Moderna CEO Stéphane Bancel said Wednesday that his company’s coronavirus vaccine won’t be ready for widespread public distribution until spring of next year, according to a report. The drugmaker also won’t seek emergency authorization for the vaccine for frontline medical workers and other at-risk individuals until November 25 at the earliest, he told the Financial Times.
Speaking at a health conference on Wednesday, Bancel said Moderna would not be ready to seek Food and Drug Administration approval for the vaccine for use in the general population until at least late January. If the vaccine is proven to be safe and effective, approval is unlikely until late March or early April.
“I think a late [first quarter], early [second quarter] approval is a reasonable timeline, based on what we know from our vaccine,” Bancel said, according to the FT.
A spokesperson for Moderna confirmed Bancel’s comment at the conference noting that the company expects to have enough vaccine testing data to apply with the FDA for emergency use authorization by November 25.
The timeline is a setback for Moderna, which said earlier this month that it could seek emergency authorization for a vaccine as soon as November 1. It also deals a blow to claims by President Donald Trump, which he repeated on Tuesday in his debate with Joe Biden, that a vaccine could be ready in a matter of weeks, or before the November 3 presidential election. [Continue reading…]
The U.S. Food and Drug Administration has broadened its investigation of a serious illness in AstraZeneca Plc’s COVID-19 vaccine study and will look at data from earlier trials of similar vaccines developed by the same scientists, three sources familiar with the details told Reuters.
AstraZeneca’s large, late-stage U.S. trial has remained on hold since Sept. 6, after a study participant in Britain fell ill with what was believed to be a rare spinal inflammatory disorder called transverse myelitis.
The widened scope of the FDA probe raises the likelihood of additional delays for what has been one of the most advanced COVID-19 vaccine candidates in development. The requested data was expected to arrive this week, after which the FDA would need time to analyze it, two of the sources said. [Continue reading…]