FDA Grants Fast Track Designation to Non-mRNA Combination Vaccines

According to a Dec. 16 article from The American Journal of Managed Care (AJMC), the FDA granted Fast Track designation to the first non-mRNA combination vaccine candidates of vaccines that have already been licensed to prevent the respiratory diseases influenza and COVID-19 for individuals 50 years and older.

The article said, “The first vaccine candidate (NCT06695117) is comprised of the influenza protein-based trivalent vaccine Fluzone High-Dose combined with the adjuvanted recombinant Novavax COVID-19 vaccine. The second candidate (NCT06695130) includes the influenza recombinant protein-based trivalent vaccine Flublok with the Novavax COVID-19 vaccine.”

Further, “Both vaccines have been proven to prevent more influenza infections in older adults than standard-dose influenza vaccines and have demonstrated significant and consistent reductions in flu-related hospitalizations in real-world evidence studies. Additionally, the Novavax COVID-19 vaccine has shown a favorable tolerability profile compared with the currently available mRNA COVID-19 vaccines when administered as a booster dose and has also demonstrated high efficacy against COVID-19 as primary vaccination in 2 pivotal phase 3 studies.”

Sanofi has begun separate studies to assess the safety and immune response caused by the 2 combination vaccine candidates.

The article added, “Recent evidence underscores their potential to boost vaccine uptake, particularly among older adults. A systematic review and meta-analysis found that a combination booster vaccine could increase COVID-19 vaccine uptake by 56% in individuals 50 years and older. These vaccines streamline the immunization process by reducing the number of shots required, leading to less pain and discomfort, as well as less time off from work or family.”

The article concluded by stating that influenza poses a significant risk to older adults and that COVID-19 is still a global health concern.