Rev. Inst. Med. Trop.

Sao Paulo
54(Suppl. 18):S22-S27, October, 2012

NATIONAL IMMUNIZATION PROGRAM: VACCINATION, COMPLIANCE AND PHARMACOVIGILANCE

Carla Magda Allan S. DOMINGUES(1,2), Antonia Maria da Silva TEIXEIRA(1) & Sandra Maria Deotti CARVALHO(1)

The vaccine is one of the main control measures available for a major diseases was the subject of pressure in the sector. A remarkable fact was
portion of infectious and transmissible diseases. It stands out as one of an epidemic of meningococcal meningitis that spread in the country in
the great discoveries of public health for the benefit of the population. the mid 70’s, the so-called “epidemic under censorship”. The insufficient
doses of vaccines in the country and of the capacity to import vaccine
In Brazil, more than two centuries have passed since the first time doses to attend the population, made the current military government to
(1804) the vaccine was administered as a control measure to prevent prevent any disclosure of the fact in the media. However, this was only
smallpox. Exactly a century later (1904), an epidemic of this disease possible while the occurrence of cases did not reach different social strata
led the President of the Republic Rodrigues Alves, to establish the of the population; when this began to occur, the information reached
obligation of the vaccination. In the same year, the hygienist Osvaldo the media, which generated population pressure on the government3,4.
Cruz coordinated the mass vaccination of the Rio de Janeiro`s population
in order to control the epidemic. This movement generated a historical Despite these contrasts, it was in this context that important
episode known as “The Vaccine Revolt” characterized by population advances occurred regarding the organization of the structure and
rebellion and rejection to the measure adopted, culminating in the actions of immunization in Brazil. In the early 70’s (1973) the National
suspension of mandatory vaccination1,2. Immunization Program (NIP) was created linked to the National Division
of Epidemiology and Health Statistics of the Ministry of Health. This
In this same century (XX), especially in the first half, epidemics aimed to arrange in a single sector immunization activities formerly
of several diseases had been occurring in the country. It was also the structured in isolated programs of disease control, especially the
moment that began the production and/or introduction of new vaccines vaccination campaign against smallpox and the National Plan for the
in the country, when the first positive results appeared in control of Control of Poliomyelitis (PNCP). It was regulated by Decree 78.231 of
some epidemics, elimination and eradication of diseases. Among the August 1976 and was the first official immunization schedule published
accomplishments of that time includes the introduction of yellow fever in 1977 by Ministerial Decree nº 452/1977 setting out the mandatory
vaccine in 1937 with the interruption of urban-form disease transmission vaccines for children under one year old: tuberculosis, poliomyelitis,
five years later (1942); the introduction of diphtheria-tetanus toxoids- measles, diphtheria, tetanus and pertussis.
cellular pertussis vaccine (DTP), tetanus toxoid (TT) in 1950 for the
prevention of tetanus, diphtheria and pertussis, diseases considered The 80’s were characterized by the creation of the National Institute
under control. for Quality Control in Health (INCQS) in 1981, the National Center for
Distribution and Storage (Cenade), in Bio-Manguinhos/Fiocruz in 1982
Early in the second half of that century poliomyelitis vaccine was and the National Self-Sufficiency Program in Immunobiologics in 1985.
introduced with the first mass vaccination campaign conducted in the They were intended to garantee the quality of the vaccines offered to the
cities of Petrópolis, state of Rio de Janeiro (RJ) and Santo André, state of population, to strengthen the capacity of production and self-sufficiency
São Paulo (SP) in 19611 and also monovalent measles vaccine deployed in by the national laboratories1,5,6.
1967 and 1968, and that disease is currently in the process of certifying
their eradication in the country. Another achievement was regarding poliomyelitis. The last case was
reported in Brazil in 1989. Factors such as the National Poliomyelitis
Regarding to smallpox, the last case reported in Brazil occurred in Control Plan established in 1971, the introduction of the oral poliomyelitis
1971 and the international certification of eradication was granted by vaccine (OPV) from 1974 and the adoption of mass vaccination national
the World Health Organization – WHO in 1973. The global eradication days in 1980, led to the second major victory in the field of immunization.
stood out as the first major victory for the public health. The disease has been certified as eradicated as the circulation of wild
viruses in the Americas in 19941,7.
During this period, if on the one hand successes were already seen by
the use of vaccines for control, elimination and eradication of diseases, Until then, NIP aimed to target primarily the pediatric population.
on the other hand, the lack or insufficient products to combat other However, with the expansion of the capacity of vaccine’s manufacturers,

