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What is the situation now? This is indicated by a quote from the GAO report of June 27, 1977, dealing with the swine flu program.
FDA AND MANUFACTURERS DIFFER IN POTENCY TEST RESULTS Three of the four swine flu vaccine manufacturers consistently reported potency test results which were higher than FDA test results for the same lots of vaccine submitted to FDA under the swine flu program. For example, one manufacturer's test results on 49 vaccine lots submitted during 1976 showed that 47 had a higher potency value than that shown by FDA's tests, 1 had the same test results, and the remaining lot scored lower. GAO report, June 27, 1977, page 34.
In addition, the tabular data provided in the GAO report show that one lot of swine flu vaccine with a designated CCA value of 800, when examined in the FDA's laboratory had a value of 696. This example and other examples given in tabular data in the GAO report clearly show that potency of swine flu vaccines was not indicated by the information on the label. In other words, the swine flu vaccine was mislabeled.
In 1972, it was brought to the attention of the Director of Division of Biologics Standards that there were no reliable data to measure the degree of protection afforded civilian populations by use of commercially available influenza vaccine.
This is indicated in by a quotation taken from the 1977 GAO report.
The Director of the Division of Biologics Standards questioned whether the use of flu vaccine had any detectable effect on the 1957 or 1968 pandemics. He stressed that priority be given to research into the problem of making sufficient vaccine available in time to counter a threatened flu epidemic.
A group of Government virologists who reviewed experience with flu between 1967 and 1972 concluded:
It is generally agreed that inactivated vaccine containing the appropriate antigenic concentration in suitable potency will provide a reasonable degree of immunity for a limited period of time. This statement simply means that on some occasions the vaccine has worked and on others it has not.*** There is no doubt that properly constituted aqueous inactivated vaccines can provide some measure of protection. How much protection they afford is open to question. Protection rates are clearly influenced by many features peculiar to the vaccine, the virus, and the host-and by methods used by the investigators. GAO report, June 27, 1977, page 40.
In assessing the value obtained from use of the swine flu vaccine the GAO report concluded:
Previous efforts to combat pandemic flu have not been successful. The swine flu program differed from past vaccination
efforts because the swine virus was isolated earlier and because the high-priority Federal mass vaccine delivery program was the first of its kind. Consequently, the potential protection provided by the swine flu vaccine is difficult to estimate based solely on previous experience. GAO report, June 27, 1977, page 38.
So, the situation now is as it was 5 years earlier: an assessment of the benefit derived from the use of influenza virus vaccine is not determined.
I would like to mention here the practice of administering influenza virus vaccine to pregnant women. In 1972 we wrote a memorandum to the director of the National Institutes of Health.
Not only has there been little or no benefit from the use of influenza vaccine in man, but harm has resulted. The vaccine contains a considerable concentration of virus material which, although inactivated, possesses toxic properties, and, if given in sufficient quantity, may cause illness in an appreciable percentage of people,
especially in children. Moreover, until recently, influenza vaccine contained (and still does in some instances) extraneous bacteria which could have been
removed during the manufacturing process, but was not, because this was not required by the Division of Biologics Standards. These, too, when injected into man, cause illness. Further, the vaccine contains antigens of chicken-egg origin which may lead to sensitization, or, rarely, to marked reactions in persons already hypersensitive to such material. In addition, the egg protein contain blood group antigens which, when injected into man, induces the formation of specific antibody directed against that antigen. In pregnant women, this can be a dangerous event and result in fetal damage. It is for this reason that pregnant women were removed from the "high risk group” (CDC Report 1962 and compare with CDC Report 1969). It will never be known with certainty whether the recommended injection of influenza vaccine into pregnant women induced fetal damage, and if it did occur the degree and extent of The damage. What is inexcusable is that pregnant women were placed on, and removed from, the “high risk group" without first making these determinations. The risk might have been justifiable if the vaccinated women had been protected from contracting influenza during pregnancy, but the chances are that they were not.
In addition, every inactivated myxovirus vaccine-measles, parainfluenza, and mumps—that has been studied prospectively has been shown to hypersensitive a certain percentage of vaccinated people to subsequent exposure to natural disease induced by a virus of the same type. See S3419 April 20 and 21 and May 3 and 4, 1972, page 526.
