the building.
"It's going to benefit the town now for the next 25 years with them being out there, from a tax base standpoint, from a jobs standpoint," Holly Springs Town Manager Carl Dean said.
Dean estimated that the town will make about $25 million a year off the plant, in addition to the new jobs the plant creates.
So far, Novartis has hired about 100 people, and local universities will provide a pool of candidates for the 200 more positions for which Novartis plans to hire over the next two years, McDonald said.
"We're looking for a lot of new grads with microbiology degrees," McDonald said, praising recent graduates from North Carolina State University as "phenomenal hires."
Amid a bidding war for the plant, Holly Springs officials offered an economic incentive package estimated to be worth about $40 million.
Novartis will use the facility, in part, to fulfill two contracts worth a total of more than $700 million from the U.S. Department of Health and Human Services. The vaccine production plant could be used to respond to pandemics.
Novartis leaders said they plan for the plant to be fully staffed and operational by the end of 2010. After undergoing inspections and licensing, the facility will make about 50 million doses of the flu vaccine annually.
http://localtechwire.com/business/local_tech_wire/biotech/story/5016256/
Re: Rush to produce H1N1 vx - Don't miss this!
Latest news article about plant status that I can find:
Novartis flu vaccine plant boosts Holly Springs' economy
By Erin Coleman
Posted: Apr. 24, 2009
Holly Springs, N.C. ? Construction of a flu vaccine-production plant by Swiss pharmaceutical giant Novartis AG has been giving Holly Springs some welcome protection against the recession.
Nonstop work for 20 months had brought the 430,000-square-foot facility halfway to completion, and installation of the reactors to grow the flu vaccine was under way when WRAL toured the site Wednesday.
"We currently have 700 people on site, so it's a substantially large construction project not just for Novartis but for the entire industry," Novartis site manager Chris McDonald said.
The $600 million facility is the largest bio-manufacturing project under construction in the United States, the site manager said.
The project is on budget and ahead of schedule, in part, because of the struggling economy, said McDonald.
"Two years ago, thing were booming here in N.C., so it was a little more difficult to attract tradesfolk to your project. And now the cost of raw materials has decreased, so overall it's probably helped us from a schedule prospective, as well as from a cost perspective," he said.
Approximately 100 local companies from drywall specialists to electricians have worked on the building.
"It's going to benefit the town now for the next 25 years with them being out there, from a tax base standpoint, from a jobs standpoint," Holly Springs Town Manager Carl Dean said.
Dean estimated that the town will make about $25 million a year off the plant, in addition to the new jobs the plant creates.
So far, Novartis has hired about 100 people, and local universities will provide a pool of candidates for the 200 more positions for which Novartis plans to hire over the next two years, McDonald said.
"We're looking for a lot of new grads with microbiology degrees," McDonald said, praising recent graduates from North Carolina State University as "phenomenal hires."
Amid a bidding war for the plant, Holly Springs officials offered an economic incentive package estimated to be worth about $40 million.
Novartis will use the facility, in part, to fulfill two contracts worth a total of more than $700 million from the U.S. Department of Health and Human Services. The vaccine production plant could be used to respond to pandemics.
Novartis leaders said they plan for the plant to be fully staffed and operational by the end of 2010. After undergoing inspections and licensing, the facility will make about 50 million doses of the flu vaccine annually.
http://localtechwire.com/business/local_tech_wire/biotech/story/5016256/
AlaskaDenise
In Memoriam
Re: First batch of H1N1 vaccine is ready
Re: First batch of H1N1 vaccine is ready
Posted on June 10, 2009 is a job opening for:
Job Details: Plant Engineer Manager, Novartis Vaccines & Diagnostics, Inc
Plant Engineer Manager
Description:
Job Purpose:
Reporting to the Associate Director of Plant Engineering and Maintenance, responsible for managing the engineering, start-up, commissioning and/or qualification of process systems, HVAC, GMP and Non-GMP utilities equipment to support Bulk manufacturing, Fill Finish, QC labs, Warehouse and Facility Operations building for a new Cell Culture based Flu Vaccine manufacturing facility to be located in Holly Springs, NC. Once the facility is operational, the incumbent?s team will provide 24 hour maintenance/engineering support for the pharmaceutical manufacturing facility to ensure maximum operational potential. The incumbent will be an integral member of an owner facility design, construction and validation management team.
