http://healthandfitness.sympatico.msn.ca/N...detect=&abc=abc


Experts mull possibility of vaccine protection against pandemic flu strains
24/04/2005 3:48:00 PM

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TORONTO (CP) - When the next influenza pandemic hits, vaccine will be the key defence for countries that can afford it. But there will be inevitable if agonizing months between the emergence of a pandemic strain and the point when vaccine is ready to be plunged into arms.


Some influenza experts, though, have started to debate whether it's really necessary to wait for a pandemic to ignite before moving to protect people against virus subtypes on flu watchers' Most Feared list.

Wracked by concerns the world might be watching the unfolding of a pandemic, they are searching for out-of-the-box solutions to reduce the devastation to human health and the global economy that one would wreak.

Dr. Jesse Goodman is among those mulling over the notion of trying to create some population immunity to threatening flu strains during interpandemic times.

The idea is still "very exploratory," admits Goodman, director of the Food and Drug Administration's centre for biologics evaluation and research, which regulates vaccine production and sales in the United States.

"I think there is an opportunity to think about: Can we prepare and provide some protection not in a crisis mode, but more ahead of time? Ahead-of-the-curve kind of mode," he suggested in a recent interview from Washington.

"I think this is a strategy worth considerable thought and discussion. . . . (But) it's not something one would just do without a lot of thought and evaluation."

The idea would most likely entail adding a fourth component to the annual flu shot, which currently protects against the three flu strains - two influenza A and one influenza B - experts predict will be dominant in the coming flu season.

Adding a fourth strain could awaken or prime the immune system to viruses it's never seen before. Like the H5N1 strain smouldering in Southeast Asia. Or the H7N3 strain behind British Columbia's 2004 avian flu outbreak. Or H2N2, the 1957 pandemic strain recently sent in unlabelled vials to more than 5,000 labs around the world.

(While the flu world fears H5N1's lethality, some experts argue H2N2 is the top contender for the next pandemic strain because of its proven ability to infect and spread among humans.)

It is widely believed people would need at least two shots - a primer and one or two boosters - to get good protection against a flu strain their immune systems has never battled.

This idea would see a generic primer to H5N1 or H2N2 delivered well in advance of need. Once a pandemic starts and a vaccine targeting the specific strain is produced, the booster or boosters would be administered. If a large segment of the population was pre-primed, vaccine production time could be cut dramatically.

University of Ottawa flu expert Dr. Earl Brown says the approach could give pre-vaccinated people "a leg up."

"It has some merit in that you should have some (protective) advantage," Brown says, adding that even without the booster shot, people who'd been primed might have some protection. "Maybe some people wouldn't get as severely diseased."

The head of the World Health Organization's global influenza program also sees the theoretical appeal of the notion.

"Logistically, it could make sense that during ... peace times like now you vaccine everybody and then when it comes to mass vaccination needs . . . you'd only need to apply one dose," says Dr. Klaus Stohr.

But Stohr is also quick to point out what might be the single biggest impediment to the idea - the issue of liability. While flu shots are considered to be among the safest medical interventions available to public health, no vaccine or drug is risk-free.

The flu community knows that too well, having learned the lesson the hard way during from the swine flu debacle. In the spring of 1976, four U.S. Army recruits fell ill with what was discovered to be a swine flu similar to the 1918 strain that caused the worst infectious disease outbreak in recorded history, the pandemic know as the Spanish Flu.

Fearing the 1918 virus was readying itself for a new assault, the U.S. government mounted a mass vaccination campaign aimed at protecting every American.

Swine flu never took off, but another health threat did - Guillain-Barre syndrome.

A small but significant number of people who got the swine flu shot developed the potentially fatal neurological condition, resulting in major lawsuits.

To this day, the rare syndrome remains linked to influenza vaccination, though only one study has shown an association and then only at the rate of one case per million people vaccinated.

