Commentary: Pandemic flu vaccine program needs help

[Shiloh]

Source: http://federaltimes.com/index.php?S=3555398

June 1st, 2008
Commentary: Pandemic flu vaccine program needs help
By NED FEDER
June 01, 2008

A government document ? never released ? presents a troubling picture of a vaccine shortage during an influenza pandemic: Overall, about 2 percent of Americans with influenza illness die. Hospitals are overwhelmed. People riot at some vaccination clinics as they are turned away or supplies run out. Trucks transporting vaccine are hijacked. Public anxiety heightens mistrust of government. Mortuaries and funeral homes are overwhelmed. The majority of people still have not been vaccinated when a second wave of influenza begins.
These descriptions come from an October 2006New York Times article by Gardiner Harris, who obtained the government document. The document was never released to the public as originally planned. Its portrayal of public chaos and a heightened mistrust of government is a reminder of past blunders ? and this may have hit too close to home.
Are these scenes an accurate forecast of a disaster that lies ahead? Or, instead, will the federal government be ready with enough vaccine when a pandemic strikes? The government has announced its plans, and they are not reassuring. The official word is that it will be several years before government-funded vaccine manufacturers are fully ready to produce vaccine. Even then, there won?t be enough vaccine for everyone until six months after the start of a pandemic.
The government?s pandemic flu vaccine program is a fairly good one, with scientists who are among the best in vaccine research and production. But the program has an obvious and easily corrected weakness: lack of transparency.

The sheer quantity of information on the government?s pandemic flu Web site, www.pandemicflu.gov, with its hundreds of documents and thousands of pages, is impressive. But much important information is missing, raising the question: Why not disclose it?
There are striking gaps in the information posted online:
? The government?s multimillion-dollar contracts with vaccine manufacturers are not posted. The contracts should be out in the open, along with evaluations of contractors? performance, updated periodically.
? Vaccine production is based on two methods: one using chicken eggs devised more than a half-century ago, and the other a cell-based method about a decade old. Promising new methods are just now being considered for the manufacture of vaccine ? methods that can produce large amounts of vaccine quickly after the start of a pandemic. However, the government?s investment in these novel approaches may be too small and too slow. The timetable, budget and other plans for large-scale implementation of the new methods should be available online for examination and comment by nongovernment experts.
? When a pandemic strikes, foreign sources of materials needed for U.S. vaccine production will probably be blocked. If any part, even a small part, of the manufacturing process in the U.S. depends on foreign sources, this fact should be disclosed publicly, along with plans for full self-sufficiency of U.S. manufacturers.
? Some nongovernment experts have indicated that the pandemic flu vaccine program is dangerously underfunded. Detailed plans and justifications of future budgets should be posted online.
A recent Project on Government Oversight report, ?Pandemic Flu: Lack of Leadership and Disclosure Plague Vaccine Program,? has a fuller discussion of the points raised above. The report ? under the publication library link at www.pogo.org ? also covers other information that should be disclosed online.
The argument is strong for posting more information. If public health and vaccine experts outside government have ready access, they can then examine the facts more easily and comment on current plans. The same is true for investigative reporters. The government?s goal should be the greatest possible transparency ? disclosure of weaknesses along with strengths.
The nation?s top health official, Secretary of Health and Human Services Michael Leavitt, should make sure that the documents and information missing from the government?s pandemic flu Web site are posted ? or explain why this information can?t be disclosed.
Ned Feder, staff scientist for the Project on Government Oversight, previously was a scientist at the National Institutes of Health.

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Re: Commentary: Pandemic flu vaccine program needs help

This report is fairly long, so here are some points/snips from the Project on Government Oversight (POGO) http://www.pogo.org/p/socialservice/so-080306-flu.html

March 6, 2008

Pandemic Flu:
Lack of Leadership and Disclosure Plague Vaccine Program

Leadership Of The Vaccine Program
The magnitude of the threat to the nation calls for a person of near-cabinet-level stature to lead the vaccine program, a person who commands respect in the business and public health communities?someone willing to blast through financial and bureaucratic roadblocks. But no such person has been appointed.

In December 2006, a new agency, BARDA (Biomedical Advanced Research and Development Authority), was created within the HHS by an act of Congress.10 BARDA?s mission is to facilitate collaboration between government, industry, and academia in the influenza vaccine program and other programs dealing with public health emergencies. Many senior federal employees in the program are recognized as world-class experts in vaccine research and production, but leadership at the top is missing.

Over twelve months have now passed since BARDA was created, and a permanent director of the new agency has still to be appointed.

