SCIENTIFIC AND PRODUCTION ACTIVITIES AND FUTURE TASKS OF USSR INSTITUTES OF VACCINES AND SERA

• Document Type: CREST
• Collection: General CIA Records
• Document Number (FOIA) /ESDN (CREST): CIA-RDP80-00809A000700240062-5
• Release Decision: RIPPUB
• Original Classification: U
• Document Page Count: 6
• Document Creation Date: December 22, 2016
• Document Release Date: July 11, 2011
• Sequence Number: 62
• Publication Date: September 26, 1955
• Content Type: REPORT

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SCIENTIFIC AND PRODUCTION ACTIVITIES AND FUTURE TASKS
OF USSR INSTITUTES OF VACCINES AND SERA
Zhurnal Mikrobioloaii Eoidemioloaii,
i Immunobiologii, No 7
Moscow, Jul 55
The institutes which produce bacterial preparations have grown out of bac-
teriological and sanitary-hygienic laboratories. The first national institute
of this type was opened at Odessa in 1886. During the next 30 years, 12 more
institutes which produced antirabies and smallpox vaccines were opened in major
centers of the country. After the October Revolution the number of institutes
began to grow rapidly. By 1930, there were more than 50 institutes of epidemi-
ology and microbiology in the USSR. These institutes combined the production of
bacterial preparations with scientific research work and antiepidemic activities.
In 1952, some institutes of epidemiology and microbiology were reorganized
into institutes of vaccines and sera, while others became institutes of epidemi-
ology, microbiology, and hygiene. The production of bacterial preparations was
concentrated in the first type of institute while the second type was charged
Primarily with antiepidemic activities. The production activity of the latter was
restricted to two or three preparations (antimeasles serum, antirabies vaccine,
and smallpox vaccine or antituberculosis vaccine). In 1954, the institutes of
vaccines and sera were included in the activity of the network of antiepidemic
institutions in the capacity of organizational and methodological centers. Thus,
bacterial preparations are at present partly produced by institutes of vaccines
and sera and partly by the institutes of epidemiology, microbiology, and hygiene.
The institutes of vaccines and sera produce 68.5% of all bacterial preparations,
and 31.5% are produced by the institutes of epidemiology, microbiology, and hygiene
and by sanitary-epidemiological stations. The sanitary-epidemiological stations
produce antimeasles serum.
The range of preparations supplied by the institutes of vaccines and sera
has expanded from year to year. In the 1930s the assortment of bacterial pre-
parations that was supplied consisted of killed vaccines of intestinal diseases,
smallpox vaccine, and several sera. By 1940 the assortment was complete with
regard to the types of products and comprised vaccines, bacteriophages, antitoxins,
sera, and diagnostic preparations. A particularly rapid increase in the number
of bacterial preparations being released took place in the past 10 years. During
this period, a number of the most important preparations were introduced into
practical use. Some of these preparations are STI vaccine, encephalitis vaccine,
brucellosis vaccine, tularemia vaccine, leptcspirosis vaccine, influenza vaccine,
cutaneous BCG [Bacillus Calmette-Guerin] vaccine, gammaglobulin, antiencephalitis
serum, antiinfluenza serum, antibrucellosis serum, and a number of diagnostic
preparations such as brucellin, tularin, etc. Vaccines against Q. fever and measles
and a number of other preparations have been developed on an experimental basis.
As a result, the assortment of therapeutic and prophylactic preparations has in-
creased to 50, while the assortment of diagnostic preparations exceeds 100. In
accordance with the tasks with which the institutes are charged ..nd which are
aimed at the elimination of infectious diseases, the institutes constantly carry
out scientific research on the perfection of available preparations and develop-
ment of new preparations for bacteriological and serological diagnosis and for
the prophylaxis and therapy of infectious diseases. However, the efficiency of
the work of the institutes is limited to a considerable extent by the state of
their technical equipment.
