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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.
  • Aliyari R; Department of Epidemiology, School of Public Health, Shahroud University of Medical Sciences, Shahroud, Iran.
  • Mahdavi S; Department of Epidemiology, School of Public Health, Shahroud University of Medical Sciences, Shahroud, Iran.
  • Enayatrad M; Clinical Research Development Unit, Bahar Hospital, Shahroud University of Medical Science, Shahroud, Iran.
  • Sahab-Negah S; Neuroscience Research Center, Mashhad University of Medical Sciences, Mashhad, Iran.
  • Nili S; Department of Public Health, Faculty of Health, Kurdistan University of Medical Sciences, Sanandaj, Iran.
  • Fereidooni M; Cellular and Molecular Research Center, Birjand University of Medical Sciences, Birjand, Iran.
  • Mangolian Shahrbabaki P; Department of Critical Care, Razi Faculty of Nursing and Midwifery, Kerman University of Medical Sciences, Kerman, Iran.
  • Ansari-Moghaddam A; Health Promotion Research Center, Zahedan University of Medical Sciences, Zahedan, Iran.
  • Heidarzadeh A; School of Medicine, Guilan University of Medical Sciences, Rasht, Iran.
  • Shahraki-Sanavi F; Infectious Diseases and Tropical Medicine Research Center, Zahedan University of Medical Sciences, Zahedan, Iran.
  • Amini Moridani M; Vice-Chancellery for Health Affairs, Guilan University of Medical Sciences, Rasht, Iran.
  • Fateh M; Center for Health Related Social and Behavioral Sciences Research, Shahroud University of Medical Sciences, Shahroud, Iran.
  • Khajeha H; Ophthalmic Epidemiology Research Center, Shahroud University of Medical Sciences, Shahroud, Iran.
  • Emamian Z; Health Technology Incubator Center, Shahroud University of Medical Sciences, Shahroud, Iran.
  • Behmanesh E; Health Technology Incubator Center, Shahroud University of Medical Sciences, Shahroud, Iran.
  • Sharifi H; HIV/STI Surveillance Research Center, Kerman University of Medical Sciences, Kerman, Iran.
  • Emamian MH; Ophthalmic Epidemiology Research Center, Shahroud University of Medical Sciences, Shahroud, Iran. emamian@shmu.ac.ir.
BMC Public Health ; 22(1): 1153, 2022 06 09.
Article in English | MEDLINE | ID: covidwho-1951158
ABSTRACT

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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Full text: Available Collection: International databases Database: MEDLINE Main subject: COVID-19 Vaccines / COVID-19 Type of study: Cohort study / Experimental Studies / Observational study / Prognostic study / Randomized controlled trials / Systematic review/Meta Analysis Topics: Vaccines Limits: Humans Country/Region as subject: Asia Language: English Journal: BMC Public Health Journal subject: Public Health Year: 2022 Document Type: Article Affiliation country: S12889-022-13575-1

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Full text: Available Collection: International databases Database: MEDLINE Main subject: COVID-19 Vaccines / COVID-19 Type of study: Cohort study / Experimental Studies / Observational study / Prognostic study / Randomized controlled trials / Systematic review/Meta Analysis Topics: Vaccines Limits: Humans Country/Region as subject: Asia Language: English Journal: BMC Public Health Journal subject: Public Health Year: 2022 Document Type: Article Affiliation country: S12889-022-13575-1