| Principal Investigator: | Bettinger, Julie (1) |
| Licence Number: | 16924 |
| Organization: | Vaccine Evaluation Center |
| Licensed Year(s): |
2021
|
| Issued: | Dec 17, 2021 |
| Project Team: | Manish Sadarangani, Kim Marty, Ivor Chee, Jasmine Baran, Kelly Simmons, Jeanelle Hazlett, Kendrix Kek, Debbie Lam, Domena Tu, Lilah Johnson, Lovelyn Charles |
Objective(s): To estimate in individuals vaccinated against COVID-19 the frequency of adverse events following immunization (AEFI) of sufficient severity to cause medical consultation or prevent daily activities and to determine whether severe AE rates in vaccines are higher than severe AE rates in controls; and, to estimate the incidence of specific AE after vaccination.
Project Description: This licence has been issued for the scientific research application No.5142. The main objectives of this project are to estimate in individuals vaccinated against COVID-19 the frequency of adverse events following immunization (AEFI) of sufficient severity to cause medical consultation or prevent daily activities and to determine whether severe AE rates in vaccines are higher than severe AE rates in controls. The secondary objectives are to estimate the incidence of specific AE after vaccination. For COVID-19 vaccines, the network is mobilized to collect safety data after each dose and 6 months after the last dose, similar to data collection for the pandemic influenza vaccine in 2009. Participants self-register online at the study website within 8 days of their first dose. An online survey is emailed to them 8 days after each dose and approx. 6 months after the last dose. To assess the underlying rate of illness (background rate), a control survey is sent to unvaccinated individuals who register to take part (please note that unvaccinated individuals may choose to get vaccinated at any time - there is no obligation or need to remain unvaccinated). In both the vaccinated and control group: those who report seeking care from any health care provider, Vaccine Evaluation Center (VEC) staff complete a follow-up call with the participant to confirm additional details about their health event. VEC staff will liaise with NWT Department of Health & Social Services staff to promote the study at COVID-19 vaccine family immunization clinics and media, as available. Weekly reports on recruitment and raw data collected are sent to the primary contact at NWT Department of Health & Social Services. If any concerns are detected, each site is notified promptly. Final study results and publications will be shared with each site. The fieldwork for this study will be conducted from December 17, 2021 to December 31, 2021
