Close on the heels of announcing additional BARDA funding for its coronavirus vaccine candidate mRNA-1273, Moderna Inc MRNA said Monday that it has commenced a late-stage study of the investigational vaccine in collaboration with the NIH and the BARDA.
Moderna Sticks With July Schedule: The Cambridge, Massachusetts-based biopharma said the Phase 3 study, dubbed COVE, has started to dose participants. The company said it expects to enroll 30,000 participants in the U.S.
The company joins a handful of Chinese firms and the Oxford University/AstraZeneca plc AZN combine that have advanced their vaccine candidates into late-stage trials.
Pfizer Inc. PFE and BioNTech SE – ADR BNTX are scheduled to start a Phase 2b/3 study of their coronavirus vaccine candidate later this month.
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Moderna's Trial Design: The Phase 3 protocol follows the FDA guidance on clinical trial design for COVID-19 vaccine studies, according to Moderna.
The Phase 3 study will be a placebo-controlled study, with study participants receiving 100mcg doses as prime and boost injections on days one and 29.
The primary endpoint is an event-driven analysis based on the number of participants with symptomatic COVID-19 disease starting 14 days after the booster dose and measured up to two years after the booster dose.
Data from the study will be reviewed throughout by an Independent Data Safety Monitoring Board organized by the NIAID, the company said.
"Working together with collaborators, the company hopes to achieve a shared goal that the participants in the COVE study are representative of the communities at highest risk for COVID-19 and of our diverse society," Moderna said in a press release.
The company reiterated that it is on track to deliver about 500 million doses per year, and possibly up to 1 billion doses per year, beginning in 2021.
Analyst Says Funding Drives Near-Term Stock Recovery: On Sunday, Moderna announced an additional award of up to $472 million from BARDA to support the expanded Phase 3 study of mRNA-1273.
The news is consistent with a permissive funding and regulatory environment for SARS-CoV-2 development programs, SVB Leerink analyst Mani Foroohar said in a Monday note.
The additional funding will drive a bullish counterbalance to IP concerns that drove the shares lower last week, the analyst said.
SVB Leerink reiterated a Market Perform rating on Moderna with a $65 price target.
MRNA Price Action: Moderna shares, which retreated 23% last week, were trading 7.92% higher at $79 off the open Monday.
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