Rolling Up Sleeves and Rolling Out Flu Shots

Responding to vaccine shortages in recent years, many more doses of flu vaccine are available this year. Those doses are starting to make their way to vaccination clinics around the country.

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IRA FLATOW, host:

Up next, a look at the preparations for the flu, both the garden variety that you may had your flu shot already for and the avian flu, which we hope that just stays where it is. Earlier this week, the World Health Organization released a new global pandemic influenza action plan, calling for an immediate increase in vaccine supply. According to the head of the WHO Vaccine Research, we are several billion doses short of the amount of vaccine we would need to protect the global population.

And part of the WHO plan is a call for everyone to get a seasonal of flu shot, which according to the logic here would make it more profitable for the drug-makers to stay in the flu shot business. Who says we need more research and vaccine production capability to avert a public health crisis. Joining me now to talk more about it are my guests, Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, at NIH in Bethesda. Welcome back to the program, Dr. Fauci.

Dr. ANTHONY FAUCI (Director, National Institute of Allergy and Infectious Diseases): Good to be here, Ira.

FLATOW: You're welcome. David L. Heymann, he's acting - let me start again. David L. Heymann, acting assistant director general for communicable diseases at the World Health Organization. And he joins us by phone from Geneva. Thanks for talking with us tonight.

Dr. DAVID L. HEYMANN (World Health Organization): Thank you, I'm pleased to be with you.

FLATOW: Let me ask you, Dr. Fauci, what is the state of the flu vaccine and the possible flu pandemic this year?

Dr. FAUCI: Well, when you talk about the flu vaccine, are you talking, Ira, about seasonal flu vaccine or are you talking about preparation for a pandemic? Because the seasonal flu vaccine - this year probably, at least in the United States, we have queued up more vaccine than we've had historically in previous years. We're going to have about 110 million doses available. And the most we've ever vaccinated in the United States on any year has been 83 million people.

FLATOW: Mm-hmm.

Dr. FAUCI: We under-vaccinate, and that's the point that you were alluding to, I believe. What the WHO was saying, appropriately so, we've got to get more serious about seasonal influenza preparedness if we're going to be better prepared for pandemic influenza preparedness. With regard to the pandemic flu vaccine, there is no pandemic flu that is spreading among humans. We have limited numbers of cases, but it has not yet begun to spread human to human. So any vaccine against pandemic flu would what we would be calling, Ira, a pre-pandemic vaccine for a strain that's circulating that has the potential to morph into a pandemic, but has not yet done that. And there's vaccine development going in and the testing of some isolate vaccine that were from viruses that were isolated either in Indonesia or in Vietnam. And there have even been some from the Hong Kong H5N1.

So, so the culprit, the potential culprit...

FLATOW: Yeah.

Dr. FAUCI: ...is an H5N1 - and that's the one that we're making these pre-pandemic vaccines for.

FLATOW: And you have found that they do offer some protection, even against the bird flu - the bad bird flu.

Dr. FAUCI: Well, the H5N1 vaccine that has been given to a limited number of volunteers is the vaccine that's - that's modeled on the H5N1 that's actually circulating predominantly in chickens in other regions of the world, particularly Southeast Asia. But have also jumped species in about 250 plus cases into humans. That vaccine, that H5N1, if you give it to normal volunteers, it induces a response that you would predict would be protective, but thus far the doses that are required to get to that particular predicted level of protection are prohibitively high.

But over the last couple of months we've seen a number of companies and studies using what we call adjuvants, which is a compound that actually expands or amplifies the body's response to a vaccine. That has in some relatively small, but nonetheless convincing studies, has shown that you can actually get away with a much lower dose than the original studies showed.

FLATOW: Uh-hmm. Dr. Heymann, if there were an outbreak of avian in which human to human transmission really got going, and we want to emphasize that has not happened yet. How would vaccination be prioritized at this point? Where would you start? Where should we start?

