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Moderna: Phase 3 of coronavirus vaccine study begins

According to an official announcment by Moderna, the clinical stage biotechnology company, Phase 3 study of its mRNA vaccine candidate (mRNA-1273) against COVID-19 has begun dosing participants.

“The Phase 3 study, called the COVE (Coronavirus Efficacy) study”, Moderna explained, “is being conducted in collaboration with the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH) and the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human Services”.

“We are pleased to have started the Phase 3 COVE study,” said Stephane Bancel, CEO at Moderna. “We are grateful to the efforts of so many inside and outside the company to get us to this important milestone. We are indebted to the participants and investigators who now begin the work of the COVE study itself. We look forward to this trial demonstrating the potential of our vaccine to prevent COVID-19, so that we can defeat this pandemic.”

According to Moderna, the Phase 3 study protocol follows the U.S. Food and Drug Administration (FDA) guidance on clinical trial design for COVID-19 vaccine studies. The randomized, placebo-controlled trial is expected to include approximately 30,000 participants in the United States, testing an mRNA-1273 dosage of 100 µg. Moderna says that the primary endpoint will be the prevention of symptomatic COVID-19 disease. Key secondary endpoints include prevention of severe COVID-19 disease (as defined by the need for hospitalization) and prevention of infection by SARS-CoV-2 regardless of symptomology. SARS-CoV-2 is the virus that causes COVID-19.

The company explained in their official announcement that the primary efficacy analysis of the Phase 3 study will be an event-driven analysis based on the number of participants with symptomatic COVID-19 disease. To ensure the ongoing safety monitoring of the participants in the trial, data will be reviewed by an independent Data and Safety Monitoring Board organized by NIAID throughout the study.

Source: Arutz Sheva

 

Notes:

Moderna said on Sunday it has received an additional $472 million from the U.S. government’s Biomedical Advanced Research and Development Authority (BARDA) to support the development of its novel coronavirus vaccine.

The U.S.-based drugmaker said the additional funding will support its late-stage clinical development including the expanded Phase 3 study of Moderna’s vaccine candidate.

In April, Moderna had received $483 million from the U.S. federal agency that funds disease-fighting technology, when the experimental vaccine was in an early-stage trial conducted by the U.S. National Institutes of Health.

“Encouraged by the Phase 1 data, we believe that our mRNA vaccine may aid in addressing the COVID-19 pandemic and preventing future outbreaks,” Chief Executive Officer Stéphane Bancel said in a press release.

BARDA’s total funding for the experimental vaccine of Moderna, the first in the United States to begin human trials of a coronavirus vaccine, is now about $955 million.

The vaccine uses synthetic messenger RNA (mRNA) to inoculate against the coronavirus. Such treatments help the body immunize against a virus and can potentially be developed and manufactured more quickly than traditional vaccines.

A Phase 3 study, conducted in collaboration with the National Institute of Allergy and Infectious Diseases, will begin on July 27 and involve about 30,000 participants, according to the company.

Moderna said it remains on track to be able to deliver about 500 million doses per year, and possibly up to 1 billion doses per year, beginning in 2021.

The announcement about further funding came two days after the drug developer said its formula used in developing the vaccine was not covered under patents owned by Arbutus Biopharma.

Pfizer Inc, Novavax Inc, Britian’s AstraZeneca Plc are other few drug makers that received funding from BARDA for coronavirus vaccine development.

Source: CNBC