(remainder of announcement is at: http://www.ncbiotech.org/ncbio/ncindustry/careers/jobs/jobdetail.cfm?jobid=9859)
Re: First batch of H1N1 vaccine is ready
Posted on June 10, 2009 is a job opening for:
Job Details: Plant Engineer Manager, Novartis Vaccines & Diagnostics, Inc
Plant Engineer Manager
Description:
Job Purpose:
Reporting to the Associate Director of Plant Engineering and Maintenance, responsible for managing the engineering, start-up, commissioning and/or qualification of process systems, HVAC, GMP and Non-GMP utilities equipment to support Bulk manufacturing, Fill Finish, QC labs, Warehouse and Facility Operations building for a new Cell Culture based Flu Vaccine manufacturing facility to be located in Holly Springs, NC. Once the facility is operational, the incumbent?s team will provide 24 hour maintenance/engineering support for the pharmaceutical manufacturing facility to ensure maximum operational potential. The incumbent will be an integral member of an owner facility design, construction and validation management team.
(remainder of announcement is at: http://www.ncbiotech.org/ncbio/ncindustry/careers/jobs/jobdetail.cfm?jobid=9859)
AlaskaDenise
In Memoriam
Re: First batch of H1N1 vaccine is ready
Re: First batch of H1N1 vaccine is ready
The later half of the Novartis press release...
Footnote
[1] Development of Novartis' cell-based influenza vaccine, construction of the cell-based influenza manufacturing facility at Holly Springs, NC and purchase of H1N1 antigen and adjuvant are being funded in whole or in part with Federal funds from the Office of Public Health Emergency Preparedness, Office of Research and Development Coordination, under Contract Numbers HHSO100200600012C, HHSO100200900101C and HHSO100200800072I, respectively.
Disclaimer
The foregoing release contains forward-looking statements that can be identified by terminology such as "will," "potential," "commitment," "expects," "plans", "can", "potentially", or similar expressions, or by express or implied discussions regarding potential marketing approvals for an influenza A(H1N1) vaccine, potential production timing and volumes for such a vaccine or regarding potential future revenues from such a vaccine. You should not place undue reliance on these statements. Such forward-looking statements reflect the current views of management regarding future events, and involve known and unknown risks, uncertainties and other factors that may cause actual results to be materially different from any future results, performance or achievements expressed or implied by such statements. There can be no guarantee that influenza A(H1N1) vaccines will be approved for sale in any market. Nor can there be any guarantee that influenza A(H1N1) vaccines will be produced by any particular date, or in any particular volumes. Neither can there be any guarantee that influenza A(H1N1) vaccines will achieve any particular levels of revenue in the future. In particular, management's expectations could be affected by, among other things, unexpected clinical trial results, including unexpected new clinical data and unexpected additional analysis of existing clinical data; unexpected regulatory actions or delays or government regulation generally; unexpected manufacturing difficulties or delays, including unexpected difficulties with our flu cell culture manufacturing facility and processes; competition in general; government, industry and general public pricing pressures; the company's ability to obtain or maintain patent or other proprietary intellectual property protection; the impact that the foregoing factors could have on the values attributed to the Novartis Group's assets and liabilities as recorded in the Group's consolidated balance sheet, and other risks and factors referred to in Novartis AG's current Form 20-F on file with the US Securities and Exchange Commission. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those anticipated, believed, estimated or expected. Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise.
