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Tozinameran is a nucleoside-modified messenger RNA (mRNA) vaccine developed by BioNTech in collaboration with Pfizer for the prevention of COVID-19. It consists of mRNA encapsulated in lipid nanoparticles (LNPs), which protect the RNA from degradation and facilitate its entry into host cells. The mRNA sequence encodes the full-length, membrane-anchored spike (S) protein of the ancestral SARS-CoV-2 virus, stabilized in its prefusion conformation by two proline mutations (K986P and V987P). Once injected intramuscularly, host cells translate the mRNA into the spike protein, which is then presented to the immune system to elicit both humoral (neutralizing antibodies) and cellular (T-cell) immune responses. Marketed under the brand name Comirnaty, tozinameran was the first mRNA vaccine to receive full FDA approval. While originally a monovalent vaccine targeting the ancestral strain, it has since served as the foundation for bivalent and variant-adapted formulations targeting Omicron subvariants.
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