Presented at the I International Symposium on Dengue of the School of Medicine University of São Paulo on October 6, 2011.
(1) Secretariat of Health Surveillance, Ministry of Health, Brasília, DF, Brazil;
(2) Center for Tropical Medicine, University of Brasília, Brasília, Brazil.
DOMINGUES, C.M.A.S.; TEIXEIRA, A.M.S. & CARVALHO, S.M.D. - National immunization program: vaccination, compliance and pharmacovigilance. Rev. Inst.Med. Trop. Sao Paulo,
54(Suppl. 18), S22-S27, 2012.

the epidemiological surveillance and improvement in vaccination coverages this had been extended to children and adolescents up to the age of 19
allowed the reduction of vaccine-preventable diseases’ incidence; new years across the country.
products have been gradually incorporated into the list of immunobiological
products already available. New vaccines were included and new It is noteworthy that, in general, the introduction of new vaccines
immunization schedules were published boosting the supply of existing in the country is based on epidemiological, economic, safety, efficacy
vaccines for other target groups in the national schedule. and logistic criteria. Studies of cost-effectiveness are important to help
prioritize the deployment of vaccines demonstrating the interest of NIP
Still at the end of the last century, in the early years of the 90’s, to make decision based on scientific evidence. Currently, NIP offers 44
hepatitis B vaccination has been initiated in areas of high endemicity. different types of immunobiological products, including vaccines and
Than in 1996, new strategies were defined in relation to hepatitis B homologous and heterologous sera.
vaccination. This should target children under one year of age throughout
the country and extend to those under 15 years old in the Legal Amazon, In accordance with the principles of universality and fairness of the
Santa Catarina, Espírito Santo and Federal District. Unified Health System (SUS), the Ordinance 1,946/2010 regulates a
different schedule for indigenous population that, given the increased
Since 1999, immunization with seasonal influenza vaccine was vulnerability of this population to disease, get benefits from products
initiated for the elderly from 65 years of age and, in the following year, not yet routinely available to the general population. Therefore, in
was extended to the elderly from 60 years of age. In that same year 1993 the implementation of the Special Immunobiologicals Reference
(1999), the combined diphtheria and tetanus toxoids vaccine (dT) began Centers (CRIES) was initiated. It consists of 42 vaccine rooms that
to compose the national immunization schedule for the population from offer immunobiologicals for people with special medical conditions,
the age of seven, replacing the tetanus toxoid. not available in the routine immunization services; also, these are
considered reference centers to manage serious adverse events following
In 2004, Ordinance 457/2004 established rules to the immunization immunization (AEFI).
schedules in a life cycle: children; adolescents; adults and elderly subjects,
thus demonstrating that the vaccine in the country was already in fact Regarding the history of organizational structure, NIP was bound
an input available to the whole family. This included definitely in the in different organs in the Ministry of Health, and remains as a strong
routine the MMR vaccine (measles, rubella and mumps vaccine) in order structure in public health policy of the country with advances in all
to replace the monovalent measles vaccine and was recommended for aspects to fulfill the important mission to vaccinate the population.
children completing one year of age, followed by a second dose between In 2003, with the creation of the Secretariat of Health Surveillance,
four and six years and also included adolescents and adults, subjects this is currently linked to the Department of Transmissible Disease
not vaccinated in the childhood. It is worth mentioning that the MMR Surveillance occupying the position of General Coordination (Decree
vaccination started in the year 1992 to the year 2000 progressively by 7,530 of July 2011). Under the federal units and cities, it is organized
the Brazilians states, through campaigns for children between one and in different structures, usually linked to the area of Health Surveillance.
11 years of age. It has a service network consisting of approximately 34,000 vaccine
rooms distributed in 5,565 cities. To reach the population, different
In 2006, by the Ordinance 1,602/2006 a new vaccine was included, immunization strategies are used: routine, campaigns, intensification and
the oral human rotavirus vaccine (RHV) in the schedule for children vaccinal blocking, the latter ones upon outbreak occurrence.
from six to 24 weeks of age.
The financing of the actions is among the priorities of Ministry of
In 2008 a national campaign was performed to reach the goal to Health with resources defined in the annual budget, in a separate item
the elimination of Rubella and the congenital rubella syndrome (CRS), for the purchase of immunobiologicals, and for such purpose, not subject
beyond aiming to consolidate the strategy to eliminate measles in the to budget cutting, as per Budget Guidelines Law – LDO nº 12,465 of
country, targeting the susceptible adult groups. 12/Aug/2011, section I, nº 618. Considering the period from 1995 to
2010, the resources spent on the acquisition of immunobiologicals
In 2010, Ordinance 3,318/2010 was published incorporating to the exceed the figure of one billion reais, given the gradual introduction of
routine pediatric schedule Pneumococcal conjugate 10-valent (PCV10) new vaccines in the national immunization schedule. In 2010 with the
and Meningococcal C conjugate vaccines, as the goal of the Strategic expenses with pandemic A influenza (H1N1) 2009 vaccine campaign,
Plan for Development of the Ministry of Health (PAC Mais Saúde). this amount exceeded two billions reais (Fig. 1).

