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Immunization Advisory Committees

FINAL REPORT

Prepared for the World Health Organization

By the Child Health Evaluation and Research (CHEAR) Unit Division of General Pediatrics, University of Michigan

Gary L. Freed, M.D., M.P.H., Director

Report Authors:

Gary L. Freed, MD, MPH Margie Andreae, MD Kara Switalski, MPH

Leah Abraham

August 2008

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I N T R O D U C T I O N Immunization Advisory Committees (IAC) are used by many nations to determine the specific vaccines recommended for use in a particular country. These committees generally bring together a panel of experts to access the wide spectrum of issues involved in the decision to recommend a vaccine. The charge of these committees may include additional responsibilities such as information dissemination, advocacy and oversight of immunization programs. Countries may also have a separate committee, called an Interagency Coordinating Committee (ICC). The goal of an ICC is to bring together domestic agencies and international donors/advisors to coordinate efficient and effective use of resources [1]. These are often separate and distinct from the technical Immunization Advisory Committees.

A recent study of IACs in 10 large industrialized nations in Western Europe revealed significant variation in the structure, function and authority of these committees [2]. The variation was often a function of the political, social and economic environment in which the committee and the specific government operated. Results demonstrated variation existed in a number of domains including composition of the committee, basis and process for decision-making, and authority of the committee. For example, some committees made decisions through member voting while others operated by consensus.

Many Member States in the EURO region are now developing their own IACs. As such, a broad understanding of the different models of such committees would be helpful in providing the options available to them. The findings from the 10 developed nations present only a limited view of the range of programs currently in place across the region. Further, many developed and developing countries will benefit from an exposure to the different methods employed by nations in this region. They can use such information to assess the structure of their own programs and consider options to improve their function.

The WHO has set goals to reduce the incidence of several vaccine preventable diseases across the EURO region. Of significant interest is the manner in which Member States approach recommendations regarding the hepatitis B and Haemophilus influenzae, type b (Hib) vaccines specifically what factors influence the decision to recommend these and other vaccines. It is unclear whether the presence or absence of an immunization advisory committee in specific countries has an impact on these policy decisions.

As such, there is a need for a more comprehensive assessment of the IAC structure and function across the EURO region. To achieve that goal, we sought to study the current status of immunization advisory committees of these nations. In addition, we examined the recommendations regarding the use of hepatitis B and Hib vaccines and the factors that influenced these decisions.

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M E T H O D S Sample There are fifty-three Member States that comprise the EURO Region of the World Health Organization (WHO). To gain an understanding of the process of immunization recommendation development and implementation throughout the region, all Member States were selected to participate. Survey Instrument In collaboration with WHO, we developed a structured questionnaire to be administered electronically. The survey contained thirty-nine items and was designed to be completed in fifteen minutes or less. The survey focused on membership of the immunization advisory committee, the committees’ meeting process, and decision-making. Specific questions addressed the recommendation process for hepatitis B and Haemophilus influenzae, type b (Hib) vaccines. The questionnaire was a composite of fixed-choice and short-answer questions. The survey and accompanying cover letter were translated from English to Russian by a professional translation service. Eleven Member States of the former Soviet Union and Eastern Europe were provided with surveys in Russian and given the opportunity to complete the survey in Russian. Questionnaire Administration The first mailing of questionnaires was sent electronically in April 2008 to managers of the Expanded Programme on Immunisation (EPI) and, where applicable, to immunization program managers. The e-mail contained an attached personalized cover letter signed by the Director of the EURO immunization program, Dr. Srdan Matic, and the survey instrument. Heads of WHO country offices within the EURO Region and Deputy Ministers of Health in the Russian-speaking countries were informed of the study and received the information electronically. The cover letter also specified that the focus of the survey was on the IAC (a.k.a, the technical committee), not the ICC (if present) in each country. Respondents had the option to return the completed survey by e-mail, fax, or complete a web-based version of the survey. Three additional mailings were sent to non-respondents in April and May 2008. In addition, follow-up contact was made with countries when data were missing or clarification was needed. Data Analysis Frequency distributions were calculated for all survey items. All free text from short answers was transcribed verbatim from the surveys. Responses in Russian were translated to English by a professional translation service. Chi-square analysis was conducted to assess differences between the Russian-speaking and English-speaking nations for some items and between countries with an IAC and without for other items. The study was approved by the University of Michigan Medical School Institutional Review Board.

