BELGIAN CONSENSUS MEETING on TRAVEL MEDICINE May 31, 2013

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1 BELGIAN CONSENSUS MEETING on TRAVEL MEDICINE May 31, 2013 Belgian Scientific Study Group on Travel Medicine PART 1a yellow fever version Pr. A. Van Gompel (ITG) Pr. F. Jacobs (Hôp. Erasme, ULB) Pr. P. Lacor (UZ-Brussel) Dr. Ph. Leonard (CHU-ULg) Pr. W. Peetermans (U.Z. - K.U.Leuven) Pr. S. Callens(UZ.- U.Gent) Dr. S.Quoilin (iph.fgov.be) Dr.P. Soentjens (Belgian Defence) Pr. B. Vandercam (CHU. St. Luc, UCL) Pr. Y. Van Laethem (CHU. St. Pierre, ULB)

2 2013 REPORT BELGIAN CONSENSUS MEETING on TRAVEL MEDICINE May 31, 2013 PART 1a The consensus meeting was chaired by A. Van Gompel Secretary of the meeting was Y, Van Laethem A preliminary PowerPoint, prepared by A. Van Gompel, was presented The discussion and recommendations of the meeting are included in this finale presentation. The ESSENTIAL SLIDES (pdf-version) & the CONSENSUS BROCHURE (in Dutch and French) highlighting the proposals for changes will been sent to all participants. May be used for teaching. These documents will serve as a proposal for approval by the governmental Belgian Health Council section Vaccinations, on Responsable final redaction : A. Van Gompel

3 2013 Not an exhaustive review of travel medicine What has changed Tips Answers to questions, asked in the last months All slides of the consensus document, as well as the hand-outs will be available on the website of the ITM, and may be used for teaching purposes

4 2013

5 2010

6 2013

7 2013

8 2013 Local Organizing Committee (LOC) and Regional Advisory Committee (RAC) CISTM 2013 Maastricht The Netherlands Chair: Gerard JB Sonder MD PhD director National Coordination Center for Travelers Health Advice LCR Amsterdam For Belgium: Alfons Van Gompel MD Antwerpen (Instituut voor Tropische Geneeskunde ITG Antwerpen) Steven Callens MD PhD Gent (Universitair Ziekenhuis-Universiteit Gent UZ.- U.Gent) Yves Van Laethem MD Brussel (Hôpital Staint- Pierre, Université Libre de Bruxelles ULB) Philippe Leonard MD Luik (Centre Hospitalier Universitaire- Université de Liège CHU-ULg)

9 2013 PDF s of the lectures are available on the website of the ISTM for the ISTM members (ISTM has 65 Belgian members) and probably also non-members embers/memberactivities/meeting s/congresses/cistm13/materials.a spx

10 2013 Additional sources for the update the 2012 edition of International Travel and Health (WHO) the 2014 edition of Health Information for International Travel (CDC) The discussion forum of the International Society for Travel Medicine International literature The updated edition of Medasso, edited by A. Van Gompel and the staff of the medical service of the Institute for Tropical Medicine Antwerp, is also recommended as a valuable source of information. ellowbook.aspx

11 COUNTRY LISTV LISTE PAR PAYS Only these chapter are freely downloadable

12 Not every advice is applicable to / acceptable in the European situation many maps are not nuanced enough (e,g, schisto-map; malaria country-maps) 2013

13 Gebruik geen verouderde versies, daar ze onbruikbaar zijn geworden en check steeds de meest recente electronische versie! Les éditions imprimées anciennes sont dépassées et donc inutilisables! Consultez toujours la version électronique la plus récente.

