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Symposia Series in Immunobiological Standardization Vol. 22 International Association of Biological Standardization

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Symposia Series in Immunobiological Standardization Vol. 22 International Association of Biological Standardization Symposia Series in Immunobiological Standardization Vol. 22 International Association of Biological Standardization Symposia Series in Immunobiological Standardization Vol. 22 Edited by the International Association of Biological Standardization INTERNATIONAL SYMPOSIUM ON VACCINATION AGAINST COMMUNICABLE DISEASES Proceedings of the 45th Symposium Organized by the International Association of Biological Standardization and held at the International Convention Centre, Monaco i4-i 7 March i973 ACTING EDITOR F. T. P E R K I N S (London) Distributed by S. KARGER BASEL MUENCHEN PARIS LONDON NEW YORK SIDNEY ORGANIZATION OF THE SYMPOSIUM Scientific programme Dr F. T. Perkins National Institute for Biological Standards and Control, London Professor W. Hennessen Behringwerke AG, Marburg, West Germany Local arrangements Mr H. C. C. Wagner Merck Sharp and Dohme International, Haarlem, The Netherlands Sessions held: I Introduction II Established vaccines for regular programmes _%/_ IXIII; VaccinesNewer vaccinesfor limited use _ _'i/' 7"J_2_' _(/_ V Production and presentation / / VI Quality control /, ,, ; ..... VII Immunization schedules VIII Safety: risks and responsibilities / _/-/_/x_ IX Field trials X Organization and execution of programmes A 'code of conduct' for clinical trials NATIONAL LIS, ARYOFMEDICIlYE BETHESDA,]]ARYLAt D20014 All rights, including that of translation into other languages, reserved. Photomeehanical reproduction (photocopy, microcopy) of this book or parts thereof without special permission of the Organization is prohibited. © Copyright x973 by the IABS Printed in Great Britain by the University Printing House, Cambridge CONTENTS Foreword page ix Opening Address by F. T. P Ea _:IN S xi Opening Address (French) by Prof. A. LAFONTAINE xiii SESSION I. INTRODUCTION Objectives of the Symposium W.C. COCKBURN 3 SESSION II. ESTABLISHED VACCINES FOR REGULAR PROGRAMMES Achievements in Europe A.H. GRIFFITH ( 13 Adaptation du calendrier de la vaccination BCG en Hongrie, pays avec 6conomie interm6diaire et epid6miologie de tuberculose dissoci6e L. LUGOSI 25 Efficacit6 de la vaccination syst6matique par Ie BCG en Hongrie depuis .... 1959. Analyse cofits/avantages L. LUGOSI 31 General discussion 35 Cost benefit analysis D.J. SENCER AND N. W. AXNICK 37 Discussion of cost benefit analysis W. SCHUMACHER 47 General discussion 49 SESSION III. NEWER VACCINES Newer vaccines (measles, mumps, rubella): potential and problems S. KRUGMAN !,'55.. Discussion of newer vaccines H.M. MEYER, JR "65 General discussion 68 SESSION IV. VACCINES FOR LIMITED USE Influenza vaccines and the role of the WHO in influenza surveillance G. C. SCHILD _--75 Smallpox and smallpox vaccine D.A. HENDERSON _5j; General discussion 95 SESSION V. PRODUCTION AND PRESENTATION Manufacture, distribution and handling of vaccines W. HENNESSEN IOI The safety and efficacy of emulsified peanut oil adjuvant 65 when applied to influenza virus vaccine M.R. HILLEMAN, A. F. WOODHOUR, A. FRIEDMAN AND R. E. WEIBEL 107 • Mineral carriers as adjuvants I. Jo6 I23 Iv] vi CONTENTS General discussion page 13 I Combined inactivated vaccines H. C o H EN, B. H o v MAN, R. B ROIJW ER, A. L. VAN WEZEL AND CH. A. HANNIK 133 Discussion on combined inactivated vaccines I. J o 6 I43 General discussion 144 Immune responses and duration of immunity following combined live virus vaccines M.R. HILLEMAN, E.B. BUYNAK, R.E. WEIBEL AND V. M. VILLAREJOS _i45 " General discussion 159 Simultaneous administration of live or killed vaccines J.J. WITTE I63 General discussion 172 SESSION VI. QUALITY CONTROL Safety testing of vaccines F.T. PERK INS I77 Quality control I. Jo6 I83 Contr61e des unit6s vivantes du BCG L. LuGosI i85 General discussion 191 SESSION VII. IMMUNIZATION SCHEDULES Immunization schedules J. W, G. SMITH 199 Etudes sur les vaccinations en Afrique E. H, RELYVELD, C. GATEFF, L. CHAMBON, N. GUERIN, M. CHARPIN ET COLLABORATEURS 215 Vaccination programmes in Belgium A. LAFONTAINE 223 The immunization programme in Bulgaria and its efficiency S. RANGELOVA 227 Vaccination against communicable diseases in Cyprus V.P. VASSI- LOPOULOS 231 The Danish immunization programme C.J. SIEVERS 235 Vaccination programmes in Finland: administrative aspects L. NORO 239 Les programmes de vaccinations en France F.M. LEVY, COLETTE FILLASTRE ET R. MANDE 249 Vaccination programmes in Iceland P. SIGUR_SSON 263 Mass vaccinations in the Netherlands H. BIJKERK 271 Immunization schedules in Spain L. VALENClANO 277 Vaccination programmes in Sweden H. LUNDBECK 279 Les vaccinations en Suisse C. FLEURY 287 Rubella immunisations in Switzerland M. JUST AND W. H. HITZI_ 291 Vaccmation programme in Yugoslavia D. JAKOVLJEVIC 295 La vaccination en Monaco J.