Vaccines in Brazil: historical analysis of the Sanitary registration and vaccine availability in the Brazilian Unified Health System

Peres, Kaite Cristiane; Buendgens, Fabíola Bagatini; Prates, Ediana Adriano; Bonetti, Norberto Rech; Soares, Luciano; Vargas-Peláez, Claudia Marcela; Farias, Mareni Rocha

doi:10.1590/1413-812320212611.13932021

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ARTICLE • Ciênc. saúde coletiva 26 (11) • Nov 2021 • https://doi.org/10.1590/1413-812320212611.13932021 copy

Vaccines in Brazil: historical analysis of the Sanitary registration and vaccine availability in the Brazilian Unified Health System

Authorship SCIMAGO INSTITUTIONS RANKINGS

Abstract

Given the COVID-19 pandemic and the importance of public social protection policies, health issues, including immunizations, have gained prominence. This paper aims to analyze the dynamics of vaccine registration in Brazil and the vaccines made available through the National Immunization Program (PNI in Portuguese), with emphasis on the 2004-2018 vaccination schedule. This descriptive, exploratory, documentary research analyzed vaccine registration procedureswith the Brazilian Health Regulatory Agency (ANVISA, in Portuguese) and the incorporation of vaccine products into the PNI. The study drew on information from the national sanitary registration database, made available by ANVISA; a document analysis of official/normative publications; and data from published literature. The data shows the incorporation of vaccines into the PNI, evidencing that Brazil is a country with industrial potential for vaccine production but that is still focused on the transfer of technologies and in need of public attention and investments for developing new technologies as a way to ensure the sector’s independence.

Key words:
Vaccines; Brazilian Health RegulatoryAgency; Biological products; Public Health

Companies owning sanitary registrations	Total number of registrations in the period	Number of active registrations in December 2018
Private Companies
Abbott Laboratórios do Brasil LTDA	2	2
Abbott Produtos para Saúde LTDA	1	0
Astrazeneca do Brasil LTDA	1	0
Baxter Hospitalar LTDA	3	0
Biotest Farmacêutica LTDA	1	0
Blau Farmacêutica S.A.	3	0
Brasvit Indústria e Comércio LTDA	2	0
Cristália Produtos Químicos Farmacêuticos LTDA	4	0
Cubanacan Comércio Internacional LTDA	2	0
GlaxoSmithKline Brasil LTDA	31	19
Laboratórios Pfizer LTDA	2	2
Medstar Importação e Exportação Eireli	2	2
Merck Sharp & Dohme Farmacêutica LTDA	11	10
Novartis Biociências S.A	12	1
Novo Nordisk Produção Farmacêutica do Brasil LTDA	1	0
Nutoth - Pharma Indústria e Comércio LTDA	2	0
Prophylaxis Clínica de Vacinação LTDA	2	0
Sanofi Pasteur LTDA	30	0
Sanofi-Aventis Farmacêutica LTDA	34	21
UCB Biopharma LTDA	1	1
Wyeth Indústria Farmacêutica LTDA	3	0
State-owned companies
Fundação Ataulpho de Paiva	2	2
Fundação Ezequiel Dias - Funed	1	1
Fundação Oswaldo Cruz	15	11
Instituto Butantan	18	12
Totais	186	83

