Global Survey on Seasonal Influenza Vaccine Policy Development and Implementation Report of Findings

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1 Global Survey on Seasonal Influenza Vaccine Policy Development and Implementation Report of Findings

2 World Health Organization 28 All rights reserved. Publications of the World Health Organization can be obtained from WHO Press, World Health Organization, 2 Avenue Appia, 1211 Geneva 27, Switzerland (tel: ; fax: ; bookorders@who.int). Requests for permission to reproduce or translate WHO publications whether for sale or for noncommercial distribution should be addressed to WHO Press, at the above address (fax: ; permissions@who.int). The designations employed and the presentation of the material in this publication do not imply the expression of any opinion whatsoever on the part of the World Health Organization concerning the legal status of any country, territory, city or area or of its authorities, or concerning the delimitation of its frontiers or boundaries. Dotted lines on maps represent approximate border lines for which there may not yet be full agreement. The mention of specific companies or of certain manufacturers products does not imply that they are endorsed or recommended by the World Health Organization in preference to others of a similar nature that are not mentioned. Errors and omissions excepted, the names of proprietary products are distinguished by initial capital letters. All reasonable precautions have been taken by the World Health Organization to verify the information contained in this publication. However, the published material is being distributed without warranty of any kind, either expressed or implied. The responsibility for the interpretation and use of the material lies with the reader. In no event shall the World Health Organization be liable for damages arising from its use.

3 Table of Contents TABLE OF CONTENTS... 3 ABBREVIATIONS AND ACRONYMS... 4 ACKNOWLEDGEMENTS... 5 EXECUTIVE SUMMARY... 6 SUMMARY OF THE GLOBAL SURVEY RESULTS GLOBAL RESPONSE SEASONAL INFLUENZA VACCINATION POLICIES INTRODUCTION OF SEASONAL INFLUENZA VACCINATION PANDEMIC INFLUENZA VACCINE: FORECASTING THE FUTURE DISCUSSION SURVEY RESULTS FROM THE WHO AFRICAN REGION REGIONAL SUMMARY OF SURVEY RESULTS PANDEMIC INFLUENZA VACCINE: FORECASTING THE FUTURE CONCLUSION SURVEY RESULTS FROM THE WHO REGION OF THE AMERICAS REGIONAL SUMMARY OF SURVEY RESULTS SEASONAL INFLUENZA VACCINATION POLICIES INTRODUCTION OF SEASONAL INFLUENZA VACCINATION PANDEMIC INFLUENZA VACCINE: FORECASTING THE FUTURE DISCUSSION SURVEY RESULTS FROM THE WHO EASTERN MEDITERRANEAN REGION REGIONAL SUMMARY OF SURVEY RESULTS INTRODUCTION OF SEASONAL INFLUENZA VACCINATION PANDEMIC INFLUENZA VACCINE: FORECASTING THE FUTURE DISCUSSION SURVEY RESULTS FROM THE WHO EUROPEAN REGION REGIONAL SUMMARY OF SURVEY RESULTS SEASONAL INFLUENZA VACCINATION POLICIES INTRODUCTION OF SEASONAL INFLUENZA VACCINATION PANDEMIC INFLUENZA VACCINE: FORECASTING THE FUTURE DISCUSSION SURVEY RESULTS FROM THE WHO SOUTH-EAST ASIA REGION REGIONAL SUMMARY OF SURVEY RESULTS INTRODUCTION OF SEASONAL INFLUENZA VACCINATION PANDEMIC INFLUENZA VACCINE: FORECASTING THE FUTURE DISCUSSION SURVEY RESULTS FROM THE WHO WESTERN PACIFIC REGION REGIONAL SUMMARY OF SURVEY RESULTS SEASONAL INFLUENZA VACCINATION POLICIES INTRODUCTION OF SEASONAL INFLUENZA VACCINATION PANDEMIC INFLUENZA VACCINE: FORECASTING THE FUTURE DISCUSSION CONCLUSION... 33

4 Abbreviations and acronyms AFR AFRO AMR PAHO EMR EMRO EPI EUR EURO GAP RF SEAR SEARO TAG UNICEF WHO WPR WPRO EPI WHO African Region WHO Regional Office for Africa WHO Region of the Americas WHO Regional Office for the Americas/Pan American Health Organization WHO Eastern Mediterranean Region WHO Regional Office for the Eastern Mediterranean Expandable Programme for Immunization WHO European Region WHO Regional Office for Europe Global pandemic influenza action plan to increase pandemic influenza vaccine supply (PAHO) Revolving Fund WHO South-East Asia Region WHO Regional Office for South-East Asia Technical Advisory Group United Nations Children s Fund World Health Organization WHO Western Pacific Region WHO Regional Office for the Western Pacific Expanded Programme on Immunization

5 Acknowledgements Acknowledgements are due to the many donors, governments, technical agencies and private-sector organizations. WHO would also like to thank all the Member States and countries/territories for their support and for their responses to the survey.

