This announcement follows positive results from a preclinical viral challenge study of mRNA-1273 and the positive interim analysis of the Phase 1 study of mRNA-1273 in adults (ages 18-55 years) and older adults (ages 56-70 and 71+) published in the New England Journal of Medicine.
Moderna has initiated the rolling submission of mRNA-1273 data for rolling review, in consideration of a potential authorization by the MHRA, provided the vaccine candidate meets the MHRA's rigorous standards of safety, effectiveness, and quality standards.
This rolling review process allows the MHRA to begin its independent assessment using the information submitted by Moderna and accept new evidence as it becomes available until the application is deemed complete.
This process can reduce time to authorization while maintaining usual high standards of safety, efficacy, and quality.
The Phase 1 interim analysis showed that mRNA-1273 was generally well-tolerated across all age groups and induced rapid and strong immune responses against SARS-CoV-2.
mRNA-1273 is currently being studied in a Phase 3 randomized, 1: 1 placebo-controlled trial of 30,000 participants at the 100 µg dose level in the US On Thursday, October 22, Moderna completed enrollment of the Phase 3 COVE study.
Moderna is advancing messenger RNA science to create a new class of transformative medicines for patients.
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.
The company's platform builds on continuous advances in basic and applied mRNA science, delivery technology and manufacturing, providing Moderna the capability to pursue in parallel a robust pipeline of new development candidates.
Moderna is developing therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases and cardiovascular diseases, independently and with strategic collaborators.
Headquartered in Cambridge, Mass., Moderna currently has strategic alliances for development programs with AstraZeneca PLC and Merck and Co., Inc., as well as the Defense Advanced Research Projects Agency (DARPA), an agency of the US Department of Defense, and the Biomedical Advanced Research and Development Authority (BARDA), a division of the Office of the Assistant secretary for Preparedness and Response within the US Department of Health and Human Services.
Moderna has been named a top biopharmaceutical employer by Science for the past five years.
Poolbeg PHarma plc receives notice of allowance for POLB 001 patent
RedHill Biopharma secures USPTO Patent for Talicia, extending protection through 2034
Micron Biomedical names new scientific advisor to CEO
Quanterix partners with leading health networks for Alzheimer's diagnosis advancements
Precision BioSciences reports FDA pre-IND feedback for PBGENE-HBV
VBI to sell manufacturing capabilities and enter new license agreement with Brii Biosciences
Ondine Biomedical's Steriwave shows promise in nasal pathogen reduction
BioSenic expands patent coverage for ATO therapeutic platform
PacBio unveils Nanobind PanDNA kit for enhanced DNA extraction solutions
Sequentify receives funding from Israel Innovation Authority
INOVIO plans BLA submission for INO-3107 as RRP treatment
ImmunityBio secures USD320m investment from Oberland Capital
Poolbeg Pharma prioritises promising RSV drug candidates identified through AI-led analysis
GHIT fund invests JPY500m in antimalarial drug clinical trial