Sol Invictus
08-17-2009, 02:52 PM
Press TV
Patricia Khashayar (http://www.presstv.ir/detail.aspx?id=103589§ionid=3510304)
15 Aug 2009
While nearly every country in the world has been swarming with the swine flu virus, scientists have not yet succeeded in producing a vaccine for the deadly virus responsible for more than 1,462 deaths.
The rapidly growing number of swine flu cases has given rise to the theory that everyone is immunologically vulnerable to the disease, indicating that the need for a vaccine is pressing particularly now that the flu season is nearing.
WHO officials have predicted that the estimated number of cases infected with the new flu virus, responsible for the first pandemic in the past 41 years, will reach two billion in the next two years, making it even more dangerous than earlier pandemics which have infected one-third of the world's population.
Unless an effective swine flu vaccine is developed and successfully produced, experts predict that several hundreds of thousands of individuals could die worldwide.
Governments and scientists are in the race to produce an H1N1 vaccine. Sanofi-Aventis -- the world leader in flu immunization, Novartis AG, Baxter International, Schering-Plough's Nobilon, GlaxoSmithKline Plc, Solvay, Australia's CSL Ltd, and AstraZeneca's MedImmune are among the companies working on this vaccine.
Regulators in Europe and the US plan to fast-track the approval of swine flu vaccines to ensure their mass production before the start of winter in the northern hemisphere.
They, however, have asserted that the safety of the drug should not be compromised by hast to produce a vaccine.
In order to achieve such goal, four 'mock-up' vaccines developed by Baxter, GlaxoSmithKline and Novartis have already been approved in the European Union based on earlier data generated with the H5N1 virus strain, which is similar to H1N1.
The main cause of such fast approvals was that previous studies on seasonal influenza vaccines had shown that inserting a new strain in a vaccine - as in mock-up vaccines for changing H5N1 to H1N1 - does not substantially affect the safety or level of protection offered by the vaccine.
Aiming to produce effective vaccines for the fastest-moving pandemic ever seen, different pharmaceutical companies have adopted different manners.
Many are using conventional egg-based technology and particles of the dead virus, as they believe that while the method is time-consuming it blocks any possible way for the transmission of influenza from the vaccine.
Novavax Inc, on the other hand, is using a gene sequence provided by the US Centers for Disease Control for producing a virus-like particle, which is not capable of replicating, with the aim of producing the vaccine in a shorter time.
Unlike currently available flu shots, AstraZeneca's MedImmune is using weakened strains of the virus for developing vaccines in the form of nasal spray.
It should be noted that the use of a dead virus or particles unable to replicate in these vaccines is aimed at preventing catastrophes such as what happened during the H1N1 outbreak in 1976, when hundreds of people developed Guillain-Barre Syndrome -- an inflammatory disorder of the peripheral nerves characterized by ascending paralysis -- a few weeks after receiving the vaccine.
Aiming to overcome the fear regarding the side effects of the vaccine, Australia (Adelaide-based Vaxine Pty Ltd and Melbourne-based CSL Biotherapies in partnership with CMAX, a clinical research organization, and Royal Adelaide Hospital) and China have launched large human trials.
Despite suppositions that companies would face difficulty finding volunteers for testing the vaccine due to the 1967 vaccine incident, many who feared contracting the 'unstoppable' virus queued up to receive the newly produced vaccines.
Several other manufacturers including Swiss-based Novartis, Paris-based Sanofi Pasteur and a number of other firms in the US have also started or will soon begin such trials.
Experts hope to conduct similar trials in children as soon as the released information confirms the safety of the product in adults. They also hope to estimate the global supply of the vaccine, the number of doses required for each individual as well as the quantity of active ingredients (antigen) needed in each vaccine dose based on the results of these trials.
Despite all these efforts, questions remain about when a swine flu vaccine will become available. WHO officials, hence, believe a fully licensed vaccine might not be ready earlier than fall.
Moreover, many believe certain countries particularly developing ones will not be able to receive their required vaccine until January 2010 due to the lengthy order list and overwhelming demand for the vaccine.
At least 50 governments have placed orders or are currently negotiating with pharmaceutical companies to secure supplies of under-development H1N1 vaccines. England, Australia and Germany have already ordered large quantities, enough for their entire population.
US officials also hope to have 160 million doses of the injectable swine flu vaccine on hand by October, with more doses coming in the form of a nasal spray. Officials, however, believe even these high doses would be sufficient for only a fraction of the population at-risk of contracting the new influenza strain.
