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Study protocol: cohort event monitoring for safety signal detection after vaccination with COVID-19 vaccines in Iran

BACKGROUND: New vaccines that are initially approved in clinical trials are not completely free of risks. Systematic vaccine safety surveillance is required for ensuring safety of vaccines. This study aimed to provide a protocol for safety monitoring of COVID-19 vaccines, including Sputnik V, Sinoph...

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Autores principales: Aliyari, Roqayeh, Mahdavi, Sepideh, Enayatrad, Mostafa, Sahab-Negah, Sajad, Nili, Sairan, Fereidooni, Mohammad, Mangolian shahrbabaki, Parvin, Ansari-Moghaddam, Alireza, Heidarzadeh, Abtin, Shahraki-Sanavi, Fariba, Amini Moridani, Mohammadreza, Fateh, Mansooreh, Khajeha, Hamidreza, Emamian, Zahra, Behmanesh, Elahe, Sharifi, Hamid, Emamian, Mohammad Hassan
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9178529/
https://www.ncbi.nlm.nih.gov/pubmed/35681132
http://dx.doi.org/10.1186/s12889-022-13575-1
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author Aliyari, Roqayeh
Mahdavi, Sepideh
Enayatrad, Mostafa
Sahab-Negah, Sajad
Nili, Sairan
Fereidooni, Mohammad
Mangolian shahrbabaki, Parvin
Ansari-Moghaddam, Alireza
Heidarzadeh, Abtin
Shahraki-Sanavi, Fariba
Amini Moridani, Mohammadreza
Fateh, Mansooreh
Khajeha, Hamidreza
Emamian, Zahra
Behmanesh, Elahe
Sharifi, Hamid
Emamian, Mohammad Hassan
author_facet Aliyari, Roqayeh
Mahdavi, Sepideh
Enayatrad, Mostafa
Sahab-Negah, Sajad
Nili, Sairan
Fereidooni, Mohammad
Mangolian shahrbabaki, Parvin
Ansari-Moghaddam, Alireza
Heidarzadeh, Abtin
Shahraki-Sanavi, Fariba
Amini Moridani, Mohammadreza
Fateh, Mansooreh
Khajeha, Hamidreza
Emamian, Zahra
Behmanesh, Elahe
Sharifi, Hamid
Emamian, Mohammad Hassan
author_sort Aliyari, Roqayeh
collection PubMed
description BACKGROUND: New vaccines that are initially approved in clinical trials are not completely free of risks. Systematic vaccine safety surveillance is required for ensuring safety of vaccines. This study aimed to provide a protocol for safety monitoring of COVID-19 vaccines, including Sputnik V, Sinopharm (BBIBP-CorV), COVIran Barekat, and AZD1222. METHODS: This is a prospective cohort study in accordance with a template provided by the World Health Organization. The target population includes citizens of seven cities in Iran who have received one of the available COVID-19 vaccines according to the national instruction on vaccination. The participants are followed for three months after they receive the second dose of the vaccine. For each type of vaccine, 30,000 people will be enrolled in the study of whom the first 1,000 participants are in the reactogenicity subgroup. The reactogenicity outcomes will be followed seven days after vaccination. Any hospitalization, COVID-19 disease, or other minor outcomes will be investigated in weekly follow-ups. The data are gathered through self-reporting of participants in a mobile application or phone calls to them. The study outcomes may be investigated for the third and fourth doses of vaccines. Other long-term outcomes may also be investigated after the expansion of the follow-up period. We have planned to complete data collection for the current objectives by the end 2022. DISCUSSION: The results of this study will be published in different articles. A live dashboard is also available for managers and policymakers. All data will be available on reasonable requests from the corresponding author.The use of the good and comprehensive guidelines provided by WHO, along with the accurate implementation of the protocol and continuous monitoring of the staff performance are the main strengths of this study which may be very useful for policymaking about COVID-19 vaccination.
