New National Vaccine Plan Draft States Serious Problems Persist
by Anthony L. Kimery
Tuesday, 09 December 2008
'Development of new vaccines is much slower than advances in our understanding of immunology'
Noting that "emerging and pandemic infections and bioterrorist threats pose new challenges for vaccine development and regulation, manufacturing, vaccine delivery, and access in the US and abroad," the Department of Health and Human Services? (HHS) 85-page draft of its updated national vaccine strategy ? coordinated by the National Vaccine Program Office - released this week is intended to update the nation's vaccine plan mandated by Congress and first released more than a decade ago.
Once finalized, the new national vaccine plan will guide the government's policy decisions on infectious disease vaccines and vaccinations.
Given that there?s a strong potential for a bio-terrorist attack within five years, as three recent reports ? two in the US and one in Great Britain ? determined, and the still looming threat of an influenza pandemic or the emergence of some other highly infectious disease, HHS?s vaccine plan urges large-scale vaccine distribution drills for the nation?s workforce and public at large in preparation for a possible biological-weapon attack or infectious disease outbreak, like a flu pandemic.
The strategy calls for the United States to develop safer and more effective vaccines; guarantee the steady production of vaccines while expanding their global distribution; and advise policy-makers, health care professionals and individuals on vaccine-related issues.
It also states a need to pursue a cross-protective vaccine for influenza.
The Plan is built around the achievement of five broad goals:
Goal 1: Develop new and improved vaccines;
Goal 2: Enhance the safety of vaccines and vaccination practices;
Goal 3: Support informed vaccine decision-making by the public, providers, and
policy-makers;
Goal 4: Ensure a stable supply of recommended vaccines and achieve better use
of existing vaccines to prevent disease, disability and death in the United States; and
Goal 5: Increase global prevention of death and disease through safe and effective
vaccination
HHS?s draft plan notes that, ?despite an increased number of vaccine manufacturers, several routinely recommended vaccines are produced by single manufacturers and intermittent supply shortages continue to occur.?
Indeed. The HHS plan points out that that despite the strides that have been made in meeting the goals of the 1994 strategy, vaccine shortages still crop up.
The new plan alarmingly pointed out that ?recent mumps and measles outbreaks and continued circulation of pertussis are reminders that despite changes in vaccine recommendations and higher coverage, vaccine preventable diseases still occur,? adding, ?the pace of development of new vaccines is much slower than advances in our understanding of immunology and several significant infectious diseases remain leading causes of death globally.?
The plan indicates that the United States has achieved most goals outlined in its original 1994 vaccine strategy, although poorly vaccinated populations and scarcity of certain treatments are among the most persistent problems.
HHS stated that ?in the US, the success in achieving high vaccination coverage among children has not been replicated for routinely recommended vaccinations among adolescents or adults. And as the cost of vaccination has increased, financial barriers to optimal program implementation have emerged for health departments, healthcare providers, and the public.?
As HSToday has reported with regard to annual flu vaccinations, among many adults there is a considerable misunderstanding about the efficacy and safety of the vaccinations. Meanwhile, there is a growing movement among parents of children and adolescents to forego allowing their children to be vaccinated for any childhood disease, let alone the flu.
HHS, the Centers for Disease Control and Prevention (CDC) and state and local public health authorities are increasingly worried that as America?s economic ills worsen, many more people will forego getting necessary vaccinations ? be it for the flu or tetanus. They?re also worried that financially strapped parents, especially those without health care, will not be able to afford routine vaccinations for their children.
At a time when there?s mounting fears over emerging and re-emerging infectious diseases, this represents a new, compounding problem for public health policy makers, authorities stressed to HSToday.us.
Indeed. Although most of the 1994 vaccine plan goals have been achieved, the new HHS plan notes that immunization rates for high-risk groups fall below their ideal levels.
Similar problems face many other countries, especially poor and developing nations, as HSToday.us has reported.
