Company: SNY
Filing Date: 2025-02-13
Form Type: 20-F
Source: 0001121404-25-000010
Chunk: 91

Company: Sanofi
Filing Date: 2025-02-13
Form: 20-F
Chunk 91
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. e) Vaccines SP0087 is a purified human rabies vaccine aimed at replacing Sanofi’s commercialized rabies vaccines (Imovax and Verorab). This next generation rabies vaccine is cultured on Vero cells and is free from animal or human material. The asset is currently under evaluation in a Phase 3 study for pre- and post-exposure prophylaxis in all age groups; results from this pivotal study are expected in the first half of 2025. The FDA has granted SP0087 fast-track designation. SP0125 is a live attenuated vaccine intended to expand protection against RSV to all toddlers, from the second season onwards (all infants can indeed be protected against RSV during their first season with Beyfortus, which is available in the US and several other countries; s ee “— B.2. Main Biopharma medicines and vaccines” ). In 2024, a Phase 3 study (PEARL) was initiated to evaluate SP0125 for the prevention of RSV in toddlers; the study is being conducted in approximately 6,300 children aged six months to less than 22 months. SP0125 has been granted fast-track designation by the FDA and PRIME designation by the EU. SP0202 is a 21-valent conjugate vaccine intended to provide expanded protection against pneumococcal disease, developed in collaboration with SK bioscience. In 2024, a Phase 3 program was initiated for SP0202, which is the first pneumococcal conjugate vaccine candidate with more than 20 serotypes to enter this clinical stage in infants and toddlers. The Phase 3 program will include more than 7,700 infants, toddlers, young children, and adolescents across multiple geographies, including the US, Europe, Australia, Asia, and Latin America. The FDA has granted SP0202 fast-track designation. SP0256 is an mRNA vaccine candidate intended to prevent RSV and human metapneumovirus (hMPV) infections in the older adult population. A Phase 1/2 study is ongoing to evaluate this combination vaccine, for which the FDA has granted fast-track designation to prevent RSV and hMPV infections in people aged 60 to 75 years. SP0218 is a live attenuated yellow fever vaccine (freeze-dried and produced in Vero cells), for subcutaneous and intra-muscular administration in people aged nine months and older. This next generation vaccine aims at replacing Stamaril (