The Pandemic Influenza A (H1N1)2009 national immunization Despite all these advances, until the mid-90’s, the records of
campaign performed in 2010, 89.5 million persons, considered the vaccination in the country weren’t adequate. At the national level, there
most vulnerable groups to get sick or die from the disease (pregnant were only data consolidated by the states (Federative Units) with no
women, children between six months and two years old, health workers, local (city) information. The ever increasing complexity of the program
indigenous and persons with chronic diseases), were vaccinated and in different areas and in particular on increasing the supply and use of
this represented 46.9% of the total population of the country. In 2011, vaccines, the knowledge of vaccination coverage in different management
the influenza vaccine has been extended to these same priority groups. levels, particularly in the city has become increasingly required and also
the impact of these on the diseases surveillance.
In this same year, vaccination to hepatitis B was also expanded for
people between 20 and 24 years of age, whereas since the mid-2000’s The first initiatives for a computerized national registry of

S23
DOMINGUES, C.M.A.S.; TEIXEIRA, A.M.S. & CARVALHO, S.M.D. - National immunization program: vaccination, compliance and pharmacovigilance. Rev. Inst.Med. Trop. Sao Paulo,
54(Suppl. 18), S22-S27, 2012.

vaccination’s recommendation; 95% for other vaccines in the pediatric

schedule and 80% for influenza vaccine.

At the national and state levels, until the late 80’s, routine vaccination
coverage did not exceed 70% of the target population. Those low rates
were insufficient to promote impact on diseases1. Only from the second
half of the 90’s coverage reached adequate rates and from those years on,
decrease was seen with emphasis on polio and measles (Fig. 2 and 3).

Considering the last ten years, the rates of vaccination coverage for
vaccines in the pediatric schedule were high, reaching or surpassing the
goals set by PNI. Exceptions are for hepatitis B vaccine, in the first five
years of the series, they were below the target (95%) and for rotavirus
vaccine since 2007 (Fig. 4).

