Development of Immunisation in Germany Strategy and Results with regard to reduction of vaccine preventable diseases in infants and pre-school children W.Singendonk, St.Petersburg Dez. 2012

„Vaccinations, especially vaccinations during childhood, have led to a larger improvement in public health than every other medical intervention in this and the last century, including antibiotics. We have the possibility to eradicate vaccine preventable diseases.“ Quoted from Prof. Pierre Van Damme

„No other intervention has the potential to save as much money while producing the same health benefits.“ Quoted from Prof. H.-J. Schmitt

3

Development of Immunisation in Germany 1807: Smallpox vaccination in Bavaria 1835: Smallpox vaccination obligatory at outbreak 1874: German Imperial Vaccination Law (Reichsimpfgesetz) : vaccination obligatory for smallpox at 2 yrs.and 12 yrs. of age until 1976 1883: Commission of specialists for medical advice to the Reichs Public Health Office 1935: Physician led public health offices: vaccinators, vaccination lists, vaccination reports

Development of Immunisation in Germany GDR responsible State Health Institutions

FRG responsible Federal states

compulsory vaccinations

since 1961 voluntary vaccinations

Public health services

Public health services, since 1980 office-based physicians

Protection Against Infection Act IfSG 01.01.2001

§ 3 Prevention through education Providing the general public with information and education about the risks of communicable diseases and the possibilities of preventing them is a public function. In particular the authorities responsible under federal state law have to provide information about possibilities for community and individual protection against infection as well as about counselling, care and treatment services.

Protection Against Infection Act IfSG 01.01.2001 §20 (2) A Standing Vaccination Commission (STIKO) shall be established at the Robert Koch Institute. The Commission issues conducted… recommendations on how vaccinations should be conducted…and develops criteria for the distinction between a normal postvaccinal reaction and a health impairment the degree of which exceeds that of a normal post-vaccinal reaction. (4) The ordinance can also incorporate regulations on the recording and transmission of anonymised data about vaccinations performed. (6) The Federal Ministry for Health shall be empowered to determine … that those segments of the population which are at risk have to undergo the vaccination. The basic constitutional right to physical integrity (artical 2, paragraph 2, sentence 1 of the basic law) can be restricted in this respect.

1.Localized and General Reactions 2.Complications diseases and symptoms timely associated with a vaccination are decribed on the basis of currently available knowledge which provides strong evidence for a causal relationship; in these cases the risk is specifically related to the vaccination, e.g.post-vaccine anaphylaxis or neuritis following a tetanus vaccination.

3.Disease / Symptoms with unresolved causal connection to the vaccination (single case reports)

4.Hypotheses, unproven statements, MMR-vaccination and autism / Crohn´s disease or Hib-vaccination and diabetes mellitus. Epid. Bulletin Nr. 25, 2007

Protection Against Infection Act IfSG 01.01.2001 § 6, 8, 11

Physician

Public health office

Pharmacist

vaccine manufacturers

STIKO Criteria for the Assessment of Vaccinations Standard operating procedures (SOP) of the German Standing Committee on Vaccination (STIKO) for the systematic development of vaccination recommendations passed on Nov. 10th 2011 version 1.0 from Jan. 24th.2012

EbM: evidence based medicine GRADE approach Grading of Recommendations, Assessment, Development and Evaluation

PICO: Population; Intervention; Comparison; Outcome

STIKO Criteria for the Assessment of Vaccinations

1. 2. 3. 4. 5. 6.

Which vaccination goal(s) can and should be reached? How high is the morbidity of the target disease? What are the anticipated effects of recommending this vaccination programm to the population (mathematical models)? Are there licensed vaccines whose action seem appropriate for reaching the anticipated vaccination goal? Which additional positive effects can be expected aside from reaching the primary vaccination goal (herd immunity, elimination) ? Which side effects and security data are known?

STIKO Criteria for the Assessment of Vaccinations 7.

8. 9. 10. 11. 12. 13.

Which epidemiologically relevant effects may occur during the implementation of a vaccination recommendation? (age shift , escape mutants) Which vaccination coverage is necessary in order to reach the vaccination goal? What is the overall assessment? (epidemiological riskbenefit analysis) How should the vaccination recommendation be rated on grounds of health economics when compared to other measures? Is it possible to implement vaccination recommendations? What data needs to be recorded, in order to document the achievement of the vaccination goal? Can public interest be assumed concerning vaccination recommendations?

Vaccination categories Epidemiological significance Cost coverage S Standard vaccination for general application B Booster vaccinations I Indicated vaccinations for risk groups with a personally (not professionally) increased risk of exposure, illness or complications well as to protect third parties N missed vaccinations

as

O e.g.

