Moderna, Inc. (MRNA - Free Report) announced that it has dosed the first patient in a phase I study, evaluating its mRNA-based vaccine candidate, mRNA-1273, against the novel coronavirus (SARS-CoV-2). This is the first study evaluating any of the company’s mRNA-based vaccine against coronavirus infection (COVID-19). Please note that the study is being conducted by the National Institutes of Health ("NIH").
The company stated that it succeeded in starting a clinical study for COVID-19 vaccine in just over nine weeks from sequence selection for the SARS-CoV-2 vaccine.
Amid the largest daily decline in the broader S&P 500 Index in last three decades, shares of Moderna rallied 24.4% on Mar 16, following the initiation of its first human clinical study related to coronavirus. In fact, the company’s shares have increased 35.5% so far this year against the industry’s 11.8% decrease. The majority of this gain in the company’s stock has been led by its progress related to coronavirus vaccine in the past month.
Moderna had stated on Jan 21 that it was working with the U.S. National Institute of Allergy and Infectious Diseases to develop a 2019-nCoV vaccine. In addition, Coalition for Epidemic Preparedness Innovations (“CEPI”) and Moderna entered into a collaboration for similar vaccine development in the same month. CEPI has funded the manufacturing of Moderna’s first clinical batch of mRNA-1273 vaccine.
The phase I study is evaluating three doses of mRNA-1273 — 25, 100 and 250 micrograms — which is being administered on a two-dose vaccination schedule, given 28 days apart, for safety and reactogenicity. The study will enroll 45 healthy adults who will be observed for 12 months following the second vaccination.
Although the study design suggests that it may take at least 12 months for top-line data, Moderna is actively preparing for initiating a phase II study to evaluate mRNA-1273. The company is also planning to work with the FDA and other government and non-government organizations to be prepared for a phase II and later-stage studies.
We note that new cases of COVID-19 infection are growing by leaps and bounds every day. As of the latest update, the number of infected people is nearing 180,000 with more than 7,000 deaths across the globe. This represents a significant opportunity for Moderna’s coronavirus vaccine, mRNA-1273.
Apart from Moderna, on Monday, Germany-based BioNTech SE (BNTX - Free Report) also announced a collaboration with Pfizer (PFE - Free Report) to co-develop mRNA-based vaccine for COVID-19. Meanwhile, Gilead’s (GILD - Free Report) antiviral candidate, remdesivir, has reportedly shown promising results in 14 Americans hospitalized in Japan for the treatment of COVID-19. Several other pharma/biotechs are actively developing treatments for COVID-19. A faster development of any treatment is necessary to save more lives as well as boost economies worldwide. Recently, monetary measures taken by the FED and ECB have failed to have any significant impact.
Moderna currently holds a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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