Vaccine effectiveness of two-dose BNT162b2 against symptomatic and severe COVID-19 among adolescents in Brazil and Scotland over time: a test-negative case-control study

Pilar T.V. Florentino; Tristan Millington; Thiago Cerqueira-Silva; Chris Robertson; Vinicius de Araújo Oliveira; Juracy B.S. Júnior; Flávia J.O. Alves; Gerson O. Penna; Srinivasa Vital Katikireddi; Viviane S. Boaventura; Guilherme L. Werneck; Neil Pearce; Colin McCowan; Christopher Sullivan; Utkarsh Agrawal; Zoe Grange; Lewis D. Ritchie; Colin R. Simpson; Aziz Sheikh; Mauricio L. Barreto; Igor Rudan; Manoel Barral-Netto; Enny S. Paixão

doi:10.1016/S1473-3099(22)00451-0

Vaccine effectiveness of two-dose BNT162b2 against symptomatic and severe COVID-19 among adolescents in Brazil and Scotland over time: a test-negative case-control study

Pilar T.V. Florentino^*
, Tristan Millington
, Thiago Cerqueira-Silva
, Chris Robertson
, Vinicius de Araújo Oliveira
, Juracy B.S. Júnior
, Flávia J.O. Alves
, Gerson O. Penna
, Srinivasa Vital Katikireddi
, Viviane S. Boaventura
, Guilherme L. Werneck
, Neil Pearce
, Colin McCowan
, Christopher Sullivan
, Utkarsh Agrawal
, Zoe Grange
, Lewis D. Ritchie
, Colin R. Simpson
, Aziz Sheikh
, Mauricio L. Barreto

Igor Rudan, Manoel Barral-Netto, Enny S. Paixão

^*Corresponding author for this work

Fundação Oswaldo Cruz
Universidade de São Paulo
University of Edinburgh
Universidade Federal da Bahia
Public Health Scotland
Universidade de Brasília
University of Glasgow
Universidade do Estado do Rio de Janeiro
Universidade Federal do Rio de Janeiro
London School of Hygiene and Tropical Medicine
Victoria University of Wellington
University of St Andrews

Research output: Contribution to journal › Article › peer-review

44 Citations (Scopus)

8 Downloads (Pure)

Abstract

Background: Little is known about vaccine effectiveness over time among adolescents, especially against the SARS-CoV-2 omicron (B.1.1.529) variant. This study assessed the associations between time since two-dose vaccination with BNT162b2 and the occurrence of symptomatic SARS-CoV-2 infection and severe COVID-19 among adolescents in Brazil and Scotland. Methods: We did test-negative, case-control studies in adolescents aged 12–17 years with COVID-19-related symptoms in Brazil and Scotland. We linked records of SARS-CoV-2 RT-PCR and antigen tests to national vaccination and clinical records. We excluded tests from individuals who did not have symptoms, were vaccinated before the start of the national vaccination programme, received vaccines other than BNT162b2 or a SARS-CoV-2 booster dose of any kind, or had an interval between their first and second dose of fewer than 21 days. Additionally, we excluded negative SARS-CoV-2 tests recorded within 14 days of a previous negative test, negative tests recorded within 7 days after a positive test, any test done within 90 days after a positive test, and tests with missing sex and location information. Cases (SARS-CoV-2 test-positive adolescents) and controls (test-negative adolescents) were drawn from a sample of individuals in whom tests were collected within 10 days of symptom onset. We estimated the adjusted odds ratio and vaccine effectiveness against symptomatic COVID-19 for both countries and against severe COVID-19 (hospitalisation or death) for Brazil across fortnightly periods. Findings: We analysed 503 776 tests from 2 948 538 adolescents in Brazil between Sept 2, 2021, and April 19, 2022, and 127 168 tests from 404 673 adolescents in Scotland between Aug 6, 2021, and April 19, 2022. Vaccine effectiveness peaked at 14–27 days after the second dose in both countries during both waves, and was significantly lower against symptomatic infection during the omicron-dominant period in Brazil (64·7% [95% CI 63·0–66·3]) and in Scotland (82·6% [80·6–84·5]), than it was in the delta-dominant period (80·7% [95% CI 77·8–83·3] in Brazil and 92·8% [85·7–96·4] in Scotland). Vaccine efficacy started to decline from 27 days after the second dose for both countries, reducing to 5·9% (95% CI 2·2–9·4) in Brazil and 50·6% (42·7–57·4) in Scotland at 98 days or more during the omicron-dominant period. In Brazil, protection against severe disease remained above 80% from 28 days after the second dose and was 82·7% (95% CI 68·8–90·4) at 98 days or more after receiving the second dose. Interpretation: We found waning vaccine protection of BNT162b2 against symptomatic COVID-19 infection among adolescents in Brazil and Scotland from 27 days after the second dose. However, protection against severe COVID-19 outcomes remained high at 98 days or more after the second dose in the omicron-dominant period. Booster doses for adolescents need to be considered. Funding: UK Research and Innovation (Medical Research Council), Scottish Government, Health Data Research UK BREATHE Hub, Fiocruz, Fazer o Bem Faz Bem programme, Brazilian National Research Council, and Wellcome Trust. Translation: For the Portuguese translation of the abstract see Supplementary Materials section.