Still, swine flu instantly comes to mind when the flu community starts discussing the ethics and liability concerns raised by the notion of vaccinating people against a theoretical risk.

"The bar does rise," Brown admits.

"If you vaccinate your whole country, you've got to be concerned that everybody for the next two or three months is going to blame whatever bad happens on the vaccine."

Vaccine expert Dr. John Treanor sees other problems as well. Treanor thinks pre-priming might actually work, though it would need to be proved through testing.

But he says with current flu vaccine production limitations - old technology, capacity to make vaccine for only a fraction of the world's populace - "it's probably not going to fly.

"It's been quite difficult just to make the regular vaccine. Add another component, it just makes it that much harder. It might make it so hard it couldn't be done," says Treanor, director of the vaccine treatment and evaluation unit at the University of Rochester, one of three centres testing an experimental H5N1 vaccine for the U.S. government.

Stohr points out another issue. Pre-priming, if it worked, is only really an option for affluent countries.

"We must also not forget that we are talking about a privileged part of the population. Those who can already afford the seasonal vaccine would have access to it. And the others would again draw the short straw."

Goodman knows all these arguments, but feels the notion is still worth exploring.

"It needs a careful discussion" he says.

"But in the long run, if you really do think about it more optimistically, what you realize is that with good surveillance systems we do have the possibility of knowing what are potential pandemic threats and thinking about these kinds of strategies."

I doubt that the U.S. will do anything in advance of a pandemic. Just look at what is in store for us gain this year on the regular flu vaccine. When the avian flu or SARS manages to come to America (it will) we will not be prepared.

April 28, 2005
Flu Vaccine Supply May Be Tight, but Not Severe, Officials Say
By ANDREW POLLACK

The Chiron Corporation said yesterday that it anticipates making only about half as many doses of flu vaccine this year as it had intended to provide last year, before its factory was shut down because of bacterial contamination.

Still, authorities said, the expected production from Chiron should be enough to stave off a severe shortage of the vaccine this winter, though it is possible supply could still be somewhat tight.

"If they can come up with that amount that will bring us closer to where we want to be," Dr. Anthony S. Fauci, director of the National Institute of Allergy and Infectious Diseases, said yesterday.

Chiron's factory in Liverpool, England, was shut down last October by British health regulators. The regulators gave permission for Chiron to resume operations early in March, but until yesterday the company had not said how much it thought it could produce this year.

Yesterday, the company said it thought it could produce 25 million to 30 million doses for the coming flu season. That is down from the 50 million doses the company had planned to ship last year.

Howard Pien, chief executive of Chiron, which is based in Emeryville, Calif., said that since the company is still fixing problems at the factory it cannot produce at full speed.

Moreover, Mr. Pien cautioned, even meeting the new production target depends on the company's continuing to pass inspections. The factory is expecting another inspection by British regulators in the next few weeks. And the Food and Drug Administration, which must still sign off on the factory, is expected to inspect it around mid-June to mid-July, Mr. Pien said.

Federal health authorities, who are trying to increase the number of people getting flu shots, had been hoping before last year's shortage that 100 million Americans would be vaccinated. In the end only about 61 million doses were available.

The number of flu shots available this year will probably fall short of 100 million.

But David Webster, a health industry consultant in Bethlehem, Pa., said typical demand is only 80 million doses. That figure can probably be met this year, he said, so the government is not likely to restrict the use of vaccine only to those most at risk.

Tom Skinner, a spokesman for the Centers for Disease Control and Prevention, said the agency is planning for many contingencies.

Sanofi Pasteur has said it can supply up to 60 million doses this year. GlaxoSmithKline is applying to enter the American market this year with about 7 million to 10 million doses, less than the 10 million to 15 million the company had previously predicted. Mr. Pien of Chiron said the prices at which the company would sell its vaccine to distributors are significantly higher than last year, an indication, he said, that demand still exceeds supply. "There's a tremendous amount of upward pressure in the short run," he said.


http://www.nytimes.com/2005/04/28/health/2...print&position=

Yup, I was right. Look at this article that I found while looking for avian flu articles.

