Moderna to ask FDA for emergency clearance of COVID-19 vaccine

Moderna said it will ask the feds to clear its experimental coronavirus vaccine for emergency use on Monday, adding to hopes that two inoculations could be available by the end of the year.

The biotech firm will be the second drugmaker to seek a so-called emergency use authorization for a COVID-19 vaccine from the US Food and Drug Administration after Pfizer and BioNTech submitted their request earlier this month.

Moderna announced the move Monday as it revealed new data showing the vaccine was 94.1 percent effective in its late-stage clinical trial — similar to Pfizer’s efficacy rate of 95 percent — and posed no serious safety concerns. The FDA’s vaccine advisory committee is expected to review data from the Phase 3 study at a Dec. 17 meeting, Moderna said.

“We believe that our vaccine will provide a new and powerful tool that may change the course of this pandemic and help prevent severe disease, hospitalizations and death,” Moderna CEO Stéphane Bancel said in a statement.

Moderna’s submission will come as US officials and drug companies prepare to distribute coronavirus vaccines to vulnerable people around the country as soon as they’re approved.

The Massachusetts-based company said it will have about 20 million doses of its vaccine available in the US by the end of the year, while Manhattan-based Pfizer expects to have produced up to 50 million doses of its shot globally. That would be enough to inoculate about 35 million people in all because the vaccines are each administered in two doses.

The FDA did not immediately respond to a request for comment Monday.

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