27 February 2020 | News
mRNA-1273 delivered from Company’s cGMP facility in 42 days from sequence selection
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Moderna, a clinical stage biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines to create a new generation of transformative medicines for patients has announced that it has released the first batch of mRNA-1273, the Company’s vaccine against the novel coronavirus, for human use. Vials of mRNA-1273 have been shipped to the National Institute of Allergy and Infectious Diseases (NIAID), a part of the National Institutes of Health (NIH) to be used in the planned Phase 1 study in the U.S.
mRNA-1273 is an mRNA vaccine against the novel coronavirus encoding for a prefusion stabilized form of the Spike (S) protein, which was selected by Moderna in collaboration with investigators at the NIAID Vaccine Research Center (VRC). Manufacture of this batch was funded by the Coalition for Epidemic Preparedness Innovations (CEPI).
“I want to thank the entire Moderna team for their extraordinary effort in responding to this global health emergency with record speed. The collaboration across Moderna, with NIAID, and with CEPI has allowed us to deliver a clinical batch in 42 days from sequence identification,” said Juan Andres, Chief Technical Operations and Quality Officer at Moderna. “This would not have been possible without our Norwood manufacturing site, which uses leading-edge technology to enable flexible operations and ensure high quality standards are met for clinical-grade material.”
The Company’s manufacturing plant in Norwood, MA manufactures Moderna’s portfolio of mRNA development candidates, including vaccines and therapeutics. To date, the Company has produced and released more than 100 batches from its Norwood site for human clinical trials. mRNA-1273 is part of the Company’s core prophylactic vaccines modality, which has had six positive Phase 1 clinical readouts across six different vaccines over the past four years.
mRNA-1273 is an mRNA vaccine against the novel coronavirus encoding for a prefusion stabilized form of the Spike (S) protein, which was designed by Moderna in collaboration with NIAID. The S protein complex is necessary for membrane fusion and host cell infection and has been the target of vaccines against the coronaviruses responsible for Middle Eastern Respiratory Syndrome (MERS) and Severe Acute Respiratory Syndrome (SARS).