Original language	English
Pages (from-to)	1577-1586
Number of pages	10
Journal	The Lancet Infectious Diseases
Volume	22
Issue number	11
Early online date	26 Oct 2022
DOIs	https://doi.org/10.1016/S1473-3099(22)00451-0
Publication status	Published - Nov 2022

Bibliographical note

Declaration of interests
MB-N reports grants from the Fazer o Bem Faz Bem programme from JBS SA. VdAO, VSB, MLB, and MB-N are employees of Fiocruz, a federal public institution that manufactures Vaxzevria in Brazil through a full technology transfer agreement with AstraZeneca. Fiocruz allocates all its manufactured products to the Ministry of Health for public health use. SVK was Co-Chair of the Scottish Government's Expert Reference Group on Ethnicity and COVID-19 and a member of the UK Government's Scientific Advisory Group on Emergencies subgroup on ethnicity. IR is a member of the Scientific Advisory Committee of the Government of Croatia and co-Editor-in-Chief of the Journal of Global Health. CRS declares funding from the Medical Research Council, the National Institute for Health Research, the Chief Scientist Office, and the New Zealand Ministry for Business, Innovation and Employment and Health Research Council during the conduct of this study. CR declares he is a Member of SPI-M, Scottish Government Scientific Advisory Committee, MHRA COVID-19 vaccine benefit and risk expert working group. AS declares that he is a member of the UK and Scottish Governments COVID-19 Advisory Boards and Astra-Zeneca's Thrombotic Thrombocytopenic Taskforce. IR is Co-Editor-in-Chief of the Journal of Global Health and President of the International Society of Global Health. All other authors declare no competing interests.

Acknowledgments

The authors acknowledge DATASUS for its diligent work in providing the unidentified databases. This study was partially supported by a donation from the Fazer o Bem Faz Bem programme from JBS SA. GLW, MLB, VSB, and MB-N are research fellows from the Brazilian National Research Council (CNPQ). MB-N acknowledges Fundação de Apoio do Estado da Bahia (FAPESB; PNX0008/2014/ Fapesb, Edital 08/2014 - Programa de Apoio a Núcleos de Excelência). GLW acknowledges Fundação Carlos Chagas Filho de Amparo à Pesquisa do Estado do Rio de Janeiro (E-26/210·180/2020). SVK is funded by an NHS Research Scotland Senior Clinical Fellowship (SCAF/15/02), the UK Medical Research Council (MC_UU_00022/2), and the Scottish Government Chief Scientist Office (SPHSU17). MB-N and VdAO are funded by the Fazer o Bem Faz Bem programme from JBS SA. MB-N is also funded by CNPQ and FAPESB (PNX0008/2014). EPS is funded by the Wellcome Trust (213589/Z/18/Z). For the purpose of open access, the author has applied a CC BY public copyright licence to any author accepted manuscript version arising from this submission. GLW is funded by the Fundação Carlos Chagas Filho de Amparo à Pesquisa do Estado do Rio de Janeiro (FAPERJ; E-26/210·180/2020). VSB is funded by CNPQ.