	First registration by private company	First registration by state-owned company	Year of incorporation into the PNI	Total number of registration processes cancelled/expired (state owned company)	Total number of active registrations (state-owned company)	Companies which own the sanitary registration (number of active registrations in December 2018)
Bacillus Calmette Guerin (BCG)	-	1998	2004*	1 (1)	2 (2)	J(2); N(0)
Cholera	2004	-	NI	2 (0)	0 (0)	V(0); X(0)
DT	1996	2003	2004	2 (0)	2 (2)	N(2); R(0); V(0)
DTP	1995	2003	2004*	1 (0)	3 (1)	M(1); N(1); V(0); X(1)
DTP + Hepatitis B	2000	-	NI	1 (0)	0 (0)	M(0)
DTP + VIP	1994	-	NI	3 (0)	3 (0)	M(1); V(0); X(2)
DTP + VIP + HIB	1999	-	NI	3 (0)	2 (0)	M(1); V(0); X(1)
DTP + VIP + HIB + Hepatitis B	2001	-	NI	0 (0)	3 (0)	M(2); X(1)
DTP + VIP + HIB + Tetanus		-	NI	2 (0)	0 (0)	V(0)
DTpa	1998	2016	2014	1 (0)	3 (1)	M(1); N(1); V(0); X(1)
Double viral ***	2000	-	-	3 (0)	0 (0)	M(0); V(0); X(0)
Yellow fever	2006	1999	2004	1 (0)	2 (1)	L(1); V(0); X(1)
Yellow fever + dengue	2015	-	NI	0 (0)	1 (0)	X(1)
Hepatitis A	1996	2016	2014	3 (0)	4 (1)	H(0); M(1); N(1); Q(1); V(0); X(1)
Hepatitis A and B	1998	-	NI	0 (0)	1 (0)	M(1)
Hepatitis B	1993	1999	2004	2 (0)	5 (2)	I(0); M(1); N(2); Q(1); V(0); X(1)
HIB + Tetanus	1998	-	NI	1 (0)	1 (0)	M(0); X(1)
HPV (16,18)	2008	-	NI	0 (0)	1 (0)	M(1)
HPV (6,11,16,18)	2006	2015	2014	0 (0)	2 (1)	N(1); Q(1)
HPV (6,18,16,11,58,52,45,33,31)	2017	-	NI	0 (0)	1 (0)	Q(1)
Influenza	1997	2000	2004	26 (4)	13 (2)	A(2); B(0); C(0); D(0); F(0); H(0); L(1); M(1); N(1); P(2); Q(0); R(1); T(0); U(0); V(0); X(4); Y(1)
Leishmaniasis	2001	-	NI	1 (0)	0 (0)	S(0)
Meningitis C + HIB	2007	-	NI	1 (0)	0 (0)	M(0)
Meningococcal,C,Y,W-135	2014	-	NI	1 (0)	2 (0)	M(1); O(1)
Meningococcal AC ***	1995	2005	-	3 (0)	2 (1)	L(1); R(0); V(0); X(1)
Meningococcal BC	1993	-	NI	1 (0)	0 (0)	I(0)
Meningococcal B	2015	-	NI	1 (0)	1 (0)	M(1); R(0)
Meningococcal C	2001	2009	2010	3 (0)	2 (1)	F(0); K(1); M(1); R(0); Z(0)
Meningococcal C + Tetanus	2002	-	NI	1 (0)	0 (0)	D(0)
Pentavalent	2007	-	2010	1 (0)	0 (0)	M(0)
Pneumococcal 10	2009	2012	2010	0 (0)	2 (1)	L(1); M(1)
Pneumococcal 13	2010	-	NI	1 (0)	1 (0)	O(1); Z(0)
Pneumococcal 23	1995	-	2004	2 (0)	1 (0)	Q(1); V(0); X(0)
Pneumococcal 7	2001	-	NI	1 (0)	0 (0)	Z(0)
Rabies**	1998	2004	-	5 (2)	3 (2)	N(2); R(0); T(0); V(0); X(1)
Rubella	1994	-	NI	2 (0)	0 (0)	G(0); V(0)
Tetanus**	1996	2003	-	1 (0)	2 (1)	N(1); V(0); X(1)
Tetraviral	2008	2015	2013	0 (0)	3 (1)	L(1);M(1); Q(1);
Tetravalent (DTP + HIB)	1996	2002	2004	2 (1)	2 (1)	L(1); V(0); X(1)
Typhoid ***	2006	-	-	1 (0)	1 (0)	V(0); X(1)
Triple Viral	1996	2004	2004	4 (0)	3 (1)	L(1); M(1); Q(1); R(0); U(0); V(0); X(0)
Varicella	1998	-	2010	4 (0)	3 (0)	E(0);G(0); M(1); Q(2); V(0); X(0)
VIP	1998	1999	2013	4 (1)	2 (1)	F(0); L(1); M(0); V(0); X(1)
VOP	1998	2007	2004*	5 (0)	2 (2)	L(2); M(0); R(0); V(0); X(0)
VORH	2005	2010	2006	0 (0)	3 (1)	L(1); M(1); Q(1)
Total				97 (9)	84 (26)

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[1] Collaborations

KC Peres, NR Bonetti, L Soares, CM Vargas-Peláez and MR Farias participated in the conception, planning, discussion, and final revision of the article. EA Prates, FB Buendgens, and KC Peres contributed in the analysis of the results, discussion and revision of the manuscript.