Investigator(s)
| WHO Technical Officer |
Sarah Jamal National professional office, Communicable Diseases WCO, Maldives Sarah Jamal 
|
| Principal Investigator |
Nashiya Abdul Gafoor National Program on Immunization and Travel Vaccine, Health Protection Agency, Ministry of Health Maldives Nashiya Abdul Gafoor
|
Title(s) and abstract
| Scientific title | Adverse Events of Special Interest (AESI) surveillance of COVID-19 vaccination in Maldives |
| Public title | Adverse Events of Special Interest (AESI) surveillance of COVID-19 vaccination in Maldives |
| Background | Large-scale vaccination is considered to be the most effective measure to control pandemic influenza and reduce associated illness, mortality and socioeconomic disruption (Banzhof A etal 2011). Rate of AESI may differ depending on the population characteristics highlighting the importance of getting local data with background rates from the population. This would be used further to generate effective communication strategies about the safety of the COVID-19 vaccines being used in the country, targeting the community, media, national regulatory authorities (NRAs), vaccine manufacturers and marketing authorization holders (MAH), WHO and other stakeholders. Findings will also allow international, subnational comparisons of the reporting rate and risk rate of the selected AESIs and pave way to detect previously unrecognised adverse reactions that maybe specific to the country setting. |
| Objectives | The primary aim of this study is to determine if COVID-19 vaccination is associated with an increased risk of selected adverse events of special interest (AESIs). We hypothesize that there is no significant difference in the relative risk of AESIs in persons who were vaccinated with a COVID-19 vaccine, compared with those who were not. The research questions for which answers are expected from this research include: ● What are the background rates of the selected AESIs during defined periods in the Maldives? ● What is the reporting rate of the selected AESIs? ● What is the rate of mortality following AESIs? ● What is the relative risk of the selected AESIs between the vaccinated and non-vaccinated? |
| Study Methods | Research design This is a retrospective search of the following databases to monitor the rates of various adverse events of special interest (AESIs) following COVID-19 vaccination and to estimate the background rates. 7.1 Aasandha National Health Insurance Database (for locals) 7.2 Medical records of all health facilities (for expatriates) 7.3 Vaccine register at Health Protection Agency 7.4 Allied Health Insurance (expatriates) |
| Expected outcomes and use of results | Part one To estimate the risk of selected and pre-defined AESIs following immunization with a COVID-19 vaccine using a self-controlled risk interval (SCRI) study design. The AESI’s will include; Anaphylaxis, Guillain-Barre Syndrome (GBS), Thrombotic Thrombocytopenia Syndrome (TTS), Multi-systemic Inflammatory Syndrome of Children/Adults (MIS C/A) and myocarditis. Part two To determine the reporting rates of selected AESIs per 100,000 COVID19 vaccine doses by; ▪ Types of AESIs, number of cases and number of events per case, Part three To estimate the background rates at different points in time and in relation to COVID-19 disease and vaccine introduction for the selected AESIs. The background rates of the selected AESIs (in both the vaccinated and unvaccinated) will be determined during three time periods as follows; o Pre-COVID time from 2015 to 2019 o COVID -19 time before vaccine introduction from March 2020 to February 2021 o After COVID-19 vaccine introduction from February 2021 to January 2022 The compare the odds of having been vaccinated among cases with the AESI under investigation with the odds of having been vaccinated among controls for AESIs using a case-control study design. |
| Keywords | AESI, Vaccination, COVID-19, Immunization, AEFI |
Research Details
| Student research | No |
| Start Date | 08-Jan-2023 |
| End Date | 31-Dec-2023 |
| Key Implementing Institution | Health Protection Agency Maldives |
| Multi-country research | No |
| Nationwide research | Yes |
| Research Domain(s) | Communicable Disease Research |
| Research field(s) | Immunization/Vaccine Preventable Disease, COVID-19 |
| Involves human subjects | No |
| Data Collection | Secondary data |
| Proposal reviewed by other Committee | Final decision available |