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O V E R A L L R E S U L T S Response Rate Of the 53 Member States (henceforth referred to as “countries”) contacted, 47 completed the survey. This yielded an overall response rate of 89%. The response rate of English-speaking countries (93%, N=39) was greater than that of Russian-speaking countries (73%, N=8). I. Immunization Advisory Committees Almost three-quarters of countries surveyed (72%, N=34) have a standing advisory committee to make national immunization recommendations. (See Appendix A) Another 15% (N=7) have ad hoc committees for special issues. (Table 1) The median year committees were established is 2000, with a range from 1963 to 2007. Table 1. Country has standing advisory committee that makes national immunization recommendations (N=47) % (N) Yes 72 (34) No; ad hoc committee(s) for special issues 15 (7) No; no immunization advisory committee 13 (6) A. Committee Membership The number of voting members on a committee range from 0 to 43 members and non-voting members range from 0 to 18. (See Appendix B) More than one-third of countries (39%, N=13) reported their voting members serve as long as desired by the Minister of Health. Of those committees that appoint voting members for specific periods of time (42%, N=14), the appointments range from 2 to 6 years. The majority of countries (70%, N=23) reported that some committee members are selected by the Minister of Health, while half of countries (50%, N=17) reported having other members who are selected by governmental agencies. More than a quarter (26%, N=9) reported having committee members who are selected by professional organizations. (Table 2)

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Table 2. Committee Membership

Number of members serve on immunization advisory committee Voting members (N=34)

Range 0-43 Mean 14

Non-voting members (N=33) Range 0-18 Mean 3

Voting members appointed to committee for specific periods of time (N=33) Percent and number of countries responding “yes” % (N)

Yes 42 (14)

Length of term: Range 2-6 years Length of term: Median 3 years

No; members serve as desired by the Minister of Health

39 (13)

No; members serve as long as they wish 15 (5)

No; other reason 6 (2)

How individuals are selected for the committee Percent and number of countries responding “yes” % (N)

Selected by Minister of Health (N=33) 70 (23) Selected by specific governmental agencies (N=34)

50 (17)

Selected by specific professional organizations (N=34)

26 (9)

Of the countries with an immunization advisory committee, at least two-thirds have voting members who represent governmental agencies (76%, N=26) and medical professional societies (66%, N=21). The majority of committees have no representation (voting or otherwise) from private insurance agencies (100%, N=32), public and/or advocacy groups (94%, N=30), vaccine manufacturers (91%, N=30), WHO (85%, N=28), other international organizations (82%, N=27), and public insurance agencies (79%, N=26). (Table 3) In addition, only a small number of countries also indicated having representatives from academia (N=7) and other healthcare entities (N=2) who serve as voting members on their committee.

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Table 3. Professional activities and voting status of committee members Percent and number of countries responding “yes” Voting

Non-Voting

Not represented

% (N) % (N) % (N) Representatives from governmental agencies (N=34)

76 (26) 35 (12) 3 (1)

Representatives of medical professional societies (N=32)

66 (21) 16 (5) 19 (6)

Representatives of specific geographical areas (e.g., states, regions) (N=31)

42 (13) 6 (2) 58 (18)

Representatives of public insurance agencies (N=33)

15 (5) 9 (3) 79 (26)

Representatives from international organizations (other than the World Health Organization) (N=33)

9 (4) 9 (3) 82 (27)

Representatives of the World Health Organization (N=33)

6 (2) 9 (3) 85 (28)

Representatives from vaccine manufacturers (N=33)

3 (1) 9 (3) 91 (30)

Representatives from the public and/or advocacy groups (N=32)

3 (1) 3 (1) 94 (30)

Representatives of private insurance agencies (N=32)

0 (0) 0 (0) 100 (32)

Nearly all committees have members with expertise in pediatrics (97%, N=33), public health (97%, N=33), infectious diseases (91%, N=31), epidemiology (91%, N=31), and immunology (79%, N=27). Over half of the committees have experts in adult medicine (62%, N=21), while fewer than half have experts in vaccine manufacturing regulations (44%, N=15), health economics (41%, N=14), and social services (21%, N=7). Only one country reported having difficulty identifying experts (in health economics) to participate on the committee. Of countries with an immunization advisory committee, eighty-five percent (N=28) reported having a legislative or administrative basis for the committee. (See Appendix C) The majority of committees have formal terms of reference (59%, N=19). Over half of the committees (55%, N=18) require their members to disclose conflicts of interest. Three countries (9%) provide payment to non-governmental committee members for serving on the committee. Of the countries with an immunization advisory committee, nearly two-thirds (65%, N=22) have at least one disease specific working group. B. Meeting Process Sixty-five percent (N=22) of the immunization advisory committees meet at regular intervals with quarterly meetings being the most common interval (41%, N=9), followed by biannual (23%, N=5) and every other month (14%, N=3). Two countries reported that their committee meets monthly and one reported meeting only once annually. The majority of committees (68%, N=23) will also meet as needed to address urgent issues.