Dr. HEYMANN: Well you know, if there were a human pandemic, there were, there are three possible ways to stop it. The first is a non-pharmaceutical way. Two things, social distancing: in other words closing theaters, closing down places where people might be meeting other people who would be infected, and keep people at a distance from each other. Along with that is infection control, making sure that those people who are infected are properly isolated and don't spread the infection to health workers or to others in their family. There's a second way, and that's a pharmaceutical intervention, which would be antiviral drugs. Which could be used to treat persons with infection, if they were treated very early in their infection. And theoretically, it could also be used to prevent disease from occurring in people who were contacts of people who had the disease and who were infected with the virus.

The third is a biological means, the vaccine, and that is by far the best. Because it - it would stop the infection itself. And we're in a difficult situation in the world today, because there are only nine companies that produce vaccines. And those nine companies have a capacity of producing, at maximum, 400 million doses of vaccine. Or, if they were to work 24 hours a day, possibly 500 million doses. This is too few doses of vaccine in a world with six billion people.

And in addition, these vaccines are made by a process which requires the virus to grow in chicken embryos, in eggs for the most part. And those vaccines, therefore, take a long time to develop. And it's six months before we can get a new vaccine each year, once the decisions made to make a new vaccine for what we call seasonal influenza. If you increase the use of seasonal vaccine, as Dr. Fauci said, what will happen is, people will be demanding more vaccines and manufacturers will see a benefit of increasing that production capacity that they have. And there is a reason to use increased in-seasonal vaccines, because it prevents absenteeism from school in children, it prevents work absenteeism in adults.

At the same time, we need to increase capacity to produce vaccines, which is the second part of WHO's initiative. The first is increase seasonal vaccine, the second is increase capacity to produce vaccine. And for that we'll be working with industries that are producing vaccines to help transfer that technology to industries that are not producing those vaccines, including some very good companies in developing countries. That will increase the capacity of vaccine production, increase that pool of vaccine available.

And the third is research and development to develop that vaccine which will be effective should there be a pandemic. And maybe one day, even developing a vaccine which has many, many different animal viruses - or avian viruses -which could be used prevent any pandemic in the future.

FLATOW: 1-800-989-8255 is our number. We're talking about the flu season that's upon us and about possibilities for an outbreak of a seasonal flu, and maybe what the state of a possible pandemic issue is.

Talking with Anthony Fauci, director of the NIAI, that's the National Institute of Allergy and Infectious Diseases, NIH. And David L. Heymann, acting assistant director general for communicable diseases at the World Health Organization. Our number again 1-800-989-8255.

Dr. Fauci, how much further are we along in developing? We were here a year ago. You were on our program. We've talked about it, you know, very much as you recall, you were a terrific spokesman for a long time last year. You're back at it again. Can you tell us any further developments in having a flu vaccine for a possible pandemic?

Dr. FAUCI: Yeah. What's happened since we spoke last, Ira, is what I alluded to briefly before, is that the studies that have used these compounds, these adjuvants. The big stumbling block in our last conversation was conceptually we were able to get a vaccine that you would predict would protect against this H5N1 or the potential pandemic flu virus. But there was a problem in that the numbers of people, the percent of people that responded with a dosage that was able to be given was about 50 percent and you needed a really high dose.

The progress that's been made since the last time we spoke is that there have been a number of companies and clinical trials that have used these adjuvants and have now gotten away with a much lower dose to reach the level of immune response that you would be satisfied with. And it's done it in an increased percentage of people.

In addition, there was an interesting study that was just presented a few weeks ago in Toronto at the Infectious Disease Society meeting. That individuals who were pre-primed with a different strain, the Hong Kong strain of H5N1, and then several years later, when they were boosted with H5N1 that was a little bit of a different strain - it was from Vietnam - that prime boost really gave them a much better immune response than if you didn't pre-prime them.

What that really means is that you can actually prepare a bit ahead of time if you have vaccine that you know is safe, that you could give to people in anticipation of a potential pandemic.

So there has been a lot of progress. But as David mentioned, which is really the critical issue, is that the production capacity is going to be the big stumbling block of this all. Because even if we do - and I feel relatively confident we'll be able to get a vaccine that is able to protect a substantial proportion of the people against a particular virus that you have in mind - the critical issue is how quickly can you get the numbers of doses that you need to protect the maximum number of people. That's even more compelling a problem than the science of actually getting the vaccine.

FLATOW: So what can you do? I mean you can't - short of the government producing its own vaccine?

