Is the vaccine safe? What if one child in a family is sick? What are the symptoms? When should a person go to the hospital? The man in charge answers these and other questions about this fall’s influenza pandemic.
As director of the National Institute of Allergy and Infectious Diseases, Dr. Anthony Fauci is the government's point man for tracking flu and finding answers to it. He and his team have been monitoring the H1N1 swine flu pandemic since its early days this spring. With the flu spreading rapidly now, and a new vaccine arriving this week, Fauci met Tuesday with USA TODAY's editorial board to address the many questions that are on people's minds. The following Q&A is adapted from that session and edited for length and clarity.
Question: Who is at risk? And how much risk is there?
Answer: The H1N1 virus that's circulating now, for 99% of the people, is a relatively mild to, at most, moderate influenza. However, the people who get into trouble are highly disproportionately young people. Generally, about 70% of them have an underlying condition. And about 30% of them are otherwise healthy. So even though the numbers are very small of people who get hospitalized and sometimes die, the striking thing about it is that you never see that in seasonal flu. I've been in infectious diseases for decades and I've never seen, in seasonal flu, a normal, robust healthy person die from influenza. Everyone I've seen die from influenza have been people who were elderly or sick. So this is a tough message here.
Is this a real serious problem? Well, it depends on who you are. But pregnant women get into trouble. There have been 28 deaths so far among pregnant women, and the people who get into trouble are disproportionately young. The other possible thing that's sort of the gray cloud over everything is that the virus can mutate and become virulent. And if it maintains its high transmissibility and mutates to become virulent, then we have a really, really serious problem. Which we don't have now.
Worried about whether you should get the swine flu vaccine? Fauci explains which groups are most at risk.
Find more of the taped Fauci interview here.
The first batch of about 600,000 vaccines arrived (Monday), with about 6 million by the end of the week and then 40 million by middle of October. What is an interesting sociological problem is the attitudes that people have toward vaccines. They perceive this as a new vaccine (and wonder) is it really safe, have you rushed it, is there more danger to the vaccine than the flu?
Q: What's the answer?
A: This really is not a new vaccine. No matter how much we try, it's a tough message to get across. Every year when we put out the seasonal influenza vaccine we change it slightly from year to year to match the drift in the virus in society. In essence, it's what we call a "strain change." That's exactly what we're doing with this H1N1 vaccine. But because it's been billed as a pandemic virus that's new to society, people are perceiving this is an untested, brand new vaccine. One of the problematic issues in biology is that nothing is 100% safe. It is as safe really as any of the vaccines that we take each year with a strain change. But that sometimes is a difficult message to get across.
Q: Has it been tested as much as seasonal vaccines are?
A: Last year, we gave about 100 million doses of seasonal flu vaccine, so you could say, by extrapolation, that it was tested on 100 million people. It was new, but it was given to 80 million people the year before in a little different version. So in the tests that we've done you get a little redness and swelling. Rarely, you get a fever. But there have not been what we call serious, adverse events that are associated with the vaccine.
Q: Has there been testing of the combination of the two vaccines seasonal and swine flu? And should people get both?
A: First of all, there's no problem with giving both together. You get as robust a response if you give one alone as if you give them together. That's the injectable version. There is an exception, that you should not give the flu mist of H1N1 at the same time as the flu mist for seasonal flu because you have the same antigen in the nasal passage competing with each other for the immune response.
Q: What about a combination of one injection and one mist?
A: That's OK. So you could give a flu mist of seasonal flu and a shot of H1N1. That's not a problem.
Q: How long does the shot take to give a person full immunity?
A: We generally say three weeks for it to reach its peak. But in the clinical trials that we did at the NIH, we were seeing very good responses at 10 days.
Q: How long will it be before everyone who wants the vaccine can get it?
A: Logistically, probably late November. There are five target groups that we're trying to get it to. Whereas it's the elderly who are at risk for seasonal flu complications, it's the younger people who are at more risk for pandemic H1N1 complications. The five groups who need to get the vaccine first are: pregnant women, at the top of the list. The caretakers of children less than 6 months old. The reason is you can't vaccinate a child who's less than 6 months because their immune system is too immature. So the way you protect the child is you form a cocoon effect around him by vaccinating the people who are taking care of the child. The third group is health care providers. The fourth group is young individuals from 6 months to 24 years, and the fifth group includes individuals from (age) 25 to 64.
Q: Why aren't the elderly higher on the list?
A: The reason is interesting. Elderly individuals at some time in the decades of their life have come into contact with a virus that has some crossover similarities with the current H1N1, and they have partial immunity to it. Now that could have been people who were vaccinated for the famous swine flu in 1976 or people who were alive and around in the '50s or the '40s, when you had H1N1 still circulating that had some similarity to this. So if you're older, you're relatively protected from H1N1.
Q: You can safely assume that elderly people will be some of the first in line for the shot. Will they be turned away because they're not in the top five risk groups?
