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FDA approves Phase 2 study of coronavirus vaccine
The Food and Drug Administration has approved a Phase 2 study of coronavirus vaccine.
The FDA has approved Moderna's COVID-19 vaccine candidate, allowing it to move to Phase II and bringing it one step closer to a potential treatment for the devastating disease.
Cambridge, Mass.-based Moderna made the announcement on Thursday that mRNA-1273 will move to Phase II "shortly" and a Phase III study could happen as soon as the "early summer" this year.
“The imminent Phase 2 study start is a crucial step forward as we continue to advance the clinical development of mRNA-1273, our vaccine candidate against SARS-CoV-2," CEO Stéphane Bancel said in a statement. "With the goal of starting the mRNA-1273 pivotal Phase 3 study early this summer, Moderna is now preparing to potentially have its first BLA approved as soon as 2021. We are accelerating manufacturing scale-up and our partnership with Lonza puts us in a position to make and distribute as many vaccine doses of mRNA-1273 as possible, should it prove to be safe and effective.”
Bancel continued: “We also are continuing to progress our development pipeline and invest in our future. We are very pleased with Vertex’s decision, based on our preclinical progress, to extend our strategic collaboration working to develop the technology to allow for delivery of mRNA in the lung.”
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The drug from the biotech company, which uses messenger RNA therapeutics and vaccines for its drugs, has gotten some praise from the scientific community, despite still being studied.
In mid-April, Fox News medical contributor Dr. Marc Siegel appeared on "Tucker Carlson Tonight" and spoke briefly about the possible coronavirus vaccine, saying White House Coronavirus Task Force member Dr. Anthony Fauci had said he was optimistic about the process.
"Tony talked to me about the vaccine development. And he said that the Moderna vaccine that the NIH is looking at is very encouraging," Siegel told Carlson. "And it's about to go out of Phase I trials and soon into Phase II, that's where they really see how effective it is. That's where they look for the manufacturing process by the time it gets to market several months from now.
Phase I began in mid-March, as the first injections were administered at Kaiser Permanente Washington Health Research Institute in Seattle, Fox News previously reported. That phase of the study tested the safety of three dose levels of the new vaccine.
Currently, there is no known scientific cure for the disease known as COVID-19, however, a number of drugs are being tested to see if they can treat it.
As of Thursday morning, more than 3.77 million coronavirus cases have been diagnosed worldwide, more than 1.22 million of which are in the U.S., the most impacted country on the planet.