Moderna gains FDA approval to enter Phase 2 trial of mRNA-1273
Category: #health  By Saipriya Iyer  Date: 2020-05-11
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Moderna gains FDA approval to enter Phase 2 trial of mRNA-1273

Moderna Therapeutics, an American biotechnology company, has recently announced the FDA approval for its COVID-19 vaccine candidate, mRNA-1273 to enter the Phase 2 clinical trial. The 2nd phase of the vaccine development will involve nearly 600 people.

The goal of the Phase 2 trial is to determine the safety and efficacy of the vaccine. The healthy adult volunteers will be administered two mRNA-1273 vaccinations at 1 of 2 dosages, or placebos, 28 days apart. The health conditions of these volunteers will be tracked for a year following the 2nd vaccination. The company also previously announced its intention to commence on the 3rd phase of the trials, by testing several people to identify the effectiveness of the vaccine. It expects the final approval of the vaccine as early as 2021.

Stéphane Bancel, CEO of Moderna, has stated that the rising manufacturing scale-up & its partnership with Lonza have enabled the company to develop and distribute as many mRNA-1273 vaccine doses as possible. It targets to develop 1 billion doses of the vaccine per year.

In addition to Moderna, several other companies are engaging in the development of the COVID-19 vaccine. For instance, Pfizer and BioNTech have commenced on the combined Phase 1 & 2 clinical trials. These companies have adopted several approaches to developing the vaccines. Moderna uses mRNA to develop the spike protein of COVID-19, which in turn, will induce the production of antibodies to fight against the virus. In March, the Phase 1 trial was initiated on 45 healthy adults in Seattle. The trial has also been conducted at 2 other sites in the United States. The success of the trial will potentially lead to the 1st vaccine ever developed by means of mRNA.

The company obtained deferral funds of nearly $483 million from the BARDA (Biomedical Advanced Research & Development Authority) to create the vaccine for FDA licensing.

Source credit:https://mirrorspectator.com/2020/05/10/moderna-therapeutics-covid-19-vaccine-approved-for-phase-2-clinical-trial/



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Saipriya Iyer

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Saipriya Iyer

Saipriya Iyer develops content for Market Size Forecasters, Algosonline, and myriad other platforms. A computer engineer by profession, she ventured into the field of writing for the love of playing with words. Having had a previous experience of 3 years under her bel...

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