The biotechnology company Moderna expects to have its first interim analysis of its Covid-19 vaccine trial data in November and critical safety data in the second half of November, CEO Stéphane Bancel said during an investor call on Thursday morning.
Bancel said that two-month safety data on 15,000 trial participants who had received two doses of the vaccine will be ready later next month.
In October, the US Food and Drug Administration made clear that it wants to see two months of follow-up data after volunteers get their second vaccine doses in clinical trials before considering any Covid-19 vaccine candidate for possible emergency use authorization.
Moderna said it plans to file for an EUA after it has positive efficacy data and two-months of safety data for the median number of participants, about 15,000.
On Thursday's call, Bancel also said that Moderna has "received $1.1 billion cash payments from governments around the world." And the company noted in a news release on Thursday that it is "actively preparing for the launch of mRNA-1273," its Covid-19 vaccine candidate.
"We have signed a number of supply agreements with governments around the world. Moderna is committed to the highest data quality standards and rigorous scientific research as we continue to work with regulators to advance mRNA-1273," Bancel said in part in the news release. "I believe that if we launch our COVID-19 vaccine, 2021 could be the most important inflection year in Moderna’s history."