Generating evidence for Guatemalan . . Generating evidence for Guatemalan decision-makers about the introduction of new vaccines in the public health sector Good afternoon I am happy to be here with you today to share with you our experience and our efforts in developing evidence for Guatemalan decision-makers about the introduction of new vaccines Rodrigo Rodríguez, MD MPH; Ana Elena Chévez, MD MPH; Joaquín Molina, Guatemala PWR

Guatemala´s Core Health Data National Health expenditure: 2007: 0.9 % of GDP Infant mortality rate: 2002: 39 / 1000 Live Births Maternal mortality rate: 2006: 128 / per 100,000 Live Births (MoH) Guatemala, located in Central America, and bordered by Mexico, Honduras and El Salvador, is a developing country with one of the lowest expenditures in health in the Americas, and with one of the highest rates of infant and maternal mortality.

Year of introduction of MMR vaccine 40´s Commercialization 80´s Uruguay (82) Cuba (86) Costa Rica (87) 90´s Chile (90) Colombia (95) Belize (96) Argentina (97) Honduras (97) Nicaragua (98) Mexico (98) Venezuela (98) El Salvador (99) Ecuador (99) 00´s Brazil (00) Bolivia (00) Guatemala (01) Peru (03) Dominican Republic (04) This low health expenditure helps explain why the MMR vaccine was not introduced in Guatemala until the year 2001, one of the last countries in the region.

Year of introduction of Hib 90´s Commercialization 90´s Mexico (98) Chile (96) Uruguay (99) Nicaragua (99) Peru (99) 00´s Costa Rica (00) Honduras (00) Panamá (00) Bolivia (00) Colombia (01) Dominican Republic (01) Brazil (02) Belize (02) El Salvador (02) Paraguay (02) Ecuador (03) Venezuela (04) Guatemala (05) In regards to the HiB vaccine, you can see that the introduction of the vaccine in Latin America began in the late 90´s, and that Guatemala was the last country in the region to introduce the vaccine.

Year of introduction of seasonal influenza vaccine Commercialization 70´s Chile 90´s Argentina (93) Mexico (98) Uruguay (98) Chile (96) Uruguay (99) Nicaragua (99) Peru (99) Brazil (99) 00´s Honduras (03) Mexico (04) Costa Rica (04) El Salvador (04) Panama (05) Colombia (05) Paraguay (05) Nicaragua (06) Ecuador (06) Venezuela (06) Guatemala (07) The flu vaccine will be introduced in Guatemala this December within the elderly and health personnel

Introduction of Rotavirus vaccine in Latin America Rotavirus vaccine has been introduced Rotavirus vaccine has NOT been introduced A similar situation has occurred with the rotavirus vaccine. This vaccine has already been introduced in 7 countries in the region, including El Salvador, Nicaragua and Panama in Central America, but Guatemala has still not introduced the vaccine.

Objectives General To provide technical and programmatic information to support the decision making process in the introduction of new vaccines of recognized effectiveness Policy decision Program Issues Financing Priority Cost-effectiveness Taking into account this situation that Guatemala has lagged in the introduction of new vaccines in comparison with other countries in the region, our general objective is to support the decision making process in the introduction of new vaccines. Vaccine Burden Performance WHO Vaccine Introduction Guidelines

Objectives Specific To reduce the time that passes between the certification of a new vaccine by WHO and UNICEF and its introduction in a developing country To reduce the gap between developed and developing countries in relation to the number of vaccines available To develop a baseline in order to measure the impact and effectiveness of the introduction of a new vaccine Our objectives include reducing in the amount of time between the certification of new vaccines and their introduction in a developing country such as Guatemala, reducing the gap between the number of vaccines available in developed countries and those available in Guatemala and developing a baseline to measure the impact of new vaccines.

Activities PAHO has been involved in: Estimation of disease burden Economic analysis Evaluation of cold chain storage capacity Within the immunization unit of PAHO we are providing technical support and leading national and regional collaborative efforts, so that there is evidence available to countries like Guatemala when making decisions about the introduction of new vaccines. Some of the topics we have been working on include: conducting disease burden evaluations, carrying out economic analyses and a diagnosing the cold chain storage capacity.

Rubella and CRS in Guatemala Active surveillance since 1999 Retrospective study (2005) 210 CRS suspicious cases 45 CRS compatible cases 5 CRS confirmed cases Treatment and rehabilitation cost of expected cases : US$ 151 million Seroprevalence study (2005) Seroprevalence ~ prevaccine era Cold chain inventory Rubella immunization campaign (2007): 99% of immunization coverage among men and women 9 – 39 years Now, getting to the point about what has been done in Guatemala and some of the results. In 1999 Guatemala began integrating the surveillance of rubella into their surveillance of measles. In 2005 a retrospective study of CRS was carried out in five hospitals. This study showed that between 2000 and 2004 there were 210 suspicious cases, 45 compatible cases and 5 confirmed cases.. The treatment and rehabilitation costs of the expected cases in Guatemala for the next 15 years has been calculated to be 151 million dollars. Two seroprevalence studies in 2005 showed that the seroprevalence in Guatemala was similar to that before the vaccine was introduced in developed countries. A cold chain analysis demonstrated that the country had sufficient storage capacity to store the 9 million doses of MR required for the national immunization campaign. Taking this evidence into consideration, the Ministry of Health decided to carry out the rubella and congenital rubella elimination campaign in April and May of this year. At the end of the campaign 99% of the target population was vaccinated.

