The US Food and Drug Administration has granted Fast Track designation to two Sanofi combination vaccine candidates to prevent influenza and COVID-19 infections in individuals 50 years of age and older. Both candidates combine two already licensed and authorized vaccines with proven efficacy through randomized controlled studies, and with favorable tolerability.
The first combination vaccine candidate (NCT06695117) consists of the influenza protein-based trivalent vaccine Fluzone High-Dose combined with the adjuvanted recombinant Novavax COVID-19 vaccine. The second candidate (NCT06695130) combines the influenza recombinant protein-based trivalent vaccine Flublok with the Novavax COVID-19 vaccine.
Both Fluzone High-Dose and Flublok have been proven to prevent more influenza infections in older adults than standard-dose influenza vaccines in pivotal randomized clinical studies. Additionally, in real-world evidence studies they have demonstrated significant and consistent reductions in flu-related hospitalizations. The Novavax COVID-19 vaccine has been shown to have a better tolerability profile than currently available mRNA COVID-19 vaccines when administered as a booster dose. It has also demonstrated high efficacy against COVID-19 as primary vaccination in two pivotal phase 3 studies.
Fast Track designation was granted based on the potential for the combination vaccine candidates to address the significant individual and healthcare system burden of two serious illnesses that can result in hospitalization and death, particularly among older adults.
Sanofi has initiated two separate phase 1/2 parallel, randomized, modified double-blind, multi-arm studies (NCT06695117 and NCT06695130) to evaluate the safety and immune response induced by the two combination vaccine candidates.
About NCT06695117 and NCT06695130
The two combination vaccine candidates consist of:
- NCT06695117: TIV-HD (FLUZONE High-Dose) combined with NVXC19 (Novavax COVID-19 vaccine) to prevent Influenza subtype A, influenza subtype B and coronavirus (SARS CoV-2) infections in individuals 50 years of age or older.
- NCT06695130: RIV3 (FLUBLOK) combined with NVXC19 (Novavax COVID-19 vaccine) to prevent Influenza subtype A, influenza subtype B and coronavirus (SARS CoV-2) infection in individuals 50 years of age or older.
One recent systematic review and meta-analysis suggests a combination booster vaccine could increase the uptake of COVID-19 vaccines among the 50 years and above age group by 56%.
Combination vaccines may also be attractive to healthcare professionals conducting immunization programs as they may be easier and quicker to administer with fewer injections to protect against multiple diseases, less errors and decreased syringe and vial disposal requirements.
Subscribe to our e-Newsletters
Stay up to date with the latest news, articles, and events. Plus, get special offers
from American Pharmaceutical Review – all delivered right to your inbox!
Sign up now!