Photo: public.hkuctc.com

VectorFlu ONE, a nasal spray COVID-19 vaccine, has been granted emergency use authorization in the Chinese mainland, its developer announced on Monday. Analysis of interim primary data from its Phase III clinical trial showed that the vaccine provided good protection against Omicron variant strains BA.2, BA.4 and BA.5.

The vaccine has been co-developed by Hong Kong University, Xiamen University and Wantai Biopharmaceutical Company.

On Monday, Wantai announced that China's National Medical Products Administration agreed to its emergency use in accordance with the relevant provisions of the Vaccine Administration Law.

The vaccine is the only nasal spray vaccine that has so far validated its safety and broad-spectrum effectiveness in Phase III clinical trials, according to an announcement made by Xiamen University on Monday.

A statement from the University of Hong Kong said that Wantai plans to produce 200 million doses of the nasal spray vaccine in the next six months.

The university also quoted a member of the research team as saying that nasal spray vaccines can effectively overcome the shortcomings of traditional vaccines, such as making it easier for children who are afraid of injections to receive the vaccine. The device for nasal spray vaccines is also simpler than other aerosol vaccines, which require an additional inhalation device.

According to data published by Wantai, the nasal spray vaccine provides good protection against Omicron infection in neocrown pneumonia, regardless of immunization history.

The Phase I clinical trial was completed with 29 volunteers aged 18 to 55 with no major adverse effects reported, showing the vaccine is safe for human use, Hong Kong's Secretary for Health Lo Chung-mau said on November 30. The Phase II clinical trial for use of the vaccine as a booster was conducted with more than 100 volunteers aged 18 to 75. The project team is currently collecting the immune response data for analysis, which is expected to be completed by the first quarter of 2023.

The primary data analysis of the Phase III clinical trial of the vaccine was completed in October. The data showed that the vaccine provided good protection against Omicron variant strains in both the baseline immunization for people with no immunization history and the sequential booster immunization for people with immunization history.

According to the announcement from Xiamen University, the vaccine has an excellent safety profile and no serious vaccine-related adverse events have occurred in clinical trials. Moreover, its protective efficacy for the elderly and chronic patients is not weaker than for young and middle-aged healthy people.

Global Times