Taking as example the vaccination coverage and homogeneity

of coverage for vaccine DTP+Hib (tetra) in children under one year
old agreed in the SUS intermanagement agreement in 95% and 70%
Fig.1 -Budget of the National Immunization Program run with the acquisition of biological, respectively, compliance was checked with the goals of coverage
Brazil, from 1995 to 2011*. throughout the period. With regard to homogeneity, this was reached since
2006, recording fluctuations in the indicator that ranged from 61.69%
immunobiological doses applied were from 1994. The Information (2005) to 88.86% (2006) of the 5,565 cities with adequate coverages
System of Evaluation of National Immunization Program (SIAPI) established of ≥ 95% (Fig. 4). A similar pattern was found for other
was developed in partnership with the Informatics Department of vaccines, such as polio and hepatitis B. In relation to MMR vaccine in
SUS (Datasus). This decentralized system for 100% of the cities and children of one year old, in the same period, the coverages remained
computerized in about 5,500 of those, makes available immunization above target of 95% and homogeneity ranged from 87.23% (2003) to
data according to immunobiologicals, age group and occurrence of 69.24% (2010) of the cities with appropriate coverage.
immunization, allowing finding out and monitoring vaccination coverage
in the different target groups of immunization. In addition, other systems Vaccination campaigns against poliomyelitis in children under five
were created to better provide information about distributed and used years of age were successful in the first five years after the implementation
doses, physical and technical losses, doses used in the CRIES, monitoring in 1980 showing a decrease in both steps within three years of the same
of AEFI, always with NIP assisting in the decision-making. decade culminating with recrudescence of cases. From 1989 (last case
reported in Brazil) appropriate rates for vaccination coverage were
VACCINATION COVERAGE IN BRAZIL recovered remaining high until the present day (Fig. 2).

The best way or indicator to evaluate the performance of vaccination In relation to cumulative vaccination coverage of hepatitis B vaccine
actions is to analyze the vaccination coverage. The vaccination coverage in children and adolescents from 1994 to June 2011, aged 1 to 24 years,
indicator represents the proportion of target population vaccinated, while this was 80% and was inversely proportional to age group, especially in
the homogeneity of coverage represents the proportion of cities or area groups one to four years, five to 10 years and 11 to 14 years old, when
within a geographic context that reached the goal set for vaccination the rates already exceed 95% coverage.
coverage8.
Regarding vaccination with seasonal influenza, the target vaccination
It is obtained by dividing the number of doses and the target coverage was originally (1999) set to 70%, remaining until 2007. In 2008
population multiplied by one hundred, and the homogeneity of coverage this was raised to 80% of the target population. Since 1999, the country
is obtained by dividing the number of cities which reached appropriate has been showing good compliance of the target population, based on the
vaccination coverage divided by the total number of cities multiplied good results of the coverage. These ranged from 67% in 2000, the only
by one hundred. The calculation of coverage takes into account the last year with VC < 70%, to 85.73% in 2006, emphasizing that in the last
dose of the recommended schedule for each vaccine. five years remained above 75%, and in some years this exceeded 80%.
The total of doses applied from 1999 on was increasing, consistent with
Both indicators are tools of agreement between all the levels of SUS the growth of the target population. The number of doses varied from 7.5
management (vaccination coverage rates) and they are very important million in 1999 to over 16 million doses in 2011 (Fig. 6).
for decision making at the different management levels since adequate
coverage, according to the parameters established for each vaccine, are With respect to immunization campaigns covering young and adult
required to obtain control, maintain eliminated and or eradicated vaccine- population, the national immunization campaign for elimination of
preventable diseases under surveillance. rubella and congenital rubella syndrome and maintenance of measles
elimination stood out. In this campaign 67.8 million Brazilians were
The rates established for vaccination coverage are: 90% for BCG vaccinated, aged 20 to 39 years throughout the country, adding to the
and Rotavirus (VRH); 100% for yellow fever vaccine in areas with group 12 - 19 years in the states of Maranhão, Minas Gerais, Mato Grosso,

S24
DOMINGUES, C.M.A.S.; TEIXEIRA, A.M.S. & CARVALHO, S.M.D. - National immunization program: vaccination, compliance and pharmacovigilance. Rev. Inst.Med. Trop. Sao Paulo,
54(Suppl. 18), S22-S27, 2012.

