On December 5, Wantai Bio issued an announcement that the nasal spray influenza virus vector new coronavirus vaccine (hereinafter referred to as "nose spray new crown vaccine") developed by Beijing Wantai Biopharmaceutical Co., Ltd., jointly developed with . Xiamen University and . The National Health Commission put forward suggestions and in accordance with Article 20 of the " Vaccine Management Law of the People's Republic of China", the State Food and Drug Administration organized a demonstration and agreed to emergency use.
announcement shows that the nasal spray new crown vaccine obtained a clinical trial approval certificate issued by the State Food and Drug Administration on August 27, 2020, and completed phase I, phase II and extended clinical trials in China. On November 10, 2021, it obtained a phase III clinical trial approval certificate issued by the South African drug regulatory authorities. Then, it obtained a phase III clinical trial approval certificate issued by the Philippines, Colombia , and Vietnamese drug regulatory authorities. Wantai Bio conducted phase III clinical trials in the above four countries.
nasal spray new crown vaccine completed the master data analysis of the Phase III clinical trial in October 2022 and obtained key data. Data show that whether it is used for basic immunization for people without immunization or for people with immunization history, nasal spraying new crown vaccine can produce good protective effect on COVID-19 caused by infection with Omicron mutant strain. The protective effect of people over 60 is not weaker than that of people aged 18-59, and it is also very safe.
Wantai Bio said that after the nasal spray new crown vaccine is approved for emergency use, it will further enhance the company's core competitiveness. If it is subsequently purchased and used by relevant national departments on a large scale, it will have a certain positive impact on the company's performance.
However, the announcement also pointed out that due to the long development cycle and many links of vaccine product, it is easily affected by some uncertain factors. At present, the nasal spray new crown vaccine has completed the collection of key data on the Phase III clinical trial. According to the clinical trial plan, subject follow-up needs to be continued, and there is uncertainty in the subsequent R&D and approval results.
[Reporter] Yan Huifang
[Author] Yan Huifang
Healthy life circle
