Expedited review granted in the United States to two combination vaccine candidates for the prevention of influenza and COVID-19
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First non-mRNA vaccine candidates combining two vaccines approved for the prevention of influenza and COVID-19 infections.
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Two phase I/II clinical studies are underway to evaluate the safety profile of these combined vaccine candidates and the immune response they induce.
Paris, December 11, 2024.
The U.S. Food and Drug Administration has granted expedited review to two combination vaccine candidates from Sanofi for the prevention of influenza and COVID-19 infections, in adults 50 years and older. The two candidates combine two vaccines already approved and authorized having demonstrated their effectiveness in the context of controlled and randomized studies, with a favorable safety profile.
The first combination vaccine candidate (NCT06695117) combines the trivalent protein-based influenza vaccine Fluzone High-Dose with Novavax, an adjuvanted recombinant COVID-19 vaccine. The second candidate (NCT06695130) combines the recombinant protein-based trivalent vaccine Flublok with the COVID-19 vaccine Novavax.
In pivotal randomized clinical studies, Fluzone High-Dose and Flublok have both demonstrated superior preventive action against influenza virus infections in adults over 50 years of age compared to influenza vaccines. at standard dose. Additionally, real-world studies have shown that these vaccines reduced flu hospitalizations significantly and consistently. Administered as a booster, the Novavax COVID-19 vaccine also presented a better safety profile than the currently available mRNA COVID-19 vaccines. It also demonstrated high efficacy against COVID-19 as primary vaccination in two pivotal Phase III studies.
Thomas Triomphe
Executive Vice President, Vaccines, Sanofi
“With our expertise in immunology and 12 years of robust clinical and real-life data, we seek to continue to innovate in the field of prevention of influenza and its serious complications. We aim to develop a combined influenza and COVID-19 vaccine with a simpler administration schedule and requiring fewer injections, without compromising the high levels of effectiveness, safety and tolerance which are the hallmark of the individual vaccines included in our combined vaccine. »
These accelerated reviews were motivated by the potential of these combination vaccine candidates to alleviate the significant burden that these two serious diseases place on individuals and health systems and to act on the risks of hospitalization and death that They can cause, particularly among older adults.
Sanofi has initiated two separate phase I/II, parallel, randomized, modified double-blind, multi-arm studies (NCT06695117 and NCT06695130) to evaluate the safety of the two combination vaccine candidates, as well as the immune response they induce.
About NCT06695117 and NCT06695130
The two combined vaccine candidates combine:
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NCT06695117: TIV-HD (FLUZONE High-Dose) combined with NVXC19 (COVID-19 Novavax vaccine) for the prevention of infections caused by influenza virus subtypes A and B and by coronavirus (SARS CoV-2) , in people aged 50 and over.
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NCT06695130: RIV3 (FLUBLOK) combined with NVXC19 (COVID-19 Novavax vaccine) for the prevention of infections caused by influenza virus subtypes A and B and by coronavirus (SARS CoV-2), in elderly people 50 years and over.
A recent systematic review and meta-analysis suggests that a combined booster vaccine could increase acceptance of COVID-19 vaccines by 56% among people aged 50 and older.
Combination vaccines may also be more attractive to health professionals in charge of vaccination programs because they can be administered more easily and quickly, require fewer injections for protection against several diseases, cause fewer errors and reduce costs. constraints relating to the disposal of syringes and vials.
Influenza (influenza) is an acute and contagious respiratory viral illness. Every year in the world, it causes 290,000 to 650,000 deaths from respiratory causes. In developed countries, most flu-related deaths occur in people over the age of 65.
Adults aged 65 and over represent the majority of hospitalizations due to influenza. Among this population, hospitalization rates for influenza are higher and the duration of hospitalizations twice as long as among young adults. A quarter of patients are hospitalized again within 90 days of leaving the hospital.
The flu can seriously disrupt major organ systems. In particular, it can increase the risk of stroke and pneumonia by eight and that of heart attack by ten. Among older adults hospitalized with the flu, one in five have difficulty performing the simplest tasks of daily life, such as washing and dressing alone.
Coronavirus disease (COVID-19) is an infectious disease caused by the SARS-CoV-2 virus. Most people infected with this virus have mild to moderate respiratory infections and recover without special treatment. However, some develop serious symptoms requiring hospitalization and potentially causing death.
Many people also experience lasting after-effects after a COVID-19 infection, or “long COVID”. Symptoms of the long form of COVID-19 can be moderate to severe, potentially requiring prolonged medical care, or even causing disability. A meta-analysis of results from 12 studies shows that 30% of COVID-19 patients have persistent symptoms two years after infection, particularly fatigue, cognitive problems and pain.
About Sanofi
We are an innovative, global health company driven by a purpose: pursuing the miracles of science to improve people's lives. Across the world, our teams are working to transform the practice of medicine to make the impossible possible. We provide therapeutic solutions that can change patients' lives and vaccines that protect millions of people around the world, guided by the ambition of sustainable development and our social responsibility.
Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY
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