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Until recently, laboratory methods rather than industrial methods were
used in the production of bacterial preparations. In connection with the pro-
duction of vaccines, culturing in small glass vessels was carried out, while in
the production of sera, separation by mechanical means and release of the sera
I. the natural state were practiced. Almost all preparations were supplied in
a liquid state, were therefore inconvenient for transportation, and had only a
short useful life.
The use of complex technical equipment in the production of bacterial prepa-
rations was begun long ago. At present, glass vessels have been replaced by
reactors it, the production of vaccines and to some extent in the production of
anatoxins. Serum production is now carried out with [large-scale] equipment
for purification, concentration, and fractionation. Furthermore, the institutes
have at their disposal drying equipment and refrigerator installations of varying
capacity.
Introduction of technological production methods made it possible to im-
prove the quality of some preparations, particularly to produce these preparations
in the dry state, to expand the production program, and to achieve a reduction
in costs. Introduction of technological methods has also contributed to the
expansion and extension of scientific research and led to the development of new
bacterial preparations, particularly virological preparations, in the production
of which the availability of equipment for carrying out processes at low tem-
peratures is of decisive importance.
However, there are serious obstacles to supplying large-scale equipment to
institutes which produce bacterial preparations. First, industry cannot under-
take the production of special equipment of this type because it cannot be mass-
produced. As a result, the institutes themselves must often construct relatively
complicated equipment at their own workshops or assemble it from parts supplied
by industrial plants. It is obvious that this equipment cannot be perfect. Also,
the institutes have only a few highly qualified technologists with adequate train-
ing, because such technologists are not provided for in the personnel setup of
the institutes and are not being trained at any technical educational institutions.
Finally, modern technical equipment requires additional space, which as a
rule is not available at the institutes because the institutes are located in
the original buildings assigned to them at the time of their founding.
The effectiveness of the preparations supplied by the institutes therefore
does not satisfy the requirements of public health work. It is necessary to
effect without delay a radical improvement In the worn of the institutes of
vaccines and sera so that in the next few years they will assure to the country
a sufficient supply of high-quality bacterial preparations.
In addition to technical equipment, there are other conditions on which
the quality of bacterial preparations depends.
one of these conditions is the availability of appropriate bacterial cultures
at the institutes. It is known that the state of the live bacterial cultures
from which bacterial preparations are produced is of great importance for the
quality of these preparations.' Nevertheless, the situation with regard to live
cultures is not satisfactory. The principal deficiency in the organization of
work pertaining to the cultures is the absence of a single center engaged in
the collection, recording, and identification of strains of bacteria, viruses,
and protozoa. The local collections of cultures at the institutes, with few
exceptions, are not equipped with vacuum apparatuses for lyophilic drying. Further-
more, not all of them have refrigerator installations. Thus, appropriate con-
ditions for storage are not being provided. As a result, the cultures change,
dissociate, and lose important properties. All this interferes with the scientific
research work and the search for the most suitable strains, thus exerting an un-
desirable effect on the quality of the bacterial preparations produced by the
institutes.
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One must therefore regard as urgent measured aiming at the improvement of
the quality of bacterial preparation, the organization of a central collection
of cultures, compilation of a special catalog of bacterial cultures available in
the USSR and abroad, and development of standard sera. TI task of supplying
the institutes with cultures has been assigned to the State Control Institute
of Sera and Vaccines imeni Tarasevich. For this reason, it would be expedient
to organize the permanent collection ("museum") of cultures at this institute.
The quality of the most important preparations supplied by the institutes
and the ways of improving the preparations should also be discussed.
Among these preparations are therapeutic sera. At present, the institutes
prepare at least 13 kinds of sera.