Worse, the method of choosing the BARDA director was flawed from the start. The government is following the standard practice used in the civil service?picking one of those who completed a job application and filed it in response to a routine government advertisement on the USAJOBS website (?Your one-stop source for Federal jobs?).11 USAJOBS is the governmental equivalent to the classified ads. This is no way to recruit a leader of the caliber that is needed. An alternative, of course, is for the government to actively seek out highly qualified candidates for the job.

Public Disclosure
Material that should be disclosed and readily accessible includes government contracts for vaccine production, as well as information about vaccine manufacturing capacity, U.S. dependence on foreign sources of material for vaccine production, intellectual property rights, alternatives to current vaccines, and the vaccine program budget. It is essential that the disclosures include a justification of the current plan for vaccine production, and should spell out the reasons for rejecting or de-emphasizing alternative strategies.

The government document of October 2005, with its graphic portrayal of a vaccine shortage, disappeared after making a single cameo appearance in the New York Times. This document should be posted on the government?s website, not suppressed.
When a pandemic strikes, problems with vaccine production will become obvious and the consequences may be dire. Government officials should level with the public about this possibility now if they want to have the public?s trust during the throes of a pandemic.

Types of Information to Disclose
(1) Government contracts for vaccine production. The full text of these multi-million dollar contracts should be published online.
(2) Manufacturing capacity.
(3) Domestic dependence on foreign production. After the start of a pandemic, manufacturers in a country will devote their full production capabilities to production of vaccine for the domestic use within that country. Foreign sources of materials for vaccine production (and steps that are part of vaccine production) that were available under non-pandemic conditions may be blocked once a pandemic starts. In the fall of 2004, shortly before the beginning of the flu season, half of the total U.S. supply of vaccine for seasonal flu was interrupted.17 The reason: a manufacturer in England, Chiron Corporation, had discovered a technical problem (bacterial contamination) that rendered its vaccine unusable. Partly as a result of this experience, the manufacturing facilities for pandemic flu vaccine are now located in the U.S. However, the manufacturers may currently be dependent on foreign sources for some materials or steps in the manufacturing process. Any such dependence on foreign sources, as well as the timetable for full self-sufficiency, should be described online.
(4) Material transfer agreements. Statements should be published online about the status of the government?s efforts to facilitate transfer of materials (such as virus samples, antibodies, and cell lines) from one research group or company to another, including a discussion of cases in which this process is not working well. For example, when efforts to enter into material transfer agreements related to the vaccine program are hindered or delayed, as much information as possible should be made public. In cases like these, as in others involving the protection of intellectual property, the business practices that are customary in ordinary circumstances may be detrimental to public health and safety in an emergency.
(5) Intellectual property. Guidelines and statements should be published online about access to intellectual property (patents, trade secrets, and know-how), including a description of the government?s efforts to broaden access through discussion, negotiation, and subsidies; the initial steps of compulsory licensing; and completion of compulsory licensing. If there are specific cases in which this process is not working well, they should be discussed publicly to the extent possible. In addition, specific plans, if any, should be outlined for head-to-head clinical comparisons of the few most promising vaccines containing patented, proprietary adjuvants and/or aluminum salt adjuvants. More generally, the timetable of plans, if any, to start discussions of compulsory licensing with patent owners (or if necessary, to impose compulsory licensing) should be described and explained online. If, as seems likely, the government?s current plan is to postpone any compulsory licensing until the start of a pandemic, reasons should be given for this decision. In that case, it is important to include an assessment of the risks of postponement. [See Appendix B for more information on patent rights.]
(6) Foreign governments and the World Health Organization. The U.S., among all countries, has made the largest monetary contribution to global efforts to prepare for a pandemic.18 The U.S. government is issuing reports on its plans for coordinating its vaccine program with that of foreign governments and the WHO.19 These public reports should be expanded to include an explicit statement of what the U.S. government will and will not do for other countries when a pandemic begins.
(7) Alternatives to current vaccines. Major increases in government support for the production of other kinds of vaccines, such as live-attenuated vaccines20 and recombinant hemagglutinin vaccines,21 should be considered and discussed online. Administrators and scientists in the government?s vaccine program are undoubtedly well aware of arguments for and against investing more heavily in the production of these types of vaccine. Live-attenuated and recombinant hemagglutinin vaccines lend themselves to rapid, large-scale production and the immunization of large populations22?a significant advantage if a pandemic should emerge within the next few years. The expertise and most of the facilities needed to produce these vaccines already exist. With the available resources and with adequate funding, billions of doses of vaccine could be produced significantly faster than six months after the start of a pandemic.23 In recent congressional testimony, a senior HHS official stated that a contract solicitation was issued in August 2007 for development of recombinant vaccines over the next three to five years.24 There should be a public explanation of the need for this long a period. The U.S could make a noteworthy and honorable contribution to world health by speeding up the timetable for flu vaccine availability around the world.
(8) Size of budget. Questions about the total federal budget for pandemic flu preparedness were raised in a 2006 Journal of Infectious Diseases article entitled, ?Seasonal and pandemic influenza: Recommendations for preparedness in the United States."25 The article contains recommendations made by representatives from the federal government, state and local governments, professional societies, academia, and the pharmaceutical industry. The authors of the article propose a several-fold increase in the level of funding?namely, an additional $30 billion?for pandemic preparedness.26 They propose that part of this amount be used to expedite vaccine development, expand domestic vaccine production sources, and increase seasonal vaccination. The arguments for and against their proposal should be discussed by federal employees on the government?s pandemic flu website for consideration by non-government experts and the general public. Changes in current plans for vaccine production may require a significant increase in the total budget of the vaccine program. However, the trend of congressional appropriations may be in the opposite direction.27

