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Swine Flu: Why a shortage? Is the government doing enough?
Administration points to drugmakers, and both point to science

David P. Fidler
Professor, Global Health and International Law, Indiana University
Tuesday, October 27, 2009 11:45 AM

David P. Fidler, professor at Indiana University and a leading expert on global health and international law, was online Tuesday, Oct. 27, at 11:45 a.m. ET to discuss whether the government's ability to combat the H1N1 virus is enough to cope with the spread of the disease.

Why such a shortage of swine flu vaccine? (Post, Oct. 27)

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David P. Fidler: Hello, this is David Fidler, here to answer questions about the H1N1 outbreak and associated issues, such as the H1N1 vaccine.

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Ann Arbor, Mich: Why hasn't virus production been switched to tissue culture systems instead of eggs? This seems a horrendous oversight... Is there any chance that going forward we will finally see virus production techniques move out of the 1950s and into the 21st century?

David P. Fidler: My understanding is that newer vaccine production technologies are not yet ready to handle the kind of vaccine production needed for the H1N1 outbreak. Vaccine experts, both in the scientific community and the commercial sector, would like to move to faster, more efficient vaccine production technologies. The problems experienced with the production of the H1N1 vaccine, especially the slower than expected growth of virus in eggs, will provide yet another stimulus for more R&D on newer, better vaccine production technologies.

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Wilmington, N.C.: Does the government keep stashed doses of vaccine for military, CIA and FBI-types? What about hospitals, did they get the first dibs? Thank you for considering my question.

David P. Fidler: The CDC issued recommendations about what groups of people should have priority in receiving initial supplies of the H1N1 vaccine. Those recommendations included giving priority, among others, health care workers, pregnant women, and children within a certain age range. The World Health Organization did likewise for global purposes. The recommendations were not geared towards institutions, such as hospitals, but rather at categories of people believed to be at higher risk of contracting the H1N1 virus. I have no knowledge of secret government stashes of H1N1 vaccine, nor have I heard anyone who was been working on this issue be concerned about such things.

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Fairfax, Va.: Why is the virus grown in eggs? Can you explain to a layman (woman) how this is all done and how they come up with an effective treatment?

David P. Fidler: The standard method for manufacturing influenza vaccines involves growing the virus that will be used in the vaccine in eggs. From one layman to another, vaccine manufacturers inject the eggs with influenza virus, and then let the virus replicate in the eggs, using the egg's contents as medium (or virus food, if you will). The virus is then extracted from the eggs and prepared for use in vaccines. Thus, the speed and quantity of vaccine available depends on how well the virus in question grows in the eggs. One of the apparent problems with the H1N1 vaccine supply is that the H1N1 virus is growing more slowly in eggs than anticipated.

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Washington, D.C.: I'd just like to comment on the question "has the government done enough" when it comes to swine flu or any other outbreak of disease: It's striking that everyone turns to the government when these things happen, and we expect the government to provide vaccines and to save us, and we hear little opposition to these efforts and yet there's an enormous effort in the broader areas of health care to "keep government out."

The hypocritical juxtaposition is laughable yet sad.

David P. Fidler: The demand for limited government, and the demand for robust ability of government to intervene in many situations, create tensions that are often experienced in public health. Public health, unlike health care, addresses population health--the health of the entire society. As such, the provision of public health is what economists call a "public good"--and public goods typically have to be produced and maintained by governments. In the H1N1 situation we are now experiencing, we are seeing people need to rely on the government to conduct surveillance and to engage in interventions, such as making vaccine available to as many people as possible. Without robust public health capabilities at the CDC and DHHS, the government cannot fulfill these purposes. The H1N1 outbreak is again testing the country's willingness and ability to empower and fund needed government services--services we increasingly understand are needed at the individual and population health levels.

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Haymarket, Va.: It is my understanding that most of the swine flu vaccine comes from overseas sources. Why don't USA companies produce the vaccine to take care of its citizens?