-P. B us 299 The programme of vaccination against communicable diseases in Greece M. VIOLAKI 3Ol Compulsory vaccinations in Hungary L. ERD6S 3O5 General discussion 31o CONTENTS vii SESSION VIII. SAFETY: RISKS AND RESPONSIBILITIES Compensation for injuries possibly related to immunization P. YON MAGNUS page 325 Contribution to discussion P.B. STONES 331 Contribution to discussion I. Jo6 333 Vaccination against poliomyelitis: vaccine-associated cases O. L AH ELL E 335 Contribution to discussion W. SCHUMACHER 337 General discussion 339 SESSION IX. FIELD TRIALS The field trial of vaccines A. BRADFORD HILL 345 Some aspects of vaccine assessments in England T.M. P o LL o c K 353 Note on vaccination in the Netherlands B. HOFMAN 357 Field trials D.J. SENCER 36I General discussion 362 SESSION X. ORGANIZATION AND EXECUTION OF PROGRAMMES Organisation and execution of vaccination programmes G. CUST 367 General discussion 377 Summary and Conclusions 383 A 'code of conduct' for clinical trials 392 Author index 394 List of participants 395 IABS information 403 FOREWORD During the last seventeen years our International Association of Biological Standardization (formerly known as the Permanent Section of Microbiological Standardization of the International Association of Microbiological Societies) has been concern.ed with the technical developments in the manufacture and control of vaccines. When the suggestion was made that we should now con- sider every facet concerning immunization of large communities against com- municable diseases we were eager to take up the challenge. The results of our formal presentations and discussions are recorded in this book. The success of the Symposium was largely due to the way in which the par- ticipants came from so many countries, mainly in Europe, willing to discuss their mutual problems. In particular it was unique in bringing together so many experts from Government Health Departments with those responsible for the production and testing of vaccines. Although it was not possible to arrive at a common immunization schedule, since each community must take into consider- ation local difficulties, we nevertheless left with a greater understanding of the part played by different conditions;. It was possible to bring together so many scientists because of the tremendous efforts of Mr H. C. C. Wagner, who obtained such generous financial support from Merck Sharp & Dohme International and we are most grateful to them for this. His tireless vigilance in making all the arrangements for our travel and comfort during the meeting are greatly appreci- ated. I feel sure that Mr Wagner would wish me to acknowledge the great help he received from his secretary Miss Muller in these arrangements. The scientific programme was helped very much by Miss Bond and Mrs Johnson, whose assis- tance I am pleased to acknowledge. This symposium was indeed a new venture for our International Association and the participants felt that it had been a great success. I hope that the record of our meeting will be accepted with the same enthusiasm. F. T. PERKINS [ ix] OPENING ADDRESS Your Serene Highness Princess Grace, Ladies and Gentlemen, The International Association of Biological Standardization has held some 45 Symposia and i z Congresses but never before have we had the privilege of opening one of our Symposia in the presence of a Princess. Not only are we delighted to be able to do so on this occasion, but to have a most beautiful Princess with us is indeed a real pleasure. As our title suggests, our International Association is concerned with the standardization of biological substances and it is understandable, therefore, that the majority of our meetings are concerned with the scientific disciplines leading towards the standardization of prophylactics against infectious diseases. On this occasion, however, we felt the need to bring together the scientists who produce and control vaccines with those responsible for their use. Accordingly, we have a number of scientists with us today who may not be familiar with the work of our Association and we are very happy that they have found the time to come and join in our discussions during the next three days. In Europe 23 Mini- sters of Health or their representatives were invited to attend and no fewer than 19 are present, I8 of whom are to talk to us about the immunization schedules that they apply in their own particular country. In all there are 29 countries represented at our meeting and in these countries there is a gross population of some 738 millions with an annual birth rate of just over i i millions, the average rate being 17. 5 births per thousand. Our discus- sions, therefore, will concern no less than one fifth of the total population of the world. It is interesting to note that we are meeting in one of the smallest countries in Europe with a population of no more than 23 thousand, who bring into the world 2I 4 babies a year. With a birth rate as low as 9.2 per thousand, it is clearly a privilege to live and to be born in Monaco - quality is often con- tained in small packages. We have a serious duty to perform, therefore, in dis- cussing our common problems concerned with the immunization of our total population against infectious diseases and I feel sure that we shall return to our various countries much the wiser having benefited from our exchange of ideas.
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