tetano
Editor, Senior Moderator
Hum Vaccin Immunother
. 2021 Aug 18;1-4.
doi: 10.1080/21645515.2021.1935170. Online ahead of print.
Improved post-marketing safety surveillance of quadrivalent inactivated influenza vaccine in Mexico using a computerized, SMS-based follow-up system
Miguel Betancourt-Cravioto[SUP] 1 [/SUP], Patricia Cervantes-Powell[SUP] 2 [/SUP], Roberto Tapia-Conyer[SUP] 3 [/SUP], Shaleesa Ledlie[SUP] 4 [/SUP], Sonja Gandhi-Banga[SUP] 4 [/SUP]
Affiliations
Abstract
Quadrivalent influenza vaccines (QIVs) are designed to prevent influenza disease caused by two influenza A viruses (H1N1 and H3N2) and both influenza B lineages. Risk-monitoring of QIVs to identify adverse events (AEs) is necessary as influenza vaccines are reformulated each year. We developed a new active surveillance system (Sistema de Control de Vacunación; SICOVA) to improve pharmacovigilance in Mexico. Participants (N = 2013) aged 0 - 96 years from nine sites across three influenza seasons (n = 1166 in 2015 - 2016; n = 633 in 2016 - 2017; and n = 214 in 2017 - 2018) agreed to receive text messages 1, 7, 28, and 42 days post-vaccination to know if they had experienced any AEs. The study was completed electronically by 1763 (87.6%) participants; manual follow-up was conducted for 250 participants whose reporting was incomplete. The overall AE rate was 9.09%. At least one AE was reported by 183 participants, of whom 131 (71.58%) did not require a medical visit and 52 (28.42%) needed medical attention, with none requiring hospitalization. Most AEs requiring medical attention occurred in children aged 0 - 5 years (n = 22, 42.31%) and adults aged 31 - 35 years (n = 5, 9.62%). These results are consistent with the established safety profile of Fluzone® Quadrivalent, and show that SICOVA can facilitate surveillance and increase AE reporting in Mexico.
Keywords: Influenza vaccines; adverse events; immunization; pharmacovigilance; post-marketing safety surveillance; risk management plan; safety; seasonal influenza; vaccination.
. 2021 Aug 18;1-4.
doi: 10.1080/21645515.2021.1935170. Online ahead of print.
Improved post-marketing safety surveillance of quadrivalent inactivated influenza vaccine in Mexico using a computerized, SMS-based follow-up system
Miguel Betancourt-Cravioto[SUP] 1 [/SUP], Patricia Cervantes-Powell[SUP] 2 [/SUP], Roberto Tapia-Conyer[SUP] 3 [/SUP], Shaleesa Ledlie[SUP] 4 [/SUP], Sonja Gandhi-Banga[SUP] 4 [/SUP]
Affiliations
- PMID: 34406896
- DOI: 10.1080/21645515.2021.1935170
Abstract
Quadrivalent influenza vaccines (QIVs) are designed to prevent influenza disease caused by two influenza A viruses (H1N1 and H3N2) and both influenza B lineages. Risk-monitoring of QIVs to identify adverse events (AEs) is necessary as influenza vaccines are reformulated each year. We developed a new active surveillance system (Sistema de Control de Vacunación; SICOVA) to improve pharmacovigilance in Mexico. Participants (N = 2013) aged 0 - 96 years from nine sites across three influenza seasons (n = 1166 in 2015 - 2016; n = 633 in 2016 - 2017; and n = 214 in 2017 - 2018) agreed to receive text messages 1, 7, 28, and 42 days post-vaccination to know if they had experienced any AEs. The study was completed electronically by 1763 (87.6%) participants; manual follow-up was conducted for 250 participants whose reporting was incomplete. The overall AE rate was 9.09%. At least one AE was reported by 183 participants, of whom 131 (71.58%) did not require a medical visit and 52 (28.42%) needed medical attention, with none requiring hospitalization. Most AEs requiring medical attention occurred in children aged 0 - 5 years (n = 22, 42.31%) and adults aged 31 - 35 years (n = 5, 9.62%). These results are consistent with the established safety profile of Fluzone® Quadrivalent, and show that SICOVA can facilitate surveillance and increase AE reporting in Mexico.
Keywords: Influenza vaccines; adverse events; immunization; pharmacovigilance; post-marketing safety surveillance; risk management plan; safety; seasonal influenza; vaccination.