Moderna shipped the first samples of messenger RNA based coronavirus vaccine to the National Institute of Allergy and Infectious Disease in Bethesda Maryland. Human clinical trials should start in 6 weeks and the results could be available in July.
The Moderna vaccine will need two doses but is considered to be safe. Moderna messenger RNA system has had 6 successful phase 1 clinical trials for other diseases. It is hoped that two doses would protect an adult against a coronavirus infection.
The Moderna Vaccine would have to prove effective and then get scaled for distribution in 2021.
They 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 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).
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.
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.