Moderna, Inc.,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).
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).
“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
Coronaviruses are a family of viruses that can lead to respiratory illness, including MERS and SARS. Coronaviruses are transmitted between animals and people and can evolve into strains not previously identified in humans. On January 7, 2020, a novel coronavirus was identified as the cause of pneumonia cases in Wuhan, Hubei Province of China.
Moderna scientists designed the Company’s prophylactic vaccines modality to prevent infectious diseases. More than 1,000 participants have been enrolled in Moderna’s infectious disease vaccine clinical studies under health authorities in the U.S., Europe and Australia. Based on clinical experience across six Phase 1 studies, the Company has designated prophylactic vaccines a core modality and intends to accelerate development of its infectious disease vaccine candidates.
The potential advantages of an mRNA approach to prophylactic vaccines include the ability to mimic natural infection to stimulate a more potent immune response, combining multiple mRNAs into a single vaccine, rapid discovery to respond to emerging pandemic threats and manufacturing agility derived from the platform nature of mRNA vaccine design and production. Moderna has built a fully integrated manufacturing plant in Norwood, MA which enables the promise of the technology platform.
Moderna currently has nine development candidates in its prophylactic vaccines modality, including:
Vaccines against serious respiratory infections
- Respiratory syncytial virus (RSV) vaccine for older adults (mRNA-1777 and mRNA-1172/V172 with Merck)
- RSV vaccine for young children (mRNA-1345)
- Human metapneumovirus and parainfluenza virus type 3 (hMPV/PIV3) vaccine (mRNA-1653)
- Novel coronavirus vaccine (mRNA-1273)
- Influenza H7N9 (mRNA-1851)
Vaccines against serious infections transmitted from mother to baby
- Cytomegalovirus (CMV) vaccine (mRNA-1647)
- Zika vaccine (mRNA-1893) with the Biomedical Advanced Research and Development Authority (BARDA)
Vaccines against common viral infections
- Epstein-Barr virus (EBV) vaccine (mRNA-1189)
To date, Moderna has demonstrated positive Phase 1 data readouts for six prophylactic vaccines (H10N8, H7N9, RSV, chikungunya virus, hMPV/PIV3 and CMV). Moderna’s CMV vaccine is currently in a Phase 2 dose-selection study. Moderna’s investigational Zika vaccine (mRNA-1893), currently in a Phase 1 study, was granted FDA Fast Track designation.