FDA Grants Fast Track Designations to 2 Combination Influenza and COVID-19 Vaccine Candidates

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The FDA has granted fast track designations to 2 combination vaccine candidates to prevent influenza and COVID-19 infections in individuals 50 years of age and older. Both vaccine candidates combine 2 already license and authorized vaccines that have previously proven efficacy and shown favorable tolerability in 2 randomized controlled studies. These fast track designations, according to experts, were granted because of the potential for the combination vaccine candidates to address the significant individual and health care system burden of influenza and COVID-19, both of which can result in hospitalization or death, particularly in older adults.¹

The first combination vaccine candidate consists of the influenza vaccine trivalent vaccine TIV-HD (Fluzone High-Dose; Sanofi) combined with the Novavax adjuvanted recombinant COVID-19 vaccine NVXC19 (Novavax, Inc.). The second combination candidate consists of the RIV3 influenza vaccine (Flublok; Sanofi) combined with NVXC19. Both vaccine candidates will undergo evaluated in 2 separate parallel, randomized, modified, double-blind, multi-arm phase 1/2 clinical trials (NCT06695117² and NCT06695130) to evaluate the safety and immune response in patients. Additionally, both trials will enroll and evaluate individuals who are 50 years of age or older.¹

According to research form randomized clinical trials, both TIV-HD and RIV3 vaccines have been proven to prevent more influenza infections in older adults compared with standard-dose influenza vaccines. In addition, real-world evidence showed significant and consistent reductions in flu-related hospitalizations. Similarly, the NVXC19 COVID-19 vaccine demonstrated better tolerability profiles compared with currently available mRNA COVID-19 vaccines when administered as a booster dose. It also showed high efficacy against COVID-19 when used as a primary vaccination in 2 phase 3 studies.¹

According to a recent systemic review and meta-analysis, combination booster vaccines could increase the uptake of COVID-19 vaccines among those aged 50 years and older by approximately 56%. The combination vaccines can also serve as a quicker and easier administration method with its fewer doses to protect against multiple diseases, less errors, as well as decreased syringe and vial disposal requirements.¹

The phase 1/2 clinical trial evaluating the combination TIV-HD flu and NVXC19 COVID-19 vaccine candidate will evaluate 980 US adults aged 50 years and older to assess the candidate’s safety and immunogenicity compared with placebo. At the time of enrollment, all patients will receive 2 intramuscular injections of the TIV-HD plus NVXC19 vaccine—of which NVXC19 will be combined with difference recombinant spike antigen levels—and compared with TIV-HD alone, NVXC19 (dose 1) alone, and TIV-HD with NVXC19 (dose 1). Additionally, placebo will be coadministered in the TIV-HD alone, NVXC19 (dose 1) alone, and TIV-HD plus NVXC19 study groups to control for the number of injections and maintain observer-blinding.²

The trial is expected to last approximately 12 months and consist of a dose escalation with sequential enrollment. Follow-up visits will be conducted on days 1, 9, 30, 182, and 366, of which days 9, 182, and 366 will be telephone calls.²

“Building on our immunology expertise and on 12 years of robust clinical and real-world data, we aim to continue leading the way in protection against flu and its severe outcomes. Our goal is to develop a combined flu and COVID-19 vaccine that offers simpler scheduling and fewer injections without compromising on the industry leading levels of efficacy, safety, and tolerability of the standalone vaccines included in our combination vaccine,” said Thomas Triomphe, executive vice president, vaccines, Sanofi, in a news release.¹

REFERENCES

1. Sanofi. Press Release: Two combination vaccine candidates for prevention of influenza and COVID-19 granted fast track designation in the US. News release. December 11, 2024. Accessed December 11, 2024.

2. Study of a Combination Vaccine Comprised of Different Recombinant Spike Antigen Levels of a Matrix-M Adjuvanted Recombinant COVID-19 Vaccine and High-Dose Inactivated Influenza Vaccine in Adult Participants 50 Years of Age and Older. ClinicalTrials.gov identifier: NCT06695117. Updated December 4, 2024. Accessed December 11, 2024. https://clinicaltrials.gov/study/NCT06695117