On May 31, Sanofi announced that its pediatric intranasal live attenuated Respiratory Syncytial Virus vaccine (referred to as “RSVt vaccine,” SP0125) had been approved by the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) to commence clinical research. This is the first pediatric vaccine in China to be included in an international multicenter clinical trial (MRCT) since the implementation of the revised "Measures for Drug Registration" in 2020. Additionally, the RSVt vaccine is the world’s first vaccine designed to prevent diseases caused by Respiratory Syncytial Virus (RSV, hereinafter referred to as “RSV”) in infants and young children, providing protection for infants aged 6 to 24 months.Full protection during infancy and early childhood is key to reducing the disease burden of respiratory syncytial virus (RSV) in children. RSV is one of the most common viral pathogens causing acute upper respiratory infections (AURI) in infants and young children.[i]At the same time, for some infants, RSV infection can develop into lower respiratory tract disease, which is also a major cause of infant hospitalization.[ii]。The respiratory mucosal immune response is an important way to defend against viral invasion of the respiratory tract. Compared with systemic injection vaccines that only induce serum immunoglobulin G (IgG) responses, intranasal vaccines can induce both serum IgG and nasal mucosal immunoglobulin A (IgA) responses, effectively blocking the infection and transmission of respiratory viruses. Studies have shown that the RSVt vaccine has demonstrated significant efficacy in young children, capable of inducing broad and long-lasting immune responses.Should[iii,iv,v]。Previously, the RSVt vaccine yielded positive results in global Phase I/II clinical trials. Data showed that the two-dose RSVt vaccine had a tolerability similar to placebo and was able to induce a 93% antibody response.[vi]Based on favorable trial data, the RSVt vaccine was granted Fast Track Designation by the U.S. Food and Drug Administration (FDA) in December 2020 and PRIME designation by the European Medicines Agency (EMA) in December 2023.The global Phase III clinical trial (VAD00004) approved this time is a randomized, observer-blinded, placebo-controlled, multicenter, multinational study evaluating the efficacy, immunogenicity, and safety of the RSVt vaccine in infants and young children. The participants are infants aged 6 to under 22 months, regardless of their baseline RSV serostatus. Subjects will be randomly assigned in a 1:1 ratio to receive two doses of the vaccine or placebo, administered intranasally with a 56-day interval between doses. This study does not include immunocompromised infants and will separately assess the vaccine’s efficacy against lower respiratory tract disease (LRTD) and upper respiratory tract disease (URTD).Sanofi is committed to becoming a global leader in the field of immunology, and respiratory syncytial virus (RSV) is one of the key areas the company has strategically focused on for immunoprevention. RSV is a common and highly contagious virus.[vii,viii]The high-risk groups for respiratory virus infections are mainly concentrated among children, the elderly, and individuals with weakened immune systems.[ix], the disease burden is severe. To meet the differentiated prevention needs of different groups, Sanofi has laid out three RSV prevention products/research pipelines, covering key populations such as infants, young children, and the elderly:In December 2023, the long-acting monoclonal antibody Beyfortus® (Nirsevimab Injection) was approved in China for the prevention of lower respiratory tract infections (LRTI) caused by respiratory syncytial virus (RSV) in newborns and infants. This is also the first RSV preventive measure in China targeting all infants, and the product is expected to be launched during the 2024-2025 RSV infection season.
The attenuated live vaccine RSVt (SP0125) for infants and young children under development is the world's first vaccine designed to protect infants and young children from respiratory syncytial virus. The global Phase III clinical trial is currently underway, and China is about to join this research.
Sanofi is also actively exploring combination vaccines to help protect the elderly from diseases caused by respiratory syncytial virus (RSV) infection.
[i] Wang Weiping, Sun Kun, Chang Liwen. Pediatrics [M]. 9th Edition. Beijing: People's Health Publishing House, 2018. 266.[ii] Demont, C., Petrica, N., Bardoulat, I. et al. Economic and disease burden
of RSV-associated hospitalizations in young children in France, from 2010
through 2018. BMC Infect Dis 21, 730 (2021).
https://doi.org/10.1186/s12879-021-06399-8.[iii] Kehagia E, et al. Advances in
intranasal vaccine delivery: A promising non-invasive route of immunization.
Vaccine. 2023 Jun 1;41(24):3589-3603. doi: 10.1016/j.vaccine.2023.05.011.[iv] Belshe R., et al. Live attenuated versus inactivated influenza vaccine in
infants and young children. The New England Joournal of Medicine. 2007;
365:685-696.[v] Jang YH, Seong
BL. Immune Responses Elicited by Live Attenuated Influenza Vaccines as
Correlates of Universal Protection against Influenza Viruses. Vaccines (Basel).
2021 Apr 7;9(4):353. doi: 10.3390/vaccines9040353.[vi] https://www.sanofi.com/assets/dotcom/content-app/events/investor-presentation/2023/vaccines-investor-event/presentation-vaccines-event-2023.pdf[vii] Reis J, Shaman J. Simulation of four respiratory
viruses and inference of epidemiological parameters. Infect Dis Model. 2018;3:23-34. Published 2018 Mar 19.
doi:10.1016/j.idm.2018.03.006[viii] Pediatric Professional Committee of China Medical Education Association, Asthma Collaboration Group of Respiratory Branch of Chinese Pediatric Society of Chinese Medical Association, Pediatric Respiratory Work Committee of Respiratory Physicians Branch of Chinese Medical Doctor Association, et al. Expert consensus on non-pharmacological interventions for respiratory viral infections in children [J]. Chinese Journal of Practical Pediatrics, 2023, 38(6): 413-420. DOI: 10.3760/cma.j.cn101070-20230424-00327[ix] "Q&A on the Prevention and Treatment of Human Respiratory Syncytial Virus Infection," National Disease Control Bureau, February 11, 2023, WeChat Official Account https://mp.weixin.qq.com/s/Jiq3M_ETKz1HksQJkAxRHw
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