SARS-CoV-2 recombinant protein vaccine (monovalent B.1.351, alternative exploratory formulation 3) + AS03 adjuvant

This is a combination vaccine composed of a recombinant protein antigen representing the SARS-CoV-2 spike protein from the B.1.351 (Beta) variant, formulated as an alternative exploratory monovalent preparation, with the AS03 adjuvant. The recombinant spike protein antigen is produced via recombinant DNA technology to mimic the virus structure and trigger a specific immune response. The AS03 adjuvant is an oil-in-water emulsion containing squalene, DL-α-tocopherol (vitamin E), and polysorbate 80[6][2]. This adjuvant enhances both humoral and cellular immune responses by promoting recruitment and activation of antigen-presenting cells and inducing cytokine production, aiming to provide broader and more robust immunity, particularly against SARS-CoV-2 variants of concern such as B.1.351 (Beta), Omicron subvariants, and D614G (ancestral strains)[1][3]. Developed platforms using this vaccine can serve as primary vaccination or booster in populations previously primed with other vaccine formats. The vaccine demonstrated in phase 3 trials to elicit robust neutralizing antibodies and a favorable safety profile as a booster in adults previously vaccinated with various authorized COVID-19 vaccines[1].