Finally, Mr. Chairman, we have discussed with the vaccine manufacturers the whole issue of liability for injuries suffered by individuals as a result of influenza immunization. We have discussed the question of liability for injuries suffered by individuals from influenza vaccinations with the drug manufacturers. In addition, CDC has surveyed the States and has engaged in extensive discussions with the Executive Committee of the Association of State and Territorial Health Officials. As you know, liability became a crippling national issue in the swine influenza program because of the vast number of people which that program sought to vaccinate. In contrast with that wholesale vaccination campaign, the proposed program is highly targeted, and the number of vaccine recipients much more limited. Furthermore, because the proposed program is similar in design to other immunization programs conducted by the States, we do not expect the question of liability to become a major source of controversy. Any concerns of the manufacturers with respect to liability will be resolved through the assumption by the Federal Government and the States of the "duty to warn" vaccine recipients of the risks and benefits of influenza vaccination.

To provide assistance to States this year, we are requesting an appropriation of $10.9 million and 20 positions under the project grant authority contained in Sections 317(g) (1) (C) and 318(f) of the Public Health Service Act. By using all of the authority under Section 317 (f) (1) (C), and by appropriating $6 million under Section 318 and, with your concurrence, allocating it to the influenza program as permitted under Section 318 (f), we will be able to proceed with implementing the program in a timely fashion. These funds will be used to assure the availability and assessability of influenza immunization services to the target population, for educational and informational activities, for the purchase of vaccine, and for the intensification of epidemiologic and laboratory surveillance of influenza disease patterns and vaccine reactions.

We are requesting 30 positions and $2.3 million to support CDC direct operations to provide national leadership in planning, establishing, and conducting influenza immunization programs directed toward high-risk populations. These resources will also enable the Center to provide appropriate national surveillance of influenza and assessment of immunization delivery services, as well as intensified influenza outbreak investigation.

To meet the demands of the program with respect to the licensure of vaccines to be utilized, $450,000 and 7 positions are needed for FDA. This will permit the Bureau of Biologics to increase the number of vaccine lots which it tests and releases, and to conduct necessary clinical investigations and related laboratory support activities.

In addition, we are requesting $1.35 million and 9 positions for NIAID for the clinical testing of vaccines in four different age/risk segments of the population. For 1979 we will be requesting a budget amendment of $20 million for the second year of operation of this program. To avoid a net increase in the 1979 budget we are currently exploring possible offsets for the $20 million increase.

The Secretary's January 30 conference, the Surgeon General, and I have all stressed that it will be important to have States' programs operating by this fall. To meet this deadline will require prompt Congressional action, in order to permit vaccine contract procedures to be initiated and to give the States adequate time to establish programs.

The program we are proposing marks an important turning point in our approach to influenza immunization-establishing a permanent, State-based system targeted at those individuals most at risk from this preventable disease. Mr. Chairman, we will be happy to respond to any questions which you and the Members of the Subcommittee may wish to ask.

Mr. FLOOD. We will proceed with the questioning.
Mr. CONTE. Mr. Chairman, may I ask a question?

Mr. FLOOD. Yes, of course.

Mr. CONTE. I got a very disturbing message last night, and I haven't been able to follow up on it before this hearing. The Mayor of Youngstown, Ohio is paralyzed. He had gotten a swine flu shot and it has paralyzed his whole body. Have you heard about that?

Dr. FOEGE. I have not heard of that specific case, no.

Mr. CONTE. Are you the person to see?

I will know about 4 o'clock. I met him and we have a very, very close mutual friend. That is who I have been trying to contact.

Dr. FOEGE. We would be happy to follow up on it.

Is this a recent injection that he got?

Mr. CONTE. I just got the call last night.

Mr. FLOOD. Is he going to follow up with you now or one of your staff people?

Dr. FOEGE. You can follow up with me.

Mr. CONTE. Thank you, Mr. Chairman.

INFLUENZA SUPPLEMENTAL REQUEST

Mr. FLOOD. We have before the committee a supplemental request for $15 million for the influenza vaccination program.

Doctor, will this influenza program, the program itself, concentrate solely on what we call the Russian flu?