Fig 2 - Incidence rates of measles and vaccination coverage with monovalent measles and triple viral*, Brazil, from 1968 to 2011.

Fig. 3 - Incidence of poliomyelitis and vaccine coverage in vaccination campaigns with OPV in children under 5 years of age*, Brazil, from 1968 to 2011.

Rio de Janeiro and Rio Grande do Norte, reaching a vaccination coverage target group was overcome in most of them, except for pregnant women
of 96.79% of the target population in about 20 weeks of vaccination. (77.1%) and in adults aged 30 to 39 years (75.3%), highlighting that this
latter group was only included in the final phase of the campaign, which
Considered the largest immunization campaign in the world, due can explain the less favorable results.
to the large number of people to be vaccinated, the immunization
campaign against rubella was exceeded by the number of doses applied Considering the heterogeneity in the vaccination results when the
by the national immunization campaign to influenza A (H1N1) 2009 situation in the context of cities for any vaccine and target population
held in 2010. This had as eligible groups health workers; patients with is analyzed, overall results demonstrate the operational capacity of
chronic illnesses, children between six months and under two years PNI in the different SUS management levels. The implementation of
old; indigenous; pregnant women and young adults aged 20 to 39 years. plans for control and elimination of diseases, the strategies adopted
89.5 million doses of vaccines were reported to be applied within three for immunization, emphasizing the multivaccination from 1990 on
months. Vaccination coverage with a established target of 80% for each the national days for immunization against polio, contributed to

S25
DOMINGUES, C.M.A.S.; TEIXEIRA, A.M.S. & CARVALHO, S.M.D. - National immunization program: vaccination, compliance and pharmacovigilance. Rev. Inst.Med. Trop. Sao Paulo,
54(Suppl. 18), S22-S27, 2012.

VC and promoting impact on disease subjected to surveillance in the

country.

The implementation of new vaccines is a goal of PNI and important

advances have occurred in the area of immunization in the country over
the past two centuries. More vaccines and target groups were gradually
included in the immunization program in Brazil. When establishing as
one of the criteria for vaccine deployment the safety and effectiveness
of the product, PNI has in its favor the credibility in the Program and
recognition of the population that the vaccine is the primary measure to
control a significant proportion of diseases.

The results observed from vaccination coverage in different strategies

testify in favor to gradual compliance of population to vaccination
whether routine immunization or in immunization campaigns, and
have as outcome preventable diseases eradicated, and or under control
Fig. 4 - Vaccination coverage (%) by type of vaccination in the child’s, Brazil, 2001 to 2011. with incalculable benefits to the population. However, the maintenance
of the current status and progress to obtain new achievements depend
on obtaining and maintaining high and homogeneous vaccination
coverage and a surveillance system for adverse events sensitive to detect,
investigate and intervene in a timely manner. These, among others, are
fundamental in order to maintain the credibility and success of PNI.

PHARMACOVIGILANCE

Vaccination programs have been one of the safest and most cost-
effective measures in public health. There is no other procedure that
produces such excellent results in reducing morbidity and mortality
and also provides so many possibilities, such as the eradication of
immunepreventable diseases, that led to eradication of smallpox in the
world, the elimination of poliomyelitis in the Americas since 1994, the
elimination of measles in Brazil (last case reported in 2000), rubella
elimination and control of congenital rubella syndrome in Brazil.