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During 2006 and 2007, committees met, on average, 3 times per year with a range of 0 to12 meetings per year. Of countries with an immunization advisory committee, approximately seventy percent (71%, N=24) reported that a governmental agency is responsible for the operation of the committee. (See Appendix D) Variability was seen among countries with an immunization advisory committee regarding who determined the meeting agenda. More than sixty percent of countries (62%, N=21) reported the committee chairperson determines the meeting agenda. Fewer than half have the Ministry of Health (41%, N=14) and/or committee members (38%, N=13) determine the agenda. (Table 4) However, all committees circulate the agenda to committee members before the meetings. Table 4. By whom meeting agenda is determined (N=34) Percent and number of countries responding “yes” % (N) Immunization advisory committee chairperson 62 (21) Ministry of Health 41 (14) Immunization advisory committee members 38 (13) Other 15 (5) Of countries with an immunization advisory committee, the majority (85%, N=29) indicated that, in addition to committee members, only invited non-members are allowed to attend committee meetings. Non-members who are invited to attend are typically experts presenting on specific topics (97%, N=28). Only 6% of committees (N=2) have their meetings open to the public. The majority of committees (65%, N=22) disseminate their meeting minutes to members only. A small number (15%, N=5) make their full meeting minutes available for public viewing while an equal number (15%, N=5) make only portions available for public viewing. Two countries reported not having any official meeting minutes. More than half of immunization advisory committees (62%, N=21) approve recommendations by consensus. Approximately one-quarter (26%, N=9) reported recommendations are approved by official vote and a small number of committees (12%, N=4) use both consensus and official vote. Of countries with an immunization advisory committee, the majority (73%, N=25) reported the committee makes recommendations directly to the Minister of Health, while less than twenty percent (15%, N=5) make recommendations directly to a Senior Officer of the Ministry of Health or Director of the Immunization Program (3%, N=1). (Table 5)

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Table 5. Government official or agency to which committee directly makes recommendations (N=34) % (N) Minister of Health 73 (25) Senior Officer of Ministry of Health 15 (5) Director of Immunization Program 3 (1) Other 9 (3) II. Immunization Policy Decisions All countries were surveyed on immunization policy decisions, regardless of presence of an immunization advisory committee. When making immunization policy decisions, the majority of countries reported formally using WHO vaccine position papers (98%, N=46), data from vaccine manufacturers (93%, N=41), studies published both in the native language (91%, N=42) and other languages (89%, N=42) as well as internal government reports (78%, N=35). A small number of countries also reported using unpublished information (N=4), European Centre for Disease Prevention and Control (ECDC) position papers (N=3), and information from the European Medicines Agency (EMEA) (N=2). The majority of countries reported vaccine safety (91%, N=43), epidemiology of disease (85%, N=40), and the severity of disease prevented (74%, N=35) as very important factors when making immunization recommendations. Seventy percent (N=32) of countries indicated that recommendations made by other countries was an important factor in their own immunization recommendation, while more than half indicated public pressure was important (55%, N=26) or very important (9%, N=4). More than one-quarter of countries reported that public pressure was not important (27%, N=13). (Table 6) A small number of countries indicated vaccine efficacy (N=3) and the logistics of vaccine administration (N=2) were very important factors.