David P. Fidler: The US does import influenza vaccines, including for H1N1, from manufacturers overseas. Your question pinpoints the importance of understanding the existing limitations of vaccine manufacturing generally and influenza vaccine manufacturing specifically. The manner in which the global pharmaceutical industry has changed during this latest era of globalization has contributed to a limited number of vaccine manufacturers located in a very limited number of countries. Many countries, not just the US, cannot supply their entire needs through domestic capacity. One of the issues that will emerge from the H1N1 outbreak and the problems with limited vaccine supplies is the need to review and work towards improving the aggregate global capacity and the geographical diversity of manufacturing facilities. Stronger demand for influenza vaccines, especially seasonal vaccines, can create demand that might lead to manufacturers investing in more production capacity, including perhaps in the United States. However, the problems of the structure of vaccine production are far worse for developing countries than the United States because the United States has the wealth to purchase vaccines from foreign manufacturers. Developing countries are at a greater disadvantage because of they generally lack the purchasing power in the market the United States and other developing countries have.

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Silver Spring, Md.: The advanced vaccine technology already exists. Adjuvanted vaccines, ones that add oil-in-water solvents to enhance the immune response from vaccines made with less antigen. The FDA has yet to license these adjuvants, even though they are routinely used in Europe. We saw a great deal of fear mongering around adjuvants, and I wonder if political pressure has kept us from using the technology we need?

David P. Fidler: The use of adjuvants has, indeed, been one of the controversial issues to surface with the H1N1 vaccine challenge. You are correct that adjuvants have been approved and used in vaccines in other countries (e.g., Europe and Canada, I believe). Some have, thus, argued that the safety and efficacy of vaccines with adjuvants are proven because of the scientific and medical oversight provided by governments with a similar aversion to risk as the United States. In addition, some have argued that, with the safety and efficacy of adjuvants established, the US has an ethical obligation to use them because use of adjuvants stretches the available stock of vaccine farther, which would increase access for U.S. citizens and for people in developing countries. I think that political concerns about the fears about adjuvants in vaccines do exist, and the scientific and pubic health case for the use of adjuvants against such threats as H1N1 has become unfortunately embroiled in the politics of vaccines in the United States.

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Minneapolis, Minn.: Here in Minneapolis, our Park Nicollet Clinic received 17,000 doses and had to "shut down its flu-shot hot line Monday after it was swamped with 120,000 calls in four hours from people trying to get the H1N1 vaccine" (From Star Tribune)

Why did the administration declare an emergency, creating panic is so many parents, when there is barely any vaccine available?

David P. Fidler: The Obama administration declared a national emergency concerning H1N1 largely because the continued spread of H1N1 is starting to cause more problems for public health and health care systems in the United States. In order to help public health authorities and health care providers provide treatment and care more effectively, the presidential declaration clears away some requirements that would normally apply to certain programs and institutions. Part of the reasoning behind the declaration, I believe, is that making responses to H1N1 infections and illnesses more robust is necessary particularly in light of the very limited supply of vaccines. In the absence of adequate vaccine supplies, better and more effective responses to illnesses are needed. Unfortunately, the declaration may have heightened fear about H1N1 and increased demand for the vaccine, which is in short supply, unintentionally creating more anxiety in the population and stress on the systems already under strain.

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Cumberland, Md.: Australia, France and other countries who stockpiled the vaccine are ensuring that THEIR CITIZENS are being vaccinated first and ONLY when the need of their citizens are satisfied will they donate the vaccine to WHO. Why is our country not putting OUR citizens needs ahead of WHO demands?

David P. Fidler: The decision by the Obama administration to donate 10% of the U.S. vaccine supply to WHO for use in developing countries was made with the commitment that the United States would still have enough vaccine for every American who wanted to be vaccinated. The reasons why vaccine is in short supply in the United States right now has nothing to do with the promise to donate vaccine supplies to WHO for use in developing countries. In fact, the problems experienced with inadequate vaccine supplies are likely to delay and cause other problems for the donation promises made, meaning that people in developing countries will have any limited access they might have had under the donations limited even more.