Dr. FOEGE. No, it will not, Mr. Chairman. The program is seen as establishing a system for year after year, despite the kind of flu. This year it would concentrate on three antigens, and the Russian flu antigen would be in the vaccine. There would also be an A-Texas flu strain and a B/Hong Kong strain in the vaccine.

Mr. FLOOD. Is that because you don't like the term "Russian flu"? Dr. FOEGE. There is one problem with it, and that is this particular strain was actually first seen in China in May of last year.

RUSSIAN FLU

Mr. FLOOD. What was the impact of this so-called Russian flu on Russia itself? Was it a severe flu? Or was it a moderate flu-that is to say, did it have a high mortality rate, or was the death rate from this flu no different than the death rate from any other flu?

Dr. FOEGE. I think the answer to that is it was not a severe flu as seen in the Soviet Union, and their experience and our experience with the Russian flu has been very similar. The first wave has involved persons under age 25 with low mortality rates. We do not know whether those low mortality rates would hold true with the second wave that we would expect to arrive this fall, but to date there have not been many deaths that one can attribute to Russian flu.

Mr. FLOOD. Did the Russians develop and administer a flu vaccine in order to combat this flu?

Dr. FOEGE. They did not have a vaccine. Their first indication of this flu strain came in November when the strain was already circulating and upon them. They did not have time to develop a vaccine. And I might ask Dr. Parkman whether they have a vaccine now.

Dr. PARKMAN. My understanding is there was a team who went over from CDC and from one of our universities, and they talked extensively with the Russians.

Mr. FLOOD. Do they have a high mortality rate?

Dr. PARKMAN. NO.

Mr. FLOOD. That is what I understand.

Dr. PARKMAN. No. They are interested, the Russians, my understanding is, are planning to prepare a vaccine that will include this in for use in their country next year.

Mr. FLOOD. What do you expect the incidence of Russian flu to be in the United States next winter?

Dr. FOEGE. First, recognize the problems we have in predicting flu of any kind.

Mr. FLOOD. I understand that.

Dr. FOEGE. But we would expect that there will be a fair amount of the Russian flu later this year, based on the fact that it was seeded in more than two thirds of the States this year, and that most of the outbreaks this year were limited to schools. So it has beeen well seeded.

MEDICAL SCIENCE'S ABILITY TO PREDICT FLU EPIDEMICS

Mr. FLOOD. What I have in mind is this, Doctor. It is our understanding, that flu is a disease that often confounds the medical science in its best efforts to predict the severity, the incidence as well, or to devise an effective response. Is that about right?

Dr. FOEGE. That is right.

Mr. FLOOD. If that is right, then the possibility exists that we might not have an epidemic next winter; is that right? We might not?

Dr. FOEGE. It exists, but I think the chances are very great that we will have an outbreak next winter. But the second part of the question, would we expect much mortality? We would not expect high rates of mortality in healthy people.

Mr. FLOOD. In other words, we could be gearing up for an epidemic that might never happen, just like the swine flu?

Dr. FOEGE. That is possible.

Mr. FLOOD. Let's look at it another way. Suppose now this committee decides to reject this supplemental request.

What in your professional opinion is the worst thing that could happen?

Dr. FOEGE. I think that the private sector will still end up immunizing about 20 percent of the high risk people. That will happen. The worst thing that could happen is the next 20 percent that we would hope this program will address itself to will not be immunized, and we would expect in that group we will see some mortality in high risk people, people that have underlying problems such as diabetes, heart disease, lung disease, and so forth.

DIFFERENCE BETWEEN PROPOSED VACCINATION PROGRAM AND SWINE FLU

PROGRAM

Mr. FLOOD. We went through this thing in this committee and we are a little gun-shy.

How will this influenza vaccination program differ from the fiasco of the swine flu?

Dr. FOEGE. First, I think with the swine flu problem, that there were very few options that people could take.

Mr. FLOOD. I was listening to you fellows.

Dr. FOEGE. That is right.

Mr. FLOOD. I took your word for it. I was the mouthpiece and there we were. By "we" I mean the committee.

