SpikeVax COVID-19 Vaccine
The SpikeVax COVID-19 Vaccine is a Messenger RNA (mRNA) vaccine targeted against the SARS-CoV-2 betacoronavirus to prevent severe COVID-19. SpikeVax encodes for a prefusion stabilized form of the Spike (S) protein selected by Moderna Inc. in collaboration with U.S. NIAID Vaccine Research Center investigators. SpikeVax's active ingredient is CX-024414 (single-stranded, 5’-capped mRNA), produced using a cell-free in vitro transcription from the corresponding DNA templates, encoding the S protein of the SARS-CoV-2 virus.
Moderna Inc. designs its mRNA vaccines using the virus's sequence but not the virus itself. mRNA is a single-stranded molecule that carries genetic code from DNA in a cell's nucleus to ribosomes, the cell's protein-making machinery. The mRNA instructs a patient's cells to produce proteins that prevent, treat, or cure disease. Moderna says mRNA plays a fundamental role in human biology, transferring the instructions stored in DNA to make the proteins required in every living cell.
On Dec. 18, 2020, the U.S. FDA issued an emergency use authorization (EUA). SpikeVax (elasomeran mRNA vaccine) Accession Number: DB15654; Preferred Substance Name: CX-024414; UNII: EPK39PL4R4; MedlinePlus a621002. On Jan. 24, 2023, the FDA published a Briefing Document, Future Vaccination Regimens Addressing COVID-19.
During the Vaccines and Related Biological Products Advisory Committee digital meeting on January 26, 2023, Moderna's Antonella Lozito, PharmD Executive Director, presented COVID-19 Bivalent Vaccines Primary Series and Booster.
Moderna, Inc. is advancing messenger RNA science to create a new transformative medicine class for patients. mRNA medicines are designed to direct the body's cells to produce intracellular, membrane, or secreted proteins that can have a therapeutic or preventive benefit and potentially address a broad spectrum of diseases—headquartered in Cambridge, MA. Moderna Inc.'s 10-Q SEC filing on Jan. 4, 2021, indicates 'mRNA is considered a gene therapy product by the U.S. FDA.' (pINN elasomeran). To learn more, visit www.modernatx.com.
Moderna's SpikeVax vaccines are offered in various doses, subject to country-based authorizations.
The first clinical batch of the Moderna vaccine candidate (CX-024414), funded by the Coalition for Epidemic Preparedness Innovations, was completed on Feb. 7, 2020.
SpikeVax COVID-19 Vaccine (Moderna) (mRNA-1273) Clinical Trials
Moderna continues to run clinical trials to evaluate the safety, immunogenicity, and reactogenicity of its COVID-19 vaccine.