Table 6. Importance of factors in making immunization recommendations Very

Important Important

Not Important

Unsure

% (N) % (N) % (N) % (N)

Vaccine safety(N=47) 91 (43) 9 (4) 0 (0) 0 (0)

Current disease burden or epidemiology of disease (N=47)

85 (40) 13 (6) 0 (0) 2 (1)

Severity of disease prevented (N=47) 74 (35) 26 (12) 0 (0) 0 (0) Adequate vaccine supply for the population (N=47)

58 (27) 38 (18) 0 (0) 4 (2)

Financial considerations (N=46) 39 (18) 52 (24) 7 (3) 2 (1)

Inclusion of vaccine in expanded program on immunizations (N=47)

38 (18) 40 (19) 13 (6) 9 (4)

Recommendations made by other countries (N=46)

13 (6) 70 (32) 13 (6) 4 (2)

Public pressure (N=47) 9 (4) 55 (26) 27 (13) 9 (4)

The majority of countries reported that the cost of vaccine (96%, N=44), cost of disease burden (96%, N=44), current budget of the Ministry of Health (85%, N=38), and cost-

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effectiveness data (94%, N=42) were important or very important financial information when implementing vaccine recommendations. Almost half of countries reported the impact on health insurance premiums was not important (48%, N=18). (Table 7) Table 7. Importance of financial information in implementing vaccine recommendations Very

Important Important

Not Important

Unsure

% (N) % (N) % (N) % (N)

Cost of disease burden (N=46) 55 (25) 41 (19) 2 (1) 2 (1)

Cost-effectiveness data (N=45) 49 (22) 45 (20) 4 (2) 2 (1)

Cost of vaccine (N=46) 41 (19) 55 (25) 2 (1) 2 (1)

Current budget of the Ministry of Health (N=45)

38 (17) 47 (21) 11 (5) 4 (2)

Impact on health insurance premiums (N=37)

11 (4) 11 (4) 48 (18) 30 (11)

Countries use a variety of methods to disseminate new immunization recommendations to vaccine providers with many using two or more methods including government publications (85%, N=40), medical professional meetings (66%, N=31), direct notification by public health officials (55%, N=26), and press releases (53%, N=25). A few countries (N=3) reported using insurance agency representatives to notify providers. When asked what support the country required from the WHO to establish or strengthen an immunization advisory committee, eighteen respondents indicated they required support. The type of support required included assistance in establishing an IAC, preparing terms of reference, WHO participation in IAC meetings and general information (See Appendix E)

III. Hepatitis B Vaccine The vast majority of study countries (87%, N=41) include hepatitis B vaccine in their routine childhood immunization schedule. For those countries that include hepatitis B vaccine, implementation of this recommendation occurred between 1989 and 2003, with the median being 1998. One country is anticipating implementation in 2008. Seventy percent of countries that recommend hepatitis B vaccine reported the epidemiology of disease (70%, N=28) and severity of disease (70%, N=28) as very important factors in making the hepatitis B vaccine recommendation. Approximately two-thirds (65%, N=26) also indicated that recommendations made by other countries were considered important in this decision. A small number of countries also indicated that WHO recommendations (N=3) and the logistics of vaccine administration (N=1) were very important factors in this recommendation. Table 8 provides additional details on the importance of factors in the hepatitis B vaccine recommendation.

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Table 8. Hepatitis B vaccine: Importance of factors in making immunization recommendation Very

Important Important

Not Important

Unsure

% (N) % (N) % (N) % (N)

Severity of disease (N=40) 70 (28) 30 (12) 0 (0) 0 (0)

Disease burden or epidemiology of disease (N=40)

70 (28) 28 (11) 2 (1) 0 (0)



18 (7) 65 (26) 15 (6) 2 (1)


Of countries that recommend the hepatitis B vaccine, the majority categorized the cost of disease burden (95%, N=37) , cost of vaccine (85%, N=34), cost-effectiveness data (85%, N=33), and the current budget (77%, N=30) as very important or important financial information when implementing this vaccine recommendation. One country reported external donor assistance as important in implementation. Almost half of countries (44%, N=15) reported the impact on insurance premiums as not an important. (Table 9) Table 9. Hepatitis B vaccine: Importance of financial information in implementing vaccine recommendations Very

Important Important

Not Important

Unsure

% (N) % (N) % (N) % (N)



Cost of vaccine (N=40) 37 (15) 48 (19) 10 (4) 5 (2)

Current budget (N=39) 33 (13) 44 (17) 15 (6) 8 (3)

Impact on insurance premiums (N=34)

6 (2) 12 (4) 44 (15) 38 (13)

Of the countries not recommending hepatitis B vaccine in the routine immunization schedule (N=6), five (83%) have considered this recommendation in the past five years, while one country plans to do so within the next year. Of those countries that reported the hepatitis B vaccine is not one of their recommended immunizations, a small number of countries indicated product availability (N=1), cost-effectiveness of vaccine (N=1), and budget constraints (N=1) were very important factors in the decision not to recommend the vaccine. Cost of vaccine (N=1) and current disease burden/epidemiology of disease (N=1) were also cited as important factors in this decision.