Fig. 5 - Vaccination accumulated hepatitis B vaccine by age group, Brazil, from 1994 to 2011. The vaccines are given to large groups of healthy individuals, and
therefore, safety and quality are of great importance. Current vaccines are
very safe, because they meet strict quality parameters from production to
their application. In general, they are among the safest pharmaceutical
products for human use, providing broad benefits to public health of a
country.

Unfortunately, like all medical interventions, the immunization

procedures are not completely safe. With the increase in vaccination
coverage, both in developed and developing countries, the reduction of
immunepreventable diseases occurs; however, there is a growing concern
about the safety of vaccines, i.e., with the increased number of adverse
events following immunization (AEFI).

Immunization programs have the responsibility to address the

public concern related to vaccines by providing workers with updated
information on safe immunization practices.

Fig. 6 - Doses administered and vaccine coverage of influenza vaccine in elderly people, Safe vaccination is a priority component of immunization programs
Brazil 1999 to 2011*. that seeks to ensure the use of quality vaccines, and this quality control
in Brazil is carried out by the National Institute for Quality Control in
greater compliance of the population. Added to these, the expansion Health, Oswaldo Cruz Foundation (Instituto Nacional de Controle de
of health services and the decentralization process, factors that directly Qualidade em Saúde da Fundação Oswaldo Cruz (INCQS/FIOCRUZ));
or indirectly contribute to the improvement of the access, increasing the shipping and storage with appropriate packaging, the use of safe

S26
DOMINGUES, C.M.A.S.; TEIXEIRA, A.M.S. & CARVALHO, S.M.D. - National immunization program: vaccination, compliance and pharmacovigilance. Rev. Inst.Med. Trop. Sao Paulo,
54(Suppl. 18), S22-S27, 2012.

