PMID- 34406896
OWN - NLM
STAT- MEDLINE
DCOM- 20220418
LR  - 20220418
IS  - 2164-554X (Electronic)
IS  - 2164-5515 (Print)
IS  - 2164-5515 (Linking)
VI  - 18
IP  - 1
DP  - 2022 Dec 31
TI  - Improved post-marketing safety surveillance of quadrivalent inactivated influenza 
      vaccine in Mexico using a computerized, SMS-based follow-up system.
PG  - 1935170
LID - 10.1080/21645515.2021.1935170 [doi]
LID - 1935170
AB  - 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 Vacunacion; 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(R) Quadrivalent, and show that SICOVA can facilitate 
      surveillance and increase AE reporting in Mexico.
FAU - Betancourt-Cravioto, Miguel
AU  - Betancourt-Cravioto M
AD  - Sociedad Mexicana de Salud Publica, CDMX, Mexico.
FAU - Cervantes-Powell, Patricia
AU  - Cervantes-Powell P
AUID- ORCID: 0000-0001-9173-9000
AD  - Medical Department, Sanofi Pasteur, CDMX, Mexico.
FAU - Tapia-Conyer, Roberto
AU  - Tapia-Conyer R
AD  - Family Medicine, School of Medicine. National Autonomous University of Mexico, 
      Mexico City, Mexico.
FAU - Ledlie, Shaleesa
AU  - Ledlie S
AD  - Epidemiology and Benefit-Risk Department, Sanofi Pasteur, Toronto, Ontario, 
      Canada.
FAU - Gandhi-Banga, Sonja
AU  - Gandhi-Banga S
AD  - Epidemiology and Benefit-Risk Department, Sanofi Pasteur, Toronto, Ontario, 
      Canada.
LA  - eng
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
DEP - 20210818
PL  - United States
TA  - Hum Vaccin Immunother
JT  - Human vaccines & immunotherapeutics
JID - 101572652
RN  - 0 (Influenza Vaccines)
RN  - 0 (Vaccines, Combined)
RN  - 0 (Vaccines, Inactivated)
SB  - IM
MH  - Adult
MH  - Child
MH  - Follow-Up Studies
MH  - Humans
MH  - *Influenza A Virus, H1N1 Subtype
MH  - Influenza A Virus, H3N2 Subtype
MH  - *Influenza Vaccines/adverse effects
MH  - *Influenza, Human/prevention & control
MH  - Marketing
MH  - Mexico/epidemiology
MH  - Vaccines, Combined
MH  - Vaccines, Inactivated/adverse effects
PMC - PMC8920169
OTO - NOTNLM
OT  - Influenza vaccines
OT  - adverse events
OT  - immunization
OT  - pharmacovigilance
OT  - post-marketing safety surveillance
OT  - risk management plan
OT  - safety
OT  - seasonal influenza
OT  - vaccination
EDAT- 2021/08/19 06:00
MHDA- 2022/04/19 06:00
PMCR- 2021/08/18
CRDT- 2021/08/18 17:16
PHST- 2021/08/19 06:00 [pubmed]
PHST- 2022/04/19 06:00 [medline]
PHST- 2021/08/18 17:16 [entrez]
PHST- 2021/08/18 00:00 [pmc-release]
AID - 1935170 [pii]
AID - 10.1080/21645515.2021.1935170 [doi]
PST - ppublish
SO  - Hum Vaccin Immunother. 2022 Dec 31;18(1):1935170. doi: 
      10.1080/21645515.2021.1935170. Epub 2021 Aug 18.