6 Executive summary Vaccines are one the most effective medical interventions that we have today for the control of pandemic and seasonal epidemics of influenza. Yet issues related to management, fiscal policies, infrastructure, and cultural perceptions impede their wider use in many Member States and associated countries/territories. Major benefits of using seasonal influenza vaccines include the prevention of unnecessary illness, reduction of absenteeism, prevention of hospitalization, and premature death. Countries using seasonal influenza vaccine should make an effort to assure the highest vaccination coverage possible in the cohorts they target. Member States that are not using seasonal influenza vaccine should establish influenza surveillance to determine the disease burden in their respective countries and to assess other evidence to support influenza vaccination policy development. Recent information from assessments conducted by the United Nations Children s Fund (UNICEF) and the World Health Organization (WHO) indicates that most low- and middle-income countries do not have the capacity and procedures to deliver and administer a pandemic influenza vaccine throughout the country within seven days. To create and maintain this capacity for pandemic preparedness will require funding, a pre-agreed vaccine distribution plan, governmental leadership on coordinated interagency and multilateral support, and periodic simulations. The WHO global pandemic influenza action plan to increase vaccine supply (GAP), developed in May 26, calls for an evidence-based increase in the use of seasonal influenza vaccine in all countries to reduce global influenza disease burden and to increase pandemic vaccine production capacity, particularly in regions where vaccine supply is suboptimal. To assess the current use of seasonal influenza vaccine and establish prospects for increasing its use among its Member States, WHO carried out a global survey to determine: a) the current use of seasonal influenza vaccine; b) prospects for increasing its use and potential future demand; and c) potential demand for a pandemic influenza vaccine should an influenza pandemic occur. This report summarizes responses to the survey received as of June 27 from 134 Member States (7%) and 12 countries/territories affiliated to Member States with a total of 146 responses for the global analysis. All data and statements on countries current activities and future plans, including projected estimates of vaccine and financial assistance requirements, are based on responses submitted by Member States and countries/territories. The survey indicated a noticeable increase in the global uptake of seasonal influenza vaccine from 192 million doses in 24 to 261 million doses in 25. Of the countries and territories that responded to the survey, 74 (51%) have routine programmes for seasonal influenza. Despite the lack of information in some Member States, the current survey has nevertheless provided a global overview on the current usage pattern of seasonal influenza vaccine and its possible introduction into countries that are not using it today, as well as existing plans for the use of a pandemic influenza vaccine in the event of an influenza pandemic. The report is divided into eight sections. Section 1 summarizes the results of the survey from a global perspective, Sections 2 to 7 summarize the respective results for each WHO region, and Section 8 outlines the conclusions. This report makes no attempt to review the inconsistencies due to incomplete or insufficient information received from the countries. Where appropriate, comments are provided on

7 the constraints encountered in interpreting and analyzing the data. The denominators for analyses vary according to the responses to specific questions received from each country.

8 Summary of the global survey results 1.1 Global response Figure 1.1: Response of Member States to WHO survey, globally (%) and per region /46 (56.5%) 34/35 (97.%) 15/21 (71.4%) 4/53 (75.5%) 5/11 (45.5%) 12/27 (44.4%) 134/193 (69.4%) AFR PAHO EMR EUR SEAR WPR Global As shown in Figure 1.1, 134 Member States responded to the WHO survey, with a 97% response rate from the Region of the Americas (PAHO). WHO has 193 Member States, some of which also represent countries and/or territories politically affiliated with them. Responses to the survey were received from 134 Member States (7%) and 12 affiliated countries/territories. These affiliated countries/territories were included in the survey and, for statistical purposes, each has been treated as a separate entity, thus bringing the overall total of responses to 146, which was used as the denominator for the data analysis. Table 1.1 lists the responses by region. Table 1.1: Number of Member States (and countries/territories), by WHO region, that provided information in the global survey form AFR PAHO SEAR EUR EMR WPR TOTAL * = * = = 146 *Non-Member States (countries/territories) that provided data. Of the 146 countries and territories that responded to the survey, 51% (N=74) indicated that they have a routine programme for seasonal vaccination against influenza. On a regional basis: none of the responses from AFR or SEAR indicated existence of a routine seasonal influenza vaccination programme. 28 countries and territories in PAHO (65%); 31 countries in EUR (8%); 5 countries in EMR (33%); and countries and territories in WPR (67%) have a routine vaccination programme in place for seasonal influenza.

9 Doses, millions Percent Figure 1.2: Member States (and countries/territories) with a routine seasonal vaccination policy: Percentage by WHO region /43 (65.1%) 31/4 (77.5%) 5/15 (33.3%) /15 (66.6%) AFR PAHO EMR EUR SEAR WPR Figure 1.2 shows countries with a seasonal influenza vaccine policy, with PAHO and EUR using 8% of the seasonal influenza vaccine reported for 25. Global summary data on the formulation of the vaccine used in seasonal influenza vaccine programmes show that 66 (8%) of the Member States (and countries/territories) use the northern hemisphere formulation, while 12 (15%) several PAHO and WPR countries, in Latin and Central America and the Pacific basin respectively use the southern hemisphere formulation, with 5 (6%) using both the northern and southern hemisphere formulation. Figure 1.3: Estimated global seasonal influenza vaccine uptake, Years Industry Estimated production of doses Reported Uptake by countries Figure 1.3 shows a noticeable increase of seasonal influenza vaccine uptake between 24 and 25. This increase is corroborated by the PAHO and EUR data. (See Sections 2 and 4 for more details.) The lighter line shows the estimated global production capacity for trivalent influenza vaccine in place for the influenza season. More up-to-date estimates by WHO indicate that annual global capacity is now closer to 386 million doses of trivalent influenza vaccine. A total of 8 countries provided data on seasonal influenza vaccine coverage for 25, but only 5 (63%) had coverage data available for the populations targeted. Figure 1.4 shows estimated vaccine coverage reported by selected countries for 25, with the countries plotted according to population size.