Vaccinations due to an increased occupational/professional risk, after risk assessment in accordance with the Occupational safety and health act /Biological Agents Ordinance /Regulation concerning occupational health care and the „G 42“ screening as well as for hygiene reasons T

Travel vaccinations

P Post-exposure prophylaxis/ring vaccinations and other specific preventive measures (adminitration of immunoglobins or chemoprophylaxis) for contact persons in the family or community S primary immunisation B booster vaccination M missed vaccination

13

Vaccination Schedule 2012

Epidemiol. Bull. 30/2012

15

Development of Immunisation in Germany IfSG §20

Federal health reform law of 2007 What the doctor gets for vaccination

RKI

STIKO

Association of Statutory Health Insurance Physicians

statutory health insurrance GKV

Recommendation

RKI : STIKO Vaccination schedule published in Epidemiological Bulletin

RKI: transmission of the current recommendations to the federal states

G-BA federal joint committee: SI-directive of vaccination: obligation service of statutory health insurrance GKV

Aside from administering the vaccine, the vaccination service provided by the physician must include:

• Information on the disease to be prevented • Information on therapy options for the disease • Providing information on the benefits of the vaccination for the individual as well as for the general public • Information on the type of vaccine • Providing information on the administration of the vaccine • Information on the beginning and duration of the protective effect • Behavioural recommendations subsequent to the vaccination • Contraindications • Possible adverse effects and/or complications

Strategies for the Implementation of Vaccination Recommendations Preventive medical check-up U1 U2 U3 U4

postpartal 3. - 10. LT. 4. - 6.LW. 3. - 4.LM.

U5 U6

5. - 6.LM 10. - 12.LM

U7 U7a U8 U9

21. 33.43. 60. -

J1

13. - 14.LJ

24.LM 38.LM 48.LM 64.LM

Information on vaccinations 1. Vaccination Hexa Pneumo 2. Vaccination Hexa Pneumo 3. Vaccination Hexa Pneumo Meningo. 4. Vaccination Hexa Pneumo 1. Vaccination MMR-VAR 2. Vaccination MMR-VAR Screening for immunisation gaps Reminder of vaccinations Screening for immunisation gaps

Strategies for the Implementation of Vaccination Recommendations

Vaccination coverage at school-entryexaminations compared in 1999/2005/2010

Vaccination coverage 1. Booster vaccination 14-17 years of age Tetanus 39.3 % Diphtheria 37.5 % 2. Vaccination Measles Mumps Rubella

77.5 % 70.8 % 59.2 % KIGGS 2003-2006

Pertussis

elle: Epidemiologisches Bulletin, 31/2009

60

58 Gesundheitswesen

50

Kita Schule

40

39

Familie

30 l h a z n A

23

20 13 10

10 0

7

5 0 1 0 0

S

0 0 1

THUE

1 1 2

S-A

4 0 1

BRA

Bundesland Quelle: Epidemiologisches Bulletin 23/2005

5 1 2

M-V

2

Gesamt

Pertussis STIKO Recommendation 2010 I If the last 10 years there has been no pertussis vaccination: • women of childbearing age • persons in close household contact (parents, siblings) and caregivers (e.g. child minders, babysitters, where applicable grandparents) should receive 1 dose of pertussis vaccine if possible 4 weeks before the birth of the child If the mother was not vaccinated before conception she should preferably be vaccinated in the first days after the birth of the child S / B Adults should receive the next due Td vaccine as a TdaP combination vaccine.

N= 18.825 25 WHO Epidemiological brief

No. 26 (September 2012)

Measles 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011

5.968 4.664 777 121 780 2.281 554 915 572 772 1608

ESPED : SSPE 2003-2007 17 children 2006: 95 children treated in hospital 2 children encephalitis (died) Berlin 2011: 152 illnesses, almost 50% > 18 years of age

Total Berlin

2012: 2012:

153 16

EUVAC.NET und Epid..Bull. 42/2010 34/2011, 3/2012

Hepatitis B

Epidemiologisches Bulletin, 29/2011

Pneumococcus conjugated vaccine: (7vPCV + 1, 3, 5, 7F, 6A, 19A) 6A 1 6B

14 5

18c 23F 7F

4

19F 9V

19A

7-valent

3

Meningokokken

31

Meningococci

Trotter CL, EXP Rev Vac 8(7)851-861, 2009

Conjugated Vaccines Meningococci Conjugated vaccines Serogroup C at 2 months of age New conjugated vaccines against meningococci Menveo und Nimenrix Menveo Serogroup A , C, W135, Y > 12. yrs. CRM197

Nimenrix

Serogruppe A, C, W135, Y

> 2. yrs. > 12 months

TT

Vaccines against serogroup B is in clinical trial phase III, i.e. approval has been applied for (4CMenB) !!!

Rotavirus

Land Brandenburg; Landesamt für Gesundheit

Afghanistan 17 Nigeria 70 Pakistan 29 Indien 1 Chad 5 Total 121

35

Poliomyelitis 3

China

458

19 Todesfälle

Afghanistan

Quelle: WHO

Measles-Elimination Reasons for not being vaccinated given by parents of 272 measles patients NRW 2006 • forgot the vaccination 36.4 % • generally against vacc. 27.8 % • doctor against vacc. 16.8 % 22,8% • vacc. was not offered by doctor 6.0 % Wichmann,O et al , Bull World Health Organ 2009;87: 108-115

Development of Immunisation in Germany • Development and improvement of vaccines • Improvement of the surveillance of vaccine preventable diseases • Standards for vaccination goals • Ongoing education of physicians • Cooperation of public health services and officebased physicians

Development of Immunisation in Germany Anyone who stops improving has stopped being good Philip Rosenthal

Thank you for your attention