About Novartis
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 AG 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 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 98,000 full-time-equivalent associates and operate in more than 140 countries around the world. For more information, please visit http://www.novartis.com.
http://www.novartis.com/newsroom/media-releases/en/2009/1322241.shtml
Re: First batch of H1N1 vaccine is ready
The later half of the Novartis press release...
Footnote
[1] Development of Novartis' cell-based influenza vaccine, construction of the cell-based influenza manufacturing facility at Holly Springs, NC and purchase of H1N1 antigen and adjuvant are being funded in whole or in part with Federal funds from the Office of Public Health Emergency Preparedness, Office of Research and Development Coordination, under Contract Numbers HHSO100200600012C, HHSO100200900101C and HHSO100200800072I, respectively.
Disclaimer
The foregoing release contains forward-looking statements that can be identified by terminology such as "will," "potential," "commitment," "expects," "plans", "can", "potentially", or similar expressions, or by express or implied discussions regarding potential marketing approvals for an influenza A(H1N1) vaccine, potential production timing and volumes for such a vaccine or regarding potential future revenues from such a vaccine. You should not place undue reliance on these statements. Such forward-looking statements reflect the current views of management regarding future events, and involve known and unknown risks, uncertainties and other factors that may cause actual results to be materially different from any future results, performance or achievements expressed or implied by such statements. There can be no guarantee that influenza A(H1N1) vaccines will be approved for sale in any market. Nor can there be any guarantee that influenza A(H1N1) vaccines will be produced by any particular date, or in any particular volumes. Neither can there be any guarantee that influenza A(H1N1) vaccines will achieve any particular levels of revenue in the future. In particular, management's expectations could be affected by, among other things, unexpected clinical trial results, including unexpected new clinical data and unexpected additional analysis of existing clinical data; unexpected regulatory actions or delays or government regulation generally; unexpected manufacturing difficulties or delays, including unexpected difficulties with our flu cell culture manufacturing facility and processes; competition in general; government, industry and general public pricing pressures; the company's ability to obtain or maintain patent or other proprietary intellectual property protection; the impact that the foregoing factors could have on the values attributed to the Novartis Group's assets and liabilities as recorded in the Group's consolidated balance sheet, and other risks and factors referred to in Novartis AG's current Form 20-F on file with the US Securities and Exchange Commission. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those anticipated, believed, estimated or expected. Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise.
About Novartis
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 AG 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 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 98,000 full-time-equivalent associates and operate in more than 140 countries around the world. For more information, please visit http://www.novartis.com.
http://www.novartis.com/newsroom/media-releases/en/2009/1322241.shtml
bubstubbler
Member
Re: Rush to produce H1N1 vx - Don't miss this!
Re: Rush to produce H1N1 vx - Don't miss this!
Re: Rush to produce H1N1 vx - Don't miss this!
Ouch.
AlaskaDenise
In Memoriam
Re: First batch of H1N1 vaccine is ready
Re: First batch of H1N1 vaccine is ready
That sounds like a "shovel ready" project for stimulus funds, doesn't it?
Maybe they could turn up the intensity and work 24/7s to speed it up, if they haven't already.
.
Re: First batch of H1N1 vaccine is ready
That sounds like a "shovel ready" project for stimulus funds, doesn't it?
Maybe they could turn up the intensity and work 24/7s to speed it up, if they haven't already.
.
sharon sanders
Editor-in-Chief & President
Re: First batch of H1N1 vaccine is ready to begin testing process. No vaccine for distribution before Fall 2009
"...Novartis expects to be able to achieve rapid scale up of influenza A(H1N1) vaccine manufacture with reassortant seed which was provided by the Centers for Disease Control and Prevention (CDC) on May 27th. The company plans to start clinical trials with that vaccine in July and expects licensure in the fall of 2009...."
There will not be distribution until then. Please do not expect this to "save" you.
Even after approval most people on earth will not receive a shot for many, many months.
The drug manufacturers routinely release very positive news about their latest accomplishments. We need to take a "wait and see" attitude.
