Safety of recombinant quadrivalent influenza vaccine compared to inactivated influenza vaccine in Chinese adults: An observational study. Issue 5 (31st January 2022)

• Record Type: Journal Article
• Authors: Hsiao, Amber; Hansen, John; Nunley, Karen Valdez; Lewis, Ned; Selmani, Alex; Inamdar, Ajinkya; Mallett-Moore, Tamala; Izikson, Ruvim; Rudin, Deborah; Klein, Nicola P.
• Is Part Of: Vaccine. Volume 40:Issue 5(2022)
• Page Start: 774
• Page End: 779
• Publication Date: 2022-01-31
• Subjects: Vaccines -- Influenza; Vaccines -- Periodicals; 615.372
• DOI: 10.1016/j.vaccine.2021.12.035
• Languages: English
• ISSNs: 0264-410X

Abstract

Highlights: Prior studies find recombinant influenza vaccines (RIV) to be safe and efficacious. Safety data for the use of RIV in Chinese subjects is limited. No safety concerns regarding the use of RIV in Chinese adults were identified. The findings are consistent with RIV clinical trials and post-marketing studies. 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.