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Phase 2 trial of Moderna’s coronavirus vaccine will shortly begin and enroll 600 participants. The company is also planning to begin phase 3 trial as early as this summer. MRNA stock is 10% up now.
Biotech company Moderna Inc. (NASDAQ: MRNA) has come one step closer to finding a COVID-19 vaccine. As Moderna has said, the Food and Drug Administration (FDA) approved its mRNA-1273 vaccine for phase 2 human trial. According to the company, this step will be “crucial” for vaccine development.
As a result of the announcement, Moderna stock has soared 7% in the pre-market. Yesterday, its closing price was $48. 94. The opening price today made up 55.78%, At the moment of writing, Moderna stock is 10.23% up, trading at $53.96 per share.
mRNA-1273 Phase 2 Trial to Shortly Begin, Phase 3 Expected in Summer
Moderna is working on its mRNA-1273 coronavirus vaccine in collaboration with the Vaccine Research Center, a unit of the National Institute of Allergy and Infectious Diseases (NIAID). The vaccine encodes for a prefusion form of the Spike (S) protein that NIAID and Moderna designed. The company is developing the vaccine by leaps and bounds. Notably, Moderna skipped the stage of the animal trials.
The Phase 1 study began on March 16. It involved 45 healthy adult volunteers between 18 to 55 years in the original three-dose cohorts. Besides, Moderna added three cohorts of older adults (56-70 years) and three cohorts of elderly adults (ages 71 and above).
On April 27, Moderna submitted an Investigational New Drug (IND) application to the FDA to evaluate the company’s COVID-19 vaccine candidate in Phase 2 and late-stage studies. Immediately, the company received initial feedback from the FDA on the design of the study expected to begin in the second quarter of 2020.
Today, Moderna said it got FDA’s approval for phase 2 trials of mRNA-1273. According to the company, it will enroll 600 participants.
Moderna CEO Stephane Bancel said:
“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. 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.”
Further, he added:
“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.”
Moderna and other biotech companies are progressing in COVID-19 vaccine development, skipping years of hard work and studies. As a rule, it takes 10-15 years to develop a vaccine. However, the coronavirus made the world to accelerate efforts and speed up. Therefore, some believe that the vaccine will be ready as soon as this year.
For example, U.S. President Donald Trump says many companies are close to a cure. According to Trump, his administration pushed the U.S. medical infrastructure. As a result of this push, the process of vaccine development is extremely fast. Therefore, we may have the vaccine at the end of this year. Other coronavirus news you may find here.