10 Number of Countries Percent Covergage Figure 1.4: Estimated vaccine coverage with seasonal influenza vaccine for the and 6+ year age groups for selected Member States (and countries/territories) in Smaller Larger populations Linear (6+) As shown in Figure 1.4, it appears that it is more difficult for countries with larger populations to achieve high vaccination coverage in the older age groups (6+ years) than for countries with smaller populations. The three data points for the estimated coverage of the 5 59 year age group show that vaccination coverage is only 3 4%, regardless of population size. Although these data are only for three points, they indicate that it may be more difficult to reach the 5 59 year age group than the 6+ age group. 1.2 Seasonal influenza vaccination policies Figure 1.5: Age groups targeted for seasonal influenza vaccination, as indicated by 54 Member States (and countries/territories) with routine programmes months 2-5 years 6-15 years years 5-59 years 6+ years Age Groups Most countries with a routine seasonal influenza programme are from PAHO and EUR, so the data reflect the vaccination polices of these regions. While the elderly (6+ year group) have traditionally been considered to be at the highest priority for vaccination programs with increased risk of influenza-related illnesses and complications, it is interesting to note that the very young are now also being targeted with seasonal influenza vaccine. Figure 1.5 demonstrates a double increase in countries targeting children in the 6 23 month age group, from nine countries in 23 to 18 in 25.

11 Number of countries Figure 1.6: Distribution pattern of seasonal influenza vaccination by high-risk groups Cardiovascular diseases Renal dysfunction Lung diseases Health workers Immunosuppressive diseases Metabolic diseases Other risk groups Pregnant women Number of countries Figure 1.6 displays the profile of the high-risk groups targeted for seasonal influenza vaccination in 25. Again the data are mainly from PAHO and EUR. 1.3 Introduction of seasonal influenza vaccination Twenty-two Member States, and three countries/territories (N=25) indicated that they plan to introduce seasonal influenza vaccine into their national immunization programmes between 26 and 2. Figure 1.7: Age groups to be targeted by 17 Member States (and countries/ territories) that plan to introduce influenza vaccine between 26 and months 2-5 years 6-15 years years 5-59 years 6+ years Age Groups Seventeen of 25 Member States (and countries/territories) that will introduce seasonal influenza vaccination into their national immunization programmes have identified target age groups for vaccination targeting mainly children in the 6 23 month age group and adults in the 6+ year age group as shown in Figure 1.7. These countries will introduce approximately 5 million doses in total with India and Uzbekistan planning to introduce 25 million and 17 million doses respectively, accounting for the majority of the doses (Figure 1.8 below). While these data are encouraging, the number of Member States (22) that indicated plans to introduce seasonal influenza vaccine is relatively small. None of the AFR countries participating in the survey indicated that they had plans to introduce seasonal influenza vaccine, and it is not possible to deduce reasons behind limited importance that countries are giving this issue. However, it could be that cost and lack of reliable disease-burden data is a factor as shown by experience with the uptake of newer vaccines such as Haemophilus influenzae type b.

12 US Dollars Doses, millions Figure 1.8 Estimated seasonal influenza vaccine doses that 17 Member States (and countries/ territories) may introduce between 26 and TOTAL Years Figure 1.9: Estimated cost per dose paid by selected Member States for seasonal influenza vaccine in PAHO/RF Estimated cost per dose, as shown above, ranges from US$ 4. to US$ 8. per dose. Difference in price reflects not only different markets but also product preferences, such as pre-filled syringes versus vials. PAHO Member States, using the PAHO Revolving Fund to purchase their influenza vaccines, pay a bulk purchase price of US$ 2.66 per dose. This may be considered still too high for a resource-poor country with many other public health priorities and a limited health budget. 1.4 Pandemic influenza vaccine: forecasting the future The survey asked countries to indicate if they would purchase a pandemic influenza vaccine in the event of a pandemic. In the case of a positive reply, further details, such as target age groups, number of doses, and whether they would need assistance to purchase it, were requested.

13 Number of countries Millions of Doses Figure 1.: Pandemic influenza vaccine doses to be purchased and financed million doses (US$ 74 Million*) 3 2 Total Doses Doses to be Financed Total AFRO PAHO EMRO EURO SEARO WPRO Of respondents, 1 Member States (and countries/territories) indicated that they would purchase an influenza vaccine in the event of a pandemic. However, only 9 provided estimated number of doses required (Figure 1.). Approximately 826 million doses of a pandemic vaccine could be requested by Member States (and countries/territories) in the event of a pandemic (Figure 1.): 1 PAHO 4 million doses; EUR 4 million doses; SEAR million doses. Approximately million doses will have to be financed with the largest requests for financial support coming from SEAR Member States, which is the equivalent of US$ 74 million based on the PAHO Revolving Fund price of US$ 2.66 per dose. These estimates do not include ancillary materials (e.g. syringes). For further details on the estimated quantities of a pandemic influenza vaccine that could be required by each region see the relevant sections. Figure 1.11: Age groups to be targeted for pandemic influenza vaccination, as indicated by 75 Member States (and countries/territories) months 2-5 years 6-15 years years 5-59 years 6+ years Age Groups Seventy-five Member States (and countries/territories) identified age groups that would be targeted with a pandemic influenza vaccination (Fig. 1.11). The distribution pattern of priority groups targeted to receive pandemic influenza vaccine is very different from that for seasonal influenza programmes (see 1 The survey assumes one dose of a pandemic vaccine per person will be required to provide protection. If two doses are required, this amount will have to be doubled.

