ARTICLE | Product Development
Moderna says Warp Speed improved quality, but not speed of its COVID-19 vaccine development
Company expects to unblind trial within weeks of EUA, predicts NIH and FDA will certify correlates of protection in 2H21
November 30, 2020 12:02 PM UTC
Updated on Dec 1, 2020 at 2:33 AM UTC
It took 322 days from the day Moderna produced the first dose of mRNA-1273 for the company to announce Monday that in a Phase III trial its vaccine had prevented 94.1% of symptomatic and 100% of severe cases of COVID-19. Moderna is now applying to FDA for emergency use authorization of the mRNA-based vaccine and the agency announced it will convene an advisory committee meeting to discuss the application on Dec. 17.
In addition to the EUA application, Moderna has rolling submissions under way for conditional approvals from EMA and other regulatory agencies. ...