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The monovalent [B.1.351] CoV2 preS dTM-AS03 is a recombinant protein subunit COVID-19 vaccine developed by Sanofi and GSK in collaboration with the National Institute of Allergy and Infectious Diseases (NIAID). The vaccine consists of a soluble, prefusion-stabilized trimeric SARS-CoV-2 spike (S) protein derived from the Beta (B.1.351) variant, produced using a baculovirus expression system in insect cells. It is formulated with GSK's AS03 adjuvant system, an oil-in-water emulsion containing α-tocopherol and squalene, which is designed to enhance the immune response and provide broader protection. This vaccine has been evaluated as a booster dose in various clinical trials, including the ACV01 study sponsored by the NIAID, which focused on patients with autoimmune diseases who exhibited poor initial responses to standard COVID-19 vaccinations.
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