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IV. Haemophilus Influenza Type B (Hib) Vaccine The majority of countries (85%, N=40) include Haemophilus influenzae type b (Hib) vaccine in their routine childhood immunization schedule. For those countries that include Hib vaccine, implementation of this recommendation occurred between 1980 and 2008 with the median being 1999. One country is planning implementation in 2009. The majority of countries that recommend Hib vaccine reported the severity of disease (80%, N=32) and epidemiology of disease (70%, N=28) as very important factors in making the immunization recommendation. Almost half of countries (47%, N=18) indicated public pressure is not an important factor. (Table 10) A small number of countries also reported that WHO recommendations (N=2) and vaccine safety concerns (N=1) were very important in this decision. Table 10. Hib vaccine: Importance of factors in making immunization recommendation Very

Important Important

Not Important

Unsure

% (N) % (N) % (N) % (N)

Severity of disease (N=40) 80 (32) 18 (7) 2 (1) 0 (0)

Disease burden or epidemiology of disease (N=40)

70 (28) 28 (11) 2 (1) 0 (0)



15 (6) 59 (23) 23 (9) 3 (1)


Of countries that recommend Hib vaccine, forty-five percent (N=18) reported that cost of disease burden was considered very important in implementation. Approximately one-third indicated the current budget (34%, N=14), cost-effectiveness data (36%, N=14), and cost of vaccine (33%, N=13) were very important financial information when implementing Hib vaccine recommendations. (Table 11) Table 11. Hib vaccine: Importance of financial information in implementing vaccine recommendations Very

Important Important

Not Important

Unsure

% (N) % (N) % (N) % (N)



Cost of vaccine (N=40) 33 (13) 48 (19) 12 (5) 7 (3)

Current budget (N=39) 34 (14) 45 (17) 13 (5) 8 (3)

Impact on insurance premiums (N=33)

3 (1) 9 (3) 52 (17) 36 (12)

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All of the countries that do not currently include Hib vaccine in their routine childhood immunization schedule (N=7) considered this recommendation in 2007. At least half of countries that do not have Hib vaccine as part of the recommended immunization schedule cited epidemiology of disease (75%, N=3), cost of vaccine (60%, N=3), budget constraints (60%, N=3), vaccine safety (60%, N=3), and cost-effectiveness of vaccine (50%, N=2) as very important factors in the decision not to recommend Hib vaccine. (Table 12) Table 12. Hib vaccine: Importance of factors in decision NOT to recommend the vaccine

Very

Important Important

Not Important

Unsure

% (N) % (N) % (N) % (N) Current disease burden / epidemiology of disease (N=4)

75 (3) 25 (1) 0 (0) 0 (0)

Budget constraints (N=5) 60 (3) 40 (2) 0 (0) 0 (0)

Cost of vaccine (N=5) 60 (3) 40 (2) 0 (0) 0 (0)

Vaccine safety (N=5) 60 (3) 20 (1) 20 (1) 0 (0)

Cost-effectiveness of vaccine (N=4) 50 (2) 25 (1) 25 (1) 0 (0)

Product availability (N=4) 25 (1) 50 (2) 25 (1) 0 (0)

V. Additional Analyses When compared to Russian-speaking countries, English-speaking countries were significantly more likely to have a standing advisory committee that makes national immunization recommendations (84% vs. 12.5%, p<.0001). (Table 13) Table 13. Country has standing advisory committee that makes national immunization recommendations (N=47)

English-speaking

countries (N=38)

Russian-speaking countries

(N=8)

% (N) % (N) p-value

Yes 84 (33) 12.5 (1)

No; no immunization advisory committee

5 (2) 50 (4)

No; ad hoc committee(s) for special issues

11 (4) 37.5 (3)

<.0001

All Russian-speaking countries in the EURO region recommend hepatitis B vaccine as part of the routine childhood immunization schedule compared to 82% of English-speaking countries. English-speaking countries were significantly more likely than Russian-speaking countries to report Hib vaccine is part of the country’s recommended schedule (92% vs. 50%, p=.0022). (Table 14)

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Table 14. Recommended immunization schedule: Hepatitis B and Hib vaccines

