Moderna Vaccine Fda

Moderna s application relies on a final analysis of its 30 000 person late stage.

Moderna vaccine fda. The fda filing would clear the way for the vaccine to be authorized for use in the united states within weeks. Moderna will submit its coronavirus vaccine for regulatory approval on monday the company said the second leading drug to pass the milestone this month. A group of fda appointed vaccine advisors appointed are set to meet for three days from december 8 to december 10 to discuss pfizer s and moderna s vaccines. In august the government also contracted to buy 100 million doses of the moderna vaccine for 1 5 billion with the option to buy more.

The fda is scheduled to meet with its vaccines and related biological products advisory committee on december 10 to review pfizer s application and on december 17 to review moderna s application. The covid 19 vaccine would be moderna s first product approved by the fda and assuming pfizer s vaccine is approved first only the second mrna medicine ever licensed. 17 to review moderna s application. Moderna will apply for emergency fda approval of its covid 19 vaccine on monday after promising data revealed it is 94 1 percent effective.

The massachusetts biotech firm said it. Moderna is part of operation warp speed the federal government s program to fast track a covid 19 vaccine and has received more than 955 million to aid in vaccine development. Moderna is the second drugmaker to submit its covid 19 vaccine to the fda for emergency use authorization.