14

15 2013 PART 1 1.a - Vaccination for Yellow Fever 1.b - Malaria PART 2 2.A - Other vaccinations 2.B - TD, other infections,., 2.C - VARIA

16 Yellow Fever

17 WHO - Yellow Fever Vaccination WER SAGE WER POSITION PAPER WER AFRICA LATIN AMERICA

18 WHO - Yellow Fever Vaccination 1. LIFELONG IMMUNITY 2. MEASLES VACCINATION 3. PREGNANCY & BREASTFEEDING 4. IMMUNODEPRESSION YOUNG & OLD AGE

19 WER SAGE YELLOW FEVER VACCINATION induces LIFELONG PROTECTION

20 SAGE New WHO recommendations??

21 specific risk groups could possibly benefit from a second primary or booster dose such as infants (below 2 years?) or HIV-infected patients other (not-severely) immunosuppressed patients? pregnant women? children who got MMR and YF vaccine within less than 30 days? Immunoscenescence? 2013

22 POSITION PAPER

23

24 New WHO recommendations CISTM 13 Gilles Poumerol, WHO, Switzerland Monday, 20 May at the CISTM-13 Maastricht The Brussels Room, Level 0, Room 0.4 Special Update: Highlights from the New Editions, WHO and CDC

25 New WHO recommendations CISTM 13 No changes to the provisions for the duration of validity of the yellow fever vaccination certificate under the international Health Regulations WHO will discuss with the countries how to best proceed Countries have discretion to implement the certificate procedure WHO will stimulate individual countries to take into account this scientific advice Changes in the implementation by countries will take time Prevailing requirements will continue

26 How to cope with the new scientific WHO/SAGE guideline versus the yet unchanged International Health Regulation? Scientific 2013 WHO advice: If no immune problems exist, the immunity is considered lifelong Somebody who will be vaccinated today, canbetold the vaccination is valid at least for 10 years probably lifelong Swiss (BOFSP ) : Il est recommandé de ne plus indiquer la date d expiration mais seulement celle du début de validité (10 jours à compter de la date de vaccination) this position is endorsed by the Belgian Scientific Studygroup on Travel Medicine specific risk groups could possibly benefit from a second primary or booster dose such as infants (below 2 years?) HIV-infected patients QUID other (not-severely) immunosuppressed patients? pregnant women? children who got MMR and YF vaccine within less than 30 days? Immunoscenescence?

27 on the one hand the situation may now become more simple For countries with risk of yellow fever transmission not requiring proof of vaccination: one vaccination is valid for life For persons with an actual absolute or relative contra-indication, but formerly vaccinated against yellow fever before becoming immune-depressed, the immunity is supposedly also longstanding possibly for life

28 on the other hand the situation may now become temporarily also more complex At this moment many countries (with or without risk of YF transmission) still require a renewed proof of vaccination after 10 years if a person plans to cross the border(or in transit) from one country with (a real or supposed) risk for YF transmission to another country she/he will then need an up-to-date Certificate that traveler may think to be in order immunologically, but not politically or legally or administratively No waiver can be delivered but for proper medical reasons (absolute or relative contra-indication)

29 L Office fédéral de la santé publique, le Comité d experts en médecine des voyages et la Commission fédérale pour les vaccinations après examen attentif des documents mis à disposition ont adapté la recommandation de la manière suivante : 1. Une vaccination de rappel contre la fièvre jaune n est désormais plus recommandée aux voyageurs qui se rendent dans une zone d endémie dans laquelle aucun certificat de vaccination contre la fièvre jaune n est exigé. 2. Lors de voyage dans les pays avec certificat de vaccination obligatoire, la pratique vaccinale appliquée jusqu ici reste pour l instant inchangée. Un rappel tous les 10 ans doit être effectué. L abandon des rappels tous les 10 ans ne s appliquera qu au fur et à mesure que les pays concernés auront intégré cette modification à leurs exigences de vaccination antiamarile. 3. Toute vaccination contre la fièvre jaune (1e dose ou rappel) doit être inscrite dans le certificat international. Il est recommandé de ne plus indiquer la date d expiration mais seulement celle du début de validité (10 jours à compter de la date de vaccination). Le SAGE a par ailleurs demandé à l OMS de revoir les dispositions relatives à la période de validité des certificats internationaux de vaccination antiamarile dans le règlement sanitaire international (RSI) 2005.