Publisher Copyright:
© 2022 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY 4.0 license

Data Availability Statement

Our agreement with the Brazilian Ministry of Health for accessing the referenced databases patently denies authorisation of access to any third parties. All requests to access these databases must be addressed to the Ministry of Health. Unlinked data are available at https://opendatasus.saude.gov.br. Data dictionaries, linkage scripts, and analyses scripts are available at https://vigivac.fiocruz.br and https://github.com/cidacslab/vigivac. Regarding Scottish data, a data dictionary covering the datasets used in this study can be found at https://github.com/EAVE-II/EAVE-II-data-dictionary. Patient-level data underlying these data are controlled and cannot be shared publicly due to data protection and confidentiality requirements. Data can be made available to approved researchers for analysis after securing relevant permissions from the data holders via the Public Benefit and Privacy Panel. Enquiries regarding data availability should be directed to [email protected]. All code used on the Scottish data in this study is publicly available at https://github.com/EAVE-II.

Funding

The authors acknowledge DATASUS for its diligent work in providing the unidentified databases. This study was partially supported by a donation from the Fazer o Bem Faz Bem programme from JBS SA. GLW, MLB, VSB, and MB-N are research fellows from the Brazilian National Research Council (CNPQ). MB-N acknowledges Fundação de Apoio do Estado da Bahia (FAPESB; PNX0008/2014/ Fapesb, Edital 08/2014 - Programa de Apoio a Núcleos de Excelência). GLW acknowledges Fundação Carlos Chagas Filho de Amparo à Pesquisa do Estado do Rio de Janeiro (E-26/210·180/2020). SVK is funded by an NHS Research Scotland Senior Clinical Fellowship (SCAF/15/02), the UK Medical Research Council (MC_UU_00022/2), and the Scottish Government Chief Scientist Office (SPHSU17). MB-N and VdAO are funded by the Fazer o Bem Faz Bem programme from JBS SA. MB-N is also funded by CNPQ and FAPESB (PNX0008/2014). EPS is funded by the Wellcome Trust (213589/Z/18/Z). For the purpose of open access, the author has applied a CC BY public copyright licence to any author accepted manuscript version arising from this submission. GLW is funded by the Fundação Carlos Chagas Filho de Amparo à Pesquisa do Estado do Rio de Janeiro (FAPERJ; E-26/210·180/2020). VSB is funded by CNPQ. MB-N reports grants from the Fazer o Bem Faz Bem programme from JBS SA. VdAO, VSB, MLB, and MB-N are employees of Fiocruz, a federal public institution that manufactures Vaxzevria in Brazil through a full technology transfer agreement with AstraZeneca. Fiocruz allocates all its manufactured products to the Ministry of Health for public health use. SVK was Co-Chair of the Scottish Government's Expert Reference Group on Ethnicity and COVID-19 and a member of the UK Government's Scientific Advisory Group on Emergencies subgroup on ethnicity. IR is a member of the Scientific Advisory Committee of the Government of Croatia and co-Editor-in-Chief of the Journal of Global Health. CRS declares funding from the Medical Research Council, the National Institute for Health Research, the Chief Scientist Office, and the New Zealand Ministry for Business, Innovation and Employment and Health Research Council during the conduct of this study. CR declares he is a Member of SPI-M, Scottish Government Scientific Advisory Committee, MHRA COVID-19 vaccine benefit and risk expert working group. AS declares that he is a member of the UK and Scottish Governments COVID-19 Advisory Boards and Astra-Zeneca's Thrombotic Thrombocytopenic Taskforce. IR is Co-Editor-in-Chief of the Journal of Global Health and President of the International Society of Global Health. All other authors declare no competing interests. The authors acknowledge DATASUS for its diligent work in providing the unidentified databases. This study was partially supported by a donation from the Fazer o Bem Faz Bem programme from JBS SA. GLW, MLB, VSB, and MB-N are research fellows from the Brazilian National Research Council (CNPQ). MB-N acknowledges Fundação de Apoio do Estado da Bahia (FAPESB; PNX0008/2014/ Fapesb, Edital 08/2014 - Programa de Apoio a Núcleos de Excelência). GLW acknowledges Fundação Carlos Chagas Filho de Amparo à Pesquisa do Estado do Rio de Janeiro (E-26/210·180/2020). SVK is funded by an NHS Research Scotland Senior Clinical Fellowship (SCAF/15/02), the UK Medical Research Council (MC_UU_00022/2), and the Scottish Government Chief Scientist Office (SPHSU17). MB-N and VdAO are funded by the Fazer o Bem Faz Bem programme from JBS SA. MB-N is also funded by CNPQ and FAPESB (PNX0008/2014). EPS is funded by the Wellcome Trust (213589/Z/18/Z). For the purpose of open access, the author has applied a CC BY public copyright licence to any author accepted manuscript version arising from this submission. GLW is funded by the Fundação Carlos Chagas Filho de Amparo à Pesquisa do Estado do Rio de Janeiro (FAPERJ; E-26/210·180/2020). VSB is funded by CNPQ.