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spelling pubmed-91785292022-06-09 Study protocol: cohort event monitoring for safety signal detection after vaccination with COVID-19 vaccines in Iran Aliyari, Roqayeh Mahdavi, Sepideh Enayatrad, Mostafa Sahab-Negah, Sajad Nili, Sairan Fereidooni, Mohammad Mangolian shahrbabaki, Parvin Ansari-Moghaddam, Alireza Heidarzadeh, Abtin Shahraki-Sanavi, Fariba Amini Moridani, Mohammadreza Fateh, Mansooreh Khajeha, Hamidreza Emamian, Zahra Behmanesh, Elahe Sharifi, Hamid Emamian, Mohammad Hassan BMC Public Health Study Protocol BACKGROUND: New vaccines that are initially approved in clinical trials are not completely free of risks. Systematic vaccine safety surveillance is required for ensuring safety of vaccines. This study aimed to provide a protocol for safety monitoring of COVID-19 vaccines, including Sputnik V, Sinopharm (BBIBP-CorV), COVIran Barekat, and AZD1222. METHODS: This is a prospective cohort study in accordance with a template provided by the World Health Organization. The target population includes citizens of seven cities in Iran who have received one of the available COVID-19 vaccines according to the national instruction on vaccination. The participants are followed for three months after they receive the second dose of the vaccine. For each type of vaccine, 30,000 people will be enrolled in the study of whom the first 1,000 participants are in the reactogenicity subgroup. The reactogenicity outcomes will be followed seven days after vaccination. Any hospitalization, COVID-19 disease, or other minor outcomes will be investigated in weekly follow-ups. The data are gathered through self-reporting of participants in a mobile application or phone calls to them. The study outcomes may be investigated for the third and fourth doses of vaccines. Other long-term outcomes may also be investigated after the expansion of the follow-up period. We have planned to complete data collection for the current objectives by the end 2022. DISCUSSION: The results of this study will be published in different articles. A live dashboard is also available for managers and policymakers. All data will be available on reasonable requests from the corresponding author.The use of the good and comprehensive guidelines provided by WHO, along with the accurate implementation of the protocol and continuous monitoring of the staff performance are the main strengths of this study which may be very useful for policymaking about COVID-19 vaccination. BioMed Central 2022-06-09 /pmc/articles/PMC9178529/ /pubmed/35681132 http://dx.doi.org/10.1186/s12889-022-13575-1 Text en © The Author(s) 2022 https://creativecommons.org/licenses/by/4.0/Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) . The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/ (https://creativecommons.org/publicdomain/zero/1.0/) ) applies to the data made available in this article, unless otherwise stated in a credit line to the data.
spellingShingle Study Protocol
Aliyari, Roqayeh
Mahdavi, Sepideh
Enayatrad, Mostafa
Sahab-Negah, Sajad
Nili, Sairan
Fereidooni, Mohammad
Mangolian shahrbabaki, Parvin
Ansari-Moghaddam, Alireza
Heidarzadeh, Abtin
Shahraki-Sanavi, Fariba
Amini Moridani, Mohammadreza
Fateh, Mansooreh
Khajeha, Hamidreza
Emamian, Zahra
Behmanesh, Elahe
Sharifi, Hamid
Emamian, Mohammad Hassan
Study protocol: cohort event monitoring for safety signal detection after vaccination with COVID-19 vaccines in Iran
title Study protocol: cohort event monitoring for safety signal detection after vaccination with COVID-19 vaccines in Iran
title_full Study protocol: cohort event monitoring for safety signal detection after vaccination with COVID-19 vaccines in Iran
title_fullStr Study protocol: cohort event monitoring for safety signal detection after vaccination with COVID-19 vaccines in Iran
title_full_unstemmed Study protocol: cohort event monitoring for safety signal detection after vaccination with COVID-19 vaccines in Iran
title_short Study protocol: cohort event monitoring for safety signal detection after vaccination with COVID-19 vaccines in Iran
title_sort study protocol: cohort event monitoring for safety signal detection after vaccination with covid-19 vaccines in iran
topic Study Protocol
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9178529/
https://www.ncbi.nlm.nih.gov/pubmed/35681132
http://dx.doi.org/10.1186/s12889-022-13575-1
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