For primary immunization, the mRNA vaccines were SARS-CoV-2 prefusion spike constructs 2 P, GSAS, 2 P/GSAS, 2 P/GSAS/ALAYT, and 6 P/GSAS described in ref. 28 (link), the subunit vaccines were CoV2 preS dTM-AS03 vaccines, where the antigens were produced using the phase-I/-II manufacturing process, 1.3- and 2.6-µg doses, or using an intermediate manufacturing process, 2.4 µg dose.
For the booster, the CoV2 preS dTM derived from the ancestral strain (D614) and the Beta variant were produced using an optimized purification process to ensure a minimum of 90% purity.
The antigens were formulated in monovalent or bivalent formulations with AS03 adjuvant. The CoV2 preS dTM was produced from a Sanofi proprietary cell culture technology based on the insect cell—baculovirus system, referred to as the Baculovirus Expression Vector System (BEVS). The CoV2 preS dTM (ancestral D614) sequence was designed based on the Wuhan YP_009724390.1 strain S sequence, modified with 2 prolines in the S2 region, deletion of the transmembrane region, and addition of the T4 foldon trimerization domain. The CoV2 preS dTM (Beta) was designed based on the Beta (B.1.351) sequence (GISAID Accession EPI_ISL_1048524) and contains the same modifications.
AS03 is a proprietary adjuvant system composed of α-tocopherol, squalene, and polysorbate-80 in an oil-in-water emulsion manufactured by GSK. Vaccine doses were formulated by diluting the appropriate dose of preS dTM with PBS–tween to 250 µL, then mixing with 250 µL of AS03, followed by inversion five times for a final volume of 500 µL. Each dose of AS03 contains 11.86 mg of α-tocopherol, 10.69 mg of squalene, and 4.86 mg of polysorbate-80 (Tween 80) in PBS.
For the booster, the CoV2 preS dTM derived from the ancestral strain (D614) and the Beta variant were produced using an optimized purification process to ensure a minimum of 90% purity.
The antigens were formulated in monovalent or bivalent formulations with AS03 adjuvant. The CoV2 preS dTM was produced from a Sanofi proprietary cell culture technology based on the insect cell—baculovirus system, referred to as the Baculovirus Expression Vector System (BEVS). The CoV2 preS dTM (ancestral D614) sequence was designed based on the Wuhan YP_009724390.1 strain S sequence, modified with 2 prolines in the S2 region, deletion of the transmembrane region, and addition of the T4 foldon trimerization domain. The CoV2 preS dTM (Beta) was designed based on the Beta (B.1.351) sequence (GISAID Accession EPI_ISL_1048524) and contains the same modifications.
AS03 is a proprietary adjuvant system composed of α-tocopherol, squalene, and polysorbate-80 in an oil-in-water emulsion manufactured by GSK. Vaccine doses were formulated by diluting the appropriate dose of preS dTM with PBS–tween to 250 µL, then mixing with 250 µL of AS03, followed by inversion five times for a final volume of 500 µL. Each dose of AS03 contains 11.86 mg of α-tocopherol, 10.69 mg of squalene, and 4.86 mg of polysorbate-80 (Tween 80) in PBS.
Free full text: Click here