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Cumberland, Md.: How can you say the government had gone enough when it plans to give away 10 percent of taxpayer-funded vaccine to WHO? I call that an abuse of taxpayer money and Congress should investigate such abuse of taxpayer money.

David P. Fidler: I just answered a very similar question, so I won't repeat what I said there, except to reinforce my point that, right now, the problems we are experiencing with the H1N1 vaccine are not caused by the U.S. pledge to donate 10% of our vaccine supply to WHO for use in developing countries. The Obama administration stressed, in making the pledge, that the U.S. would still retain enough vaccine to be able to vaccinate all Americans who wanted to be vaccinated. A critical development that helped enable this pledge was the finding that a single-dose injection would be sufficient to create a sufficiently strong immune system response in adults, meaning that the amount of vaccine we thought we needed for a two-dose regimen was effectively doubled. The real test of the pledge will come if vaccine supplies do not reach sufficient levels to vaccinate everyone in the US who wants to be vaccinated. Will the US, at that point, not fulfill its pledge to the developing world?

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Virginia: Can someone PLEASE at the government level issue a warning that if PEOPLE ARE SICK TO STAY HOME! I work with people who are recovering from the swine flu and they are coming into work! I have complained and complained to HR but they will not do anything about it. I have a spouse that suffers from lung ailments and I cannot afford to get this virus!

David P. Fidler: The CDC, state public health departments, local public health officials, and even leaders of large institutions (e.g., universities) have issued repeated advice that people who are sick with influenza should stay home and not return to work or school until they are well. The advice, and its reasoning, has been issued, over and over and over. As your comment illustrates, sometimes this advice is not heeded, often for economic reasons related to the need to be at work for paycheck purposes. One of the hardest things that companies, schools, and universities have to struggle with in the context of H1N1 is how to create sufficient economic space for employees to heed the advice of public health officials and not fear adverse personal economic consequences.

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Northern Virginia: I was a volunteer at our mass vaccination event in Fairfax county Sat. I was partnered with a nurse vaccinator. Most folks were patient and quite understanding about the limitations in supply and the need to vaccinate priority groups first. I'm not saying they liked the restrictions but they understood the rationale.

David P. Fidler: Yes, the media and the blogosphere likes to focus on things more dramatic than lots of people behaving in a manner that reflects that they understand the problems and are willing to bear additional personal inconvenience and burdens. Public health officials know that their greatest ally in dealing with threats such as H1N1 is an informed public that acts on the basis of public health advice. One of the problems that has arisen in the H1N1 outbreak is that the communications from public health officials have, for various reasons, become confused and, to the public, confusing. Many of the questions I am seeing in this session reflect a high level of confusion about H1N1 and the vaccine. Most of these questions I cannot answer because they are scientific in nature or seek a medical opinion. But, the questions reflect the anxiety that is growing in communities and families as fear about the virus grows, fears not helped by answers from the government that many people believe are not forthright or helpful.

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Lafayette Hill, Pa.: Why aren't all states mandating coverage for the H1N1 shot like New York?

David P. Fidler: Recently, the New York mandate for the H1N1 vaccine was struck down by the courts and rescinded by the Governor of New York. So, the fate of the mandate in New York might help explain why other states did not follow New York's lead. The question of mandatory vaccination raises issues of civil rights and civil liberties, and thus is usually always very controversial. The State of New York had a hard time, apparently, justifying the infringement of individual rights the mandated vaccine created for those under its mandate (e.g., health care workers). The fact that no other state issued a similar mandate probably undercut New York's claim that the mandate was justified from a public health perspective.

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David P. Fidler: Thank you for all your questions. Too many for me to answer in an hour. I hope that my responses were responsive and helpful, and I encourage everyone to stay engaged with the issues. This issue may be a defining moment not only for the United States as well as the world.

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