Inovio also expects to have its vaccine tested in "a large, phase two trial" by the end of the year
In an interview with Goldman Sachs’ representatives, Moderna's (MRNA) CEO Stephane Bancel said that its experimental vaccine for COVID-19 could be available to a select few, such as healthcare workers, in the fall of 2020. This comes as the Food and Drug Administration and the National Institutes of Health slash red tape to expedite research as the deadly outbreak of the novel coronavirus continues worldwide.
MRNA-1273 IN PHASE 1 TRIAL: In a regulatory filing, Moderna provided a business update on its mRNA-1273, "an mRNA vaccine against SARS-CoV-2 encoding for a prefusion stabilized form of the Spike protein, which was selected by Moderna in collaboration with investigators from the Vaccine Research Center at the National Institute of Allergy and Infectious Diseases, a part of NIH. Manufacture of the first clinical batch was funded by the Coalition for Epidemic Preparedness Innovations."
"The Phase 1 study, which dosed the first participant on March 16, 2020, is evaluating the safety and immunogenicity of three dose levels of mRNA-1273 administered on a two-dose vaccination schedule, given 28 days apart. A total of 45 healthy adults will be enrolled in the study. Participants will be followed through 12 months after the second vaccination. The primary objective is to evaluate the safety and reactogenicity of a two-dose vaccination schedule of mRNA-1273. The secondary objective is to evaluate the immunogenicity to the SARS-CoV-2 S protein. As of the date hereof, the Phase 1 study is proceeding in accordance with the protocol under the direction of NIAID," the company explained.
Over the weekend, Stephen Hoge, President of Moderna, appeared in an interview on the television program "60 Minutes" and discussed the company's work on mRNA-1273. The company was the first one to go into human trials. "[The technology we're using] allows us to move incredibly quickly - when we have a pandemic situation like the one we're in," Hoge explained.
During the interview, the executive noted that, "if we're able to show there's a clear benefit-- we're gonna need to be able to make sure that it's accessible to everybody who needs it. And so we've actually already started the investment to scale up supply into the millions of doses. But ultimately what we really need to focus on is generating the clinical data that shows that the vaccine, in fact, does have a benefit, that it's safe and effective."
Also present during the "60 Minutes" interview, Senior Vice President of Research and Development at Inovio Pharmaceuticals (INO) Kate Broderick said that, "We're hoping to have our vaccine tested in what we call a large, phase two trial by the end of the year, which would be potentially hundreds, if not thousands, of subjects being treated. But to have it rolled out to the public is likely to take longer than that."
VACCINE COULD BE AVAILABLE TO SOME THIS FALL: On March 20, 2020, Stephane Bancel, CEO of Moderna, was interviewed by representatives of Goldman Sachs regarding the company's work on COVID-19. During the interview, Bancel indicated that while a commercially-available vaccine is not likely to be available for at least 12-18 months, it is possible that under emergency use, a vaccine could be available to some people, possibly including healthcare professionals, in the fall of 2020. In addition, the executive confirmed that the company is scaling up manufacturing capacity toward the production of millions of doses per month, in the potential form of individual or multi-dose vials.
PRICE ACTION: In morning trading, shares of Moderna have gained about 2% to $28.67. Meanwhile, shares of Inovio are down 5.4%, or 39c, to $6.83.