What is the situation now? We learn now that after injecting swine flu vaccine into pregnant women who were told that:
“Flu vaccine can be taken safely during pregnancy,”—GAO report, June 27, 1977, Appendix I, page 87—that the center for disease control is supporting two studies on women who received the swine flu vaccine to identify unfavorable pregnancy outcomes, such as spontaneous abortions, stillbirths, and congenital malformations. These studies will follow reactions in children up to 6 weeks beyond birth, born to women in the studies. Letter GAO to Congressman Waxman, June 27, 1977,
I might note here that if they stop the study at 6 weeks, I think that it would be very difficult to determine what definite results there are from these injections.
This series of events would, in my judgment, be serious endictments of vaccine regulation and of the Government's vaccine regulatory agency. In fact, Mr. Joseph Califano, Jr., Secretary of HEW on March 2, 1977, on Meet the Press, said:
The greatest damage the swine flu program has done, aside from the human tragedy of the individual paralyzed and killed, has been the impact on immunization programs, and a large part of that is attributable to the people's fear about immunization programs.
Mr. Califano said further: "We have got to restore confidence in immunization programs." I doubt that under the current managers of vaccine regulation in this country, this confidence is restorable and it is my judgment that the widespread skepticism that followed the swine flu fiasco is fully justified.
I thank you for your attention.
Mr. MAGUIRE. Mr. Chairman, the GAO witness this morning gave testimony that the vaccine which was released for the swine flu program met the Food and Drug Administration safety standards. They said that almost 30 percent of the vaccine was considered subpotent initially, and the agency did not permit its release to the public until the minimum potency requirement was met.
Now you are saying, I take it, that initially there was a problem. I think that it would
be interesting to know why 30 percent of the vaccine did not meet the potency requirements, but presumably that is a question we can address to the manufacturers.
The GAO said that when it was discovered that it did not meet the potency standards, that deficiency was corrected before it was used in the program. Now would you comment on that?
Dr. MORRIS. Yes. First of all, the GAO assumed that the CCA value, which is the measure, has meaning or is meaningful, when in fact the CCA value does not have meaning. I might mention parenthetically here that Dr. Hilleman in his comments made before one of the influenza vaccine workshops, said that he recognized that Dr. Hilleman is a virologist who works for Merck Sharp & Dohme, and he recognizes the inability to measure the potency of the vaccine by the CCA procedure.
Mr. MAGUIRE. The CCA procedure is completely unhelpful with respect to measuring the potency levels? Dr. MORRIS. The CCA procedure
is used to measure the agglutination of chicken red blood cells. There is no positive relationship whatsoever between that measurement and the ability of this vaccine to protect a person against influenza.
Therefore, I was interested in the comments made by Dr. Millar this morning, when he continuously stated that swine flu vaccine immunized its recipients. This vaccine induced the formation of swine antibodies, but Dr. Millar has yet to demonstrate that swine flu vaccine immunized anyone against anything.
Mr. MAGUIRE. Surely you recognize that there are other people in the field who disagree with you?
Dr. MORRIS. Let us take one, Dr. Sabin, before a congressional committee in June 1976, said, and I paraphrase: I am giving you a battery of reasons as to why I am withdrawing my support from this program. One of these reasons is the inability of anyone to measure with accuracy the potency of the influenza virus vaccine.
Mr. MAGUIRE. I think everyone has recognized that we are not as far along in developing the immunization potential and capacity of our inoculations with respect to influenza as well as some other things. Everybody has recognized that.
To move from that to the statement that it does not have any utility at all, does surprise me a bit. Are you saying, in effect, then, that all of the influenza immunization programs that we have had, whether it be the Hong Kong, the A-Victoria, or whatever, in recent years have been of no utility?
Dr. MORRIS. In my estimation, there is no substantial information in the medical literature which demonstrate satisfactorily that influenza virus vaccine has protected man against influenza.
Now this was brought to the attention of the speakers this morning. I think that it was Dr. Millar who said, in I paraphrase: Despite the use of 20 million doses of influenza virus vaccine, in 1957 the course of the 1957 epidemic was not altered. The same situation was true in 1968 despite the use of approximately 20 million doses or more of influenza virus vaccine, the course of the epidemic was not altered.
The reasons given by the Government in those two instances are that the vaccine was too little and too late.
Mr. MAGUIRE. There are examples, one can go over the data and say that the course of the epidemic was altered by timely application?
Dr. MORRIS. There is no record in the medical literature that indicates that the course of an influenza epidemic has ever been altered by the use of influenza virus vaccine.
Mr. MAGUIRE. Aside from your more general point, what would be the reason why tests by manufacturers and by the FDA would vary substantially with respect to the CCA factor, whatever that value may be?