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

SDG 3 Good Health and Well-being

Access to Document

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Florentino_etal_LID_VaccineEffectivenessofTwoDose_VOR
Licensed under a Creative Commons CC-BY 4.0 license, article is free to read, share, and reuse, with attribution to the authors https://creativecommons.org/licenses/by/4.0/
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Cite this

Florentino, P. T. V., Millington, T., Cerqueira-Silva, T., Robertson, C., de Araújo Oliveira, V., Júnior, J. B. S., Alves, F. J. O., Penna, G. O., Vital Katikireddi, S., Boaventura, V. S., Werneck, G. L., Pearce, N., McCowan, C., Sullivan, C., Agrawal, U., Grange, Z., Ritchie, L. D., Simpson, C. R., Sheikh, A., ... Paixão, E. S. (2022). Vaccine effectiveness of two-dose BNT162b2 against symptomatic and severe COVID-19 among adolescents in Brazil and Scotland over time: a test-negative case-control study. The Lancet Infectious Diseases, 22(11), 1577-1586. https://doi.org/10.1016/S1473-3099(22)00451-0

Vaccine effectiveness of two-dose BNT162b2 against symptomatic and severe COVID-19 among adolescents in Brazil and Scotland over time: a test-negative case-control study. / Florentino, Pilar T.V.; Millington, Tristan; Cerqueira-Silva, Thiago et al.
In: The Lancet Infectious Diseases, Vol. 22, No. 11, 11.2022, p. 1577-1586.

Research output: Contribution to journal › Article › peer-review

Florentino, PTV, Millington, T, Cerqueira-Silva, T, Robertson, C, de Araújo Oliveira, V, Júnior, JBS, Alves, FJO, Penna, GO, Vital Katikireddi, S, Boaventura, VS, Werneck, GL, Pearce, N, McCowan, C, Sullivan, C, Agrawal, U, Grange, Z, Ritchie, LD, Simpson, CR, Sheikh, A, Barreto, ML, Rudan, I, Barral-Netto, M & Paixão, ES 2022, 'Vaccine effectiveness of two-dose BNT162b2 against symptomatic and severe COVID-19 among adolescents in Brazil and Scotland over time: a test-negative case-control study', The Lancet Infectious Diseases, vol. 22, no. 11, pp. 1577-1586. https://doi.org/10.1016/S1473-3099(22)00451-0

Florentino PTV, Millington T, Cerqueira-Silva T, Robertson C, de Araújo Oliveira V, Júnior JBS et al. Vaccine effectiveness of two-dose BNT162b2 against symptomatic and severe COVID-19 among adolescents in Brazil and Scotland over time: a test-negative case-control study. The Lancet Infectious Diseases. 2022 Nov;22(11):1577-1586. Epub 2022 Oct 26. doi: 10.1016/S1473-3099(22)00451-0

@article{37da51cfc5584e5283d4d6f11c84967d,

title = "Vaccine effectiveness of two-dose BNT162b2 against symptomatic and severe COVID-19 among adolescents in Brazil and Scotland over time: a test-negative case-control study",