30 2013 The wording needs to be changed (in the fall of 2013)

31 Swiss example :

32 WHO - Yellow Fever Vaccination MEASLES VACCINATION

33 SAGE

34 SAGE

35 POSITION PAPER

36 POSITION PAPER

37

38 Combination of life-attenuated vaccines 2012

39 Vaccine 1998

40 Vaccine

41 2011 Combination of YF-vaccine and MMRvaccine Administration of two life-attenuated vaccines can be done simultaneously without relevant influence on immunogenicity. For measles and varicella the doses, when not given simultaneously, must be separated by 30 days because of the interferon production induced by the first vaccine shot. This is not so for the combination of measles and yellow fever vaccination. CDC says that any interval can be used if yellow fever vaccination is indicated, irrespective when measles vaccine was given previously.. Studies are actually ongoing that might change this advice :

42 combination of measles and yellow fever vaccination 2011 Subjects injected YFV and MMR simultaneously had lower seroconversion rates 90% for rubella, 70% for yellow fever and 61% for mumps compared with those vaccinated 30 days apart 97% for rubella, 87% for yellow fever and 71% for mumps. Seroconversion rates for measles were higher than 98% in both comparison groups. Geometric mean titers for rubella and for yellow fever were approximately three times higher among those who got the vaccines 30 days apart. For measles and mumps antibodies GMTs were similar across groups.

43 combination of measles and yellow fever vaccination 2011 MMR s interference in immune response of YFV and YFV s interference in immune response of rubella and mumps components of MMR had never been reported before but are consistent with previous observations from other live vaccines. These results may affect the recommendations regarding primary vaccination with yellow fever vaccine and MMR.

44 combination of measles and yellow fever vaccination 2011 These conclusions apply to primary vaccination in children less than two years old. As primary vaccination against yellow fever in older children and adults, and a booster dose at any age induce stronger immune response, interference from other live virus vaccines should be less pronounced and possibly irrelevant.

45 CDC 2014 Simultaneous Administration of Other Vaccines and Drugs ACIP recommends that yellow fever vaccine be given at the same time as other live-virus vaccines. Otherwise, the clinician should wait 30 days between vaccinations, as the immune response to one live-virus vaccine might be impaired if administered within 30 days of another live-virus vaccine. A recent study involving the simultaneous administration of yellow fever and measles-mumps-rubella (MMR) vaccines in children found a decrease in the immune response against yellow fever, mumps, and rubella when the vaccines were given on the same day versus 30 days apart. Additional studies are needed to confirm these findings, but they suggest that if possible, yellow fever and MMR should be given 30 days apart.

46 WHO - Yellow Fever Vaccination PREGNANCY & BREASTFEEDING

47 SAGE

48 SAGE

49 3 cases of benign self-limiting meningoencephalitis because of transmission of vaccine strain of yellow fever virus to an infant via breast milk have been published 1 Kuhn S, Twele-Montecinos L, MacDonald J, Webster P, Law B. Case report: probable transmission of vaccine strain of yellow fever virus to an infant via breast milk. CMAJ. 2011;183(4):E Epub 2011/02/ Transmission of yellow fever vaccine virus through breastfeeding - Brazil, MMWR Morb Mortal Wkly Rep. 2010;59(5): Epub 2010/02/ Traiber C, Coelho-Amaral P, Ritter VR, Winge A. Infant meningoencephalitis caused by yellow fever vaccine virus transmitted via breastmilk. J Pediatr (Rio J). 2011;87(3): Epub 2011/04/05.