Country recommends Hepatitis B vaccine by language of survey (N=47)

English-speaking

countries (N=39)


(N=8)

% (N) % (N) p-value

Yes, Hepatitis B vaccine is recommended

82 (32) 100 (8)

No, Hepatitis B vaccine is not recommended

18 (7) 0 (0) .1940

Country recommends Hib vaccine by language of survey (N=47)

English-speaking

countries (N=39)


(N=8)

% (N) % (N) p-value

Yes, Hib vaccine is recommended 92 (36) 50 (4)

No, Hib vaccine is not recommended

8 (3) 50 (4) .0022

Countries that have an immunization advisory committee are more likely to use studies published in their native language when making immunization policy decisions (97% vs. 75%, p=.0197). (Table 15) However, no significant differences were seen between these groups in their use of WHO vaccine position papers, data from vaccine manufacturers, studies published in other languages and internal government reports. Table 15. Sources of information formally used in making immunization policy decisions by presence of advisory committee Yes, Country has

advisory committee

No, Country has ad hoc or no

committee

% (N) % (N) p-value Studies published in native language (N=46)

Yes 97 (33) 75 (9) No 3 (1) 25 (3)

.0197

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S U M M A R Y O F I M P O R T A N T F I N D I N G S

• The majority of countries within the EURO region have standing immunization advisory committees (IAC) in some form already in place. The composition of members of these committees was narrow with members mainly representing governmental agencies and medical professional societies.

• When compared to Russian-speaking countries, English-speaking countries were

significantly more likely to have a standing IAC. This finding may reflect the evolving nature of the health care system in the Russian-speaking countries. Understanding the political and economical constraints inherent in these nations is important as recommendations are made on the structure and function of an IAC

• Countries with an IAC did not report any difficulty identifying experts to serve on the committee. However we do not know if it is difficult for countries without a standing committee to identify experts.

• While the majority of committees have formal terms of reference, 41% do not.

Several countries requested assistance from the Who in drafting formal terms of reference (Appendix E).

• Forty-five percent of the committees do not require their members to disclose

conflicts of interest. This issue may have an impact on public trust and should be addressed in the development of formal terms of reference.

• IAC representatives from governmental agencies, medical professional societies,

specific geographical areas and public insurance agencies were more likely to be voting members than representatives from the WHO or vaccine manufacturers. IAC membership also was more likely to have a higher ratio of voting to non-voting members. However, the majority of IACs approve recommendations on consensus rather than official vote. This may indicate (1) that non-voting members have more input in decision making than inferred from voting status, and/or (2) that decisions regarding immunizations only occur after a process of consensus-building among committee members.

• In an in-depth analysis of countries of the former Soviet Union conducted by this

research team, immunization program officials in countries without an IAC commented that the presence of a standing committee would result in too much time wasted in meetings as a rationale for not having a committee. This study showed that committees meet on average three times per year.

• The current burden of disease was the factor most commonly reported as very

important in vaccine policy decision making by countries responding to the survey. Countries with an IAC were more likely to report this as a very important factor compared to countries without an IAC. This finding emphasizes the importance of adequate disease surveillance protocols to support policy decisions regarding adoption of new vaccines.

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• Over one third of countries reported that public pressure was not an important

factor in making immunization recommendations and only four countries felt it was a very important factor. Despite concerns about increasing public attention to the safety of vaccines, public pressure has not risen to the level of importance for some countries in the EURO region to influence immunization policy decisions. At the same time, significant sensitivity to this issue was apparent as vaccine safety was reported as important or very important in making immunization recommendations by all countries.

• The majority of countries include both hepatitis B and Hib vaccines in their routine

childhood immunization schedules. Countries not including these vaccines indicated that the burden of disease and factors associated with the cost of the vaccine (e.g., budget constraints, cost-effectiveness of the vaccine) were important factors in this decision. This finding again highlights the importance of accurate disease surveillance and also emphasizes financial constraints as a critical factor in adoption of these relatively new vaccines into the routine schedule.

• The vast majority of countries do not allow the public to attend meetings of the

immunization advisory committees nor distribute publicly the minutes of their meetings. There is increasing public attention to a variety of aspects of government action in developed nations. As such, the lack of public access to decisions regarding immunization policy has an impact on public trust of the process in the future.