Please prepare yourself and your near ones as if you will not have access to a vaccine.
"...Novartis expects to be able to achieve rapid scale up of influenza A(H1N1) vaccine manufacture with reassortant seed which was provided by the Centers for Disease Control and Prevention (CDC) on May 27th. The company plans to start clinical trials with that vaccine in July and expects licensure in the fall of 2009...."
There will not be distribution until then. Please do not expect this to "save" you.
Even after approval most people on earth will not receive a shot for many, many months.
The drug manufacturers routinely release very positive news about their latest accomplishments. We need to take a "wait and see" attitude.
Please prepare yourself and your near ones as if you will not have access to a vaccine.
Dark Horse
In Memoriam
Re: First batch of H1N1 vaccine is ready to begin testing process. No vaccine for distribution before Fall 2009
With all this vaccine happy talk and the assumptions that individuals draw from it, I would expect that people will fall into a very false sense of security. I think governments need to be a bit clearer on this issue.
With all this vaccine happy talk and the assumptions that individuals draw from it, I would expect that people will fall into a very false sense of security. I think governments need to be a bit clearer on this issue.
AlaskaDenise
In Memoriam
Re: First batch of H1N1 vaccine is ready to begin testing process. No vaccine for distribution before Fall 2009
Hopefully, all available resources will be allocated to remedy the situation, e.g, speeding up construction on North Carolina VAX plant, & if/when the situation worsens, the health industry can maintain some credibility.
.
They haven't given enough thought to the public reaction when they realize there is no near-time vaccine availability nor sufficient supply. Should this flu gain lethality in the next year or two, and there is insufficient or poorly matched vaccine, health authorities will loose badly-needed credibility.
Hopefully, all available resources will be allocated to remedy the situation, e.g, speeding up construction on North Carolina VAX plant, & if/when the situation worsens, the health industry can maintain some credibility.
.
AlaskaDenise
In Memoriam
Re: First batch of H1N1 vaccine is ready to begin testing process. No vaccine for distribution before Fall 2009
Novartis Marburg-produced Optiflu "Summary of Product Characteristics" here:
http://www.emea.europa.eu/humandocs/PDFs/EPAR/optaflu/H-758-PI-en.pdf
Note (page 20) that it is not recommended for use on children under the age of 18 (due to lack of testing). Also the "safety of Optiflu for pregnant and breastfeeding women has not been determined" due to "limited data".
It must be kept refrigerated, which will impact it's suitability in underdeveloped areas.
.
Novartis Marburg-produced Optiflu "Summary of Product Characteristics" here:
http://www.emea.europa.eu/humandocs/PDFs/EPAR/optaflu/H-758-PI-en.pdf
Note (page 20) that it is not recommended for use on children under the age of 18 (due to lack of testing). Also the "safety of Optiflu for pregnant and breastfeeding women has not been determined" due to "limited data".
It must be kept refrigerated, which will impact it's suitability in underdeveloped areas.
.
Siegfried X
Well-known member
Re: First batch of H1N1 vaccine is ready to begin testing process. No vaccine for distribution before Fall 2009
-- quote from Novartis
The vaccine is available IMMEDIATELY from the GERMAN plant, as described in the press release. The second plant, which will be completed in the USA in 2010 is irrelevant. Ground was broken on the US plant before the new swine H1N1 was discovered. So the press release is correct, and any implication that the vaccine will be held up waiting for the US plant in North Carolina is inaccurate.
-- quote from US HHS on Thursday
Late September is exactly what the US government and vaccine makers have always said, that the virus would be publicly available 4 to 6 months after the seed virus was released by the CDC, which was the end of May.
.
-- quote from Novartis
The vaccine is available IMMEDIATELY from the GERMAN plant, as described in the press release. The second plant, which will be completed in the USA in 2010 is irrelevant. Ground was broken on the US plant before the new swine H1N1 was discovered. So the press release is correct, and any implication that the vaccine will be held up waiting for the US plant in North Carolina is inaccurate.