[gsgs]

Re: Commentary: Pandemic flu vaccine program needs help

the key question is :

when panflu starts badly, will the vaccine be available for purchase
and what will it cost ? Can we increase the production as long
as there is demand ?
We were being told that this is the case with cell-based
production -which does already exist- but not with egg based.
That was the reason why cell-based flu-vaccine production
was established, as we were told. Still I often see concerns
about there limited capacity.


why isn't this question being asked, being examined ?
Or why are the results of this examination not public ?

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Re: Commentary: Pandemic flu vaccine program needs help

GS, vaccine production was a concern in the POGO report, too. Here are some additional comments:

"In July 2007, Health and Human Services (HHS) Secretary Mike Leavitt announced that, over the next five years, vaccine manufacturers will develop the capacity to produce and deliver enough vaccine for the American public within six months of the appearance of a pandemic virus.

It should not take that long. The government should be able to speed up the nation?s ability to produce enough vaccine. But problems with the current vaccine program, including inadequate leadership and limited public disclosure of information, may be impeding progress."

"A national commitment to combat a deadly threat is not unprecedented. One such case is the Manhattan Project."

"Similar forces drove the rapid development of vaccines, including the first influenza vaccine, during World War II. As historian Kendall Hoyt has observed:
Why were vaccine development efforts so much more productive during this period than any other period in the 20th century? In part, a sense of national urgency to defend against war-enhanced disease threats fostered unprecedented levels of federal support and a spirit of collaboration between military, industrial, and academic scientists."
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Regarding your question, due to our laws, I doubt that an individual would be able to buy vax. Even if there was extra available.

How about in Germany?

[gsgs]

Re: Commentary: Pandemic flu vaccine program needs help

they only consider US-production, they don't talk about just
buying the vax. Maybe to avoid questions whether the
investments in US-vaccine plants was reasonable ?
There is the issue with safety,security,side effects,
but with a high CFR pandemic these are expected to
become less important (compared to : no vax at all)

And as always the issue is competition and the price for the vaccine.

Ask HHS(or DHS ?), whether they could file an APA (advance purchase agreement) for the whole US-population and what it would cost.
Just to see, whether it's possible and what amounts of investments
we are talking about.

If the vaccine is approved by FDA, then what law can forbid
citizens to buy it ? Is that compatible with your constitution ?
Shouldn't some court decide this now ?
Let's organize and get this clarified.

In Germany, I asked a doctor and he would write a prescription,
once the vaccine is available. But the pharmacies don't have it (yet)
and Glaxo refuses to comment whether it will be available.
They are obviously trying to prevent private purchase of vaccine (why ?)
But would it stand, if you go to court ?

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Re: Commentary: Pandemic flu vaccine program needs help

I'm sorry.. I think I'm misunderstanding your question.

If vaccine was available, then we would most likely be able to get vaxed just like we get vaxed for seasonal flu.

To be able to buy some to have in your medicine cabinet at home just in case you need it, probably will not happen here (imo). There needs to be a qualified individual to administer the injection.

Giving private individuals the ability to prebuy would make sense.
Ordering could be done through doctors' offices.
I have no idea why this isn't being considered by our govt.
You're right; we should be working on this.

[gsgs]

Re: Commentary: Pandemic flu vaccine program needs help

there is prepandemic vaccine which is available now but no exact match

and there is pandemic vaccine, whose strain is not known yet.
Governments file (pay for) "advance purchase agreements" with
vaccine companies
so they preferrable can buy the matching vax, should panflu break out.

administering the injection should be no problem

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Re: Commentary: Pandemic flu vaccine program needs help

administering the injection should be no problem

Maybe for some people (if you are talking about self-administering). Others of us might have a slight problem with that.

I found the New York Times article linked in Shiloh's post. An interesting scenario was included: "Pig herds acquire infection with the pandemic virus and are decimated; large numbers of workers in those settings become ill."