US biotech firm Moderna is expecting interim results of its coronavirus vaccine trials in November following which the US government could authorise emergency use of the company's experimental inoculation in December.
Speaking during The Wall Street Journal's annual Tech Live conference on Monday, October 19, CEO Stephane Bancel said if satisfactory interim results from the study take longer to get, government authorisation of the COVID-19 vaccine may not happen until early next year.
Moderna has one of the leading coronavirus vaccine candidates in the development stage, along with an inoculation it is developing with Pfizer Inc. and BioNTech SE.
The American pharma giant had recently said that it might seek emergency-use authorisation (EUA) for its COVID-19 vaccine after November 25 once it has enough safety data.
Drug regulators permit the EUA of unapproved medical products or treatments during public health emergencies.
Bancel had recently told Forbes that "November 25 is the time when we will have enough safety data to be able to put into an emergency-use authorisation file that we would send to the FDA." He, however, added that the approval wouldn't be likely until the late first quarter or early second quarter of 2021.
Bancel's comments indicate Moderna's timetable isn't far off from Pfizer's, which also said last week that it expects to seek US government's EUA for its vaccine by late November. "Let me be clear, assuming positive data, Pfizer will apply for Emergency Authorisation Use in the US soon after the safety milestone is achieved in the third week of November," Pfizer CEO Albert Bourla said recently.
Moderna's coronavirus vaccine candidate mRNA-1273 is currently undergoing phase-3 human trials in the US and is being tested on 30,000 participants. The company began the study in July this year.
In the clinical trial, half of the study participants receive the vaccine and half get a placebo, and the scientists then calculate how many get symptomatic COVID-19.
The first analysis of this study is expected to take place in November, but "it is hard to predict exactly which week because it depends on the cases, the number of people getting sick," Moderna Chief Executive Bancel said.