50 POSITION PAPER

51 POSITION PAPER

52 Relapsing remitting MS 2012

53 WHO - Yellow Fever Vaccination IMMUNODEPRESSION YOUNG & OLD AGE

54 SAGE

55 SAGE

56 POSITION PAPER

57 POSITION PAPER

58 POSITION PAPER

59 POSITION PAPER

60 Yellow Fever Vaccination and Relapsing & Remitting Multiple Sclerosis

61 Relapsing remitting MS??? 2012

62 CDC 2012 YF vacc & Multiple Sclerosis The Multiple Sclerosis Council for Clinical Practice Guidelines, published in 2001, contain the clinical practice guidance on Immunizations and Multiple Sclerosis. The expert panel that developed this guidance used CDC recommendations as their foundation. Updated comments are posted on the National Multiple Sclerosis Society website (www.nationalmssociety.org ). People with MS who are having a serious relapse (exacerbation) interfering with the activities of daily living should defer immunization until 4 6 weeks after onset of the relapse. Inactivated vaccines are generally considered safe for people with MS. Administration of tetanus, hepatitis B, or influenza vaccines does not appear to increase the shortterm risk of relapses in people with MS. However, published studies are lacking on the safety and efficacy of other vaccines (such as those against pneumonia, meningitis, typhoid, polio, hepatitis A, human papilloma virus, and pertussis). Inactivated vaccines are theoretically safe for people being treated with an interferon medication, glatiramer acetate, mitoxantrone, or natalizumab, although efficacy data are lacking. In the past, many practicing neurologists have strongly advised their MS patients against the use of live-virus vaccines at any time. Live-virus vaccines should not be given to people during therapy with immunosuppressants, such as mitoxantrone, azathioprine, methotrexate, or cyclophosphamide, or during chronic corticosteroid therapy. However, a few published studies suggest that measles, rubella, and varicella vaccines may be safe in people with MS if administered several weeks in advance of, or several weeks after, immunosuppressive therapy. Yellow fever vaccine should not be given unless there is a compelling reason to do so (such as unavoidable direct exposure) and there has been a consultation with the patient s neurologist. 2012

63 CDC 2014 YF vacc & Multiple Sclerosis Inactivated vaccines are generally considered safe for people with MS, although vaccination should be delayed during clinically significant relapses until patients have stabilized or begun to improve from the relapse, typically 4 6 weeks after it began. Administration of tetanus, hepatitis B, or influenza vaccines does not appear to increase the short-term risk of relapses in people with MS. However, published studies are lacking on the safety and efficacy of other vaccines (such as those against hepatitis A, human papilloma virus, meningitis, pertussis, pneumonia, polio, and typhoid). Inactivated vaccines are theoretically safe for people being treated with an interferon medication, glatiramer acetate, mitoxantrone, fingolimod, or natalizumab, although efficacy data are lacking. A few published studies suggest that measles, rubella, varicella, and zoster vaccines may be safe in people with stable MS if administered 1 month before starting or 1 month after discontinuing immunosuppressive therapy. Modern MS therapy includes aggressive and early immunomodulatory therapy for almost all MS patients, even those with stable disease. Live-virus vaccines should not be given to people with MS during therapy with immunosuppressants, such as mitoxantrone, azathioprine, methotrexate, or cyclophosphamide; during chronic corticosteroid therapy; or during therapy with the agents listed in Table However, patients on glatiramer acetate and interferons have more limited immune deficits. Yellow fever vaccine and smallpox vaccine have not been well studied in people with MS and should only be given if there is a compelling reason to do so (such as unavoidable direct exposure and the risks of potential adverse events are carefully weighed against the likelihood of exposure to these potentially fatal illnesses); these decisions should be made in consultation with the patient s neurologist. 2013

64 Useful literature ORIGINAL STUDY Yellow Fever Vaccination and Increased Relapse Rate in Travelers With Multiple Sclerosis. Farez & Correale. Arch Neurol. 2011;68(10): Online June 13, doi: /archneurol COMMENTS AND OPINIONS Methodological Issues With the Risk of Relapse Study in Patients With Multiple Sclerosis After Yellow Fever Vaccination. Pool & al. & REPLY Farez & Correale. Arch Neurol. 2012;69(1): REVIEW Vaccination against infection in patients with multiple sclerosis, Loebermann & al. Nat. Rev. Neurol. 8, (2012); online 24 January 2012, doi: /nrneurol SEP et vaccins : l'état des lieux, Mrejen & Papeix (département de Neurologie, hôpital de la Salpêtrière, Paris) Journal international de médecine 2012 Publié le 11/07/2012