Last week, a WHO study published in the online edition of The Lancet reported that an alarming lack of availability of essential medicines in the public sector forces patients to pay higher prices in the private sector - or go without. WHO stated that its report confirms that governments must do more to improve access to essential medicines as part of their efforts to make national health systems more efficient and equitable.
Meanwhile, the world?s vaccine makers urged governments to prevail over their "pandemic fatigue" towards large-scale public pandemic preparedness and move quickly on completing their respective and coordinated global response plans to confront an influenza pandemic.
Stephen Gardner of GSK Biologics said last week that the pharmaceutical industry is "very close to ready" to respond to a pandemic by shifting its seasonal flu vaccine production to begin manufacturing a vaccine for a pandemic strain ? or, God forbid, multiple pandemic strains.
Gardner said at a news conference that it?s imperative that all nations stop stalling on sharing influenza viruses with one another and immediately come to terms on an agreement to share samples of virus strains that potential could mutate into pandemic strains in order to pick up the pace on efforts to create effective vaccines.
"We don't have time to negotiate a new agreement when a pandemic arises. We need to get on with manufacturing quickly," Gardner told reporters, emphasizing that ?time is of the essence to ensure good vaccine supply."
As HSToday.us has reported, Indonesia, the country most affected by H5N1 bird flu, has resisted providing viral samples to the international community because it argues that material is then used by big drugmakers to create vaccines that poorer countries cannot afford or use.
For their part, they do have legitimate reasons to be worried. For example, if a flu pandemic were to erupt today, it would take the handful of vaccine manufacturers predominately in the West between six to nine months to produce the first batch of roughly 1 billion doses of a vaccine ? one billion doses for the entire world.
More than just a few global public health authorities have expressed concern that developing nations are likely indeed to be the last to see any appreciable supplies of a pandemic vaccine because of the need by the industrialized nations to ensure that vital global infrastructure, health, commerce, military and security forces are first inoculated.
The World Health Organization (WHO) this week is hosting host an inter-governmental meeting during which the agency's member states will discuss the highly charged issue of virus sample sharing and access to vaccines ? and even antivirals - in the event of a flu pandemic.
http://www.hstoday.us/content/view/6377/149/
by Anthony L. Kimery
Tuesday, 09 December 2008
'Development of new vaccines is much slower than advances in our understanding of immunology'
Noting that "emerging and pandemic infections and bioterrorist threats pose new challenges for vaccine development and regulation, manufacturing, vaccine delivery, and access in the US and abroad," the Department of Health and Human Services? (HHS) 85-page draft of its updated national vaccine strategy ? coordinated by the National Vaccine Program Office - released this week is intended to update the nation's vaccine plan mandated by Congress and first released more than a decade ago.
Once finalized, the new national vaccine plan will guide the government's policy decisions on infectious disease vaccines and vaccinations.
Given that there?s a strong potential for a bio-terrorist attack within five years, as three recent reports ? two in the US and one in Great Britain ? determined, and the still looming threat of an influenza pandemic or the emergence of some other highly infectious disease, HHS?s vaccine plan urges large-scale vaccine distribution drills for the nation?s workforce and public at large in preparation for a possible biological-weapon attack or infectious disease outbreak, like a flu pandemic.
The strategy calls for the United States to develop safer and more effective vaccines; guarantee the steady production of vaccines while expanding their global distribution; and advise policy-makers, health care professionals and individuals on vaccine-related issues.
It also states a need to pursue a cross-protective vaccine for influenza.
The Plan is built around the achievement of five broad goals:
Goal 1: Develop new and improved vaccines;
Goal 2: Enhance the safety of vaccines and vaccination practices;
Goal 3: Support informed vaccine decision-making by the public, providers, and
policy-makers;
Goal 4: Ensure a stable supply of recommended vaccines and achieve better use
of existing vaccines to prevent disease, disability and death in the United States; and
Goal 5: Increase global prevention of death and disease through safe and effective
vaccination
HHS?s draft plan notes that, ?despite an increased number of vaccine manufacturers, several routinely recommended vaccines are produced by single manufacturers and intermittent supply shortages continue to occur.?