A: We're getting the message out to try to get it out to the five target groups first, and when you do that, then go and get the rest. But I have to tell you, I can't imagine if a 75-year-old grandmother comes up to a place and says, "I'd like my vaccine," that somebody will say, "No, go away and come back in two weeks." Somehow I don't see that.
Q: The flip side is people who fear they'll be forced to get the vaccine, such as health care workers. What about them?
A: At the federal level there will be no mandate. But the rationale for health care workers getting vaccinated is quite sound, because there are well-documented cases of health care workers giving influenza to patients. And health care workers who themselves get sick are not able to perform their function very well.
Q: Why do otherwise healthy people die from H1N1 while the great majority recover?
A: Honestly, we don't know. But it follows the pattern of biological variability. It's kind of a bell-shaped curve. There are some people who don't get sick at all and there are some people who get very ill and expire from the illness. And then there's the vast majority of people — in the bell-shaped curve — who do just fine after an illness. I believe that the 30% of the deaths among people who are otherwise healthy is the biological variability among the human species. There may be some genetic factors that are not recognized that don't allow them to respond very well to influenza, even though everything else about them is healthy. And that holds true for a lot of diseases.
Q: Of the fatalities, how many are preventable with early intervention through Tamiflu or some other means?
A: I can't give you a precise number, but there are three things that would help to lessen the morbidity and mortality. First is proper and early diagnosis. The other thing is Tamiflu. Tamiflu helps if you give it early, and the earlier, the better. But from 30% to 40% of the deaths that have occurred thus far have had a serious superimposed bacterial pneumonia, which is highly sensitive to penicillin. So if they had been treated early, they may have survived.
Q: What is the course of the disease for the people who become severely infected? What physically happens?
A: It generally starts off with severe pulmonary disease — difficulty breathing, viral pneumonia, super-imposed in about 40% of them with bacterial pneumonia, and you either recover from it or you progress and you unfortunately and tragically die. When you get very serious pneumonia and you have real difficulty exchanging oxygen, that doesn't stay limited to the lung. Once your system starts to deteriorate, you go into renal failure, you go into heart failure, you get shock, you get super-imposed infections and you get an irreversible situation.
Q: Do you see any disconnect in the federal guidance which seems to be: Don't go to the emergency room unless you're very sick and don't administer Tamiflu unless someone's in a high-risk group. By the time that happens, is it too late for some people?
A: The messaging is difficult. I know, I try it out with people like my sister, who's a really smart non-medical person and she asked a question of me. She said, "Tell me, what do you mean by really sick? How do you determine if you have plain old flu, you should go home, take some anti-inflammatories, take some chicken soup, you don't need Tamiflu, you don't need anything."
But if you look at my children, for instance, their response to being sick is off-the-board variability. One is stoic — she never says anything's wrong — and the other is melodramatic. Everything is. So who's really sick and who is not?
If somebody really understood mild illness, it's that you get a sore throat, you get a low-grade fever, you get some aches, you feel badly, you go home. Over a period of 24 hours, if you don't get significantly worse, you just want to stay in bed. You're coughing a little, but you're not having any difficulty breathing. That's when you stay at home. Don't go to the emergency room. Call up your doctor. You probably don't need Tamiflu. But any difficulty in breathing — where you really feel like you have a problem with breathing — you absolutely go to the emergency room, go to the doctor, you probably get in the hospital and you need Tamiflu.
Q: An otherwise healthy 14-year-old girl in Texas came down with the flu. She went to see a doctor, who citing CDC guidelines sent her home without treatment. She later died. Does this kind of case suggest that you need to revisit those guidelines?
A: The guidelines were made for the purpose of not overwhelming the system with everyone who gets a sniffle and thinks they have the flu going to the emergency room. In such cases, two bad things can happen: Many of the people in the emergency room likely have the flu, so if you didn't have it when you went in, you're probably going to have it when you go out. And the other is, not allowing the health care providers to really take care of the very sick person. The one accident that happens with somebody who really looks like they're OK and then rapidly goes downhill ... that's unfortunate when that happens. But I'm not so sure that would require a changing of the recommendations and the guidelines.
Q: You've mentioned that young people are particularly vulnerable. Why?
A: Two reasons: the very fact that they've only been around for 10, 20, 30 years at the most; those individuals have much less of a chance in their lives to have come in contact with a virus that would give them a degree of cross-protection that we know is clearly protecting the 65-, 70- and 75-year-olds. Point No. 2, demographically, they cluster as opposed to older people who tend to go their own way. Everyone's a social being and interacts, but kids cluster in schools, in gymnasiums, in places like that. So it's a combination of a lack of underlying immunity and the way they live their lives.
Q: How many people were in the clinical trials of the current vaccine, and what, if any, side effects did you find?
A: A little bit over 3,000 people (including 600 children). But 100 million people got a strikingly similar vaccine last year, and there's no reason to believe that the safety profile of the H1N1 that went into the clinical trials just over the past couple of months is any different, or will be any different, from the safety profile of the vaccine that we administered last year.
Q: People might be fearful of Guillain-Barré syndrome. Can you talk about that?