Flu Prevention

Post
Tuesday, April 26, 2005; A14



WITH IMPRESSIVE patience, the World Health Organization is carefully following the progress of H5N1 avian flu, the virus that has now killed more than 50 people in Asia. Scientists tracking the virus have recently observed that fewer people who contract the disease die immediately. They've also found that some who test positive for the virus show no symptoms. Paradoxically, these changes could mean the disease has become more dangerous: The virus may be mutating, acquiring characteristics that help it spread faster.

The cooperation behind this international tracking system is unprecedented: Even North Korea posted a report this week on a strain of bird flu its scientists said they had contained. But while this may well be the first time in history that scientists have managed to observe the birth of a flu pandemic, there is still no international agreement about what preventive measures should be taken. Only the United States has invested in new, tissue-based vaccine technology, which could be used to develop a vaccine quickly in case the virus does begin to spread. Research, though, is still in the early stages -- and in the meantime, the United States has fallen behind other countries in stockpiling the one other known antidote, the antiviral oseltamivir, commercially known as Tamiflu.

While Tamiflu won't cure or halt the spread of bird flu, recent research shows that it can ease some of the symptoms and might slow the spread. For the drug to be effective, however, large numbers of people will have to take it every day -- meaning that Tamiflu will need to be on hand in almost unthinkably large quantities. Toward that end, a number of countries, including Australia and Japan, have decided to stockpile the drug. The British government recently decided to buy some 15 million courses of the drug, enough to treat one-quarter of Britain's population. To date, the United States has acquired about 2.3 million courses , which would cover a much smaller proportion of its population. Given that international supplies of the drug will vanish if a pandemic begins, this seems extraordinarily imprudent. U.S. officials point out that the drug is not perfect and say that they are still "exploring all options." A part of the problem may also be overall reluctance in Washington to recognize the danger that a flu epidemic poses. Given the almost daily reports of the virus's progress, and given the U.S. government's early recognition of the danger and its investment in vaccines, "we didn't know" will be a weak retrospective excuse.

http://www.washingtonpost.com/wp-dyn/conte...2501355_pf.html

Here is another article from April 13.

Worrisome Gaps In U.S. Planning For An Avian Flu Outbreak, New Analysis
13 Apr 2005

Trust for America's Health (TFAH) today released a review of US pandemic flu plans that found many planning topics remain under-addressed and additional actions could be taken to improve preparations and reduce the risks posed by an outbreak. Some key areas of concern include vaccine and treatment shortfalls, gaps in containment strategies, limited plans for how to keep the public informed, and inadequate review of state plans for quality and feasibility.

The findings are particularly troubling in light of the severity of the avian influenza virus circulating in Asia. TFAH's analysis follows warnings issued by the Centers for Disease Control and Prevention (CDC) and the World Health Organization (WHO) about the pandemic, “killer flu” threat. Preparations for an outbreak of the avian or pandemic flu are the topic of a Congressional hearing being held today by the U.S. House of Representatives Committee on Appropriations, Subcommittee on Labor, Health and Human Services, Education, and Related Agencies.

“The threat of a pandemic flu is deadly serious. Experts worldwide are calling it inevitable,” said Shelley A. Hearne, DrPH, Executive Director of TFAH. “We're not talking about the kind of flu Americans are used to where you bounce back after a week of bed rest. There are a number of concrete steps that the U.S. can and should take swiftly to better protect the health and safety of Americans.”