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REFERENCES

1. FitzSimons D, Van Damme P, E,moroglu N, Godal T, Kane M, Malyavin A,

Margolis H, Meheus A. Strengthening immunization systems and introduction of hepatitis B vaccine in central and eastern Europe and the Newly Independent States. Vaccine 2002;2 20:1475-9.

2. Freed GL. The structure and function of immunization advisory committees in

Western Europe. Hum Vaccin 2008; 4 (4):292-7

Appendix A. Official name of immunization advisory committee

Country Official committee name Formal written terms of reference

Albania National Technical Immunization Committee Andorra Consell Assessor de Vacunes (Advisory Committee of

Vaccines)

Austria Impfaussschuss des OSR Belgium Hoge Gezondheidsraad (Superior Health Council – SHC)

Permanente Werkgroep Vaccinatie X

Bosnia & Herzegovina

Immunization Committee of the Republic of Srpska

Bulgaria Advisory Committee for surveillance of Communicable Diseases, immune-prophylaxis and anti-epidemic control

X

Cyprus National Immunization Advisory Committee X Czech Republic

Advisory board for preventable diseases

Denmark Sundhedsstyrelsens vaccinationsudvalg Estonia Expert Committee for Immunoprophylaxis X Finland National Advisory Committee on Vaccination (=KRAR,

Kansallinen rokotusasiantuntijaryhmä) X

France Comité technique des vaccinations / Haut conseil de la santé publique

X

Georgia Interagency Coordination Committee X Germany German Standing Committee on Vaccination (STIKO) X Greece National Immunization Committee Hungary Immunization Advisory Body (Hun: Védőoltási Tanácsadó

Testület)

Iceland Sottvarnarad Ireland National Immunisation Advisory Committee Israel The Advisory Committee on Infectious Diseases and

Immunizations X

Italy National Vaccination Committee Kyrgyzstan Republican Board for Immunoprophylaxis X Latvia State immunization council (Imunizācijas valsts padome) X Lithuania Board for coordination of National Immunization

Programme

Macedonia National Immunization Commitie Malta Advisory Committee on Immunisation Policy X Netherlands Health Council, committee NIP (Gezondheidsraad,

commissie RVP) X

Poland 1985 Sanitary – Epidemiological Council X Portugal Comissão Técnica de Vacinação X Slovakia Working Group for Immunization Issues X Spain National Vaccines Committee (Ponencia de Vacunas) Sweden We have both a standing advisory committee and ad hoc

committees for special issues, but neither of these make the national immunization recommendations. Such recommendations are made by the National Board of Health and Welfare, with due respect to the work of the committees. The official name of the standing committee is “SMI advisory committee on vaccinations (REFVAC).” SMI = the abbreviation for Swedish Institute for Infectious Disease Control.

Switzerland Commission fédérale pour les vaccinations; Schweizerische Kommission für Impffragen; Commissione federale per le vaccinazioni

X

Turkey Immunization Advisory Committee X United Kingdom

Joint Committee on Vaccination and Immunisation X

Appendix B. Members of Immunization Advisory Committees by country Members of immunization advisory committees by country (N=34 countries) Voting members

(N) Non-voting members

(N) Albania 20 3 Andorra 10 0 Austria 18 0 Belgium 29 3 Bosnia & Herzegovina 5 0 Bulgaria 13 2 Cyprus 5 Czech Republic 12 0 Denmark 0 15 Estonia 12 12 Finland 12 0 France 20 13 Georgia 13 0 Germany 19 9 Greece 11 0 Hungary 12 0 Iceland 7 0 Ireland 18 0 Israel 14 0 Italy 24 0 Kyrgyzstan 17 0 Latvia 12 0 Lithuania 13 0 Macedonia 12 0 Malta 8 2 Netherlands 13 3 Poland 17 0 Portugal 20 0 Slovakia 9 0 Spain 19 5 Sweden 0 18 Switzerland 16 4 Turkey 43 15 United Kingdom 15 4

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Appendix C. Legislative or administrative basis for the committee Country Legislative/administrative basis Albania Directive of Public Health Institute Director Andorra Mandatory sistematic vaccinations Plan Regulation (Amendment