abstract = "Background: Little is known about vaccine effectiveness over time among adolescents, especially against the SARS-CoV-2 omicron (B.1.1.529) variant. This study assessed the associations between time since two-dose vaccination with BNT162b2 and the occurrence of symptomatic SARS-CoV-2 infection and severe COVID-19 among adolescents in Brazil and Scotland. Methods: We did test-negative, case-control studies in adolescents aged 12{\textendash}17 years with COVID-19-related symptoms in Brazil and Scotland. We linked records of SARS-CoV-2 RT-PCR and antigen tests to national vaccination and clinical records. We excluded tests from individuals who did not have symptoms, were vaccinated before the start of the national vaccination programme, received vaccines other than BNT162b2 or a SARS-CoV-2 booster dose of any kind, or had an interval between their first and second dose of fewer than 21 days. Additionally, we excluded negative SARS-CoV-2 tests recorded within 14 days of a previous negative test, negative tests recorded within 7 days after a positive test, any test done within 90 days after a positive test, and tests with missing sex and location information. Cases (SARS-CoV-2 test-positive adolescents) and controls (test-negative adolescents) were drawn from a sample of individuals in whom tests were collected within 10 days of symptom onset. We estimated the adjusted odds ratio and vaccine effectiveness against symptomatic COVID-19 for both countries and against severe COVID-19 (hospitalisation or death) for Brazil across fortnightly periods. Findings: We analysed 503 776 tests from 2 948 538 adolescents in Brazil between Sept 2, 2021, and April 19, 2022, and 127 168 tests from 404 673 adolescents in Scotland between Aug 6, 2021, and April 19, 2022. Vaccine effectiveness peaked at 14{\textendash}27 days after the second dose in both countries during both waves, and was significantly lower against symptomatic infection during the omicron-dominant period in Brazil (64·7\% [95\% CI 63·0{\textendash}66·3]) and in Scotland (82·6\% [80·6{\textendash}84·5]), than it was in the delta-dominant period (80·7\% [95\% CI 77·8{\textendash}83·3] in Brazil and 92·8\% [85·7{\textendash}96·4] in Scotland). Vaccine efficacy started to decline from 27 days after the second dose for both countries, reducing to 5·9\% (95\% CI 2·2{\textendash}9·4) in Brazil and 50·6\% (42·7{\textendash}57·4) in Scotland at 98 days or more during the omicron-dominant period. In Brazil, protection against severe disease remained above 80\% from 28 days after the second dose and was 82·7\% (95\% CI 68·8{\textendash}90·4) at 98 days or more after receiving the second dose. Interpretation: We found waning vaccine protection of BNT162b2 against symptomatic COVID-19 infection among adolescents in Brazil and Scotland from 27 days after the second dose. However, protection against severe COVID-19 outcomes remained high at 98 days or more after the second dose in the omicron-dominant period. Booster doses for adolescents need to be considered. Funding: UK Research and Innovation (Medical Research Council), Scottish Government, Health Data Research UK BREATHE Hub, Fiocruz, Fazer o Bem Faz Bem programme, Brazilian National Research Council, and Wellcome Trust. Translation: For the Portuguese translation of the abstract see Supplementary Materials section.",

author = "Florentino, \{Pilar T.V.\} and Tristan Millington and Thiago Cerqueira-Silva and Chris Robertson and \{de Ara{\'u}jo Oliveira\}, Vinicius and J{\'u}nior, \{Juracy B.S.\} and Alves, \{Fl{\'a}via J.O.\} and Penna, \{Gerson O.\} and \{Vital Katikireddi\}, Srinivasa and Boaventura, \{Viviane S.\} and Werneck, \{Guilherme L.\} and Neil Pearce and Colin McCowan and Christopher Sullivan and Utkarsh Agrawal and Zoe Grange and Ritchie, \{Lewis D.\} and Simpson, \{Colin R.\} and Aziz Sheikh and Barreto, \{Mauricio L.\} and Igor Rudan and Manoel Barral-Netto and Paix{\~a}o, \{Enny S.\}",

