JOINT REGIONAL MEETING
FOR THE AMERICAS & EUROPE
Vaccine introductions: from evidence to
implementation – country perspective
Brazil
Ministry of Health - MoH
National Immunization Program
Ana Goretti K. Maranhão, Dr.
Sandra M. Deotti Carvalho, Dr. MSc
Madrid, 1 Feb 2017
Brazil: Administrative Division and Population
Federal Republic
 5 regions, 27 federal units,
5,570 municipalities

Estimated population: 207,6 million
inhabitants (IBGE, 2017)
 ~ 2.9 million <1 year; ~ 15 million <5
years and ~ 22 million ≥ 60 years
(census 2013)

Border with 10 countries

Area: 8,5 million Km2 (3,3 million sq mi)
Atlantic Ocean

2017 National Immunization Schedules
Infants, Children and Preteens (birth - 9 yrs)
Teens and Adults
1.
BCG – ID - at birth
1. Hepatitis B
2.
Hepatitis B – 1st dose at birth
3.
DTPw/Hib/HepB (Penta) - 2, 4, 6 mos
4.
Inactivate poliomielytis (PV) - 3 doses (2, 4, 6 mos)
5.
Bivalent oral poliomielytis (bOPV) – 15 mos / 4 yrs (boosters)
6.
Oral Human Rotavirus - Rota (VRH) – 2, 4 mos
7.
Pneumococcal conjugated 10 valent (PCV10) - 2, 4 and 12 mos
8.
Meningococcal conjugated C (MenCC) - 3, 5 and 12 mos
9.
Yellow fever (YFV) – 9 mo / 4 yrs
10. MMR – 12 mo
11. MMRV - 15 mo
12. DTPw – 15 mo and 4 yrs (boosters)
2. Tetanus, diphtheria - dT
3. dTpa - pregnancy
4. Yellow fever
5. MMR
6. HPV4: girls 9 to 13 yrs - 2 doses
Special conditions
1. DTP acellular - AEFI
2. Influenza (annual campaign):
1.
Health professionals
2.
Children 6 mo to 4 yrs
3.
Pregnancy
4.
Seniors 60 yrs and older
5.
Comorbidities, chronic health conditions
3. Reference Centers of Special Immunobiologicals - CRIE

Peumococcal polysaccharide vaccine - PPSV23 Indian people, Institutionalized
people, chronic health conditions

Haemophilus influenzae b

DTPa (Acellular DTP):
 Human imunoglobulins: against hepatitis B, antirabies, antitetanus and antivaricellazoster
National vaccination strategies
Routines
• 36,450 vaccination rooms
• 47 Reference Centers of Special Immunobiologicals (CRIE)
Campaigns
• Influenza (pregnancy, elderly, indians, infants, health professionals,
Comorbidities , chronic health conditions ) 60 millions of persons
• Multivaccination: up dating missed immunizations
• HPV4 – communication campaigns March and September
Outbreaks
• Rabies
• Measle
• Others: yellow fever, influenza
Criteria for the introduction of new vaccines
To introduce a new vaccine, it must be ensured that several questions are answered:
 Does the vaccine meet the country's epidemiological need?
The disease’s matter as a public health problem, prevalence, incidence,
hospitalization rates, the mortality rates
 Does the vaccine meet the immunological criteria - lasting and effective
protection?
Safety: Is it a safe vaccine?
Criteria for the introduction of new vaccines
 Will have transfer of technology? What is the logistics of distribution and storage?
 Is the vaccine effective? Cost-effectiveness studies
 Approval of committees?
NITAG – National Advisory Committee on Immunization: Act Nº- 232, November, 24/2011
evidence-based recommendations particularly for new vaccine introduction process
 CONITEC - National Committee for Incorporation of Technologies in SUS: LAW nº 12.401, April, 28/2011
 Is there an assurance of financial resources for acquisition and sustainability?
 National Resource Planning; allocation for all vaccination actions annually
 Previous resource location: prior identification of vaccine costs and production capacity to meet NIP’s
demand
 National and international manufacturers
 PAHO Revolving Fund
MoH/NIP’s budget for vaccines (R$)* and introduction of new vaccines
bOPV
Source: NIP/SVS/MS
* 1 R$ = US$3,55. 2016 ˜ US$ 958 miilions
NIP: MoH 2nd annual budget of ministries/federal government
Jan 2017: HPV4 boys 12-13 yrs
MenCC: tenns 12-13 yrs
MoH vaccines acquisition (doses units). BRA, 2004 to 2016.
500.0
452.0
450.0
400.0
328.2
350.0
302.0
312.3
306.8
Millions
300.0
250.0
237.7
219.0
228.5
244.1
264.0
257.3
214.7
184.3
200.0
150.0
100.0
50.0
0.0
2004
Source: NIP/SVS/MS.
2005
2006
2007
2008
2009
2010
2011
2012
2013
2014
2015
2016
Communication strategies
 Pre-introduction:







Pre-implementation: planning and training
Technical reports
Meetings with immunizations coordinators of all states, partners (scientific societies)
Definition of target population
Extensive mobilization: different ministries, scientific societies, schools, churches, etc
Strengthening AEFI Surveillance
Implementation of NIP’s information system – nominal registration
 Disclosure
 Advertising campaigns

o TV, radio, newspaper, social networks, MoH site:
http://portalsaude.saude.gov.br/; videos
o Blog: http://www.blog.saude.gov.br/
Posters / Folders
Adverse events following immunization (AEFI) - HPV4
• September 3, 2014
•
80 girls with
11 to 13 years of age vaccinated at school –
Bertioga/SP
• 13 girls (16,2%) presented:
• Clinical symptoms: paresis, numbness, temporary legs
paralysis (stop walking and with spontaneous recovering) with normal neurological examinations, normal MRI
•
All hospitalized
•
Good evolution with discharge in good health
•
State of São Paulo AEFI committee – Psychiatrist consultant
•
Causality
reaction
assessment:
Immunization
anxiety
related
Girls stays with paralysed legs after HPV vaccination in São Paulo
Feeling better girls are discharged from hospital
HPV4 vaccine coverage
1st and 2nd dose, girls aged 11 to 13 years. Brazil. 2015
Acumulated vaccine coverage – HPV4, girls 9 through 14 yrs of
age. BRA, 2013 a 2016
Source:
Goal: 80%
Thank you
Gracias
Muito obrigada
www.saude.gov.br/svs
Disque Saúde - 136
Disque Notifica
0800-644-6645
notifica@saude.gov.br
cgpni@saude.gov.br
Sandra .deotti@saude.gov.br