▎WuXi AppTec Content Team Report

Respiratory Syncytial Virus（RSV）It is a common respiratory virus,It can cause lung and respiratory infections in infected individuals. This virus is very common, and most children are infected with it before the age of 2.In adults, the elderly, and healthy children, the symptoms of respiratory syncytial virus are milder.. However,Respiratory Syncytial VirusCan lead to severe infections in certain populations，Including babies within 1 year old and younger, the elderly, patients with cardiopulmonary diseases, orImmune SystemVulnerable populations，Hospitalization is required.

Public information shows that Pfizer's RSV vaccine is aBivalent Vaccine(Product name: Abrysvo, also known as RSVpreF),Composed of an equal amount of recombinant prefusion F protein from RSV virus subtypes A and B. The study found that,Prefusion F ProteinA key form of the viral fusion protein F used by the RSV virus to enter human cellsSpecific antibodies targeting the pre-fusion form of the protein are highly effective in blocking viral infection, which indicatesVaccines based on the pre-fusion F protein may provide excellent protection against RSV.。

May 2023,United StatesFDA ApprovalRSVpreF VaccineLaunched for the prevention of acute respiratory disease and lower respiratory tract disease caused by RSV in adults aged 60 years and above. This is also the indication approved for clinical use in China this time.

RSVpreFThe vaccine has alreadyIn a Phase 3 RENOIRClinical TrialObtained in the testPositive Top-Line Results. The studyEvaluated the efficacy, immunogenicity, and safety of a single dose of RSVpreF vaccine in adults aged 60 years or older.The trial recruited approximately 37,000 participants.Data show that, compared with placebo, the vaccineThe efficacy rate in preventing RSV-related lower respiratory tract diseases with at least two symptoms is 66.7%, and the efficacy rate in preventing infections with three or more symptoms is 85.7%.。In addition, the vaccineWell tolerated, with no safety concerns observed.

In addition to the aforementioned indications, the RSVpreF vaccine also received FDA approval in August 2023.Re-approval, used forPregnant women at 32 to 36 weeks for active immunization, thereby preventingInfants from Birth to 6 MonthsCaused by RSVLower Respiratory Tract DiseasesAnd SevereLower Respiratory Tract Diseases. In addition, in April this year, Pfizer also announced that another Phase 3 pivotal clinical study of the product achieved positive results, and it is about to submit for...Adults aged 18 to 59OfNew IndicationsListing Application.

The approval of this innovative vaccine for clinical trials in China means that it is about to commence clinical research in the country.

Respiratory Syncytial VirusInfection has always been a major public health challenge globally. Currently, RSV recombinant protein vaccines, RSV preventive antibody therapies, and RSV mRNA vaccines, among othersApproved in successionThe listing marks a significant advancement in the prevention and treatment of RSV, filling the previous gap in therapies for preventing the RSV virus.

Currently, the pharmaceutical industry is still actively developing new RSV vaccine products. These include multipleRSV mRNA Vaccine, such asHualan BioRSV mRNA Vaccine Product Introduced from SirnaomicsRV-1770Has been approved by the FDA to commence Phase 1 clinical trials,CSPC Pharmaceutical GroupRespiratory Syncytial Virus (RSV) mRNA Vaccine Also Received Clinical Trial Approval in China in July This YearTacit ConsentIn June this year, Sanofi's live attenuated intranasal respiratory syncytial virus vaccine for infants and young children was also approved in China.Phase 3 Clinical Trial, this product is expected to provide protection for infants and young children aged 6 to 24 months.

References:

[1] Website of the Center for Drug Evaluation, National Medical Products Administration of China. Retrieved Aug 21, 2024, from https://www.cde.org.cn/main/xxgk/listpage/da6efd086c099b7fc949121166f0130c