Moderna says new data shows Covid vaccine is more than 94% effective, plans to ask FDA for emergency clearance later Monday
Shares of Moderna were up more than 16% in afternoon trading Monday.
Moderna said Monday it will request emergency clearance from the Food and Drug Administration for its coronavirus vaccine after new data confirms the vaccine is more than 94% effective in preventing Covid-19 and was safe.
Moderna will be the second drugmaker to seek emergency use from the FDA after Pfizer, another front-runner in the Covid-19 vaccine race, applied for the same authorization on Nov. 20. The announcement means some Americans could get the first doses of Moderna’s two-dose vaccine within a few weeks.
The new analysis from Moderna evaluated 196 confirmed Covid infections among the late-stage trial’s 30,000 participants. The company said 185 cases of Covid were observed in the placebo group versus 11 cases observed in the group that received its vaccine. That resulted in an estimated vaccine efficacy of 94.1%, the company said.
The company released on Nov. 16 an early analysis of its phase three trial based on just 95 Covid-19 cases that showed its vaccine was at least 94% effective. Monday’s data provides a more complete picture of the vaccine’s effectiveness.
The FDA’s review of Moderna’s vaccine is expected to take a few weeks. The agency will likely schedule an advisory committee meeting to review the vaccine on Dec. 17, Moderna said. It has already initiated rolling submissions with several regulatory agencies around the world, including the European Medicines Agency.
Federal agencies are already sending vaccination plans around to staff. Five agencies have started telling employees they could receive Pfizer’s or Moderna’s Covid-19 vaccine in as little as eight weeks, a person with firsthand knowledge of those plans told CNBC on Nov. 20.
Reference: CNBC
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