65 Medasso Patiënten met Multipele Sclerose mogen ook gevaccineerd worden indien ze geen immuundeprimerende medicatie nemen in geval van de relapsing-remitting vorm moet er wel een afweging gemaakt worden: In 2011 werd een studie gepubliceerd (Archives of Neurology - Farez & Correale, 2011) over een kleine groep patiënten met relapsing-remitting Multipele Sclerose die gele koorts vaccinatie gekregen hadden er werd een significante stijging van relapse risico vastgesteld in de 6 weken na de vaccinatie, vergeleken met de twee jaar follow-up periode nadien. Hoewel het om een kleine niet-dubbel blinde studie gaat, met grote confidentie-intervallen, moet bij patiënten met MS die naar een gelekoortsgebied reizen het risico voor een relapse dus zorgvuldig afgewogen worden tegen het risico van blootstelling aan de potentieel dodelijke gele koorts. Voor details in verband met vaccinaties bij Multipele Sclerose zie ook search: 'vaccinations'.

66 Medasso Les patients atteints de sclérose en plaques peuvent également être vaccinés s ils ne prennent pas de médication immunosuppressive en cas de type à rechutes et rémissions il faut peser le pour et le contre : en 2011, une étude a été publiée (Archives of Neurology - Farez & Correale, 2011) sur un petit groupe de patients avec une sclérose de type à et rechutes et rémissions ayant reçu une vaccination contre la fièvre jaune et on a constaté une augmentation significative du risque de rechute pendant les 6 semaines après la vaccination, comparé avec la période de suivi de deux ans de suivi ultérieure ensuite. Même s il ne s agit que d une petite étude, non en double aveugle, avec de grands écarts d intervalles de confiance, il faut soigneusement peser le pour et le contre du risque de rechute comparé au risque d exposition à la fièvre jaune potentiellement mortelle pour les patients avec SEP qui se rendent dans une un pays endémique de fièvre jaune. Pour de plus amples détails en matière de vaccinations dans la sclérose en plaques, voir également search: 'vaccinations'.

67 In the 2012 National consensus report was said : There is a relative contraindication / precaution for using live-virus vaccines in patients with an exacerbation of relapsing remitting multiple sclerosis. This will be for 2013 changed in to : In a limited and contested study of YF vaccination in clinical relapsing remitting MS the risk of relapse within 3 months after YF vaccination was significantly increased. Therefore YF vaccination is generally contraindicated (= relative contraindication / precaution), although the risk of relapse due to vaccination should always be weighed against de risk of acquiring a letal travel related infection.

68 CDC YF vacc & Multiple Sclerosis MS en gele koortsvaccinatie zie mailverkeer met Paul De Munter & travelmed april

69 Some former slides on Yellow Fever Vaccination

70

71 For Details See = strongly recommended or even obligatory See

72 For Details See = strongly recommended or even obligatory See

73 2011

74 2011 The Belgian group (as well as The Netherlands) reformulates this advice as follows: low risk area, but yellow fever vaccination is recommended unless there is a (relative) contra-indication for vaccination.