14 Fig.1.5). There is more concern over the effects of the illness on society on the part of the countries showing a more equitable approach, i.e. wider coverage of the population to include as many people as possible. This report is unable to make further comments on the issue of pandemic influenza vaccine requirements other than to state that the information requested by the survey is of crucial importance if the industry is to plan and prepare for the possible uptake of pandemic influenza vaccine doses. Therefore, it is vital that every Member State and country/territory does the groundwork necessary to manage and mitigate an influenza pandemic using a vaccine. 1.5 Discussion The prospect of increasing the use of seasonal influenza vaccine in countries that do not currently use it is not very promising. The survey showed that approximately 5 million doses could be requested by the countries who indicated that they plan to introduce it in the next four years. The survey also showed that there are some large countries that do not have routine seasonal influenza vaccination programmes private sector providers account for their uptake of seasonal influenza vaccine and most of their Expanded Programme on Immunization (EPI) vaccinations are delivered through a network of public health clinics. None of the AFR countries that responded to the survey indicated plans to introduce seasonal influenza vaccine within the next four years. Advocacy, coupled with good disease surveillance to provide data on the burden of seasonal influenza, will be necessary to provide decision-makers with information to assess the benefits of introducing seasonal influenza vaccine. Many countries with mature influenza programmes cannot provide basic information on seasonal vaccine coverage. The data are difficult to obtain in countries where the majority of seasonal influenza vaccinations are provided by the private sector. Countries where seasonal influenza vaccination coverage is under 9% of the targeted population need to focus on advocacy and create more opportunities for the targeted population to be vaccinated. The fact that 59 Member States did not reply to the survey tempers the discussion and limits the conclusions that can be drawn on the prospects of increasing the uptake of seasonal vaccine. Many countries with large populations failed to provide key information and, furthermore, the quality of the data is weakened by inconsistencies and lack of responses. In an influenza pandemic situation, low- and middle-income countries will require financial assistance to buy a pandemic vaccine. Despite having neither a routine seasonal influenza programme nor disease surveillance in place, some low-income countries indicated that they plan to target children in the 6 23 month age group, in addition to other age groups, with a pandemic influenza vaccine. Clinical trials will be necessary to demonstrate the safety of seasonal influenza vaccine in very young children.

15 Number of countries Millions of Doses 2. Survey results from the WHO African Region 2.1 Regional summary of survey results In the WHO African Region (AFR), 28 of 46 Member States (61%) responded to the survey. All respondents indicated that they a) did not have a routine programme of seasonal vaccination against influenza and b) did not plan to introduce seasonal influenza vaccine within the next four years. 2.2 Pandemic influenza vaccine: forecasting the future Figure 2.1: Pandemic influenza vaccine doses to be purchased and required financing Total Doses 4.2 million ($US7 Million)# Doses to be Financed Total Eriteria Sierra Leone Cameroon Cape Verde Togo Gambia Benin Ethiopia Zambia Madagascar Senegal Malawi Ghana # Cost estimate based on $266 per dose seasonal influenza vaccine PAHO-RF-27 # Cost estimate based on $2.66 per dose seasonal influenza vaccine PAHO- RF- 27 Of 28 Member States, 13 indicated that they would purchase a pandemic influenza vaccine and would need financial support. They would require an estimated total of 5 million doses, of which 4.2 million doses would have to be financed. Further analysis was not possible due to incomplete or inconsistent replies. Figure 2.2: Age groups that 17 AFR Member States indicated they would target for pandemic influenza vaccination months 2-5 years 6-15 years years 5-59 years 6+ years Age Groups Out of 28 AFR Member States, 17 identified age groups for pandemic influenza vaccination (Figure 2.2) showing an equitable approach to distribution. Only one Member State indicated that it would purchase enough pandemic influenza vaccine to vaccinate its entire population.

16 2.3 Conclusion Of the 28 responses to the survey not one country indicated that it would introduce seasonal influenza vaccine into its national immunization programme within the next four years. The current prospects to increase the use of seasonal influenza vaccine in the African Region are therefore not very promising. Due to the poor quality of some of the data received and lack of response from many AFR Member States, WHO cannot analyse properly the state of global pandemic vaccine preparedness in the African Region and establish a starting point for evaluating current planning on the possible use of a pandemic vaccine.

