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The SARS-CoV-2 recombinant protein vaccine (monovalent B.1.351, alternative exploratory formulation 2) + AS03 is a subunit vaccine developed by Sanofi and GSK to provide protection against COVID-19, specifically targeting the Beta (B.1.351) variant. The vaccine consists of a recombinant SARS-CoV-2 spike (S) protein, stabilized in its pre-fusion conformation and produced using a baculovirus expression system in insect cells. It is formulated with the AS03 adjuvant system, an oil-in-water emulsion containing squalene, DL-α-tocopherol, and polysorbate 80, which enhances the magnitude and breadth of the immune response by activating the innate immune system and promoting high titers of neutralizing antibodies. This specific formulation was evaluated in clinical trials, including the Phase 2 VAT00002 study, to determine the optimal antigen dose and safety profile for use as a booster. The monovalent Beta vaccine was subsequently authorized by the European Medicines Agency (EMA) under the brand name VidPrevtyn Beta for use as a booster in adults.
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