-- quote from US HHS on Thursday
Late September is exactly what the US government and vaccine makers have always said, that the virus would be publicly available 4 to 6 months after the seed virus was released by the CDC, which was the end of May.
Laidback Al
Well-known member
Re: First batch of H1N1 vaccine is ready to begin testing process. No vaccine for distribution before Fall 2009
Part of the problem is lack of critical, in-depth news reporting. The level 6 pandemic announcement was buried in a short article on page 4 or 5 of our local newspaper on June 11. Public health officials have little control or input into the "two minute" sound bites that dominate news media outlets today.
As is apparent to all of the posters and readers here at FT there will not be enough novel vaccine for wide spread innoculation. Only if the virulence increases will the public pay attention, and it will be too late by then. It is best to follow Florida1's advice above for everyone to prepare with no expectation of receiving a vaccination for this novel strain.
Part of the problem is lack of critical, in-depth news reporting. The level 6 pandemic announcement was buried in a short article on page 4 or 5 of our local newspaper on June 11. Public health officials have little control or input into the "two minute" sound bites that dominate news media outlets today.
As is apparent to all of the posters and readers here at FT there will not be enough novel vaccine for wide spread innoculation. Only if the virulence increases will the public pay attention, and it will be too late by then. It is best to follow Florida1's advice above for everyone to prepare with no expectation of receiving a vaccination for this novel strain.
AlaskaDenise
In Memoriam
Re: First batch of H1N1 vaccine is ready to begin testing process. No vaccine for distribution before Fall 2009
This article has an interesting description of the cell-based process.
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Flu Vaccine 2009 Produced, Ready for Testing
Flu Cell Tissue Cultures Used for Pandemic Swine H1N1 Vaccine
© Donald Reinhardt
Jun 12, 2009
The MCDK cell flu vaccine, prepared in large fermenters and later purified, will be tested to determine its effectiveness for immune protection against swine H1N1 flu.
The technology for flu vaccines has taken a dramatic, new and very good turn. Chicken eggs are no longer the mainstay for production of flu vaccines, and that is good news as will be seen below. Soon millions of doses of highly-protective vaccine should be available throughout the world. Vaccination costs will run into the billions world-wide and that large expense for producing safe and effective vaccines can save lives and prevent illness.
Cell and Tissue Culture Vaccines Compared with Egg-Based Influenza Vaccines
The important production time and allergy considerations for vaccine production are compared below:
•Egg-based vaccines take 6-9 months to get into full production, may produce egg allergies or exacerbate allergies in people who have them.
•Cell Culture-derived vaccines are up and running into full production within weeks and massive large amounts can be produced without fear of egg allergy problems.
Flu Cell and Tissue Culture-Derived Vaccines, What They Are, How They Work
Here are the Novartis procedures for production of the new flu vaccine:
•MDCK cells (derived in 1958 from a healthy dog's kidney) are removed from a deep freezer at -196 degrees centigrade and thawed . These cells are optimal for flu virus production.
•Cells are added to 10 L stainless steel incubators in clean rooms to maintain “sterile” conditions. The cells proliferate into large, suspended tissue masses while incubated in liquid-based nutrient medium at controlled pH and temperature that is monitored constantly by computerized technology. After adequate growth, transfers are made to 100 L and 1,000 L tanks. Three weeks later the cells are ready for viral inoculations and the proliferation and production of viruses.
•Cells are piped to a 2,500 L fermenter with fresh nutrients and flu viruses are added. The viruses attach to the cells, enter, replicate, kill the cells and seek any remaining viable kidney cells. A few days later, the viruses abound in the culture fluid.
•Column chromatography is used for the separation of culture cells from viruses,
•Ultrafiltration is used to concentrate the viruses to 100X (now 25 liters of the original 2500L).