note = "Declaration of interests MB-N reports grants from the Fazer o Bem Faz Bem programme from JBS SA. VdAO, VSB, MLB, and MB-N are employees of Fiocruz, a federal public institution that manufactures Vaxzevria in Brazil through a full technology transfer agreement with AstraZeneca. Fiocruz allocates all its manufactured products to the Ministry of Health for public health use. SVK was Co-Chair of the Scottish Government's Expert Reference Group on Ethnicity and COVID-19 and a member of the UK Government's Scientific Advisory Group on Emergencies subgroup on ethnicity. IR is a member of the Scientific Advisory Committee of the Government of Croatia and co-Editor-in-Chief of the Journal of Global Health. CRS declares funding from the Medical Research Council, the National Institute for Health Research, the Chief Scientist Office, and the New Zealand Ministry for Business, Innovation and Employment and Health Research Council during the conduct of this study. CR declares he is a Member of SPI-M, Scottish Government Scientific Advisory Committee, MHRA COVID-19 vaccine benefit and risk expert working group. AS declares that he is a member of the UK and Scottish Governments COVID-19 Advisory Boards and Astra-Zeneca's Thrombotic Thrombocytopenic Taskforce. IR is Co-Editor-in-Chief of the Journal of Global Health and President of the International Society of Global Health. All other authors declare no competing interests. Acknowledgments The authors acknowledge DATASUS for its diligent work in providing the unidentified databases. This study was partially supported by a donation from the Fazer o Bem Faz Bem programme from JBS SA. GLW, MLB, VSB, and MB-N are research fellows from the Brazilian National Research Council (CNPQ). MB-N acknowledges Funda{\c c}{\~a}o de Apoio do Estado da Bahia (FAPESB; PNX0008/2014/ Fapesb, Edital 08/2014 - Programa de Apoio a N{\'u}cleos de Excel{\^e}ncia). GLW acknowledges Funda{\c c}{\~a}o Carlos Chagas Filho de Amparo {\`a} Pesquisa do Estado do Rio de Janeiro (E-26/210·180/2020). SVK is funded by an NHS Research Scotland Senior Clinical Fellowship (SCAF/15/02), the UK Medical Research Council (MC\_UU\_00022/2), and the Scottish Government Chief Scientist Office (SPHSU17). MB-N and VdAO are funded by the Fazer o Bem Faz Bem programme from JBS SA. MB-N is also funded by CNPQ and FAPESB (PNX0008/2014). EPS is funded by the Wellcome Trust (213589/Z/18/Z). For the purpose of open access, the author has applied a CC BY public copyright licence to any author accepted manuscript version arising from this submission. GLW is funded by the Funda{\c c}{\~a}o Carlos Chagas Filho de Amparo {\`a} Pesquisa do Estado do Rio de Janeiro (FAPERJ; E-26/210·180/2020). VSB is funded by CNPQ. Publisher Copyright: {\textcopyright} 2022 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY 4.0 license",

year = "2022",

month = nov,

doi = "10.1016/S1473-3099(22)00451-0",

language = "English",

volume = "22",

pages = "1577--1586",

journal = "The Lancet Infectious Diseases",

issn = "1473-3099",

publisher = "Elsevier Limited",

number = "11",

}

TY - JOUR

T1 - Vaccine effectiveness of two-dose BNT162b2 against symptomatic and severe COVID-19 among adolescents in Brazil and Scotland over time

T2 - a test-negative case-control study

AU - Florentino, Pilar T.V.

AU - Millington, Tristan

AU - Cerqueira-Silva, Thiago

AU - Robertson, Chris

AU - de Araújo Oliveira, Vinicius

AU - Júnior, Juracy B.S.

AU - Alves, Flávia J.O.

AU - Penna, Gerson O.

AU - Vital Katikireddi, Srinivasa

AU - Boaventura, Viviane S.

AU - Werneck, Guilherme L.

AU - Pearce, Neil

AU - McCowan, Colin

AU - Sullivan, Christopher

AU - Agrawal, Utkarsh

AU - Grange, Zoe

AU - Ritchie, Lewis D.

AU - Simpson, Colin R.

AU - Sheikh, Aziz

AU - Barreto, Mauricio L.

AU - Rudan, Igor

AU - Barral-Netto, Manoel

AU - Paixão, Enny S.