17 Millions Doses Millions Doses 3. Survey results from the WHO Region of the Americas 3.1 Regional summary of survey results The WHO Region of the Americas (PAHO) had the highest response rate (97%), with all but one Member State participating (N=34) in the survey and nine countries/territories also completing the survey. Of the 43 PAHO respondents, 28 (65%) indicated that they have routine vaccination programmes in place against seasonal influenza. There was a lower uptake of seasonal influenza vaccine in 24 than in 23 and 25 (Fig.3.1). This may be the result of a production problem with the suppliers leading to a vaccine shortage, rather than programme performance. In 25, estimated uptake for seasonal influenza vaccine was 125 million doses. Figure 3.1: Regional trends in seasonal influenza vaccine uptake in PAHO, Years Of 29 PAHO Member States (and countries/territories), 23 (77%) responded to the question and indicated that they use the northern hemisphere formulation for seasonal influenza vaccine, while seven respondents (23%) use the southern hemisphere formulation. Figure 3.2: Reported trends in seasonal influenza vaccine uptake in eight PAHO Member States Argentina Brazil Canada Chile USA Mexico Uruguay Cuba

18 Percent Covergage Figure 3.3 Seasonal influenza vaccine uptake, six largest PAHO Member States in 25 Argentina Brazil Canada Chile Mexico USA Figure 3.3 compares estimated uptake of doses of seasonal influenza vaccine for the six largest PAHO Member States that account for nearly 98% of the doses reported for 25; 4% of the total is accounted for by the US. Figure 3.4: Estimated coverage with seasonal influenza vaccine for the 5 59 and 6+ year age groups in selected PAHO Member States (and countries/territories) in Smaller Larger populations Linear (6 +) Between 24 and 25, four other countries with smaller populations introduced seasonal influenza vaccine into their programmes. Reasons for this could include: a) a regional approach to policy-making on seasonal influenza as a result of regional Technical Advisory Group (TAG) meetings; b) increased surveillance to provide decision-makers with burden-of-disease data; and c) a decrease in unit price (US$ 3. in 25, US$ 2.66 in 27) obtained by the PAHO RF for all countries, irrespective of size. Nine of the 28 PAHO respondents with routine seasonal influenza vaccination programmes in place provided coverage data for the 5 59 and 6+ year age groups in 25 (Figure 3.4). It may be inferred that countries with large populations are less likely to achieve high coverage in the older age groups (6+ years) than countries with smaller populations. It also appears to be more difficult to reach the 5 59 year cohort than the elderly. A few countries indicated that they had launched their seasonal influenza programmes in 26, so no data was available.

19 Number of countries Number of countries 3.2 Seasonal influenza vaccination policies Figure 3.5: Age groups targeted to receive seasonal influenza vaccine, 16 PAHO Member States (and countries/territories) with routine programmes months 2-5 years 6-15 years years 5-59 years 6 years + Age Groups Unlike the European Region (see Section 5), countries in the Region of the Americas appear to target children in younger age groups to receive routine seasonal influenza vaccination at a higher rate (Figure 3.5). 3.3 Introduction of seasonal influenza vaccination Nine Member States and one territory indicated their plan to introduce seasonal influenza vaccine into their national immunization programmes in the coming years. Approximately 5.4 million doses will be required by the PAHO countries which plan to introduce seasonal vaccination between 27 and 2, of which 4.7 million are accounted for by Peru alone. Children 6 23 months of age and adults over 6 years, will be targeted for seasonal influenza vaccination (Figure 3.6). Figure 3.6: Age groups targeted for seasonal influenza vaccination, as indicated by PAHO Member States (and countries/territories) that plan to introduce the vaccine between 27 and months 2-5 years 6-15 years years5-59 years 6+ years Age Groups

20 Number of countries 3.4 Pandemic influenza vaccine: forecasting the future Of 3 respondents, 28 indicated that they would purchase a pandemic influenza vaccine in the event of a pandemic, and approximately million doses would be required. Of these, an estimated 47.2 million doses would require external financing. The overall cost of doses to be financed is estimated to be US$ 126 million, excluding the cost of ancillary materials. Figure 3.7: Age groups to be targeted for pandemic influenza vaccination, by 13 PAHO Member States (and countries/territories) months 2-5 years 6-15 years years 5-59 years 6+ years Age Groups Only 13 respondents (46%) provided data on the population that would be targeted for vaccination with a pandemic influenza vaccine: two countries (Canada and the United States of America) plan to vaccinate their entire populations, while 11 would target selected groups (Figure 3.7). Those who did not provide information on the possible use of a pandemic influenza vaccine, however, include a country with a population of 15 million, thus tempering interpretability of results. 3.5 Discussion Use of seasonal influenza vaccine has been on the rise among PAHO Member States (and countries/territories). Nine Member States and one territory indicated that they plan to introduce seasonal influenza vaccine into their national immunization programmes in the coming years. In PAHO, for respondents that have recently started routine seasonal influenza vaccination and those that plan to introduce it in the near future, good disease surveillance and monitoring of coverage (particularly with respect to reaching all target groups) are necessary to properly assess and improve programme performance. Despite high regional participation in the survey, lack of or incompleteness in replies regarding planned usage of a pandemic influenza vaccine circumscribe the analysis of the state of pandemic vaccine preparedness in the Americas Region. Nevertheless, current planning is bolstered by the fairly comprehensive findings on pandemic vaccine dose and financing requirements.