Dr. MORRIS. There is a standard procedure, a set of measures that when applied by a manufacturer, or the FDA, or any other interested party, should result, in a series of measurements that approach similarity. If you measure with an inch, an inch is an inch, but when you measure the potency of influenza virus vaccine by the CCA test procedure, you get results which are shown, for example, in the GAO report, that in the test procedure the measurement unit-the CCA unit-may vary by approximately 100 percent.
You have figures given in my statement where the test results for a particular lot of swine vaccine was 690 in one laboratory and 1,008 in another laboratory by applying the same test procedure to the same lot of vaccine. These results should indicate the unreliability of the test procedure.
Mr. MAGUIRE. So we have in your mind a question about the value of the CCA value itself. You have questions about the test procedures and their accuracy.
Let me ask you whether you agree that the vaccines that were administered to the American public under the swine flu program met the minimum CCA standards as the GAO said they did, or whether you also doubt whether that was the fact or not?
Dr. MORRIS. That depends. The GAO has reported, if I remember correctly, that when certain lots of vaccine in rare instances did not meet the minimum requirement, in order to facilitate the passage of the vaccine lot, the requirement was lowered. It depends on what you mean by the requirement.
If you lower the requirement, then it is not that difficult to meet the requirement.
Mr. MAGUIRE. What about the ones that went out to the American public, did they meet whatever the requirements were that were in force at that time?
Dr. MORRIS. Each of these lots did meet the requirements which were standard at that particular time.
Mr. MAGUIRE. The implications in the witness's testimony go rather far, and I find myself unable at this point to pursue those various avenues. I yield back the balance of my time.
Mr. ROGERS. Mr. Waxman?
Mr. WAXMAN. Dr. Morris, if there were a rapidly growing epidemic and a clear national emergency, would you, then, favor mass immunization as long as any risk from the vaccine were disclosed?
Dr. MORRIS. There is no evidence in the medical literature which would suggest that an inactive influenza virus vaccine will alter the course of an epidemic of influenza. That fact is established.
There is evidence that a live influenza virus vaccine is capable of controlling influenza infections. You asked the question as to why a live influenza virus vaccine is not available. It is not available because of great shortcomings on the part of NIH in developing this vaccine.
When the NIH came before the Congress in 1972, if I remember correctly before Mr. Rogers, and said that there are serious shortcomings which characterized the activity of the virus vaccine. We would like to ask for an appropriation to develop a live influenza virus vaccine.
If I remember correctly, several million dollars were appropriated for that purpose to develop a lab to work on that virus. The reason for that development was the inadequate nature of the dead vaccine. There were serious problems encountered in the develop ment of that vaccine, but there is no doubt that this vaccine does, in fact, protect you against influenza. That is the path that has to be followed in the future.
One has to abandon the hope that an inactive vaccine will ever protect man in an appreciable way against influenza. The avenue must be changed, and it should be changed toward the live influenza virus vaccine.
Mr. WAXMAN. Do you have any information as to the cost of the vaccine for swine flu, which would be helpful to us in developing that question?
Dr. MORRIS. The information I have, and I would rather not give it because it is not solid.
Mr. ROGERS. We very much appreciate your testimony. Thank you.
The next witnesses are a panel of vaccine manufacturers.
I would appreciate it if the witnesses would keep their testimony limited to 5 minutes. The statements will be included in their entirety in the record. STATEMENTS OF ROBERT F. HENDRICKSON, VICE PRESIDENT,
OPERATIONS, MERCK SHARP & DOHME DIVISION, MERCK & CO., INC.; ACCOMPANIED BY CLARENCE A. ABRAMSON, SENIOR COUNSEL; CHARLES F. HAGAN, GENERAL COUNSEL, AMERICAN HOME PRODUCTS CORP.; FRANK MARKOE, JR., VICE CHAIRMAN, BOARD OF DIRECTORS, WARNER-LAMBERT CO. (PARKE-DAVIS); AND FREDERIC D. LAMB, VICE PRESIDENT AND LEGAL COUNSEL, MERRELL-NATIONAL LABORATORIES
Mr. HENDRICKSON. My name is Robert F. Hendrickson, and I am Vice President for Operations of Merck Sharp & Dohme. I would like to make two brief points, and then we will be pleased to answer any questions.
I would like first to reaffirm that the vaccine manufacturers continue to be an important national resource for public health programs, able to tailor production rapidly to meet emerging needs when given a reasonable amount of advance warning and a reasonable degree of cooperation.
Second, I want to reemphasize that we could not be expected to participate effectively in public health programs if we were unable to obtain insurance, or otherwise be protected against liability from
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