Summary of the National Advisory Committee on Immunization (NACI) Supplemental Statement on Recombinant Influenza Vaccines.

Background: Recombinant protein technology is a novel platform for influenza vaccine manufacturing that differs significantly from existing egg-based and mammalian cell culture-based technologies. Supemtek™ is the first and, to date, the only recombinant quadrivalent influenza vaccine (RIV4) authorized for use in Canada in adults aged 18 years and older. The objective is to review the available evidence for efficacy, effectiveness, immunogenicity and safety of RIV4, and to summarize the National Advisory Committee on Immunization (NACI) recommendation regarding the use of Supemtek.

Methods: A systematic literature review and meta-analysis on the vaccine efficacy, effectiveness, immunogenicity and safety of RIV4 in adults was conducted according to methodology specified a priori in a written protocol. NACI evidence-based process was used to assess the available evidence and develop a recommendation regarding the use of Supemtek.

Results: Ten eligible studies were included in the evidence synthesis. One randomized controlled trial (RCT) in adults aged 50 years and older provided evidence that RIV4 may potentially offer improved protection against laboratory-confirmed influenza A infection compared to standard egg-based influenza vaccines. Data from eight RCTs assessing immunogenicity and five RCTs and one post-marketing surveillance study assessing safety indicated that Supemtek is a safe, well tolerated, and immunogenic alternative to conventional egg-based influenza vaccines for adults.

Conclusion: There is fair evidence that Supemtek is effective, safe, and has non-inferior immunogenicity to comparable vaccines, based on direct evidence in adults 18 years of age and older; thus, NACI recommends that Supemtek may be considered among the seasonal influenza vaccines offered to adults 18 years of age and older for their annual influenza vaccination.