tetano
Editor, Senior Moderator
Vaccine
. 2022 Jan 6;S0264-410X(21)01641-8.
doi: 10.1016/j.vaccine.2021.12.035. Online ahead of print.
Safety of recombinant quadrivalent influenza vaccine compared to inactivated influenza vaccine in Chinese adults: An observational study
Amber Hsiao[SUP] 1 [/SUP], John Hansen[SUP] 2 [/SUP], Karen Valdez Nunley[SUP] 2 [/SUP], Ned Lewis[SUP] 2 [/SUP], Alex Selmani[SUP] 3 [/SUP], Ajinkya Inamdar[SUP] 4 [/SUP], Tamala Mallett-Moore[SUP] 3 [/SUP], Ruvim Izikson[SUP] 3 [/SUP], Deborah Rudin[SUP] 3 [/SUP], Nicola P Klein[SUP] 2 [/SUP]
Affiliations
Abstract
Background: Recombinant influenza vaccine (RIV) has been in use in US adults since 2013. This study evaluated the safety of quadrivalent recombinant influenza vaccine (RIV4, Flublok® Quadrivalent, Sanofi Pasteur) compared with standard-dose quadrivalent inactivated influenza vaccine (SD-IIV4) in self-identified Chinese adults at Kaiser Permanente Northern California (KPNC).
Methods: This study evaluated adults aged 18-64 years within KPNC during the 2018-2019 influenza season who self-identified as Chinese (NCT03694392). We compared the rates of prespecified diagnoses of interest in the emergency department and inpatient settings as done in prior influenza studies, for three risk intervals: 0-2 days, 0-13 days, and 0-41 days following influenza vaccination, as well as number of deaths within 0-180 days after vaccination. We estimated the odds ratios (ORs) and 95% confidence intervals using logistic regression adjusted for sex, age group, presence of comorbidities, and same-day concomitant vaccination.
Results: Comparing 15,574 adults who received RIV4 with 27,110 who received SD-IIV4, there was no statistically significant difference in the prespecified diagnoses of interest and deaths between the 2 groups. There were 35 deaths total, none of which were considered to be related to influenza vaccination.
Conclusions: This study did not identify any safety concerns regarding RIV4 use among 18-64-year-olds who self-identified as Chinese. This study supports the safety of RIV4 vaccine in this population.
Keywords: Influenza; Vaccines.
. 2022 Jan 6;S0264-410X(21)01641-8.
doi: 10.1016/j.vaccine.2021.12.035. Online ahead of print.
Safety of recombinant quadrivalent influenza vaccine compared to inactivated influenza vaccine in Chinese adults: An observational study
Amber Hsiao[SUP] 1 [/SUP], John Hansen[SUP] 2 [/SUP], Karen Valdez Nunley[SUP] 2 [/SUP], Ned Lewis[SUP] 2 [/SUP], Alex Selmani[SUP] 3 [/SUP], Ajinkya Inamdar[SUP] 4 [/SUP], Tamala Mallett-Moore[SUP] 3 [/SUP], Ruvim Izikson[SUP] 3 [/SUP], Deborah Rudin[SUP] 3 [/SUP], Nicola P Klein[SUP] 2 [/SUP]
Affiliations
- PMID: 34998605
- DOI: 10.1016/j.vaccine.2021.12.035
Abstract
Background: Recombinant influenza vaccine (RIV) has been in use in US adults since 2013. This study evaluated the safety of quadrivalent recombinant influenza vaccine (RIV4, Flublok® Quadrivalent, Sanofi Pasteur) compared with standard-dose quadrivalent inactivated influenza vaccine (SD-IIV4) in self-identified Chinese adults at Kaiser Permanente Northern California (KPNC).
Methods: This study evaluated adults aged 18-64 years within KPNC during the 2018-2019 influenza season who self-identified as Chinese (NCT03694392). We compared the rates of prespecified diagnoses of interest in the emergency department and inpatient settings as done in prior influenza studies, for three risk intervals: 0-2 days, 0-13 days, and 0-41 days following influenza vaccination, as well as number of deaths within 0-180 days after vaccination. We estimated the odds ratios (ORs) and 95% confidence intervals using logistic regression adjusted for sex, age group, presence of comorbidities, and same-day concomitant vaccination.
Results: Comparing 15,574 adults who received RIV4 with 27,110 who received SD-IIV4, there was no statistically significant difference in the prespecified diagnoses of interest and deaths between the 2 groups. There were 35 deaths total, none of which were considered to be related to influenza vaccination.
Conclusions: This study did not identify any safety concerns regarding RIV4 use among 18-64-year-olds who self-identified as Chinese. This study supports the safety of RIV4 vaccine in this population.
Keywords: Influenza; Vaccines.