A: Guillain-Barré is an autoimmune — meaning the body reacts against its own tissue — neurological disease that's characterized by ascending paralysis. People usually recover, but it's a very serious disease that can cause death. Guillain-Barré occurs in about one of 100,000 people in the United States. On a yearly basis, there's between 5,000 and 6,000 cases of Guillain-Barré. In 1976, there was a very well-recognized, historic incident called the swine flu affair. What happened is that a few hundred soldiers in Fort Dix, N.J., got a virus that was linked to a swine influenza. They isolated it. One soldier died. It was really a case study in why the president of the United States should never get involved in a vaccine program. People were so sensitized to this being another 1918 pandemic flu where 50 million to a 100 million people died worldwide that they said if it spreads throughout the world, or the United States, we could have another catastrophe. So they decided to manufacture a vaccine against this particular swine flu. The problem was that they brought in all of the big health pundits. They had (Albert) Sabin and (Jonas) Salk in the same room, which was very unusual since they hated each other. But they had them actually agree that we needed to make a vaccine, and we needed to administer it once we made it. That was the mistake because it violated a fundamental risk of vaccinology. As they were making it, it became clear that the swine flu never got out of Fort Dix. But nonetheless, they went ahead and vaccinated 40 million people against a pandemic that didn't materialize. So what you were left with was you had all the risk of the vaccine, and none of the risk of the pandemic.
Q: In the spring, schools with swine flu cases seemed uncertain as to when or whether they should close and send students home. Is there a formula school administrators can apply?
A: There were some sections of the country that were quick on the draw to close the schools and others where the parents complained that they didn't close it quickly enough. There is no mathematical formula, but the CDC has revised its guidelines and turned the knob more toward doing what you can within reason to not close the schools, because they found when they did there was a significant disruption of society out of proportion to what they thought the benefit of closing the schools. Namely, children who didn't go to school congregated in places that was almost equivalent to congregating in the schools. They'd go to a mall; they would not socially distance themselves from each other. So you're almost nullifying the very reason for keeping them out of school. And the way the recommendations go now are that if it's mild, encourage parents not to send sick children to school. If it gets worse than in the spring and goes from mild to moderate, you switch to active surveillance of kids who come in. You have somebody standing at the door, looking at the kids.
Q: Say you're a family of five and one of your children has been diagnosed with swine flu. What do you do?
A: If it's mild, then the kids who are in the family, if they don't have symptoms, they should go to school. If they develop symptoms, they don't. It's going to be very difficult for the parent. You just sort of try as best as possible to have few people interacting with the sick person. If it gets severe, and it's widespread, then the recommendation is that the household contacts of a sick person should not go to school or work for at least the 24 to 48 hours to see if they're actually infected.
Q: If you suspect that you've been exposed to swine flu, should you still get vaccinated?
A: Yes, because you just don't know. There are a lot of viruses out there that aren't necessarily influenza. If I had a laboratory test that definitively said, yes, you did get infected with H1N1, I would tell you no, don't get vaccinated because natural vaccination is the best vaccine you can give for yourself. But unless you're sure, I would go ahead and take it.
Q: Are you worried that in the media and in the general population, myths and misinformation are being spread?
A: We are putting in an extraordinary amount of time into messaging. We try to spend as much time as we possibly can with the media, on TV, in meetings like this, putting things on websites to try and dispel myths. I've been doing these public health-type things for a very long time, going back to HIV/AIDS and SARS and the anthrax attacks, and the ability of misinformation to get propagated continually astounds me. I mean, we even had a report that one of the TV programs asked me to dispel the myth that somebody was reporting that there were serious adverse events that occurred from the first H1N1 vaccine that was given to a group of kids about two weeks ago. There was no H1N1 vaccine that was given to anybody two weeks ago.
Q: What scenario keeps you up at night?
A: A lot of scenarios. I don't sleep very well! The thing that worries me the most is the combination of a highly transmissible respiratory infection, which influenza is the most likely, that is combined with a high degree of virulence. That's the thing that worries me the most, because that would out-terror any bioterror attack.
Q: Do you have any expectations that the virus will mutate this flu season in a way that might fit the scenario that you just described?
A: It is more likely than not that it won't, because it doesn't appear there are obvious pressures for it to change. Once it recirculates back, then I would say there's a better chance now that it would change. But when viruses mutate, they don't necessarily mutate toward a more virulent form.
Q: This flu will probably stretch the U.S. health care system. Will we see emergency rooms and doctors' offices overwhelmed?
A: Do I think it's going to be chaos? No, I really don't. Do I think it's going to be challenging to the health care system? Yes. Since most of the people who are getting infected are of the younger age group, I'm encouraged by what I'm seeing schools, particularly the colleges, setting up. Remember, the thing that's disturbing is its propensity to infect young people (but) a very small fraction gets seriously ill or require hospitalization or require respirators. But the number of people who are getting infected, this is a very, very small minority.
Posted at 12:15 AM/ET, October 07, 2009 in Q&A | Permalink
