By Zacks Equity Research
December 11, 2024
Source: Yahoo
Photo / Image Source: Unsplash,
In This Article:
SNY -0.19%
MRNA +3.25%
NVAX +0.57%
PFE -1.33%
Sanofi SNY announced that the FDA has granted a Fast Track designation to two combination vaccine candidates to prevent influenza and COVID-19 infections in people aged 50 years and above.
NCT06695117, the first vaccine candidate, combines SNY’s influenza protein-based trivalent vaccine, Fluzone High-Dose and Novavax’s NVAX adjuvanted recombinant Novavax COVID-19 vaccine, NVXC19.
NCT06695130, the second vaccine candidate, combines SNY’s influenza recombinant protein-based trivalent vaccine, Flublok with NVXC19.
SNY markets Fluzone High-Dose and Flublok flu vaccines.
Novavax recently signed a multi-billion dollar deal with Sanofi for its protein-based COVID-19 vaccine.
Per the deal, from 2025 onwards, Sanofi will gain rights to co-market Novavax’s COVID-19 vaccine globally, except in certain countries where the company has existing partnership agreements. The French drugmaker also has the sole license to develop and market the Novavax vaccine in combination with its influenza vaccine.
Year to date, shares of Sanofi have lost 3.3% against the industry’s growth of 8.9%.
More on SNY's Combination Vaccine Candidates
Per the company, NCT06695117 and NCT06695130 are the first non-mRNA combination vaccine candidates that include two licensed vaccines for the prevention of influenza and COVID-19 infections.
When administered as a booster dose, Novavax’s NVXC19 has also demonstrated a better tolerability profile than the currently available mRNA COVID-19 vaccines.
NVXC19 has also demonstrated high efficacy against COVID-19 as a primary vaccination in two phase III studies.
Two ongoing phase I/II studies are currently evaluating the safety profile and immune response induced by NCT06695117 and NCT06695130.
SNY Boasts a Strong Vaccine Segment
Sanofi possesses one of the world’s leading vaccine operations, with total annual sales of more than €5 billion in the past five years. The company’s Vaccine unit has delivered mid-to-high-single-digit sales growth since 2018. SNY also has a strong position in both seasonal and pre-pandemic influenza vaccine spaces.
In the first nine months of 2024, the Vaccines unit generated sales worth €6.12 billion increasing 14.5% year over year at a constant currency rate.
Sanofi has at least five vaccine candidates, which are expected to enter phase III development by 2025. SNY expects annual net sales to be more than €10 billion from its Vaccines unit by 2030 backed by the company’s innovation efforts. Sanofi continues to expand its vaccine business further.
Other Players Developing COVID-Flu Combination Shots
Apart from Sanofi, Moderna MRNA and Pfizer PFE are also developing their respective COVID/flu combination vaccines using mRNA technology.
Moderna is developing mRNA-1083, its investigational mRNA-based combination vaccine against influenza and COVID-19. In June, MRNA announced that the phase III study evaluating its COVID/flu combination vaccine, mRNA-1083, in older adults (50 years and older) met the primary endpoints.
Subject to discussions with the FDA, Moderna plans to submit a regulatory filing, seeking approval for the COVID/flu combination vaccine shortly.
Meanwhile, Pfizer suffered a major setback in August when it reported data from a phase III study on its investigational mRNA-based COVID/flu combination vaccine. The study missed one of its two primary immunogenicity objectives.
PFE is currently evaluating adjustments to its combination vaccine program and plans to discuss the next steps with health authorities. Pfizer is developing this vaccine in collaboration with BioNTech.
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