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The Policy for the Introduction of New Vaccines in Brazil

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The Policy for the Introduction of New Vaccines in Brazil Case Study: The Policy for the Introduction of New Vaccines in Brazil CARLA MAGDA ALLAN SANTOS DOMINGUES, ANTÔNIA MARIA TEIXEIRA, AND SANDRA MARIA DEOTTI CARVALHO 2 Case Study: The Policy for the Introduction of New Vaccines in Brazil Case Study: The Policy for the Introduction of New Vaccines in Brazil Carla Magda Allan Santos Domingues National Immunization Program — Ministry of Health, Brazil Antônia Maria Teixeira National Immunization Program — Ministry of Health, Brazil Sandra Maria Deotti Carvalho National Immunization Program — Ministry of Health, Brazil Introduction The National Immunization Program (NIP) of the Ministry of Health (MoH) of Brazil was created in 1973, and the first national immunization schedule was published in 1977 with four mandatory vaccines in the first year of life (tuberculosis, poliomyelitis, measles, and DTPw [diphtheria, tetanus and pertussis]).1 During this time, vaccine production in the country was going slowly. The private sector considered that the national vaccine market was limited in contrast to other areas within the pharmaceutical sector, given its low profitability as compared to other profitable lines of business within the sector. This was a discouragement for the entry of private vaccine manufacturers to the national vaccine market.2 Despite the institutional effort to maintain the flow of supplies offered by the PNI, a significant crisis erupted in connection with the shortage of immunobiologicals as a result of the closure of Sintex of Brazil that was a privately-owned foreign-capital company that addressed the demand for products such as sera and the DTP vaccine. So, in 1985, the need for such products demanded the creation of the National Program for Self- Sufficiency in Immunobiologics (PASNI). With PASNI, the MoH sought to establish coordinated actions by stimulating investments and improving the quality of the production between the national vaccine manufacturers: Instituto Butantan (São Paulo), Instituto de Tecnologia em Imunobiológicos Bio-Manguinhos/Fiocruz and Instituto Vital Brazil (Rio de Janeiro), Instituto de Tecnologia do Paraná (TECPAR) (Paraná), and Fundação Ezequiel Dias (Minas Gerais). PASNI led to the expanding production of sera and vaccines in the Brazilian market aiming to meet the NIP’s1 demands and allowing for an increased supply of vaccines for other population segments other than just infants under one year of age.3 VACCINOLOGY IN LATIN AMERICA IN LATIN VACCINOLOGY Domingues, Teixeira, and Carvalho 3 Current Situation Presently, Brazil is one of the countries that offers the highest number of vaccines distributed free of charge as part of a defined schedule covering all age groups. The immunization schedule for children includes 14 vaccines, for adolescents and adults it includes five vaccines, and for older adults it includes four vaccines (Table 1). Table 1. National Immunization Schedule, 2018 CHILDREN ADOLESCENTS AND ADULTS 1. BCG 1. Hepatitis B vaccine 2. Hepatitis B vaccine 2. Td (Tetanus, Diphtheria) 3. Pentavalent vaccine (DTP/Hib/Hep B) 3. Yellow Fever vaccine 4. IPV (Inactivated poliovirus vaccine) 4. MMR (Measles, Mumps & Rubella) 5. OPV (Oral poliovirus vaccine) 5. Tdap (pregnant women) 6. RV (Human-attenuated oral rotavirus vaccine) 6. Influenza vaccine 7. PCV-10 (10-valent pneumocccal vaccine) 7. HPV (Human papillomavirus vaccine) 8. Yellow Fever vaccine 8. MenC (Meningococcal C conjugate vaccine) 9. MMR (Measles, Mumps & Rubella vaccine) 10. DTP (Diphtheria, Tetanus & Pertussis vaccine) 11. MenC (Meningococcal C conjugate vaccine) OLDER ADULTS 12. Influenza vaccine 1. Influenza vaccine 13. MMRV (Measles, Mumps, 2. PCV-23 (23-valent pnemococcal Rubella & Varicella vaccine) polysaccharide vaccine) 14. Hepatitis A vaccine 3. Td (Tetanus, Diphtheria) 4. Yellow Fever vaccine 5. Hepatitis B vaccine Personalized immunization schedules are available for the indigenous populations and for groups under special conditions such as immunodeficiencies at the Reference Centers for Special Immunobiologicals (CRIE). In total, NIP purchases 45 types of immunobiologicals (including vaccines, sera and immunoglobulins) and every year an estimated 300 million doses are distributed. As the immunization schedule expansion request is increasing every day, the MoH has adopted new criteria for the introduction of new vaccines. This policy implementation has guaranteed an efficient and quick expansion still in observance of the regulations for immunization actions throughout the country. So, the introduction of new vaccines relies on an epidemiological criterion which considers the population needs to reduce morbidity and mortality rates for a specific disease. In