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Effects of killed virus vaccine in preventing disease as well as
in interrupting circulation of wild virus in Sweden and Finland,
confirms that intestinal infection with live virus vaccine
is not essential for eradication of wild virus from a population

Killed Virus Vaccine

"Since 1963 there has been no domestic case in
Sweden, and the circulation of the virus... so
far as can be established, has been interrupted.
We have found in the past few years a few positive
isolations in a mass investigation of sewage, but
since the beginning of the 1960s we have not been
able to isolate the virus from people... There
is very little circulation, if any, in the community
of wild virus."

Dr. Holger Lundbeck
Sweden
(1973)

"In Sweden and Finland, we have not only eradicated poliomyelitis but have also eradicated the live virus."

From:

International Symposium on Vaccination against Communicable Diseases, Monaco 1973; Symp. Series Immunobiol. Standard, vol. 22, pp. 319-320.

Senator KENNEDY. We will now hear from Prof. Kari Penttinen of University of Helsinki, Helsinki, Finland.

Welcome to the subcommittee, Dr. Penttinen.

STATEMENT OF DR. KARI PENTTINEN OF THE UNIVERSITY OF
HELSINKI, HELSINKI, FINLAND

Dr. PENTTINEN. Thank you very much, Mr. Chairman.
I can concentrate our experience in just a few words.

Finland and Sweden are probably the sole countries where killed polio vaccines only have been used. Since 1954, poliomyelitis field trial, killed vaccines have been in use in Finland, but only in 1960. and 1961 did they become significant from the point of view of the public health.

Since 1964 no case of polio has been registered in Finland.

The largest polio epidemics in Finland occurred in 1954, 790 cases, 1955, 370 cases, 1956, 623 cases, 1959, 302 cases, and in 1960, 273

cases.

During the 12 polio-free years there has been a continuous search for the polio virus and for the disease, but they have disappeared.

Yearly about 600,000 to 700,000 doses of killed vaccine are used in Finland. This is equivalent to about 25 to 30 million doses in the United States.

Finland is not producing polio vaccine, but buys it in bulk from Belgium.

In Sweden killed polio vaccine has been in use since 1957. The first polio-free year was 1963 and no cases were recorded between 1967 and 1973. During the other years altogether six cases, part of them imported, have been registered. Some strains of polio viruses have been isolated, specially from children adopted from Korea or Vietnam. Sweden produces polio vaccine for its own use.

In Norway living oral vaccine has been in use since 1965. At least eight cases of polio have been recorded since the beginning of the program and they have all been vaccine-associated cases. The use of killed polio vaccine for primary vaccination has been considered.

Denmark has been using inactivated polio vaccine, of its own production from 1955, but the case rate and antibody studies showed it low efficacy. Since 1963 live vaccine has been used, but four to five vaccine-associated cases have been reported. After 1970 killed vaccine was again taken into use for primary vaccination. The first polio-free year was 1964, but only from 1970 has this been a rule.

In Finland killed mumps virus vaccine has been in use since 1954 and from 1960 all conscripts in the Finnish Defence Force have been vaccinated against mumps, 1960-70 more than 600,000 men. The results have been very good, over 95 percent protection, and no adverse reactions have been reported.

Senator KENNEDY. Thank you very much.

You believe the killed vaccine provides adequate and complete protection for the people of Finland?

Dr. PENTTINEN. Yes. In Finland we have now 12 years of experience. In 1974 Sweden had one case of polio, but it was imported from another country.

Senator KENNEDY. Why do you prefer it to live vaccine?

Dr. PENTTINEN. Just because we had that in use in Finland. You could be sure we would have had some cases of polio if we had used live vaccine. What would we say then to those that we had given false advice, and to the people, what would we say even if there is one polio case, when we do not now have one after the use of only killed vaccine?

Senator KENNEDY. That really leads to the next question for Dr. Salk. Do you believe the American people are getting the truth about the risk and benefits of live polio vaccine?

Dr. SALK. I do not believe that either the American people, or even the practicing physicians are aware of some of the facts that I have alluded to, and presented in the documents.

I have drawn attention to these facts before committees, in a very close-knit scientific community. By and large, this knowledge about the risk is not known either to the medical profession at large, or to the public.

Senator KENNEDY. Why not?

Dr. SALK. Well, in part by referring to the live virus vaccine as an oral vaccine, most people think that the oral vaccine is simply an oral version of the killed vaccine.

They do not understand the difference between the live and the killed.

Second, when risk data are presented, they are presented in terms of such ratios as 1 in 5 million and 1 in 10 million. The denominator sounds astronomical.

To me, what is more meaningful is the numerator, since the denominator can be expanded to any size.

The denominator, for example, refers to the number of doses distributed, not the number used; nor is there any qualification given for the fact that some are second or third or fourth doses, or that the vaccine had been given to people who had already been immunized with the killed polio-virus vaccine.

Calculations of risk rates in Norway, for example, indicate 1 per 300 thousand for the live virus vaccine which is the same as that used in the United States and in Britain. The fact that all domestic cases that occurred in the United States in 1973 were vaccine-associated, is new information, new knowledge, in the sense that it has not previously been presented in this way.

The impression has been given that there is a risk, but that it is trivial.

There is a tendency to minimize that which I have attempted to maximize.

Senator KENNEDY. Is the informed consent adequate?

Dr. SALK. In my judgment it is not.

Senator KENNEDY. Why not?

Dr. SALK. Because it does not reveal the relative risk of taking the vaccine, or not taking the vaccine.

It does not reveal that if one does not take the vaccine at the present time, the risk is less, and the consent form that I have seen makes no reference to the existence of killed vaccine as a possible alternative.

Now, I must add in this regard, that when the use of the live poliovirus vaccine was promoted as it was, the market for the killed polio-virus vaccine disappeared, and its manufacture in the United States also disappeared.

However, there is a licensed manufacturer of killed polio-virus vaccine in Canada. They prepared the virus for the vaccine prepared for the field trial in 1954.

They have continued to make the vaccine. I visited them recently, and they are in a position to satisfy any demand that will arise in the United States.

They have a certain stockpile on hand now, and they are willing and able with a short leadtime to provide the necessary need. Therefore, it is not necessary that we create a new industry. All that is necessary is to take advantage of a currently existing manufacturer who is in a position to provide this need should the alternative be made known to the public.

[The prepared statement of Dr. Penttinen follows:]