China grants EUA to Covid-19 vaccineCovid-19 vaccine against XBB descendent lineages

疫苗紧急使用授权上市批准临床研究信使RNA
China grants EUA to Covid-19 vaccine against XBB descendent lineages
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来源: Pharmaceutical Technology
The vaccine demonstrated an excellent safety profile and 93.28% protective efficacy 14 days after injection. Credit: WestVac BioPharma Co., Ltd./ CNW.
WestVac Biopharma has announced that the Chinese authorities have granted emergency use authorisation (EUA) for coviccine trivalent XBB.1.5-recombinant Covid-19 trivalent (XBB.1.5+BA.5+delta) protein vaccine (Sf9 cell).
This marks the world’s first Covid-19 vaccineCovid-19 vaccine approved for emergency use against XBB descendent lineages of SARS-CoV-2.
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The vaccine has been developed by WestVac Biopharma along with the West China Medical Center and Sichuan University.
WestVac Biopharma and its subsidiary WestVac Biopharma (Guangzhou) constructed the vector for the coviccine vaccine using the fast response of the insect cell expression platform.
The subunit antigen in the vaccine has been based on the structure of the targeting S-RBD and HR proteins of the XBB and BA.5 subvariants.
It is self-assembled into stable trimeric protein particles with the addition of squalene-based oil-in-water emulsion adjuvant following purification and mixing.
Trials demonstrated that the vaccine induced a high titer of neutralising antibodies against several subvariants, including Omicron subvariants XBB.1.5, XBB1.16, XBB1.9.1, XBB.2.3, BA.2.75, BQ.1, BA.5 and BF.7.
The vaccine demonstrated an excellent safety profile and 93.28% protective efficacy against XBB.1, XBB.1.5, and XBB1.9, 14 days after injection.
The results indicated that coviccine trivalent XBB.1.5 is a Covid-19 vaccineCovid-19 vaccine with a broad spectrum to tackle several prevalent subvariants in China and globally.
China’s authorities granted an EUA for WestVac Biopharma’s coviccine-recombinant Covid-19 vaccineCovid-19 vaccine (Sf9 cell) in December 2022.
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