Despite all these contracts and orders, public health officials foresee "vaccine wars", an ugly scramble over the swine flu vaccine when it becomes available.
"Pandemic vaccine will be a valuable and scarce resource, like oil or food during a famine," said David Fidler, a professor of law at Indiana University who has consulted for WHO. "We've seen how countries behave in those situations, and it's not encouraging."
Experts warn that during a global epidemic, such as what the world is experiencing now, countries with flu vaccine plants might decide to seize all vaccines, aiming to first protect their own citizens before allowing companies to export the vaccine.
Such an act, hence, would break the pharmaceutical contracts promising other countries vaccine supplies, leaving countries such as Britain and the US - which import all or the majority of the flu vaccines they use -- not only without vaccine, but without legal recourse.
"There's nothing in international law that helps you resolve this, it's just a political nightmare happening in the midst of an epidemiological nightmare," added Fidler.
Meanwhile, in order to overcome the fear regarding the shortage of vaccine in poor nations, several pharmaceutical companies have promised to provide developing countries with certain amounts of the vaccine at a reduced price when they become available. Two manufacturers have guaranteed to give out 150 million doses for health workers in poor countries.
Considering the limited amount of vaccine, countries are identifying their at-risk population with the aim of curbing the spread of the disease with their restricted vaccine quantity. Experts, however, are not sure whether individuals would be willing to skip getting a vaccine, if there are to be limited swine flu shots.
WHO officials believe healthcare workers should be the first to be immunized in all countries in order to retain a functional health system as the virus evolves. Pregnant women and immunosuppressed individuals are also on top of the list.
UK officials, however, have included drug addicts on methadone in the group who will be given priority for the vaccine. Many, however, believe the revelation of such decision would lead to disagreements at a time when there is increasing public concern over swine flu.
Despite all these limitations, many governments are relying on these vaccines to contain the spread of the disease, providing a potential sales windfall for the companies that are able to deliver quickly and in large volumes. With little or no safety data about the swine flu vaccine, these governments are planning to conduct mass inoculation programs as soon as the vaccine becomes available, an act considered as a gamble by many individuals.
Many governments have decided to protect their citizens against the new flu with the seasonal flu vaccine for the time being, saying that both diseases stem from the same “A” virus strain.
Reports, however, suggest that the vaccine can only reduce the chances of contracting the H1N1 virus by 50 to 60 percent.
Patricia Khashayar (http://www.presstv.ir/detail.aspx?id=103589§ionid=3510304)
15 Aug 2009
While nearly every country in the world has been swarming with the swine flu virus, scientists have not yet succeeded in producing a vaccine for the deadly virus responsible for more than 1,462 deaths.
The rapidly growing number of swine flu cases has given rise to the theory that everyone is immunologically vulnerable to the disease, indicating that the need for a vaccine is pressing particularly now that the flu season is nearing.
WHO officials have predicted that the estimated number of cases infected with the new flu virus, responsible for the first pandemic in the past 41 years, will reach two billion in the next two years, making it even more dangerous than earlier pandemics which have infected one-third of the world's population.
Unless an effective swine flu vaccine is developed and successfully produced, experts predict that several hundreds of thousands of individuals could die worldwide.
Governments and scientists are in the race to produce an H1N1 vaccine. Sanofi-Aventis -- the world leader in flu immunization, Novartis AG, Baxter International, Schering-Plough's Nobilon, GlaxoSmithKline Plc, Solvay, Australia's CSL Ltd, and AstraZeneca's MedImmune are among the companies working on this vaccine.
Regulators in Europe and the US plan to fast-track the approval of swine flu vaccines to ensure their mass production before the start of winter in the northern hemisphere.
They, however, have asserted that the safety of the drug should not be compromised by hast to produce a vaccine.
In order to achieve such goal, four 'mock-up' vaccines developed by Baxter, GlaxoSmithKline and Novartis have already been approved in the European Union based on earlier data generated with the H5N1 virus strain, which is similar to H1N1.
The main cause of such fast approvals was that previous studies on seasonal influenza vaccines had shown that inserting a new strain in a vaccine - as in mock-up vaccines for changing H5N1 to H1N1 - does not substantially affect the safety or level of protection offered by the vaccine.
Aiming to produce effective vaccines for the fastest-moving pandemic ever seen, different pharmaceutical companies have adopted different manners.
Many are using conventional egg-based technology and particles of the dead virus, as they believe that while the method is time-consuming it blocks any possible way for the transmission of influenza from the vaccine.
Novavax Inc, on the other hand, is using a gene sequence provided by the US Centers for Disease Control for producing a virus-like particle, which is not capable of replicating, with the aim of producing the vaccine in a shorter time.