Concerns with National Pandemic Flu Planning In August 2004, the U.S. Department of Health and Human Services (HHS) released a draft plan of U.S. strategy to deal with a flu pandemic. The plan is the first of its kind to be released and TFAH commends HHS for the development of this very important effort that outlines proposed collaboration among jurisdictions and preparedness and response guidelines for federal, state, and local health officials. CDC is also working on a federal plan to address specifics needed during a pandemic in coordination with the HHS plan. HHS has solicited comments on the plan and has received responses from many leading experts in the U.S. and throughout the world. Some key concerns expressed include:

-- Coordination, Details, and Funding: Lack of coordination of state, federal, and international efforts, lack of detail about how the plan would be implemented, and limits on available funding to carry out the plan;

-- Surge Capacity Capabilities: Limited planning based on factoring of how hospitals and the health care system would be overwhelmed;

-- Vaccine and Treatment Limitations: A gap in determining who in the government would control and distribute vaccine and treatments, in addition to the lack of plans to stockpile stopgap antiviral medications and vaccines, limited planning based on the small supplies of drugs that will be available versus the need and demand, and no focus on liability issues for vaccine makers;

-- Public Information Planning: Lack of a clear action plan for what information would be made available to the public and on what time frame; and

-- Monitoring Outbreak and Managing Containment: Gaps exist in coordinating containment efforts, including insufficient surveillance and tracking systems to monitor and detect outbreaks, infected persons, vaccine supply, and the readiness of infected survivors to re-enter the workplace.

Concerns with States' Pandemic Flu Planning

Most states are developing pandemic response plans, however, a recent report by TFAH found only between 25-30 states have made their plans publicly available. All of the plans have yet to be evaluated for quality and feasibility. TFAH is recommending immediate action be taken to build a strong, cohesive, fast-tracked U.S. pandemic flu strategy. These actions are consistent with guidance from the federal government and the WHO.

TFAH Recommendations for 10 Key Components that Should Be Included in State Pandemic Plans

-- Outbreak Tracking: Ensure adequate laboratory surveillance of influenza, including the ability to isolate and subtype influenza viruses year round. Following federal guidelines outlined by HHS, states must report all necessary data and information to federal and other health officials as soon as it becomes available to federal officials.

-- Securing Back-Up Doctors and Health Care Support: Conduct and maintain an inventory of healthcare professionals including current and retired doctors, nurses, veterinarians, emergency medical staff, and other potential volunteers. Tracking survivors, who are presumably immune to the virus, should be done to help support treatment and care efforts.

-- Mass Vaccination and Treatment Systems: Develop and maintain a system for tracking and distributing antiviral medication and vaccines, once they are developed. One of the best ways to improve vaccination preparations for a pandemic outbreak is to enhance annual flu vaccination coverage for non-traditional high-risk groups (e.g. minorities and persons younger than 50) to facilitate access to these populations.

-- Prioritization of Who Would Receive Antivirals and Vaccines Based on Limited Supplies: Define high priority populations, such as health care workers, prior to an outbreak. Establish priority for which groups should receive antiviral medications and vaccines, and in what order, particularly since the amount of available pharmaceuticals will be limited.

-- Surge Capacity Capabilities: Account for the likelihood that hospitals would be quickly overwhelmed, by developing auxiliary sites (such as shelters, schools, nursing homes, hotels, and daycare centers) for surge capacity treatment and for treatment of the “walking well.” States should be conducting surveys of potential sites and obtaining agreements.

-- Measures to Manage Mass Death: Conduct and maintain an inventory of facilities with sufficient refrigerated storage to serve as temporary morgues.

-- Public Information Campaign in Place: Identify and train spokespersons (in multiple languages) and educate public health officials, politicians, community leaders, partners, and the media about what information will and will not be available during a pandemic. Create information templates (in multiple languages) that can be used on Web sites, public service announcements, and in other materials aimed at informing the public of the best ways possible to protect their health and safety.

-- Ensuring Food, Water, and Other Supplies will Be Available: Ensure that food, water, and other basic supplies will be available and able to be delivered in the case of an outbreak. Factor in potential complications of infected food and delivery workers, possible infected store facilities, and limitations on public interaction both for those infected and the general population at-risk of exposure. The issue of “just-in-time” manufacturing of food and supplies must also be weighed, since reserves of supplies would not be available. Additionally, the limitations of medical equipment manufacturing (much of which is imported from Asia) must be addressed.