N1 - Declaration of interests MB-N reports grants from the Fazer o Bem Faz Bem programme from JBS SA. VdAO, VSB, MLB, and MB-N are employees of Fiocruz, a federal public institution that manufactures Vaxzevria in Brazil through a full technology transfer agreement with AstraZeneca. Fiocruz allocates all its manufactured products to the Ministry of Health for public health use. SVK was Co-Chair of the Scottish Government's Expert Reference Group on Ethnicity and COVID-19 and a member of the UK Government's Scientific Advisory Group on Emergencies subgroup on ethnicity. IR is a member of the Scientific Advisory Committee of the Government of Croatia and co-Editor-in-Chief of the Journal of Global Health. CRS declares funding from the Medical Research Council, the National Institute for Health Research, the Chief Scientist Office, and the New Zealand Ministry for Business, Innovation and Employment and Health Research Council during the conduct of this study. CR declares he is a Member of SPI-M, Scottish Government Scientific Advisory Committee, MHRA COVID-19 vaccine benefit and risk expert working group. AS declares that he is a member of the UK and Scottish Governments COVID-19 Advisory Boards and Astra-Zeneca's Thrombotic Thrombocytopenic Taskforce. IR is Co-Editor-in-Chief of the Journal of Global Health and President of the International Society of Global Health. All other authors declare no competing interests. Acknowledgments The authors acknowledge DATASUS for its diligent work in providing the unidentified databases. This study was partially supported by a donation from the Fazer o Bem Faz Bem programme from JBS SA. GLW, MLB, VSB, and MB-N are research fellows from the Brazilian National Research Council (CNPQ). MB-N acknowledges Fundação de Apoio do Estado da Bahia (FAPESB; PNX0008/2014/ Fapesb, Edital 08/2014 - Programa de Apoio a Núcleos de Excelência). GLW acknowledges Fundação Carlos Chagas Filho de Amparo à Pesquisa do Estado do Rio de Janeiro (E-26/210·180/2020). SVK is funded by an NHS Research Scotland Senior Clinical Fellowship (SCAF/15/02), the UK Medical Research Council (MC_UU_00022/2), and the Scottish Government Chief Scientist Office (SPHSU17). MB-N and VdAO are funded by the Fazer o Bem Faz Bem programme from JBS SA. MB-N is also funded by CNPQ and FAPESB (PNX0008/2014). EPS is funded by the Wellcome Trust (213589/Z/18/Z). For the purpose of open access, the author has applied a CC BY public copyright licence to any author accepted manuscript version arising from this submission. GLW is funded by the Fundação Carlos Chagas Filho de Amparo à Pesquisa do Estado do Rio de Janeiro (FAPERJ; E-26/210·180/2020). VSB is funded by CNPQ. Publisher Copyright: © 2022 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY 4.0 license

PY - 2022/11

Y1 - 2022/11

N2 - Background: Little is known about vaccine effectiveness over time among adolescents, especially against the SARS-CoV-2 omicron (B.1.1.529) variant. This study assessed the associations between time since two-dose vaccination with BNT162b2 and the occurrence of symptomatic SARS-CoV-2 infection and severe COVID-19 among adolescents in Brazil and Scotland. Methods: We did test-negative, case-control studies in adolescents aged 12–17 years with COVID-19-related symptoms in Brazil and Scotland. We linked records of SARS-CoV-2 RT-PCR and antigen tests to national vaccination and clinical records. We excluded tests from individuals who did not have symptoms, were vaccinated before the start of the national vaccination programme, received vaccines other than BNT162b2 or a SARS-CoV-2 booster dose of any kind, or had an interval between their first and second dose of fewer than 21 days. Additionally, we excluded negative SARS-CoV-2 tests recorded within 14 days of a previous negative test, negative tests recorded within 7 days after a positive test, any test done within 90 days after a positive test, and tests with missing sex and location information. Cases (SARS-CoV-2 test-positive adolescents) and controls (test-negative adolescents) were drawn from a sample of individuals in whom tests were collected within 10 days of symptom onset. We estimated the adjusted odds ratio and vaccine effectiveness against symptomatic COVID-19 for both countries and against severe COVID-19 (hospitalisation or death) for Brazil across fortnightly periods. Findings: We analysed 503 776 tests from 2 948 538 adolescents in Brazil between Sept 2, 2021, and April 19, 2022, and 127 168 tests from 404 673 adolescents in Scotland between Aug 6, 2021, and April 19, 2022. Vaccine effectiveness peaked at 14–27 days after the second dose in both countries during both waves, and was significantly lower against symptomatic infection during the omicron-dominant period in Brazil (64·7% [95% CI 63·0–66·3]) and in Scotland (82·6% [80·6–84·5]), than it was in the delta-dominant period (80·7% [95% CI 77·8–83·3] in Brazil and 92·8% [85·7–96·4] in Scotland). Vaccine efficacy started to decline from 27 days after the second dose for both countries, reducing to 5·9% (95% CI 2·2–9·4) in Brazil and 50·6% (42·7–57·4) in Scotland at 98 days or more during the omicron-dominant period. In Brazil, protection against severe disease remained above 80% from 28 days after the second dose and was 82·7% (95% CI 68·8–90·4) at 98 days or more after receiving the second dose. Interpretation: We found waning vaccine protection of BNT162b2 against symptomatic COVID-19 infection among adolescents in Brazil and Scotland from 27 days after the second dose. However, protection against severe COVID-19 outcomes remained high at 98 days or more after the second dose in the omicron-dominant period. Booster doses for adolescents need to be considered. Funding: UK Research and Innovation (Medical Research Council), Scottish Government, Health Data Research UK BREATHE Hub, Fiocruz, Fazer o Bem Faz Bem programme, Brazilian National Research Council, and Wellcome Trust. Translation: For the Portuguese translation of the abstract see Supplementary Materials section.

