Moderna Inc (MRNA) - Get Report said Thursday that more than 25,000 people have enrolled in a trial that will test its experimental coronavirus vaccine as it looks for potential FDA approval before the end of the year.
As part of the company's annual "R&D Day" presentation, Moderna said it is seeing progress across all three of its current clinical stage trials, including the phase 3 study of its MRNA-1273 coronavirus vaccine candidate, which has an enrollment of 25, 296 participants. The drugmaker also said it would enter the seasonal flu market as part of an overall increase in vaccine investments.
Moderna CEO, Stéphane Bancel, told Reuters Thursday that a 70% success rate for the vaccine could trigger a petition to the FDA for Emergency Use Approval as early as October.
“We are actively preparing for a potential commercial launch of mRNA-1273, our COVID-19 vaccine, and we continue to expand the breadth of Moderna’s platform,” Bancel said in a statement. “We are announcing that we are increasing our investment in vaccines and we will develop a seasonal flu vaccine given the unmet need for highly effective vaccines."
"As we continue to scale for commercialization, we are more committed than ever to our mission to deliver on the promise of mRNA medicines to treat or prevent serious diseases," he added.
Moderna shares were marked 2.7% lower in early trading following the data release to change hands at $38.22 each, a move that would trim the stock's six-month gain to around 148%.
The World Health Organization says that around 150 potential vaccines are currently under some form of study, with 34 active human trials taking place from Russian to Bahrain.
Several U.S. firms are also in the hunt, including Moderna, Johnson & Johnson (JNJ) - Get Report, Novavax (NVAX) - Get Report and Pfizer (PFE) - Get Report, which said earlier this month that it's eyeing regulatory approval for it mRNA-based vaccine as early as October.
AstraZeneca's (AZN) - Get Report pause of its late-stage study with Oxford University, however, has ignited the race for a workable vaccine heading into the one-year anniversary of the pandemic, which has infected 30 million people and claimed nearly one million lives.
Dr. Anthony Fauci, the U.S.'s foremost expert on infectious diseases, said AstraZeneca's decision to pause was "unfortunate", but a likely necessary "safety valve" in the complicated clinical trials process.
His comments echoed those published in a letter signed by the CEO's of nine pharmaceutical companies -- including Moderna -- on September 8, pledging to 'stand with science' and not rush any potential vaccine to market before proper safety procedures were followed in “large, high quality clinical trials”