addition, other aspects are considered as the vaccine itself (immunobiological factors) as well as the operational, socioeconomic, technological, financing and legal factors.4 4 Introduction Sustainability of National Production The MoH sustainability policy is based on the strengthening of the national health industrial park, where the main strategic supplies must be produced by the public laboratories. This action guarantees the self-sufficiency of national production, avoids product shortages and any restrictions due to market forces besides the maintenance of high vaccination coverages in all Brazilian municipalities. Two main mechanisms were adopted to foster national production: the incentivization of development of national products and the identification of partnership (private manufacturers) with the purpose of technology transfer to the Brazilian’s public manufacturers. These actions have enabled the national production of all the main strategic supplies. In this context, the introduction of new vaccines favors and implements the policy of supporting financial investments in the public vaccine manufacturers, strengthens the national market, decreases import costs and benefits the national trade balance in Brazil. This complex process involves several social actors from various other sectors besides the MoH. This policy has guaranteed the provision of vital strategic inputs and so the NIP has efficiency contributed to the control, elimination and eradication of vaccine-preventable diseases. In the event that acquiring immunobiologicals from the national producers is not possible, the acquisition of these inputs is sought by the Revolving Fund for Strategic Public Health Supplies that was created in 2000 by the Pan American Health Organization (PAHO) as a request of the Member States. This initiative was intended to facilitate the purchasing and access of medicines and strategic supplies and by facilitating low cost procurement on behalf of the Member States. The chance of acquiring immunobiologicals through the Revolving Fund has made it possible to guarantee the NIP’s supply of the needed inputs, especially for those inputs in which there are no established technology transfer partnerships or in situations where national production does not meet the country demand.5 New vaccines introduction demands additional resources which requires a budget proposal and the approval by the National Congress. The States and municipalities also need to allocate resources to guarantee the payment of human resources, the logistics of storage and distribution of the immunobiologicals and the acquisition of needles and syringes supplies. Once this additional budget has been approved, there is an annually guaranteed allocation of funds (Law 12.919 of 12/24/2013) as a mandatory action, which does not allow contingency of this action. Furthermore, the inclusion of a new vaccine in the National Immunization Schedule requires consideration of the cold chain networks capacity at all the three government levels (national, state and municipal). For this, a structured cold chain network is essential from the manufacturer to the vaccination room, with responsibilities defined by the receipt, storage and distribution of the immunobiologicals. The MoH maintains the National Center for Storage and Distribution of Inputs — CENADI, responsible to receive all the national and international products purchased by NIP and to distribute them to the States and the Federal District where they are stored in central cold chains for redistribution to regional and/or municipal centers, and from there to the vaccination rooms. The MoH has been putting in its investment plan the restructuring of this network as a priority action. However, it is an extremely expensive and complex process that demands effort and financial resources. Between 2006 and 2015, an additional eight new vaccines were introduced in the National Immunization Schedule and even some conjugated vaccines already included in the schedule. Such vaccine additions have reduced the total number of vaccines in the national schedule without impacting the number of diseases VACCINOLOGY IN LATIN AMERICA IN LATIN VACCINOLOGY Domingues, Teixeira, and Carvalho 5 targeted for prevention, such as the pentavalent vaccine (diphtheria, tetanus, pertussis, Haemophilus influenzae type b and hepatitis B vaccine). During the same period the following vaccines were introduced into the National Immunization Schedule for children: oral rotavirus vaccine (2006)6; 10-valent pneumococcal vaccine (2010); meningococcal serogroup C conjugate vaccine (2010)7; DTP/Hib/HB vaccine (2012); inactivated polio vaccine (2012) as part of the sequential schedule with the oral polio vaccine (OPV)8; tetravalent measles-mumps-rubella-varicella (MMRV) vaccine (2013); and the hepatitis A vaccine (2014). In 2014,
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