Press Release: Two Combination Vaccine Candidates for Influenza and COVID-19 Prevention Receive Fast Track Designation in US | 11.12.24

Two combination vaccine candidates to prevent influenza and COVID-19 have received Fast Track designation in the US

• First non-mRNA combination vaccine candidates that include two already licensed vaccines to prevent influenza and COVID-19 infections
• Two Phase 1/2 clinical trials are ongoing to evaluate the safety profile and immune response induced by the combination vaccine candidates

Paris, December 11, 2024. 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 people age 50 and older. Both candidates combine two vaccines already licensed and authorized, with proven efficacy in randomized controlled trials and favorable tolerability.

The first combination vaccine candidate (NCT06695117) consists of the Fluzone High-Dose trivalent influenza protein-based vaccine combined with the adjuvanted Novavax COVID-19 recombinant vaccine. The second candidate (NCT06695130) combines the Flublok recombinant influenza protein-based trivalent vaccine with the Novavax COVID-19 vaccine.

Both Fluzone High-Dose and Flublok have been shown to prevent more flu infections in older adults than standard-dose flu vaccines in pivotal randomized clinical trials. 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 given as a booster dose. It also demonstrated high efficacy against COVID-19 as primary vaccination in two pivotal phase 3 studies.

Thomas Triomphe
Executive Vice President, Vaccines, Sanofi
“Based on our expertise in immunology and 12 years of solid real-world and clinical data, we aim to continue to lead the way in protection against influenza and its severe outcomes. Our goal is to develop a combination influenza and COVID-19 vaccine that offers simpler scheduling and fewer injections, without compromising the industry-leading levels of efficacy, safety, and tolerability of the stand-alone vaccines included in our combination vaccine.“

Fast Track designation was granted based on the combination vaccine candidates’ potential to address the significant individual and healthcare system burden of two serious diseases that can lead to hospitalization and death, particularly among older adults.

Sanofi initiated two separate parallel, randomized, modified, double-blind, multi-arm phase 1/2 studies (NCT06695117 and NCT06695130) to evaluate the safety and immune response induced by the two combination vaccine candidates.

About NCT06695117 and NCT06695130
The two candidate vaccine combinations 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 people aged 50 years or more.
• 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 people 50 years of age or older.

A recent systematic review and meta-analysis suggests that a combination booster vaccine could increase the uptake of COVID-19 vaccines among the 50 and older age group by 56%.

Combination vaccines may also be attractive to health professionals running immunization programs because they can be easier and faster to administer with fewer injections to protect against more diseases, fewer errors, and lower disposal requirements of syringes and vials.

Influenza (influenza) is an acute, contagious viral respiratory disease. Each year, globally, there are approximately 290,000 to 650,000 respiratory deaths from influenza. In developed countries, most flu-related deaths occur in people 65 years of age or older.

Adults age 65 and older account for the most hospitalizations due to the flu. Among this population, there is a higher rate of hospitalization for influenza, with an average length of hospitalization twice as long as younger adults. A quarter of patients are readmitted to the hospital within 90 days of discharge.

The flu can wreak havoc on major organ systems. It can lead to an 8-fold increased risk of stroke and pneumonia, a 10-fold increased risk of heart attack, and among older adults hospitalized for the flu, 1 in 5 experience a decrease in their ability to and independently perform simple daily tasks such as bathing and dressing.

The coronavirus disease (COVID-19) is an infectious disease caused by the SARS-CoV-2 virus. Most people infected with the virus will experience mild to moderate respiratory illness and will recover without requiring special treatment. However, some will become seriously ill, leading to hospitalization and death.

Many individuals continue to experience long-term sequelae of COVID-19, also referred to as “long covid.” Long-term symptoms of COVID can range from mild to severe, requiring extensive medical attention and even disability. A meta-analysis. of 12 studies show that 30% of patients with COVID-19 have persistent symptoms two years after infection, the most common of which are fatigue, cognitive problems, and pain.

About Sanofi
We are an innovative global healthcare company driven by one purpose: we pursue the miracles of science to improve people’s lives. Our worldwide team is dedicated to transforming the practice of medicine by working to make the impossible possible. We provide life-changing treatment options and life-saving vaccine protection to millions of people around the world, while putting sustainability and social responsibility at the heart of our ambitions.
Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY

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