Moderna Inc. Chief Executive Stéphane Bancel said the company could secure an emergency use permission for its potential COVID treatment from the federal government by December if they provide positive initial results from its extensive clinical test next month.
In a Tech Live conference hosted by The Wall Street Journal on Monday, Bancel said if substantial results from the clinical trials take longer to get, authorization from Food and Drug Administration for its experimental drug may not happen until early 2021. Thus, in order for Moderna to file an emergency use authorization (EUA), it needs to provide enough safety and efficacy data.
The Massachusetts-based Moderna kicked off its late-stage clinical test in July with 30,000 participants, and to be able to apply for emergency authorization, 53 of the patients must be infected with COVID, and infection rates must be higher in half of the patients that were given a placebo, WSJ said.
Moderna has one of the leading coronavirus vaccines currently in development, along with a treatment being co-developed by Pfizer and BioNTech.
Massive U.S. trials for two other potential vaccines from AstraZeneca and Johnson & Johnson have been temporarily suspended, while the pharmaceutical groups conduct a probe into unexplained sickness among trial participants.
Moderna is on course to make around 20 million doses of its candidate drug by end of 2020, adding it had enrolled 25,297 subjects out of a proposed 30,000 for its final-phase research.
Moderna is conducting clinical trials on one of four candidate COVID vaccines, and the company's timetable is closest to Pfizer, which announced last week that it seeks a EUA for its own vaccine in late November.
Bancel also stressed that accelerating production is a major challenge. He said that if one ingredient is missing, they cannot produce the vaccine, WSJ reported.
Vaccine producers are scrambling to manufacture a COVID vaccine, with over 150 candidate treatments being developed and tested around the world.