Dr. FOEGE. Given the same condition, we would have to recommend the same thing. but this program is different in the following ways.

First, there is the flexibility. States can enter if they want. They don't have to if they don't want. If they don't enter this year, they can enter

next year.

Number two, we are talking about an ongoing program year after year rather than a one-shot program that tries to cover the population.

FEDERAL ROLE

Mr. FLOOD. What about this? Specifically now what will be the role of the Federal Government under this proposed supplemental? The original budget justifications for the supplemental, and I might add the Secretary's press release about the whole program, described the Federal role to be simply one of giving the money to the States, and the States would buy and administer the vaccine.

Why have you changed this from a decentralized program to a centralized and federally dominated program? Did the States object to this idea of a decentralized approach, or again was it the manufacturers who objected to the decentralized approach?

Dr. FOEGE. It would still be decentralized in the sense that every State would have their own program, and would apply for a grant. One thing has been centralized. Instead of the States purchasing the vaccine from the manufacturers, we would consolidate the orders and pay for this out of grant money. Everything else would still be decentralized in terms of running the program. The Federal role would be to do national surveillance, assessment, studies on vaccines, those sort of things, that can be best done nationally, but the States would run the programs.

LIABILITY

Mr. FLOOD. That brings me around to this question of what concerns us, the question of liability.

Will the Federal Government be legally liable for injuries suffered by individuals from flu vaccinations received under this supplemental? That is a very, very important question.

I want the record to be very careful about this, and you give an answer now off the top of your head and then later on for the record you may want to prepare that answer, because this one had better be quite an answer.

Dr. FOEGE. Fine.

Let me mention two components of the swine flu program, and then what we would intend this time. In swine flu, we did two things. We assumed the duty to warn the individual who would receive the vaccine of the risks they would take. In addition, we asked the Congress for liability protection.

With this program we are instead saying we will do it the same way as the childhood immunization program, that is, we will sign a contract with the providers of vaccine which says we will warn the individuals of both the risks and the benefits that they can get from vaccine. We will pass that duty to warn on to the States as part of the grant award. So we are assuming the duty to warn vaccinees, but that is all we are assuming.

Mr. FLOOD. Keep in mind that the liability has become a national issue in the swine flu program, you know, because of the unprecedented role taken by the Federal people.

Dr. FOEGE. It was a large program covering many people at one time with a great deal of publicity.

Mr. FLOOD. When you get that record back, you read that answer, and go over it with your people and make that one good, because that is loaded.

Dr. FOEGE. I might ask if Mr. Dick Beattie has something he would like to add.

Mr. BEATTIE. Yes, sir.

Mr. FLOOD. It is your show.

Mr. BEATTIE. We will go over it. I don't have anything to add. I think Dr. Foege explained it well.

Mr. FLOOD. Out of an abundance of caution, take a second look at it, will you?

Mr. BEATTIE. Yes, sir.

Mr. FLOOD. Has HEW worked out the rules of liability with the individual States that we are talking about?

Dr. FOEGE. We have not worked out the roles of liability.
Do you want to comment on what we think would happen?

Mr. BEATTIE. What we think will happen, Mr. Chairman, is that we will accept by contract this duty to warn. We will pass that on to the States, and they will do that also. If there is an injury, someone will obviously sue all of the participants, but if the duty to warn, the obligation to provide the warning has been met, then there will be no liability on the part of the State or government.

Mr. FLOOD. Let me ask you: Are you aware, this is to you, Doctor, of any State that will not be able to secure adequate liability insurance, and, of course, thus prevent them from participating in the proposed vaccination program? Are you aware of anything like that?

Dr. FOEGE. There are States that have told us they will not participate because of liability. New Jersey has recently said that because of the liability question, they would not participate. When we queried the States as to whether they would ask for grant money if there would be a Federal program, 42 answered. Thirty said yes, they would ask for grant money. Three said they would not. Nine said they were undecided.

Mr. FLOOD. I tell you what you do. This will bring you in again, for the record. Don't do it right now but for the record. Submit a very good statement now from HEW's general counsel which outlines his understanding of the extent of the Federal Government's liability under this proposed vaccination program.

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