Unlike currently available flu shots, AstraZeneca's MedImmune is using weakened strains of the virus for developing vaccines in the form of nasal spray.
It should be noted that the use of a dead virus or particles unable to replicate in these vaccines is aimed at preventing catastrophes such as what happened during the H1N1 outbreak in 1976, when hundreds of people developed Guillain-Barre Syndrome -- an inflammatory disorder of the peripheral nerves characterized by ascending paralysis -- a few weeks after receiving the vaccine.
Aiming to overcome the fear regarding the side effects of the vaccine, Australia (Adelaide-based Vaxine Pty Ltd and Melbourne-based CSL Biotherapies in partnership with CMAX, a clinical research organization, and Royal Adelaide Hospital) and China have launched large human trials.
Despite suppositions that companies would face difficulty finding volunteers for testing the vaccine due to the 1967 vaccine incident, many who feared contracting the 'unstoppable' virus queued up to receive the newly produced vaccines.
Several other manufacturers including Swiss-based Novartis, Paris-based Sanofi Pasteur and a number of other firms in the US have also started or will soon begin such trials.
Experts hope to conduct similar trials in children as soon as the released information confirms the safety of the product in adults. They also hope to estimate the global supply of the vaccine, the number of doses required for each individual as well as the quantity of active ingredients (antigen) needed in each vaccine dose based on the results of these trials.
Despite all these efforts, questions remain about when a swine flu vaccine will become available. WHO officials, hence, believe a fully licensed vaccine might not be ready earlier than fall.
Moreover, many believe certain countries particularly developing ones will not be able to receive their required vaccine until January 2010 due to the lengthy order list and overwhelming demand for the vaccine.
At least 50 governments have placed orders or are currently negotiating with pharmaceutical companies to secure supplies of under-development H1N1 vaccines. England, Australia and Germany have already ordered large quantities, enough for their entire population.
US officials also hope to have 160 million doses of the injectable swine flu vaccine on hand by October, with more doses coming in the form of a nasal spray. Officials, however, believe even these high doses would be sufficient for only a fraction of the population at-risk of contracting the new influenza strain.
Despite all these contracts and orders, public health officials foresee "vaccine wars", an ugly scramble over the swine flu vaccine when it becomes available.
"Pandemic vaccine will be a valuable and scarce resource, like oil or food during a famine," said David Fidler, a professor of law at Indiana University who has consulted for WHO. "We've seen how countries behave in those situations, and it's not encouraging."
Experts warn that during a global epidemic, such as what the world is experiencing now, countries with flu vaccine plants might decide to seize all vaccines, aiming to first protect their own citizens before allowing companies to export the vaccine.
Such an act, hence, would break the pharmaceutical contracts promising other countries vaccine supplies, leaving countries such as Britain and the US - which import all or the majority of the flu vaccines they use -- not only without vaccine, but without legal recourse.
"There's nothing in international law that helps you resolve this, it's just a political nightmare happening in the midst of an epidemiological nightmare," added Fidler.
Meanwhile, in order to overcome the fear regarding the shortage of vaccine in poor nations, several pharmaceutical companies have promised to provide developing countries with certain amounts of the vaccine at a reduced price when they become available. Two manufacturers have guaranteed to give out 150 million doses for health workers in poor countries.
Considering the limited amount of vaccine, countries are identifying their at-risk population with the aim of curbing the spread of the disease with their restricted vaccine quantity. Experts, however, are not sure whether individuals would be willing to skip getting a vaccine, if there are to be limited swine flu shots.
WHO officials believe healthcare workers should be the first to be immunized in all countries in order to retain a functional health system as the virus evolves. Pregnant women and immunosuppressed individuals are also on top of the list.
UK officials, however, have included drug addicts on methadone in the group who will be given priority for the vaccine. Many, however, believe the revelation of such decision would lead to disagreements at a time when there is increasing public concern over swine flu.
Despite all these limitations, many governments are relying on these vaccines to contain the spread of the disease, providing a potential sales windfall for the companies that are able to deliver quickly and in large volumes. With little or no safety data about the swine flu vaccine, these governments are planning to conduct mass inoculation programs as soon as the vaccine becomes available, an act considered as a gamble by many individuals.
Many governments have decided to protect their citizens against the new flu with the seasonal flu vaccine for the time being, saying that both diseases stem from the same “A” virus strain.
Reports, however, suggest that the vaccine can only reduce the chances of contracting the H1N1 virus by 50 to 60 percent.