RE: Moderna says seeking approval for COVID–19 ? Pending US Elections30 Sep 2020 22:55
Moderna will not be ready to seek emergency use authorization from the Food and Drug Administration before Nov.
25 at the earliest, the report said, citing Bancel.
The company's experimental vaccine is among the leaders in the race to develop a safe and effective vaccine to tackle the COVID-19 pandemic. The candidate is currently being tested in a large decisive trial.
The race to come up with a vaccine has become a divisive issue for the U.S. presidential election and was of significant importance in the presidential debate on Tuesday between U.S. President Donald Trump and contender Joe Biden.
Bancel earlier this month had said he expects the company to file for an Emergency Use Authorization in 2020, which could occur in November or even as early as October depending on interim analysis. ...
Results from an early safety study of Moderna's coronavirus vaccine candidate in older adults on Tuesday showed that it produced virus-neutralizing antibodies at levels similar to those seen in younger adults.