20/06/2007) Austria Law Belgium Yes for the SHC, not for the specific work group vaccination Bosnia & Herzegovina Regulations of Immunization Bulgaria Special article of the Administration Act provides possibility to the Minister

of Health to create committees to advise him in different topics Cyprus Administrative basis, Permanent Secretary of the Ministry of Health Estonia Ministerial directive France 2 “arêtes” (decree?) for members composition and for members nomination Georgia Decree of MoH Germany Protection Against Infection Act (IfSG) Greece Ministerial directive Iceland It is an advisory committee for the Minister of Health Italy A ministerial decree defines the list of component, the mandate and the

role of the committee Kyrgyzstan Order of the Ministry of Health of the Kyrgyz Republic No. 187 dated

February 6, 2006, as amended. Latvia Cabinet Regulation No. 330 (adopted 26 September 2000) “Vaccination

Regulations” article No 9 Lithuania Order of minister of health Macedonia Decision sent by Minister of Health Malta Legal notice passed through parliament Netherlands Health legislation Enabling legislation Advisory Committees Poland 1985 National Sanitary Inspection Law Portugal Ministry of Health Decree Slovakia Ministerial decree Spain Administrative basis (Agreement No 174/1991 Inter-Territorial Council) Switzerland Legislative basis Turkey Ministerial directive United Kingdom The Joint Committee on Vaccination and Immunisation (JCVI, the

committee) is a Non-Departmental Public Body (NDPB). It is a statutory expert Standing Advisory Committee established in England and Wales under the NHS Act 1977 and the NHS (Standing Advisory Committees) Order 1981 as the Standing Advisory Committee on Vaccination and Immunisation.

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Appendix D. Governmental agency responsible for operation of immunization committee Country Name of governmental agency Albania Institute of Public Health Belgium Superior Health Council (SHC) Bosnia & Herzegovina PHI Cyprus Medical and Public Health Services of the Ministry of Health Denmark National Board of Health (Sundhedsstyrelsen) Estonia Ministry Finland KTL (National Public Health Institute) France Not an agency but a specific department from the Ministry of Health Georgia National Center for Disease Control and Public Health of Georgia Germany Robert Koch Institute, Berlin Iceland The Head Epidemiologist’s Office Italy Ministry of Health Kyrgyzstan Republican Center for Immunoprophylaxis (RCI) Latvia State Agency “Public Health Agency” Netherlands Health Council Portugal Directorate General of Health Slovakia Public Health Authority of the Slovak Republic Spain Secretary of the Inter-Territorial Council Sweden Swedish Institute for Infectious Disease Control (SMI) Switzerland The Federal Office of Public Health (Immunisations Section) Turkey Primary Health Care General Directorate United Kingdom Department of Health

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Appendix E. Support country requires from the World Health Organization to establish or strengthen immunization advisory committee (transcribed verbatim from the survey received) Country Support required Albania WHO should assist National Advisory Committee to prepare proper terms of

reference and improve the functions of such committee Armenia Provide informational bulletins about its roles and duties. Provide an

opportunity to find out more about successful work experiences of immunization advisory boards in different countries

Belgium Participation of the WHO in the meetings of the work group would be a plus Bosnia & Herzegovina Financial support for committee Germany We see a need to network with other European immunization advisory

committees Hungary More powerful communication on the immunization programs Iceland Minor Kazakhstan Participation by WHO experts to prepare a document package for

establishing an immunization advisory board. Kyrgyzstan Information about new vaccines and post-vaccination complications Macedonia WHO has a permanent member in the National Imunization Commitie who

gives recommendations and financial, medical and technical support for immunization program

Poland General recommendations for advisory committee charter Portugal Very satisfied with the “WHO position papers” and guidelines. The

meetings organized by WHO with the EPI managers are very useful. Romania To provide examples of functional committees and terms of reference for

the committee Serbia National Commision for Infection Diseases sent request to Minister of

Health (2008) to establish an Immunization Advisory Committee. We hope so that his answer bill be positive. I believe that recommendation (letter) WHO (Regional or County office) can help us in this process.

Slovakia Recommendations, information Switzerland Guidelines for cost-effectiveness studies accepted by the economics

partners (like insurance) Tajikistan If an advisory board is established, there is no need for WHO assistance

except for the provision of updated information and data on immunoprophylaxis issues for the board.

Turkmenistan Information on how the Boards work in other countries, regulation on the board operations, benefits of establishing the Boards/Committees

The following countries indicated they did not require support: Bulgaria, Czech Republic, Denmark, Finland, France, Iceland, Ireland, Israel, Italy, Netherlands, Slovenia, United Kingdom

who immunization advisory committees€¦ · 3 methods sample there are fifty-three member states...

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