As a result of numerous investigations carried out at the Institute of
Epidemiology and Microbiology imeni N. F. Gamaleya, Academy of Medical Sciences
USSR, the method of enzymatic (proteolytic) purification and concentration
('diaferm") has been introduced in the production of antitoxic sera. Many-
aided investigations carried out at the institute with the participation of
biochemists and mechanical engineers have made it possible to construct special
equipment which assures the mechanization of the most important production
processes. As a result, the time needed for carrying out the over-all process
has been shortened to 6-7 days from 45 days and the titers of the sera have
been improved by a factor of 5-8. However, many problems which have a bearing
on the improvement of the quality of the sera remain unsolved and require urgent
study. Among these problems are the reduction of the percentage of wasted anti-
toxin, improvement of titers, and an increase in the yields of sera obtained
from producer animals.
One must also mention the attempts of the Moscow Institute of Vaccines and
Sera imeni I. I. Mechnikov to purify the therapeutic equine sera by separating
definite fractions of globulins. At present, gamma globulins have been obtained
under experimental conditions from the antidiphtheria, antitetanus, antien-
cephalitis, and antiplague sera. The institute should expedite the development
of this highly effective type of preparation which can be used and stored con-
veniently.
Particular attention should be paid to the problem of obtaining sera in
the dry state. Using ordinary drying equipment, the Kharkov Institute of
Vaccines and Sera imeni I. I. Mechnikov has developed a method of obtaining
anaerobic equine sera in the dry state. At the Institute of Epidemiology and
Microbiology imeni N. F. Gamaleya, Academy of Medical Sciences USSR, special
equipment is being developed for the drying of large volumes of sera. It is
necessary to expedite this work so that it will be possible to pass from ex-
perimental investigations to the production of large quantities of dried sera
in the shortest possible time.
One must also mention another serum preparation, the antimeasles gamma
globulin. This preparation, although it has been thoroughly introduced into
practical use, is applied for the prophylaxis of measles but not for the pro-
phylaxis of other infectious diseases (poliomyelitis, hepatitis, and dysentery)
because it is produced in only limited quantities. The production of gamma
globulin should be greatly expanded by using placental blood and also placenta,
by applying more efficient equipment in its production, and by organizing its
production at a number of additional institutes.
Among vaccine preparations, the vaccines against intestinal infections
should be mentioned first. At present, the institutes supply both corpuscular
and chemical typhoid-paratyphoid-dysentery vaccines. The method of culturing
in depth (i.e., the method of submerged culture] has been firmly introduced into
the technology of their production. However, the use of this method is not
assured by the availability of sufficiently effective equipment provided with
an automatic air supply, recording instruments, etc.
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The production of vaccines effective against intestinal diseases depends on
the solution of a number of special problems, among which are the selection of
the most highly immunogenic strains, a type of treatment which has the least harm-
ful effect on bacterial suspensions (replacement of formalin with Merthiolate),
and development of methods for the standard laboratory testing of the quality of
vaccine preparations. One must especially emphasize the necessity of the rapid
introduction into production of a method of treatment with alcohol which has been
developed by the Moscow Institute of Epidemiology, Microbiology, and Hygiene in
connection with the production of therapeuty dysenteria vaccine.
In th of ular va for the Intestinal
infections, thedinstitutescareufac d withcthesfollowingptas s: morefconcentrated
work on strains, the replacement of formalin with a milder preservative, and
further perfection of the equipment and technology applied in connection with
culturing in depth.
The production of a chemical vaccine (the NIISI polyvaccine) has been com-
pletely developed by the Moscow Institute imeni I. I. Mechnikov. However, the
quality of this preparation has been criticized for the low effectiveness of
individual components and the high tendency of the vaccine to produce reactions.
The institute must exert every effort to improve this preparation as soon as
possible.
It is urgent that associated vaccines against infectious diseases be devel-
oped which will be effective after a minimum number of injections (one, or in
an extreme case, two injections).
Bacteriophage, particularly dysentery bacteriophage, used to be important.
During the past few years, however, this preparation has not been produced by
the institutes of vaccines and serums because its quality did not satisfy the
organs of public health. However, experimental data are now available which
testify to the possibility of improving the bacteriophage uy special selection
and adaptation to definite strains. It is expedient, therefore, to summarize
the results of the experimental investigations on the subject and settle the
question of the possibility of producing highly effective bacteriophages against
the causative factors of intestinal diseases and possibly against the causative
factors of other infections (e.g., pyophages and wound (infection) phages).