•Viruses are inactivated chemically and only the surface H and N antigens are used.
Swine H1N1 Flu Cell Vaccine Production Final Steps
Typical flu vaccine always contains three of the predominant circulating viruses in the world population. Thus, three different vaccine batches must be combined to produce a single vaccine. Novartis reports that every 3 X 2500 L batch generates 450,000 flu vaccine units for immunization. At the mixing and filling stage the process has taken a total of 16 weeks, 4 months to complete.
There is another caveat to all this. The influenza viruses are notorious for shifts and drifts in their genetics.
If a new strain be produced by gene mutations or recombination, then any current vaccine could be only partially or minimally protective. This is just another reason why life never simple or straightforward. Stay alert and be informed.
http://human-infections.suite101.co...09_produced_ready_for_testing#ixzz0IOArTHSt&D
This article has an interesting description of the cell-based process.
--------------------------------------------------------------------------
Flu Vaccine 2009 Produced, Ready for Testing
Flu Cell Tissue Cultures Used for Pandemic Swine H1N1 Vaccine
© Donald Reinhardt
Jun 12, 2009
The MCDK cell flu vaccine, prepared in large fermenters and later purified, will be tested to determine its effectiveness for immune protection against swine H1N1 flu.
The technology for flu vaccines has taken a dramatic, new and very good turn. Chicken eggs are no longer the mainstay for production of flu vaccines, and that is good news as will be seen below. Soon millions of doses of highly-protective vaccine should be available throughout the world. Vaccination costs will run into the billions world-wide and that large expense for producing safe and effective vaccines can save lives and prevent illness.
Cell and Tissue Culture Vaccines Compared with Egg-Based Influenza Vaccines
The important production time and allergy considerations for vaccine production are compared below:
•Egg-based vaccines take 6-9 months to get into full production, may produce egg allergies or exacerbate allergies in people who have them.
•Cell Culture-derived vaccines are up and running into full production within weeks and massive large amounts can be produced without fear of egg allergy problems.
Flu Cell and Tissue Culture-Derived Vaccines, What They Are, How They Work
Here are the Novartis procedures for production of the new flu vaccine:
•MDCK cells (derived in 1958 from a healthy dog's kidney) are removed from a deep freezer at -196 degrees centigrade and thawed . These cells are optimal for flu virus production.
•Cells are added to 10 L stainless steel incubators in clean rooms to maintain “sterile” conditions. The cells proliferate into large, suspended tissue masses while incubated in liquid-based nutrient medium at controlled pH and temperature that is monitored constantly by computerized technology. After adequate growth, transfers are made to 100 L and 1,000 L tanks. Three weeks later the cells are ready for viral inoculations and the proliferation and production of viruses.
•Cells are piped to a 2,500 L fermenter with fresh nutrients and flu viruses are added. The viruses attach to the cells, enter, replicate, kill the cells and seek any remaining viable kidney cells. A few days later, the viruses abound in the culture fluid.
•Column chromatography is used for the separation of culture cells from viruses,
•Ultrafiltration is used to concentrate the viruses to 100X (now 25 liters of the original 2500L).
•Viruses are inactivated chemically and only the surface H and N antigens are used.
Swine H1N1 Flu Cell Vaccine Production Final Steps
Typical flu vaccine always contains three of the predominant circulating viruses in the world population. Thus, three different vaccine batches must be combined to produce a single vaccine. Novartis reports that every 3 X 2500 L batch generates 450,000 flu vaccine units for immunization. At the mixing and filling stage the process has taken a total of 16 weeks, 4 months to complete.
There is another caveat to all this. The influenza viruses are notorious for shifts and drifts in their genetics.
If a new strain be produced by gene mutations or recombination, then any current vaccine could be only partially or minimally protective. This is just another reason why life never simple or straightforward. Stay alert and be informed.
http://human-infections.suite101.co...09_produced_ready_for_testing#ixzz0IOArTHSt&D