The U.S. Food and Drug Administration (FDA) has expedited the approval process for two of Sanofi’s combined vaccine candidates that aim to protect individuals aged 50 and above from influenza and Covid-19. These candidates integrate existing vaccines that have demonstrated effectiveness in controlled trials and are well-tolerated.
The first vaccine candidate (NCT06695117) pairs the trivalent protein-based Flu vaccine Fluzone High-Dose with the adjuvanted Novavax Covid-19 vaccine. The second candidate (NCT06695130) merges the Flublok influenza vaccine with the Novavax Covid-19 vaccine.
Extensive studies have shown that both Fluzone High-Dose and Flublok outperform standard-dose flu vaccines in preventing influenza among older adults. Furthermore, they significantly reduce flu-related hospital admissions, as evidenced by real-world data. The Novavax vaccine has a higher tolerability profile compared to current mRNA Covid-19 vaccines and demonstrates reassuring efficacy in preventing Covid-19 in primary vaccinations, as confirmed by pivotal phase 3 studies.
Thomas Triomphe, Executive Vice President of Vaccines at Sanofi, emphasized the company’s commitment to leveraging its immunological expertise and comprehensive data history to innovate in flu and Covid-19 protection. The goal is to simplify vaccination schedules through a combined vaccine that maintains the standalone vaccines’ high standards of efficacy, safety, and tolerability.
The expedited approval by the FDA is based on the potential of these combination vaccines to lessen the burden of two critical illnesses that can lead to severe outcomes, notably in older populations.
Sanofi has started two initial phase 1/2 double-blind trials to assess the safety and immune response of these vaccine combinations.
Details of the Vaccine Candidates:
– NCT06695117: Combines Fluzone High-Dose and Novavax to shield against influenza subtypes A and B, as well as SARS-CoV-2, in those aged 50 and above.
– NCT06695130: Merges Flublok with Novavax for similar preventive measures in the same age group.
Studies suggest that combining vaccines might enhance Covid-19 vaccine uptake by 56% among those aged 50-plus. The combination approach may also be favored by healthcare providers for its efficiency and reduced requirement for multiple injections, along with minimizing errors and decreasing waste from syringes and vials.
Additional Insights:
– Influenza is a highly contagious viral respiratory disease causing significant global fatalities each year, primarily affecting older adults.
– Covid-19, caused by the SARS-CoV-2 virus, can result in severe illness and long-term complications, with persistent symptoms seen in about 30% of patients even two years post-infection.
The initiative aims not only to protect against these diseases but also to streamline healthcare delivery, improving outcomes for older adults who are most vulnerable to hospitalization and severe aftereffects.