AB - Background: Little is known about vaccine effectiveness over time among adolescents, especially against the SARS-CoV-2 omicron (B.1.1.529) variant. This study assessed the associations between time since two-dose vaccination with BNT162b2 and the occurrence of symptomatic SARS-CoV-2 infection and severe COVID-19 among adolescents in Brazil and Scotland. Methods: We did test-negative, case-control studies in adolescents aged 12–17 years with COVID-19-related symptoms in Brazil and Scotland. We linked records of SARS-CoV-2 RT-PCR and antigen tests to national vaccination and clinical records. We excluded tests from individuals who did not have symptoms, were vaccinated before the start of the national vaccination programme, received vaccines other than BNT162b2 or a SARS-CoV-2 booster dose of any kind, or had an interval between their first and second dose of fewer than 21 days. Additionally, we excluded negative SARS-CoV-2 tests recorded within 14 days of a previous negative test, negative tests recorded within 7 days after a positive test, any test done within 90 days after a positive test, and tests with missing sex and location information. Cases (SARS-CoV-2 test-positive adolescents) and controls (test-negative adolescents) were drawn from a sample of individuals in whom tests were collected within 10 days of symptom onset. We estimated the adjusted odds ratio and vaccine effectiveness against symptomatic COVID-19 for both countries and against severe COVID-19 (hospitalisation or death) for Brazil across fortnightly periods. Findings: We analysed 503 776 tests from 2 948 538 adolescents in Brazil between Sept 2, 2021, and April 19, 2022, and 127 168 tests from 404 673 adolescents in Scotland between Aug 6, 2021, and April 19, 2022. Vaccine effectiveness peaked at 14–27 days after the second dose in both countries during both waves, and was significantly lower against symptomatic infection during the omicron-dominant period in Brazil (64·7% [95% CI 63·0–66·3]) and in Scotland (82·6% [80·6–84·5]), than it was in the delta-dominant period (80·7% [95% CI 77·8–83·3] in Brazil and 92·8% [85·7–96·4] in Scotland). Vaccine efficacy started to decline from 27 days after the second dose for both countries, reducing to 5·9% (95% CI 2·2–9·4) in Brazil and 50·6% (42·7–57·4) in Scotland at 98 days or more during the omicron-dominant period. In Brazil, protection against severe disease remained above 80% from 28 days after the second dose and was 82·7% (95% CI 68·8–90·4) at 98 days or more after receiving the second dose. Interpretation: We found waning vaccine protection of BNT162b2 against symptomatic COVID-19 infection among adolescents in Brazil and Scotland from 27 days after the second dose. However, protection against severe COVID-19 outcomes remained high at 98 days or more after the second dose in the omicron-dominant period. Booster doses for adolescents need to be considered. Funding: UK Research and Innovation (Medical Research Council), Scottish Government, Health Data Research UK BREATHE Hub, Fiocruz, Fazer o Bem Faz Bem programme, Brazilian National Research Council, and Wellcome Trust. Translation: For the Portuguese translation of the abstract see Supplementary Materials section.

UR - https://www.scopus.com/pages/publications/85136660340

U2 - 10.1016/S1473-3099(22)00451-0

DO - 10.1016/S1473-3099(22)00451-0

M3 - Article

C2 - 35952702

AN - SCOPUS:85136660340

SN - 1473-3099

VL - 22

SP - 1577

EP - 1586

JO - The Lancet Infectious Diseases

JF - The Lancet Infectious Diseases

IS - 11

ER -

Vaccine effectiveness of two-dose BNT162b2 against symptomatic and severe COVID-19 among adolescents in Brazil and Scotland over time: a test-negative case-control study

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