Recombinant COVID-19 Trivalent (XBB.1.5+BA.5+Delta) Trimer Protein Vaccine (Sf9 Cell)
[NAME OF THE MEDICINAL PRODUCT] Recombinant COVID-19 Trivalent (XBB.1.5+BA.5+Delta) Trimer Protein Vaccine (Sf9 Cell) [ADJUVANT] Squalene-based oil-in-water emulsion adjuvant[THERAPEUTIC INDICATION] This vaccine is indicated for active immunization to prevent COVID-19 caused by SARS-CoV-2 variants.[STRENGTHS] Each vial contains 0.5 mL, with a total of 60 μg of recombinant S-RBD-HR trimeric protein (2 doses for human use). A single human dose is 0.25 mL containing 30 μg of recombinant S-RBD-HR trimeric protein.[EFFICACY】The efficacy against symptomatic COVID-19 caused by SARS-CoV-2 was 93.28% (95% CI: 92.76%, 93.81%) more than 14 days after vaccination. Preliminary results of gene sequencing suggested that this vaccine has a good broad-spectrum efficacy against symptomatic COVID-19 caused by SARS-CoV-2 Omicron XBB.1, XBB.1.5, and XBB.1.9 variants. Long-term efficacy (6 months): 86.18% (95% CI: 84.24%, 88.12%) against symptomatic COVID-19 caused by SARS-CoV-2 after vaccination with this product.Another investigator-initiated trial (IIT) evaluated the protective efficacy of this vaccine against emerging subvariants, including KP.3, XDV, XEC, and LP.8.1, by measuring serum neutralizing antibody titers in 64 subjects. Pseudovirus neutralization assays demonstrated that the GMTs of neutralizing antibodies against the KP.3, XDV, XEC, and LP.8.1 subvariants before vaccination were 77, 87, 78, and 86, respectively. At 14 days post-vaccination, the GMT levels increased to 903, 668, 704, and 816, respectively, demonstrating significant elevation compared to the level before vaccination, with GMT fold increases of 11.73, 7.67, 9.02, and 9.49, respectively.
On June 8, 2023, it was approved by the relevant national authorities for emergency use.
Recombinant COVID-19 Trivalent (XBB.1.5+BA.5+Delta) Trimer Protein Vaccine (Sf9 Cell) Package Insert