21 Thousands Doses Millions Doses 4. Survey results from the WHO Eastern Mediterranean Region 4.1 Regional summary of survey results The Eastern Mediterranean Region (EMR) had 21 Member States in 26, of which 15 (71%) responded to the survey. Five of the EMR respondents (33%) have a routine vaccination programme for seasonal influenza in place. Four of these use the northern hemisphere formulation for seasonal influenza vaccine; the fifth uses both northern and southern hemisphere formulations. Two responding to the survey indicated that seasonal influenza vaccination is offered only by the private sector to pilgrims travelling to Mecca. These countries showed a remarkable increase in the seasonal influenza vaccine uptake in 25 compared to 23, more than doubling the number of doses (Figure 4.1). Figure 4.1: Uptake of seasonal influenza vaccine in the EMR, Years Figure 4.2: Uptake of seasonal influenza vaccine in six EMR Member States, Bahrain Iran Qatar Oman Syria Iraq Six Member States responding to the survey provided specific uptake data for the period (Figure 4.2). The increase in uptake is especially marked in Iran, Iraq and Qatar. Note, though, that the uptake reported by Iraq is for the private sector only. Just two respondents provided data on the age groups (5 59 and 6+ year olds) targeted to receive seasonal influenza vaccine in 25. No other data was provided on seasonal influenza vaccination policies.

22 Millions of Doses Number of countries 4.2 Introduction of seasonal influenza vaccination Five of the Member States (5%) without a seasonal influenza vaccination programme in place intend to introduce it between 27 and 2. They would collectively require 4.3 million doses during this time frame, of which 3 million are accounted for by Iraq alone. Older adults (over 5 years), adults (16 49 years), and children (6 23 months) will be the main target for seasonal influenza vaccination. Figure 4.3: Targeted age groups for seasonal influenza vaccination in five EMR Member States planning to introduce the vaccine between 27 and months 2-5 years 6-15 years years 5-59 years 6+ years Age Groups 4.3 Pandemic influenza vaccine: forecasting the future The results indicate that 13 of 15 respondents would purchase a pandemic influenza vaccine in the event of a pandemic. Of these, 9 respondents provided details on pandemic vaccine requirements: They would require approximately 16 million doses of a pandemic influenza vaccine, and 7 of the 9 countries would require external financing for 3 million of these doses (Figure 4.3). Figure 4.3: Pandemic influenza vaccine doses to be externally financed, seven EMR Member States Doses to be Financed Total Yemen Lebanon Iraq Jordan Syria Djibouti Afganistan Though one of these nine countries indicated that it would attempt to vaccinate its entire population, the remaining eight countries would target selected groups. It appears that the EMR respondents would take a fairly uniform approach to protect all segments of the population in the event of a pandemic (Figure 4.4).

23 Number of countries Figure 4.4: Age groups to be targeted for pandemic influenza vaccination, by nine EMR Member States months 2-5 years 6-15 years years 5-59 years 6+ years Age Groups 4.4 Discussion Six countries, each with a population greater than 2 million and with a combined population of approximately 274 million, did not participate in the survey. Due to the absence of such a large segment of the regional population, an analysis of the current status of seasonal influenza vaccine in the region lacks confidence. Of five Member States which currently vaccinate against seasonal influenza, there has been an impressive increase in the use of seasonal influenza vaccine in recent years. A further five countries indicated that they plan to introduce seasonal influenza vaccine into their national immunization programmes between 27 and 2. However, lack of coverage data on routine seasonal influenza vaccination from respondents prevents a proper assessment of the performance of these programmes. Improved disease surveillance and programme monitoring will be crucial to evaluate programme performance. The approximation of regional pandemic influenza vaccine requirement, at 16 million doses, is likely to be grossly underestimated, since five Member States with populations greater than 2 million either did not participate in the survey or participated but failed to provide data on pandemic influenza vaccine doses required. These five countries combined account for more than half of the region's population. Therefore, an analysis of the state of pandemic vaccine preparedness in the region is extremely limited. Nevertheless, the data provided indicate anticipation of heavy reliance on external financing, a finding which should prompt urgent planning.

24 Millions Doses Millions Doses 5. Survey results from the WHO European Region 5.1 Regional summary of survey results The European Region (EUR) had a fairly high response rate (75%), with 4 of 53 Member States participating in the survey. Of these, 31 (78%) indicated routine vaccination programmes in place for seasonal influenza. All but one (97%) use the northern hemisphere vaccine formulation. The region experienced a progressive uptake of seasonal influenza vaccine from 23 to 25 (Figure 5.1). It is worth noting that 9% of the region's 78 million doses reported for 25 were consumed by just countries. Germany and the Russian Federation account for approximately half the total estimated uptake; Spain and the United Kingdom together account for another 25%. Data from eight respondents provide details for this period, with five confirming a progressive increase in uptake (Figure 5.2). Figure 5.1: Uptake of seasonal influenza vaccine in the EUR, Years Figure 5.2: Uptake of seasonal influenza vaccine in eight EUR Member States, Romania Spain U.K. Sweden Russia Hungary Germany Netherlands