-- Quarantine Measures and Authority to Close Public Places: Clear legal authority and emergency measures in place to be able to contain the spread of disease through the prohibition of public gatherings, closing public facilities and schools, and placing restrictions on travel at any stage of the outbreak.

-- Defined Roles and Responsibilities: Define and agree upon leadership, roles, and responsibilities with respect to who is in charge of a state's public health and health care decisions. Also a clear ‘chain of command,' including designation of a liaison, must be defined to work with federal officials.

The Pandemic Potential

The avian influenza virus circulating in Asia has killed 50 individuals since its emergence in 2003 and has spread rapidly among bird populations. Health officials are concerned that it could become more contagious among humans and that it could remain in a strain against which humans have no natural resistance. The “world is now in the gravest possible danger of a pandemic,” according to a statement made in February 2005 by the WHO regional director for the afflicted Western region. In recent months, health officials and governments around the world have taken a series of steps that demonstrate the seriousness of the potential threat:

-- In April 2005, President George W. Bush approved use of quarantine in the event of a U.S. outbreak of “influenza caused by novel or reemergent influenza viruses that are causing, or have the potential to cause, a pandemic,” which includes, but is not limited to the H5N1 strain of avian flu currently in Southeast Asia.

-- In April 2005, the U.S. Department of State issued a warning statement about the avian flu and announced it is taking measures to support the WHO efforts to contain the outbreak.

-- In April 2005, CLSA Asia-Pacific Markets, the Asian investment banking arm of Crédit Agricole of France, estimated that the avian influenza had already cost the region $8 billion to $12 billion, mostly from lost revenue from poultry and related industries. -- In March 2005, in the U.S. Department of State authorization bi

ll (S.600), the U.S. Senate proposed including $25 million for International Famine and Disaster Assistance to prevent and respond to a possible outbreak of the avian flu and called for a task force to coordinate U.S. policy toward combating the avian flu.

-- As of March 2005, CDC advises travelers and U.S. citizens living in countries with known avian flu outbreaks to avoid poultry farms and contact with animals in live food markets, to ensure poultry and eggs are thoroughly cooked before eating, and to frequently wash their hands with soap or alcohol-based hand rubs.

-- In March 2005, the National Institutes of Health (NIH) began a trial of an experimental avian flu vaccine.

-- In February 2005, WHO released a report that recommended nations around the world stockpile antiviral medication to protect against the lethal current avian strain of the flu. This is recommended as a “stopgap” measure, since it would likely take a minimum of six months to develop a vaccine after a widespread outbreak. The amounts of both the antiviral medication and a vaccine would be limited and countries around the world would all be seeking supplies. On April 5, 2005, the New York Times reported on efforts different countries are taking to stockpile Tamiflu, produced by the pharmaceutical company Roche, which is the recommended antiviral medication for stopgap use against the avian flu. The U.S. has stockpiled approximately 2.3 million treatment courses of the drug stockpiled in comparison to Britain which has ordered 14.6 million courses, France which has ordered 13 million, and Canada which has ordered 5.4 million. It will take several years to fill these orders.

-- In March 2004, the U.S. Department of Agriculture (USDA) placed restrictions on imports of poultry and poultry products from Asian countries.

Trust for America's Health is a non-profit, non-partisan organization dedicated to saving lives by protecting the health of every community and working to make disease prevention a national priority.

http://www.healthyamericans.org
http://www.medicalnewstoday.com/medicalnews.php?newsid=22774

Thursday, April 28, 2005

We need luck to avoid flu pandemic

By TED VAN DYK
SEATTLE POST-INTELLIGENCER COLUMNIST

This is not to frighten you, but to take a sober look at a health crisis that could soon be at our doorsteps. We have been getting fragments of it from inside-page newspaper stories and an occasional broadcast report.

