RSV (Respiratory Syncytial Virus) is a common cause of respiratory infections across all age groups, particularly prevalent among children, the elderly, and adults with immune deficiencies or underlying diseases. Currently, several RSV vaccines have been approved globally, yet there is no RSV vaccine available on the market in China. Thus, the development of RSV mRNA vaccines holds significant importance for public health security in our country.
Recently, two RSV mRNA vaccine candidates have received approval for clinical trials in China, marking a new phase in RSV vaccine research and development in our country, where their safety and efficacy will soon be evaluated in humans.
International Research Background
Despite the lack of specific antiviral therapies for RSV infections, with treatment primarily focused on supportive and symptomatic care, preventive vaccination as an active immunization strategy is considered crucial in preventing severe RSV infections and reducing mortality rates.
Currently, over 20 RSV vaccine candidates are under clinical investigation worldwide. One factor driving differentiation in the vaccine market is technological diversity, with protein-based and live-attenuated vaccines being the most commonly used technologies, followed by innovative mRNA-based vaccines.
Figure Source: PATH Official Website
RSV mRNA Vaccines
Developer: Hefei AlphaNano Biotechnology Co., Ltd.
Approval Date: July 5, 2024
Approving Agency: Center for Drug Evaluation, National Medical Products Administration
Approval Content: Receipt of the "Notice of Approval for Drug Clinical Trial"
Vaccine Features: The only RSV mRNA vaccine candidate in Anhui Province to receive approval for clinical trial application.
Bivalent RSV mRNA Vaccine
Developer: Shenzhen Shenxin Biotechnology Co., Ltd.
Approving Agency: Center for Drug Evaluation, National Medical Products Administration
Approval Content: Implicit approval for clinical trial
Vaccine Features: Intended for active immunization to prevent lower respiratory tract diseases (LRTD) caused by RSV in individuals aged 60 and above. It is the first domestic RSV vaccine product to receive clinical trial approval in China, the first non-COVID mRNA preventive vaccine product to receive clinical approval domestically, and the world's first bivalent RSV mRNA vaccine to receive FDA IND clearance.
Outlook and Conclusion
As clinical trials for RSV mRNA vaccines progress, we anticipate seeing more data on their safety and efficacy in the future. If these vaccines demonstrate favorable safety and efficacy profiles in clinical trials, they are likely to be approved for market launch, offering new options for preventing RSV infections.
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