Moderna stock surged more than 14 percent in after-hours trading following positive results from the company's "Phase 1" study of its mRNA-1273 COVID-19 vaccine candidate.
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Moderna’s experimental vaccine contains genetic material called messenger RNA, or mRNA which is a genetic code that tells cells what to build. According to the results published in the New England Journal of Medicine, mRNA-1273 "induced rapid and strong immune responses" against the coronavirus and "binding antibodies."
The study included 45 healthy adults between the ages of 18 and 55 who received two vaccinations 28 days apart. Participants were split into three groups with one given a dose of 25 micrograms or μg, another given 100 μg, and another given 250 μg (1 ug equals 1/1,000 of a miligram).
The vaccine was found to be generally safe and well-tolerated, with the most notable adverse events from the first vaccination seen at the 250 µg dose level, with three of the group's 14 participants (21 percent) reporting one or more severe events.
Adverse events were more common after the second vaccination, occurring in seven of 13 or 54 percent of participants in the 25 µg group.
In addition, all 15 participants in the 100 µg group and all 14 participants in the 250 µg group suffered some type of adverese impact, the most common of which coming out of the 100 ug group were:
- Fatigue -- 80 perecent reporting
- Chills -- 80 percent reporting
- Headache -- 60 perecent reporting
- Myalgia -- 53 percent reporting
All reported cases were mild or moderate in severity, though pain at the injection site was reported at 100 perecent .
The mRNA-1273 vaccine candidate was found to produce the highest immune response with the 100 μg dosage.
The "Phase 1" data is "encouraging and represent an important step forward in the clinical development of mRNA-1273, our vaccine candidate against COVID-19," Stéphane Bancel, Chief Executive Officer of Moderna said in a statement , “We are committed to advancing the clinical development of mRNA-1273 as quickly and safely as possible while investing to scale up manufacturing so that we can help address this global health emergency.”
Moderna's vaccine candidate is currently in a "Phase 2" study to evaluate its safety, potential adverse side effects, and immune response with each participant being given 50 μg or a 100 μg dose at two vaccinations given 28 days apart.
Moderna has plans for a "Phase 3" study beginning on July 27 with 30,000 participants. Moderna said it has completed manufacturing of the vaccine required to start the "Phase 3" study and remains on track to be able to deliver approximately 500 million doses per year, and possibly up to 1 billion doses per year, beginning in 2021.
Moderna has never scored a commercial approval for any of its drugs or vaccines, but analysts with Jefferies think the company's mRNA-1273 vaccine candidate could be promising.
Jefferies analyst Michael Yee wrote in a note to clients that there is a "good probability Moderna's vaccine will work and get at least emergency use authorization in 2021,” and that a safe and effective vaccine “can generate billions in sales, which we see as reasonable given there would be high demand over the first 1-2 years.”
Jeffries analysts predict 50 million people will be vaccinated in 2021 at $50 per dose. Under that scenario, Moderna could earn about $2 billion in 2021 and $5 billion over the next few years.
Yee added that if 100 million or 200 million people get vaccines at a higher price point, “this can quickly get to big numbers of $10-20B+ in theory.”
However, he also acknowledged that if the vaccine is not found to be safe and effective, Moderna stock would be "hit hard."
Moderna's vaccine candidate is one of five selected as part of the White House's Operation Warp Speed Initiative to accelerate the development of a coronavirus vaccine.
|JNJ||JOHNSON & JOHNSON||167.91||-2.57||-1.51%|
|MRK||MERCK & CO. INC.||77.09||-3.20||-3.99%|
Other companies with vaccine candidates selected by the program include Astrazeneca, Johnson & Johnson, Merck & Co., and Pfizer.