In six months during 1918, 1,600 people died in Seattle during a Spanish flu pandemic. Worldwide, 40 million died in 1918-19 -- more than were killed in World War I.

In its first year Spanish flu killed more than died in the Black Death bubonic plague of 1347-51. Some 28 percent of Americans were infected. The flu was most deadly for those between the ages of 20 and 40.

A number of global health experts are warning that, right now, we must prepare to combat an Asian virus, of the H5 subtype, which has never before circulated in human populations and which is similar to the Spanish flu virus in its potential for harm. It could strike us during the autumn flu seasons of 2005 or '06.

There have been other, less lethal flu pandemics since that of 1918-19.

As an Army infantry trainee at Fort Ord, Calif., I was hit in 1957 by what was known simply as Asian flu and was hospitalized with an ensuing pneumonia. About a third of the thousands of troops on the base became ill. A few died. Those of us hospitalized were treated with massive doses of penicillin -- for lack of a better idea. Over time, we recovered and returned to duty. Worldwide, nearly 4 million died; in the United States, 70,000. This flu was most dangerous for those over 65. A similar flu, the Hong Kong flu, struck in 1968. As the 1957 flu, it struck hardest those over 65. It claimed 54,000 U.S. lives.

Both the 1957 and 1968 pandemics were caused by an exchange of genes between avian and human influenza viruses. The 1918 pandemic began following mutation of an avian virus that acquired, during subsequent human infections, adaptations needed to sustain direct human-to-human transmission.

The present influenza virus is thought to be like that which struck in 1918. It brings on severe symptoms and high mortality. It hits the 20-40 age group. It results in primary viral pneumonia in the absence of secondary bacterial infection. It mutates. It can recur at unpredictable intervals.

The virus is being spread in China and several other Asian countries from aquatic migratory birds to poultry, livestock, other animals and people. Millions of birds have been killed in an attempt to block the virus. It is thought to reside now in millions of chickens and ducks in rural Asian barnyards. World Health Organization scientists and Asian governments are trying to get ahead of the problem. Our National Institutes of Health and the Pasteur Institute in Paris are trying to develop vaccines. The virus has kept popping up in new, geographically separated places in Asia and claiming new human victims.

It recently was discovered, additionally, that prior flu-virus strains all were being transmitted, via regular mail, in test kits to laboratories around the world. No one knows for certain who does and does not have them or if any have been let loose accidentally.

Anyone born since 1968 is particularly vulnerable to a new flu pandemic. If it were to explode, it could happen quite quickly. Air travelers from Hong Kong or Seoul could, for example, bring the flu to Seattle, Los Angeles, London or Paris in well under its 24-hour incubation period. Old systems of containment -- designed when people traveled by sea between continents -- would be useless, although national governments could be expected to close ports and airports, impose quarantines and generally attempt to seal their borders. International commerce would come to a standstill.

Even hospital-rich Seattle has too few beds to accommodate those who might contract the flu. We and other countries have inadequate vaccine-production capacity -- if and when an appropriate vaccine is developed. Lip service is being given to international cooperation in vaccine production and sharing but, in practice, it is lacking. If and when a full-blown pandemic arrived, national leaders understandably would try to protect their own.

Pandemics of one kind or another have recurred through human history. At first, as with the HIV/AIDS scourge, they often are not recognized as the threat they are. Then, as the human toll rises, we scramble to catch up with them. In time they recede, leaving their wreckage behind.

If a historic pandemic strikes in the autumns of 2005 or '06, we'll repeat the cycle once again. In the meantime, we have a period of months in which governments can attempt through research, public health measures, vaccine development and production, public education and international cooperation to avert the worst. Drinking lots of orange juice will not be enough. To avoid a replay of 1918-19 we will need blind luck.

Ted Van Dyk has been involved in national policy and politics since 1960. E-mail: t_van_dyk@hotmail.com.

http://seattlepi.nwsource.com/opinion/221869_vandyk28.html