Indeed. The HHS plan points out that that despite the strides that have been made in meeting the goals of the 1994 strategy, vaccine shortages still crop up.
The new plan alarmingly pointed out that ?recent mumps and measles outbreaks and continued circulation of pertussis are reminders that despite changes in vaccine recommendations and higher coverage, vaccine preventable diseases still occur,? adding, ?the pace of development of new vaccines is much slower than advances in our understanding of immunology and several significant infectious diseases remain leading causes of death globally.?
The plan indicates that the United States has achieved most goals outlined in its original 1994 vaccine strategy, although poorly vaccinated populations and scarcity of certain treatments are among the most persistent problems.
HHS stated that ?in the US, the success in achieving high vaccination coverage among children has not been replicated for routinely recommended vaccinations among adolescents or adults. And as the cost of vaccination has increased, financial barriers to optimal program implementation have emerged for health departments, healthcare providers, and the public.?
As HSToday has reported with regard to annual flu vaccinations, among many adults there is a considerable misunderstanding about the efficacy and safety of the vaccinations. Meanwhile, there is a growing movement among parents of children and adolescents to forego allowing their children to be vaccinated for any childhood disease, let alone the flu.
HHS, the Centers for Disease Control and Prevention (CDC) and state and local public health authorities are increasingly worried that as America?s economic ills worsen, many more people will forego getting necessary vaccinations ? be it for the flu or tetanus. They?re also worried that financially strapped parents, especially those without health care, will not be able to afford routine vaccinations for their children.
At a time when there?s mounting fears over emerging and re-emerging infectious diseases, this represents a new, compounding problem for public health policy makers, authorities stressed to HSToday.us.
Indeed. Although most of the 1994 vaccine plan goals have been achieved, the new HHS plan notes that immunization rates for high-risk groups fall below their ideal levels.
Similar problems face many other countries, especially poor and developing nations, as HSToday.us has reported.
Last week, a WHO study published in the online edition of The Lancet reported that an alarming lack of availability of essential medicines in the public sector forces patients to pay higher prices in the private sector - or go without. WHO stated that its report confirms that governments must do more to improve access to essential medicines as part of their efforts to make national health systems more efficient and equitable.
Meanwhile, the world?s vaccine makers urged governments to prevail over their "pandemic fatigue" towards large-scale public pandemic preparedness and move quickly on completing their respective and coordinated global response plans to confront an influenza pandemic.
Stephen Gardner of GSK Biologics said last week that the pharmaceutical industry is "very close to ready" to respond to a pandemic by shifting its seasonal flu vaccine production to begin manufacturing a vaccine for a pandemic strain ? or, God forbid, multiple pandemic strains.
Gardner said at a news conference that it?s imperative that all nations stop stalling on sharing influenza viruses with one another and immediately come to terms on an agreement to share samples of virus strains that potential could mutate into pandemic strains in order to pick up the pace on efforts to create effective vaccines.
"We don't have time to negotiate a new agreement when a pandemic arises. We need to get on with manufacturing quickly," Gardner told reporters, emphasizing that ?time is of the essence to ensure good vaccine supply."
As HSToday.us has reported, Indonesia, the country most affected by H5N1 bird flu, has resisted providing viral samples to the international community because it argues that material is then used by big drugmakers to create vaccines that poorer countries cannot afford or use.
For their part, they do have legitimate reasons to be worried. For example, if a flu pandemic were to erupt today, it would take the handful of vaccine manufacturers predominately in the West between six to nine months to produce the first batch of roughly 1 billion doses of a vaccine ? one billion doses for the entire world.
More than just a few global public health authorities have expressed concern that developing nations are likely indeed to be the last to see any appreciable supplies of a pandemic vaccine because of the need by the industrialized nations to ensure that vital global infrastructure, health, commerce, military and security forces are first inoculated.
The World Health Organization (WHO) this week is hosting host an inter-governmental meeting during which the agency's member states will discuss the highly charged issue of virus sample sharing and access to vaccines ? and even antivirals - in the event of a flu pandemic.
http://www.hstoday.us/content/view/6377/149/