25 Number of countries Percent Covergage A majority of respondents with seasonal influenza vaccination programmes in place did not have coverage data for 25; nine countries (27%) provided this data for 5 59 and 6+ year age groups (Figure 5.3). As in PAHO, it appears that countries with large populations are less likely to achieve high coverage in older age groups (6+ years) relative to smaller countries. Figure 5.3: Estimated seasonal influenza vaccine coverage for 5 59 and 6+ year age groups, nine EUR Member States, Smaller Larger populations Linear (6 +) 5.2 Seasonal influenza vaccination policies Of the 31 respondents with seasonal influenza vaccination programmes in place, 2 (65%) provided data on the age groups targeted in 25. It is evident that in most European countries the elderly (6+ years) are a priority target group. This is in contrast to PAHO (see Chapter 3), where younger age groups are targeted for routine seasonal influenza vaccination at a higher frequency. Figure 5.4: Targeted age groups for seasonal influenza vaccination, 2 EUR Member States, months 2-5 years 6-15 years years 5-59 years 6+ years Age Groups

26 Millions of Doses Number of countries 5.3 Introduction of seasonal influenza vaccination Of the nine participating countries without seasonal influenza vaccination programmes in place, three indicated plans to introduce a programme between 27 and 2. Uzbekistan would introduce approximately 17 million doses by 27, while Armenia and Croatia indicated that they would introduce 1.5 million and 7, doses, respectively, without providing a time frame. No information was provided on intended seasonal influenza vaccination policies. Figure 5.5: Targeted age groups for seasonal influenza vaccination in two EUR Member States planning to introduce the vaccine between 27 and months 2-5 years 6-15 years years 5-59 years 6+ years Age Groups Only two of five countries identified age groups for the introduction of seasonal influenza vaccine in their countries (Figure 5.5) with people of 6 months to 15 years of age and the elderly (6+) being the main target groups. 5.4 Pandemic influenza vaccine: forecasting the future Among the respondents, 33 countries in the region indicated that they would purchase pandemic influenza vaccine in the event of a pandemic. Of these, 26 countries estimated that, together, they would require approximately 268 million doses. An estimated 59 million of these doses (23%) would need to be externally financed for 17 countries, almost 8% of which would be destined for Belarus, Romania, Ukraine, and Uzbekistan (Figure 5.6). Figure 5.6: Pandemic influenza vaccine doses to be externally financed in 17 EUR Member States Estimated doses to be financed Uzbeksistan Belarus Ukraine Georgia Kazakhstan Turkmenistan

27 Number of countries Four countries did not indicate target populations for pandemic influenza vaccination; a few indicated that they were in the process of deciding or would wait for data on the epidemiology of the pandemic virus before determining the segments of the population to vaccinate. Of the 23 respondents to this question, nine indicated that they would target their entire population, while 15 would target selected groups. Of these, 23 respondents provided detailed data on the age groups they would target (Figure 5.7). Compared with the distribution of priority groups targeted to receive seasonal influenza vaccination (Figure 5.4), it appears that responding countries in the region plan to target all segments of the population uniformly. Figure 5.6: Targeted age groups for pandemic influenza vaccination, by 23 EUR Member States months 2-5 years 6-15 years years 5-59 years 6+ years Age Groups 5.5 Discussion Survey results from the European Region indicate that use of seasonal influenza vaccine is rising in 31 Member States that currently have seasonal influenza vaccination programmes, and three additional countries plan to introduce it in the coming years. This finding is not necessarily undermined by the lack of participation: it is known that many of the 13 Member States which did not participate in the survey do use seasonal influenza vaccine. On the basis of survey responses alone, though, robust conclusions on the current and future use of seasonal influenza vaccine in the region cannot be made confidently. It is surprising that the majority of respondents with seasonal influenza vaccination programmes in place could not provide coverage data or information regarding target groups. Disease burden surveillance and programme monitoring are strongly advisable to achieve optimal performance. The approximation of 268 million doses as a regional pandemic influenza vaccine requirement is a useful start for analysing the state of pandemic vaccine preparedness in the region. It underestimates the true demand, since five Members States in the region with populations greater than 5 million either did not participate in the survey or participated but failed to provide data on pandemic influenza vaccine doses required. Nonetheless, pandemic influenza planning should already be undertaken in the region, especially in the four Member States which most strongly anticipate the need for external financing.

28 Number of countries 6. Survey results from the WHO South-East Asia Region 6.1 Regional summary of survey results Five (46%) of the 11 Member States in the South-East Asia Region (SEAR) participated in the survey, while six with an estimated total population of more than 1 million did not. None of the respondents indicated that they currently have a routine vaccination programme for seasonal influenza. 6.2 Introduction of seasonal influenza vaccination One respondent, India, indicated that it plans to start seasonal vaccination in 29 and would require 25 million doses per year from then on. It plans to target young children aged from 6 months to 5 years old and adults 6+ years for seasonal influenza vaccination. 6.3 Pandemic influenza vaccine: forecasting the future All five respondents indicated interest in purchasing pandemic influenza vaccine, but two did not estimate the number of doses required in the event of an influenza pandemic. The remaining three countries would require an estimated total of 112 million doses. All replied that they would need financial support to purchase a pandemic influenza vaccine, which would cost approximately US$ 298 million (US$ 2.66 per dose). Very young children would be targeted at a slightly higher frequency than the other age groups (Figure 6.1). Figure 6.1: Targeted age groups for pandemic influenza vaccination in three SEAR Member States months 2-5 years 6-15 years years 5-59 years 6+ years Age Groups 6.4 Discussion One of the five countries that responded to the survey indicated that it would introduce seasonal influenza vaccine into its national immunization programme within the next four years. WHO believes that the introduction of seasonal influenza vaccine, coupled with good disease surveillance, could provide data that might encourage other countries in the region to introduce it. However, for a region with a population of over 1.7 billion, the forecasted demand for seasonal influenza vaccine is relatively low. Moreover, three Member States with populations greater than 2 million either did not participate in the survey or did not quantify possible use of a pandemic influenza vaccine. This limits the discussion on pandemic influenza vaccine requirements and on potential uptake in the region as a whole in the event of a pandemic.

