TOPICS > Health

Newsmaker: FDA Commissioner Dr. David Kessler

December 18, 1996 at 12:00 AM EDT


CHARLAYNE HUNTER-GAULT: Each year, most Americans who get a flu shot do so by the end of December. And this year, more than 70 million people have already been vaccinated. But in an unprecedented move, scientists are warning that some of the vaccines given out were not strong enough. To explain the situation and how it will affect people, we’re joined by Dr. David Kessler, the commissioner of the Food & Drug Administration. Dr. Kessler, thank you for joining us. First, tell us about the warning, why it was issued.

DR. DAVID KESSLER, Food and Drug Administration: First, it’s important to stress this is “not” about safety. This is about whether certain batches work, whether they work as well as we would like them to work. There are four manufacturers of influenza vaccines, and some of the batches of “one” of the manufacturers, those batches lost their strength over time, so they don’t stimulate the same kind of degree of protection that we would like. It’s not that they don’t work at all; it’s just they don’t work quite as well as we would like.

CHARLAYNE HUNTER-GAULT: And to issue a warning like this, that sort of has the potential for setting off alarm bells.

DR. DAVID KESSLER: No alarm here at all. We’re not talking about a major public health risk. But for those individuals who are at high risk, those individuals who have chronic diseases, such as heart and lung disease, and who have received the batches from the recalled lots, then they should talk to their physicians and consider being re-immunized.

CHARLAYNE HUNTER-GAULT: Okay. Now, how does someone know that they–will they know that they got a weakened batch, or just people who are in the category you just mentioned, is at high risk, the elderly and–

DR. DAVID KESSLER: People who have chronic lung disease, chronic heart disease, those who’ve been in the hospital of late with those conditions. It’s very important to emphasize that we’re not talking about re-immunizing healthy individuals. We’re not talking about re-immunizing those who are at high risk. What we’re talking about is re-immunizing those who are at high risk and did receive one of the lots that was recalled.

CHARLAYNE HUNTER-GAULT: Now why do they need to go back and get another one?

DR. DAVID KESSLER: Well, we would like–they’re at the greatest risk of the complications of influenza.


DR. DAVID KESSLER: In most people it’s fever, it’s aches and pains, but there can be serious respiratory complications. Each and every year, thousands of people–again, those who are at the highest risk, I mean, can have serious complications and could even die, so we want to make sure that those who are at the highest risk have the greatest degree of protection.

CHARLAYNE HUNTER-GAULT: How did this come about, that there was a batch of this vaccine that is not as strong as the others?

DR. DAVID KESSLER: Charlayne, we still do not know. Every year we have to change the influenza vaccine somewhat because there’s a different strain of influenza that’s likely to appear several months later. Is there something to do about the biology of this particular strain? Again, it’s not a safety issue, but we’re investigating.

CHARLAYNE HUNTER-GAULT: I understand that this happened sometime ago, but the alert has just come out. Why did it take the government so long?

DR. DAVID KESSLER: The clinical data, the clinical data that suggests that there wasn’t the degree of protection that we would like, again, in a relatively small number of these lots, that data only came in at the end of last week, and I spent the weekend and early this week with the best experts in the country going over that clinical data.

CHARLAYNE HUNTER-GAULT: And how many people are we talking about who need to get the shot out of a total of how many who took it?

DR. DAVID KESSLER: Well, as you mentioned earlier, about 70 million people take the shot. That includes healthy people. We’re really talking about 2 million people consider–to consider having re-immunization, those who are at high risk. And, again, it’s those who are at high risk and have received one of the lots that’s not quite as strong, not quite as potent as we would like.

CHARLAYNE HUNTER-GAULT: So they won’t know, but they should just go anyway and routinely have another one?

DR. DAVID KESSLER: No. Absolutely not. They should talk to their physician, and the physician should look and see what lot–physicians write down–most physicians write down the lots that they use to immunize. And, again, if that person fits into that high risk group and had one of the lots, then that person should be re-immunized. There’s no increased risk of re-immunization, but we don’t want everybody running for flu shots because it’s late in the season, and, again, the supply tends to be more limited at the end. But there is one other point that–

CHARLAYNE HUNTER-GAULT: Excuse me–more limited, therefore, you want to be able to save what’s left for the people who really need it the most, is that the reason?

DR. DAVID KESSLER: Very well said. And the other point is that those who are at high risk and who have not had gone at all for their first immunization, they should have their first priority.

CHARLAYNE HUNTER-GAULT: Are all of the weakened batches–is all of the weakened batch now collected and out of circulation?

DR. DAVID KESSLER: Yes. It’s all been recalled.

CHARLAYNE HUNTER-GAULT: There’s no risk that you’d get a weakened–

DR. DAVID KESSLER: That’s correct. It’s been recalled.

CHARLAYNE HUNTER-GAULT: What does a flu shot do?

DR. DAVID KESSLER: First of all, the shot–the vaccine, itself, are components of a killed–the killed virus. You can’t “get” the flu from the vaccine. Sometimes you can get some side effects, but you can’t get the flu. And those components of the killed virus, they stimulate antibodies, and those antibodies protect you. They circulate in your blood system, and they protect you when you get–if you get infected.

CHARLAYNE HUNTER-GAULT: So does getting the second shot, in the case of the people you’re encouraging to go and see if they need to get it, guarantee that they won’t get the flu, and does having the shot mean you won’t get the flu?

DR. DAVID KESSLER: It’s a terrific question, and that’s the question I spent a lot of time talking to the experts over the weekend. Generally, the higher the level of antibodies that you have on board, the greater the degree of protection, but I can’t sit here and guarantee you that for any given individual who may be at high risk who’s had the recall lot, a second immunization will guarantee that they have protective antibodies, but it’s likely.

CHARLAYNE HUNTER-GAULT: How long does it take to be effective?

DR. DAVID KESSLER: About two weeks.

CHARLAYNE HUNTER-GAULT: And is it the case still that you shouldn’t take it if you have a cold or some other illness, or is it okay to get it because the virus is–the vaccine is–the virus is dead?

DR. DAVID KESSLER: I think that you leave to the individual judgment of the physician to assess the medical condition.

CHARLAYNE HUNTER-GAULT: Now, is this flu that’s out there now more virulent than flues in the past, or different?

DR. DAVID KESSLER: Well, if you look at the data that’s come in as of last week, and understand the data continues to come in as the influenza peak, which is usually around January and February, we are certainly seeing a significant number of outbreaks of influenza A, but the complications don’t seem–at least as of now–to be any higher than in previous years, but, again, we’re going to have to wait and look at the data at the end of the season.

CHARLAYNE HUNTER-GAULT: And is this the only flu that’s out there this–what did you say–what did you call it?



DR. DAVID KESSLER: In fact, the strain that we’re talking about was first identified in China the last year and then proceeded to move to Guam and Japan and then come here. People use the word “flu” for a lot of conditions. What we’re talking about is a very particular kind of flu-like illness. It’s the flu-like illness caused by influenza virus.

CHARLAYNE HUNTER-GAULT: With fever and–briefly–

DR. DAVID KESSLER: It’s fever and real muscle aches and cough. It’s not the common cold.

CHARLAYNE HUNTER-GAULT: Okay. Well, thank you, Dr. Kessler.