Dr. FAUCI: And that's not going to work, as we mentioned last time. We've got to get the expertise and the will of companies that have the capability; or even those who don't, but to get them to build the capability of being able to make vaccines in much greater quantity and spread among many more companies than we do right now. And that gets to the point that David was trying to make and made very well, is that if you start that with seasonal flu and you get more companies, more doses, then each year the risk of these companies getting involved and putting their resources into expanding their vaccine production capacity becomes less and less because more and more people on a regular basis are using seasonal flu vaccine.

And when that happens, you - as a secondary big plus, you increase your capacity that you ultimately would use for the development of a pandemic flu vaccine.

FLATOW: 1-800-989-8255 is our number. We're talking about the flu and the flu vaccine this season on TALK OF THE NATION: SCIENCE FRIDAY from NPR News.

Talking with Dr. Anthony Fauci and Dr. David Heymann.

Have you gotten - is this pure speculation, Dr. Fauci, that you would help these companies stay in business and make a profit, or have they told you this?

Dr. FAUCI: No, no, it's experience, Ira. Experience is that you know...

FLATOW: Then why doesn't the government just say, we'll guarantee X number of doses? Well, I mean if you make it?

Dr. FAUCI: Yeah. Well, that's a very a good point. That has been discussed; that's not an official policy. But a version of that is coming across right now. Because what we're seeing with the CDC, at least in the United States -now this is not global - but what the CDC is doing is expanding the recommendations that they are making for people to get a vaccine so that there will unquestionably be more people who will be demanding vaccines. That will drive the market, so that when the companies see that if they make a hundred million doses or 50 million doses, that they will be used.

The chances of them being used are much greater if we in the federal government and the public health sector push the envelope to get people to get vaccinated. It's an interesting balance of a back and forth. You always bring up the point, which is a reasonable point, about guaranteed purchase. We haven't gotten to that point yet, except for a small amount of reserve guaranteed purchase that the government buys fundamentally as a reserve.

But we don't at this point in time have guaranteed purchases for each and every company. We're trying to get them much more involved by pushing the market by recommendations.

FLATOW: Dr. Heymann, one last question for you. There was a new study from Johns Hopkins that found that one-third of countries engaged in pandemic flu planning have not prioritized who should get vaccinations or anti-viral medications. Doesn't it seem like people are as - I think as third to me is a low number. How do you react to that?

Dr. HEYMANN: Well, it certainly is, and it's a very difficult issue to decide when you have a limited number of doses of vaccine or of a drug who gets those. And interestingly enough, this week in Geneva we've had just our first meeting on ethics and pandemic influenza, trying to identify all that glue that will hold the various activities together. The glue that would tell which people should have priority in getting drugs or in getting a vaccine, should it be available. And this meeting has identified very many different things that we have to consider.

For example, we have to consider whether health workers can be asked to work if they don't have a vaccine or if they have a drug - if they don't have a drug that could prevent them from being infected. A whole series of issues like that which we're trying to grapple with now with the international community through representatives from the world meeting here in Geneva to discuss those issues.

But we're very positive in trying to move ahead with vaccines and with other issues because we have so many good partners from around the world. Just for example, for this vaccine program that was launched this week, we have an initial $10 million from the U.S. We have funding from Canada, funding from Japan, and other countries now are rallying in to provide the funding necessary for WHO to facilitate the activities that companies and others must do to get the vaccines and to get the drugs out to the people who need them.

FLATOW: So you're optimistic?

Dr. HEYMANN: Very optimistic. We have to keep working. We're working ahead. Last year, WHO reacted to outbreaks as they occurred. This year we're now able to step back and begin to plan appropriately for a pandemic. And if this pandemic doesn't come, one day there will be a pandemic and the world would not be prepared.

FLATOW: Got to go, Dr. David Heymann. Anthony Fauci, thank you both for taking time to be with us.

Dr. FAUCI: You're welcome, Ira.

FLATOW: Good luck to you.

Dr. FAUCI: Thank you.

FLATOW: Short break. We'll be back switching gears. Stay with us. Don't go away.

I'm Ira Flatow. This is TALK OF THE NATION: SCIENCE FRIDAY from NPR News.

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