injection practices from appropriate administration to final disposal, the Every event in which the patient, parents or guardians, the public,
performance of surveillance of adverse events following immunization health professionals consider related to the administration of a vaccine
with early and efficient investigations and strengthening alliances with the should be investigated in the place of occurrence. If the period of onset
media according to the perception of the population using clear messages and the symptoms/signs indicate the possibility that this event has a
to the public about the strategies, priorities and safety of vaccination. relationship with the vaccine, further investigation should be immediately
initiated with assistance of state and national levels. The purpose of the
An adverse event following immunization (AEFI) is any health investigation is to confirm or discard the event notified, to determine
problem temporally related to vaccination, caused or not by the whether there are other possible causes, to check if this is an isolated
vaccine administered. Such events may be related to the composition event and to report to the parties involved.
of the vaccine, the individuals vaccinated, the technique used for
administration (programming errors), or overlapping with other health The early, honest and efficient communication of the results of one
problems. Given the nature and characteristics of immunebiologicals, investigation assure the integrity of immunization programs11.
as well as the knowledge already available from experience, events
can be expected: fever, local pain, myalgia, headache, hyporesponsive International experience shows that the supply and use of safe
hypotonic episode, among others, or unexpected, which are those not and quality vaccines is a prerequisite for the high compliance of the
previously identified (e.g.: new vaccines) or resulted from problems population, as well as health workers, to the immunization programs.
related to production (inappropriate endotoxin content in certain However, it is expected that a healthy and democratic debate about risks
vaccines causing febrile reactions similar to sepsis, contamination of and benefits of immunization is ruled by the need for caution and great
batches causing abscesses)9. responsibility on issues of such relevance to the health of Brazilian
population12.
For best results all the people who participate in safe immunization
activities should exercise their activities in an integrated manner: REFERENCES
National Regulatory Agency - Anvisa, epidemiological surveillance,
national laboratory for quality control, anatomical pathology laboratories, 1. Brasil. Ministério da Saúde. Secretaria de Vigilância em Saúde. PNI/30 Anos. Cap.
2. Pela eficácia das vacinas. In: Datas e fatos históricos das imunizações e doenças
professional organizations, communicators, vaccine producers, World
imunopreveníveis no Brasil e no mundo. Brasília: SVS; 2003. p. 57-107.
Health Organization/Pan American Health Organization and cooperating
bodies10. 2. Viveiro A. A revolta da vacina. Rev Eletrônica Ciênc. [cited: 2011 October 4].
Available from: http://cdcc.usp.br/ciencia/artigos/art_49/editorial_ed49.html.
Since 1991 the World Health Organization (WHO) recommends
3. Uma epidemia sob censura. [Cited: Oct 4 2011]. Available from: http://www.ccs.
surveillance of adverse events following immunization. Since 2000, the
saude.gov.br /revolta/pdf/M9.pdf.
Brazilian Ministry of Health implemented the information system for
surveillance of adverse events following immunization (SI-EAPV) and 4. Barata RC. Saúde e direito a informação. Cad Saúde Pública. 1990;6:385-99. Available
because of the importance, by the ordinance of the Secretariat of Health from: http://www.scielo.br/pdf/csp/v6n4/v6n4a03.pdf.
Surveillance, this was introduced as an injury of compulsory reporting (Pt
5. Temporão JG. O Programa Nacional de Imunizações (PNI): origens e desenvolvimento.
SVS/MS nº 33 of 25/Jul/2005), and according to Resolution RDC Anvisa
Hist Cienc Saude Manguinhos. 2003;10(Suppl 2):601-17. Available fromhttp://www.
nº 4 of 10/Feb/2009, which sets forth the standards of pharmacovigilance scielo.br/scielo.php.
to record holders of medicinal products for human use, who must notify,
as soon as possible, any adverse event ocurring in the national territory, 6. A produção e o desenvolvimento de vacinas no Brasil. [cited: 2011 October 4].
setting the maximum period of seven days from the date of knowledge Available from: http://www.scielo.br/pdf/hcsm/v3n1/v3n1a08.pdf.
of the adverse event information.
7. Campos ALV, Nascimento DR, Maranhão E. A história da poliomielite no Brasil e seu
controle por imunização. Hist Ciênc Saúde Manguinhos. 2003;10(Suppl 2):573-600.
The objectives of AEFI surveillance are: to regulate the recognition
and procedure in the case of adverse events following immunization 8. Brasil. Ministério da Saúde. Secretaria de Vigilância em Saúde. Relatório da
(AEFI), to identify serious adverse events, new and/or rare, to establish or verificação dos critérios de eliminação da transmissão dos vírus endêmicos do sarampo
e rubéola e da síndrome da rubéola congênita (SRC) no Brasil. Brasília: Secretaria
rule out a causal relationship with the vaccine, to identify more reactional
de Vigilância em Saúde; 2003.
batches, to detect, correct and prevent programmatic or operational errors,
to update contraindications and analysis of risks and benefits, to estimate 9. Brasil. Ministérioda Saúde. Manual de vigilância epidemiológica de eventos adversos
incidence rates and generate new hypotheses. pós-vacinação. 2ª ed. Brasília: Ministério da Saúde; 2008.

10. Vacunación segura: módulos de capacitación. Washington: Organización

All public and private health services offering vaccine rooms,
Panamericana de la Salud/Organización Mundial de la Salud; 2007.
basic health units, emergency care and hospitals are responsible for
notifying AEFI. Notification is a mechanism that helps maintain an 11. Waldman EA, Luhm KR, Monteiro AS, Freitas FR. Vigilância de eventos adversos
active monitoring system and a status of permanent alertness of the pós-vacinação e segurança de programas de imunização. Rev Saude Publica
health worker for the detection of AEFI10. Also highlighted is that in 2011;45:173-84.
any epidemiological situation, serious AEFI should be reported within
12 . Martins RM, Maia MLS. Eventos adversos pós-vacinais e resposta social. Hist Ciênc
24 hours from the occurrence, from local to national level following Saúde Manguinhos. 2003;10(Suppl 2):807-25.
the flowchart determined by the National Immunization Program of the
Ministry of Health.

S27