75 = CHANGED IN : 2011 (1) Het blootstellingsrisicio voor gele (1) Le risque d'exposition au virus de la koorts virus is in deze gebieden laag fièvre jaune dans ces régions est bas à tot zeer laag. Gele koorts vaccinatie très bas. La vaccination contre la fièvre wordt aangeraden op voorwaarde dat jaune est recommandée à condition que er geen (relatieve) medische le patient ne présente pas de contre- tegenindiciatie bestaat. Gele koorts indications (relatives) à la vaccination. vaccinatie is zeker aanbevolen voor La vaccination contre la fièvre jaune est reizigers die een verhoogd certainement recommandée chez les blootstellingsrisico hebben met het gele voyageurs qui sont à risque accru koorts virus (bijvoorbeeld lang verblijf, d'exposition au virus de la fièvre jaune verhoogde blootstelling aan muggen (par exemple un voyage prolongé, une overdag, onvermijdbare exposition importante à des moustiques muggensteken). pendant la journée, l'incapacité à éviter Bij het overwegen van de gele koorts les piqûres de moustiques). vaccinatie moet bij elke reiziger het Lorsque l'on considère la vaccination, il blootstellingsrisico met het gele koorts faut prendre en compte chez chaque virus, de vereisten van het voyageur le risque d'exposition au virus desbetreffende land, de mogelijke de la fièvre jaune, les exigences en toekomstige reizen naar gele koorts matières vaccinales du pays visité, les gebieden en de individuele éventuels futurs voyages dans des zones risicofactoren afgewogen worden à risque, ainsi que les facteurs de risque tegenover de zeer zeldzame ernstige individuels (par ex. âge, neveneffecten bij een primovaccinatie. immunosuppression) de réactions Dit kan steeds besproken worden in sévères très rarement associées à la het gespecialiseerde primo-vaccination. vaccinatiecentrum. Ceci est à discuter au sein du centre de vaccination.

76 2008

77 yellow fever certificate : waiver / exemption If a waiver has to be declared, it must be specified that the waiver is given for a limited period of time. The proposed statement says yellow fever vaccination temporarily not indicated. It seems wise to give an explanatory letter to the patient who then must decide to whom this letter is given in order to explain the medical reason for the yellow fever vaccination waiver (CDC 2008) No need for children less than 6 mo 12 mo (according to guidelines per country)

78 yellow fever certificate : waiver / exemption indication of time period

79 yellow fever certificate : waiver / exemption WHO 2008 WHO : no need to specify diagnosis Travellers who possess an exemption from yellow fever vaccination, signed by an authorized medical officer or an authorized health worker, may nevertheless be allowed entry, subject to the provisions of the foregoing paragraph of this Annex and to being provided with information regarding protection from yellow fever vectors. Should the travellers not be quarantined, they may be required to report any feverish or other symptoms to the competent authority and be placed under surveillance. Les voyageurs en possession d un certificat d exemption de vaccination antiamarile signé par un médecin autorisé ou un agent de santé agréé peuvent néanmoins être autorisés à entrer sur le territoire, sous réserve des dispositions de l alinéa précédent de la présente annexe et pour autant qu ils aient reçu des informations sur la protection contre les vecteurs de la fièvre jaune. Les voyageurs qui n ont pas été mis en quarantaine peuvent être tenus de signaler tout symptôme fébrile ou tout autre symptôme pertinent à l autorité compétente et placés sous surveillance. IHR 2005

80 CDC CDC model Waiver Letter from Physicians contains the diagnosis A physician s letter clearly stating the contraindications to vaccination is acceptable to some governments. Ideally, it should be written on letterhead stationery and bear the stamp used by health department and official immunization centers to validate the ICVP. Under these conditions, it is also useful for the traveler to obtain specific and authoritative advice from the embassy or consulate of the country or countries he or she plans to visit. Waivers of requirements obtained from embassies or consulates should be documented by appropriate letters and retained for presentation with the completed Medical Contraindication to Vaccination section of the ICVP

81 Transit in aeroport 2011 In principle yellow fever vaccination is not required if the traveler stays in the transit zone of the airport for maximum 12 hours with an entry and exit record of the same day. Some countries require vaccination certificate for any transit in an endemic country, irrespective of the duration (e.g. South Africa uses any transit time). The recommendation must also take into consideration that flight itineraries can change unannounced (e.g. stopover in Ethiopia or Senegal). Changes?

82 Belgian cases?? 2012

83 risk assesment 2010!! PRIMOVACCINATION!! the risk of a serious side effect due to vaccination (varying from 0, 00 to 4 / depending on age) is on average lower than The risk of death caused by Yellow Fever in an endemic area (varying from 20 to 1600 / per month)

84 End Yellow Fever

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