$483 Million Funding For Coronavirus Vaccine Development
A funding commitment of up to $483 million from the Biomedical Advanced Research and Development Authority (BARDA), a division within the U.S. Department of Health and Human Services (HHS), was announced to accelerate the development of Moderna’s mRNA vaccine candidate mRNA-1273.
This experimental vaccine targets the novel coronavirus known as SARS-CoV-2 which causes COVID-19 disease.
Under the terms of this agreement, BARDA said on April 16, 2020, it will fund the advancement of mRNA-1273 to FDA licensure.
A Phase 1 study of mRNA-1273 is currently being conducted by the National Institutes of Health (NIH).
This Phase 1 open-label study, began on March 16, 2020, has completed enrollment of the original study: 45 healthy adult volunteers ages 18 to 55 years in three dose cohorts (25 µg, 100 µg and 250 µg).
The NIH recently amended the Phase 1 protocol to include an additional six cohorts: three cohorts of older adults (ages 56 -70) and three cohorts of elderly adults (age 71 and above). Enrollment for these cohorts is ongoing.
If supported by safety data from the Phase 1 study, Moderna said it ‘intends to begin a Phase 2 study of mRNA-1273 under its own Investigational New Drug (IND) application in the second quarter of 2020.’
Subject to data from these studies and discussions with regulators, a Phase 3 study could begin as soon as fall, 2020.
BARDA funding will support these late-stage clinical development programs, as well as the scale-up of mRNA-1273 manufacture in 2020 to enable potential pandemic response.
“Vaccines are a critical tool for saving lives and stopping the spread of the SARS-CoV-2 virus,” said BARDA Director Rick Bright, Ph.D.
“Delivering a safe and effective vaccine for a rapidly spreading virus requires accelerated action.”
“BARDA’s goal is to have vaccine available as quickly as possible and preparing now for advanced-stage clinical trials and production scale-up while the Phase 1 is underway could shave months off the development of COVID-19 vaccines.”
mRNA-1273 is an mRNA vaccine against SARS-CoV-2 encoding for a prefusion stabilized form of the Spike (S) protein, which was selected by Moderna in collaboration with investigators from Vaccine Research Center at the National Institute of Allergy and Infectious Diseases, a part of the NIH.
The first clinical batch, which was funded by the Coalition for Epidemic Preparedness Innovations, was completed on February 7, 2020, and underwent analytical testing; it was shipped to NIH on February 24, 42 days from sequence selection.
The first participant in the NIH-led Phase 1 study of mRNA-1273 was dosed on March 16, 63 days from sequence selection to Phase 1 study dosing.
A summary of the Company’s work to date on SARS-CoV-2 can be found here.
Moderna scientists designed the Company’s prophylactic vaccine modality to prevent infectious diseases.
The potential advantages of an mRNA approach to prophylactic vaccines include the ability to combine 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.
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 have the potential to address a broad spectrum of diseases.
Headquartered in Cambridge, Mass., Moderna currently has strategic alliances for various development programs.
SARS-CoV-2 vaccine development news published by Precision Vaccinations.