Moderna’s Chief Executive Stéphane Bancel said the US government could authorize emergency use of the company’s experimental Covid-19 vaccine in December, if the company gets positive interim results in November from a large clinical trial.
Bancel warned however that should sufficient interim results from the study takes longer to get, government authorization of the vaccine may not occur until early next year.
US-based Moderna has one of the leading Covid-19 vaccines in development as large U.S. trials for two other leading Covid-19 vaccines, from AstraZeneca and Johsnon & Jonhson have been paused with the companies involved investigating unexplained illnesses among study patients.
Mr. Bancel’s comments suggest Moderna’s timetable isn’t far off from Pfizer’s, which said last week it expects to seek Government authorisaton of emergency use of its vaccine by late November.
The company also must monitor the safety of at least half of the study subjects for two months after vaccination before it can seek an authorization for emergency use. The company is confident of reaching that threshold in late November. If Moderna files for an emergency use authorization soon after, the Food and Drug Administration may take a few weeks to review the application before deciding in December.
If the vaccine doesn’t demonstrate sufficient efficacy at the first interim analysis, the company will conduct a second analysis when 106 cases of symptomatic Covid-19 occur. Mr. Bancel said that would likely happen in late in the year, which could push back any FDA decision to late January or early February.
via WSJ