29 Millions Doses 7. Survey results from the WHO Western Pacific Region 7.1 Regional summary of survey results The survey response rate among Member States in the Western Pacific Region (WPR) was 12 out of 27 (44%), though an additional three countries and territories also completed the survey. Of the 15 total respondents, (66%) indicated that they have routine vaccination programmes in place against seasonal influenza, nine of which disclosed what vaccine formulation is used by their programmes: five use the northern hemisphere formulation, two use the southern, and two use both. Four respondents in the region provided data on uptake of seasonal influenza vaccine for the period 23 25, showing a total estimated uptake of 57.6 million doses in 25 (Figure 7.1). Japan accounts for almost two-thirds of these reported doses and demonstrates a progressive increase in uptake over the period with the other three respondents (Australia, Korea, and New Caledonia) showing a relatively constant uptake during the period. Other WHO sources indicate that China consumes approximately 14 million doses of seasonal influenza vaccine per year; however, this data is not analysed because China did not provide this information in the survey. Figure 7.1: Seasonal influenza vaccine uptake, four WPR Member States (and countries/territories), Republic of Korea Australia New Caledonia Japan * New Caledonia indicated that 25, were purchased each year for 23, 24, & 25 Only three respondents in the region indicated vaccine coverage for the 6+ year age group in 25 these estimates ranged from 65% and 8% (both relatively populous Member States), to % coverage (a small territory). One of these three also indicated an estimated coverage of 35% of its 5-59 year age group. 7.2 Seasonal influenza vaccination policies Data for 25 provided by seven respondents on the age groups targeted to receive seasonal influenza vaccination indicate that the elderly (6+ years) are prioritized most often, followed by young children, 6 23 months old (Figure 7.2).

30 Number of countries Number of countries Figure 7.2: Age groups targeted for seasonal influenza vaccination, as indicated by seven WPR Member States (and Countries/territories), months 2-5 years 6-15 years years 5-59 years 6+ years Age Groups 7.3 Introduction of seasonal influenza vaccination Four Member States and two countries and territories indicated that they plan to introduce seasonal influenza vaccination into their national immunization programmes between 27 and 2 with an estimated annual requirement of approximately 232, doses per year, of which 22, doses are accounted for by Malaysia. Five of six Member States and countries and territories provided information on the age groups they would target one would distribute it equally to all age groups, the other would target the youngest groups (6 23 months and 2 5 years) groups while one indicated that it would only target health workers (Figure 7.3). Figure 7.3: Age groups to be targeted for seasonal influenza vaccination, as indicated by five WPR Member States that plan to introduce the vaccine between 27 and months 2-5 years 6-15 years years 5-59 years 6+ years Age Groups

31 Number of countries Thousands of Doses 7.4 Pandemic influenza vaccine: forecasting the future Eleven of 15 responding countries in the region indicated that they would purchase pandemic influenza vaccine in the event of a pandemic (73%). Six of these 11 countries indicated that they would require a total of 5.5 million doses with five requiring financial assistance, of which 4.5 million doses would be destined for Singapore (Figure 7.4). Figure 7.4: Externally financed pandemic influenza vaccine doses, as indicated by six WPR Member States (and Countries/territories) 5.5 million doses 4.5 million Estimated doses to be financed Cook Island New Caledonia Guam Samoa Mongolia Singapore Eight countries identified target groups for pandemic vaccination: six would target their entire populations and two, segments of the population. Distribution by age group targeted for pandemic influenza vaccination is fairly uniform (Figure 7.5), in contrast with the distribution for seasonal influenza vaccination (Figure 7.2). This attempt to protect all segments of the population equally is largely on par with the findings from other regions. Figure 7.5: Age groups that would be targeted for pandemic influenza vaccination, by eight WPR Member States (and countries/territories) months 2-5 years 6-15 years years 5-59 years 6+ years Age Groups

32 7.5 Discussion Four Member States and two territories that do not currently have seasonal influenza vaccination as part of their national immunization programmes indicated that they plan to introduce it in the coming years. Evidence from Japan points to progressive increases in the use of seasonal influenza vaccine, however, due to limited data on vaccine coverage as well as lack of information from 15 Member States (with a combined total population of 32 million) that did not participate in the survey, it is not possible to draw conclusions on the current and future use of seasonal influenza vaccine in the region. The overall quality of the data suffers from the lack of replies to some questions and general inconsistencies. Indeed, six Members States with populations larger than 2 million each (and a combined total population of 1.5 billion) either did not reply to the WHO survey or did reply but did not quantify possible use of a pandemic influenza vaccine. As such, WHO cannot make a definitive analysis of the state of pandemic vaccine preparedness in the region thereby limiting discussion on pandemic influenza vaccine requirements and on potential uptake in the region in the event of a pandemic.

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