In virus infections, particular at-_;ntion has been paid by investigators
during recent years to influenza, encephalitis, poliomyelitis, infectious
hepatitis, hemmorhagic fever, etc. Numerous investigations have resulted in
the development of a number of prophylactic preparations which have now been
introduced into practical public health work. Among these are the live in-
fluenza vaccine, dry antiinfluenza serum, a vaccine against spring and autumn
encephalitis, and a vaccine against acute encephalomyelitis and multiple
sclerosis. However, all of these preparations are being produced in inadequate
quantities as yet and require further improvement.
One of the old vaccines against virus infections, i.e., antirabies vaccine
deserves particular attention. This vaccine is produced in large quantities
not only by the institutes of vaccines and se-- and the institutes of epidemiology,
microbiology, and hygiene but also by sanitary-epidemiological stations.
This vaccine has one substantial drawback: its useful life is brief, so
that planned supplying with this preparation is difficult. During the past 2-3
years, a number of institutes have successfully developed methods for the pro-
duction of a dry antirabies vaccine. However, this preparation has not yet been
introduced into production. This problem must be solved quickly.
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Live vaccines developed by Soviet scientists are used in the prophylaxis
of particularly da?gerous ir'ectiuns. It is necessary to develop the production
of these vaccines at several institutes.
The problem of the quality of the anatoxins being supplied by the insti-
tutes of vaccines and sera must also be considered. Antiepidemic practice indi-
cates. that the diphtheria antitoxin is not sufficiently effective. Some investi-
gators feel the reason for its inadequate effectiveness lies in shortcomings
connected with the methods of inoculation, while others accuse the preparation.
This imposes on the institutes a number of problems the solution of which would
establish the reasons for the inadequate effectiveness of antidiphtheria inocu-
lations and make possible the improvement of the quality of the diphtheria ana-
toxin. Work on these problems should comprise the selection of new strains, the
development of optimal nutrient media, and the introduction of the use of puri-
fied and adsorbed preparations. Purified adsorbed preparations have been de-
veloped by the Institute of Epidemiology and Microbiology imeni N. F. Gamaleya,
Academy of Medical Sciences USSR. Although they are supplied for use on a mass
scale, they have not yet been applied extensively in practice.
Everything that has been said in regard to purified and adsorbed preparations
applies to tetanus anatoxin, which should be supplied only in a purified and con-
centrated state.
It has been mentioned above that the institutes produce more than 100 kinds
of diagnostic preparations. At some institutes both sera and diagnostic pre-
parations are produced in the dry state. It is obvious that the quality of
diagnostic preparations depends on the quality of the initial bacterial cultures.
The unsatisfactory state of the permanent collections for the storage of cultures
has been adequately described above. It is only necessary to add that the sera
and diagnostic preparations must be supplied in complete assortments and that
they should be accompanied by clear instructions as to their use.
In summary therefore, in the production of bacterial preparations, the
following measures are essential as far as the future development of the insti-
tutes of vaccines and sera is concerned: First and most important is the re-
inforcement of the material and technological basis of the institutes. Second
is the organization of an expedient use of technology; for this purpose
special experimental and technical laboratories must be organized at the insti-
tutes, and highly qualified specialists must be provided. Third is the creation
of a central collection of live cultures and organization of the industrial pro-
duction of nutrient media and spacial laboratory Glassware.
In an evaluation of the activity of institutes which produce microbiological
preparations, it can be concluded that the institutes have carried out extensive
work on the development and introduction into practical use of new therapeutic
and prophylactic preparations and also of new technical methods which have made
it possible to improve the quality of these preparations and to increase their
quantity considerably. There is every reason to believe that the institutes of
vaccines and sera in their future work will supply the country with still more
perfect preparations and in doing so will contribute to the rapid elimination of
infectious diseases.
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