17 Apr 2020. A government preparedness agency awarded biotechnology company Moderna Inc. $483 million to advance its Covid-19 vaccine through clinical trials. The Cambridge, Massachusetts company also plans to add 150 new hires to manufacture large quantities of its preventative vaccine, once approved by regulators.
Moderna is one of a few biotechnology companies and labs now with a candidate vaccine to prevent against Covid-19 infections in early-stage clinical trials. The company develops protective vaccines against infectious diseases with a technology that synthesizes messenger RNA, a nucleic acid based on the genetic code from DNA, and used by cells to produce amino acids in proteins for cellular functions. Moderna manipulates the coding region in messenger RNA chemistry to provide instructions for cells to produce proteins with specific therapeutic properties.
Those coding instructions are contained in a standard package that appears in most cases like natural RNA to avoid triggering an immune response, and reach the desired cells where the protein is needed. For protective vaccines, Moderna delivers messenger RNA with instructions for cells to produce proteins with enough resemblance to viruses to generate an immune response, but are still safe for the recipient.
As reported by Science & Enterprise in January, Coalition for Epidemic Preparedness Innovations, or CEPI, is funding initial work on Moderna’s vaccine, code-named mRNA-1273, with National Institute of Allergy and Infectious Diseases, or NIAID, part of National Institutes of Health. The current clinical trial is an early-stage study testing the safety of mRNA-1273 among healthy adults, as well as the vaccine’s ability to trigger an immune response. Participants are receiving two injections of the vaccine, about one month apart, in three dosage levels.
The Biomedical Advanced Research and Development Authority, or BARDA, an agency of the U.S. Department of Health and Human Services, yesterday awarded Moderna $483 million to advance mRNA-1273 through later-stage clinical trials, for a review by the Food and Drug Administration. BARDA is the HHS department’s agency that sponsors development and production of countermeasures for emergencies such as pandemics and biological warfare threats.
Moderna already plans to conduct a mid-stage trial of mRNA-1273 to begin in the second quarter of 2020, and should the early findings indicate its safety and ability to invoke an immune response, a late-stage trial as soon as the fall of 2020. Once the vaccine is approved, BARDA funds are also expected to help scale-up production of the vaccine. For that purpose, Moderna plans to hire up to 150 manufacturing technicians to produce the vaccine in the U.S. The company expects, when fully staffed, to operate three shifts per day, seven days a week.
“Time is of the essence to provide a vaccine against this pandemic virus,” says Stéphane Bancel, Moderna’s CEO in a company statement. “By investing now in our manufacturing process scale-up to enable large scale production for pandemic response, we believe that we would be able to supply millions of doses per month in 2020 and with further investments, tens of millions per month in 2021, if the vaccine candidate is successful in the clinic.”
More from Science & Enterprise:
- Five Covid-19 Vaccines in Clinical Trials
- Covid-19 Vaccine in Development, Trial Planned
- Trial to Test Electronic-Aided Covid-19 Vaccine
- Trial to Test Malaria Drug to Stop Covid-19
- Sanofi, Biotech Partner on RNA Covid-19 Vaccine
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