The Influenza Vaccine in Guatemala 2006: Influenza surveillance 2007: FLUNET member (Global Influenza Surveillance Network) 2007: Influenza vaccine introduction in December In regards to the influenza vaccine, in 2006 the country started strengthening the capacity of the laboratories and the national influenza surveillance. This year the country became a member of FLUNET. And during the past two years we have been sharing with the National Immunization Program in Guatemala and the National Center of Epidemiology the experiences and impact of the introduction of this vaccine in other countries in the region. Guatemala will introduce the flu vaccine in December of this year.

Rotavirus Indicators of Rotavirus Hospital-based Surveillance. Guatemala 2005 - 2007 Indicators 2005 2006 2007* Number of hospitalizations in children <5 years 18,568 15,380 12,993 Hospitalizations due to diarrhea in children < 5 years 2,502 (13.5%) 2,905 (13.6%) 2,135 (16.4%) Children <5 years that meet the case definition 1,391 (55.6%) 1,483 (51.0%) 903 (42.3%) Children < 5 years with report form and stool sample collected 1,035 (74.4%) 1,197 (80.7%) 823 (91.1%) Confirmed rotavirus cases 616 (59.5%) 623 (52.0%) 348 Due to financing support for PCR equipment & kits, as well as lab training and the establishment of hospital-based surveillance, Guatemala has been measuring rotavirus regional indicators since 2005. We now have data that shows that every year more than 2,000 children under five are hospitalized with diarrhea in the five hospitals where surveillance has been established. Around 50% of these cases meet the rotavirus diarrhea case definition. A stool sample was collected for over 70% of those cases that meet the case definition. We now know that in these five hospitals a combined total of 600 rotavirus cases are received every year. * September 2007

Rotavirus incidence. Guatemala, 2005 - 2007 2005 2006 2007 G9P8 G1P8 G3P8 G2P8 G2P4 G2/9P8 G2/9P4/8 Number of cases We have also learned about which kind of rotavirus genotypes have been circulating in the country over the past two years. In 2005 the G9P8 genotype was the most frequently isolated. In 2006 it was the G2P8 genotype. We still haven't received information for 2007. Positive cases Suspected cases

Regional Vaccine System (SIREVA) Argentina, Brasil, Colombia, Chile, México, Uruguay Bolivia, Ecuador, Perú, Paraguay, Venezuela, Guatemala, El Salvador, Nicaragua, Honduras, Costa Rica, Trinidad y Tobago Panamá, República Dominicana y Cuba Through the application of PAHO´s practical guide for the surveillance of the bacterial pneumonia and meningitis in children under 6, Guatemala has become part of the Regional Vaccine System. Along with Guatemala, 19 countries in the region, 2 sub regional labs in Brazil and Colombia and one regional reference lab in Canada are participating. 20 Countries, 2 Sub regional Labs & 1 Regional Reference Lab

Streptococcus Serotypes Isolated in Children under Six. Guatemala, 2000 - 2005 Year Total 2000 2001 2002 2003 2004 2005 n % 36 38 41 49 37 46 247 100% Becoming a member of SIREVA has enabled Guatemala to isolate and characterize the most frequent streptococcus serotypes. We have been able to prove that the heptavalent pneumococcus vaccine makes up 52.8% of the serotypes that are currently in circulation. SIREVA. II Regional Report. 2000-2005

In the case of the human papillomavirus PAHO is supporting the analysis of the situation of Cervical Cancer in Latin America and the Caribbean. The PAP coverage is low due to limited access to health services and cultural barriers. Therefore the vaccine would be a good intervention in addition to improving the PAP program. But the cost of the vaccine complicates the introduction of this vaccine.

Conclusion There have been advances in the documentation of rotavirus Guatemala has purchased the seasonal influenza vaccine A cost-effectiveness study of the rotavirus vaccine is in process The cold chain storage capacity is not sufficient to introduce new vaccines Information now available for decision makers about the introduction of new vaccines Policy decision Program Issues Financing Priority Cost-effectiveness - In conclusion we can say that without any doubt there is already some evidence which should be considered by Guatemalan decision-makers when making decisions about the introduction of new vaccines. However, we believe that there is much more that needs to be done in order to keep building evidence about the introduction of new vaccines IN GUATEMALA AND IN THE REGION IN GENERAL. Vaccine Burden Performance WHO Vaccine Introduction Guidelines

Recommendations Increase the cold chain storage capacity before introducing new vaccines Carry out economic studies for other vaccines, especially seasonal influenza and neumococal invasive diseases Design a lobbying strategy for legislators, health authorities, political leaders and communicators. As Recommendation- Increase the cold chain storage capacity before introducing new vaccines - Carry out economic studies for other vaccines, especially seasonal influenza and neumococal invasive diseases - Design a lobbying strategy for legislators, health authorities, political leaders and communicators.

Acknowledgements Guatemalan Ministry of Health National Immunization Program (PNI) National Health Laboratory National Epidemiology Center (CNE) Hospitals Guatemalan Social Security System (IGSS) Canadian International Development Agency (CIDA) Center for Disease Control and Prevention (CDC) Swedish International Development Cooperation Agency (ASDI/SIDA) Social Security and Public Sentinel Hospitals in Guatemala Kathryn Janzen, PAHO Guatemala We would like to thank all of the national and international institutions and organizations who are supporting PAHO´s goal to generate scientific evidence for Guatemalan decision-makers.

Thank you for your attention. Any questions?? Rubella Immunization Campaign. Health Center in San Vicente Xenacoj, Momostenango, Totonicapán