Approval Status [48, 49, 50] |
FDA Approved August 23, 2021 |
Emergency Use Authorization (EUA) December 18, 2020 |
Phase 2b/3 (NCT04652102) |
Submitted for full Approval August 25, 2021 |
Lipid Formulation (% Molar ratio of Ionizable: Cholesterol: Neutral lipid: PEGylated lipid) [9•] |
46.3:42.7:9.4:1.6 |
50:38.5:10:1.5 |
50:38.5:10:1.5 |
N:P Molar Ratio [9•] |
6 |
Cap [51, 52, 53] |
Cap-1 |
5′-UTR [54] |
5′ -untranslated region derived from human alpha-globin RNA with an optimized Kozak sequence |
Undisclosed |
5′ UTR: Artifacts from restriction and transcription site, plus Kozak sequence |
S protein antigen [53,55] |
Codon-optimized sequence encoding full-length SARS-CoV-2 spike (S) glycoprotein containing mutations K986P and V987P |
Codon-optimized sequence encoding full-length SARS-CoV-2 spike (S) glycoprotein containing mutations K986P and V987P |
Codon-optimized and engineered sequence encoding full-length SARS-CoV-2 spike (S) glycoprotein containing mutations K986P and V987P |
Modified nucleotides [54] |
N1-methyl-pseudouridine |
N1-methyl-pseudouridine |
Unmodified nucleotides |
3′-UTR [54] |
3′ UTR comprising two sequence elements derived from the amino-terminal enhancer of split (AES) mRNA and the mitochondrial encoded 12S ribosomal RNA |
Undisclosed |
3′ UTR comprising human alpha-globin 3′ UTR sequence element |
Poly(A) Tail [52,53] |
A 110-nucleotide poly(A)-tail consisting of a stretch of 30 adenosine residues, followed by a 10-nucleotide linker sequence and another 70 adenosine residues. |
Undisclosed |
64 Poly (A) tail |
Storage [9•,56] |
−60°C to −80°C for six months −15°C to −25°C for two weeks 2°C–8°C for 5 days |
−15°C to −20°C for six months 2°C–8°C for 30 days |
2°C–8°C for three months |
Buffer [9•] |
PBS |
Tris |
Undisclosed |
Cryoprotectant [9•] |
Sucrose |
Sucrose |
Undisclosed |