#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 Christmas.

The biotech firm will submit the second request for a so-called emergency use authorization for a COVID-19 vaccine from the US Food and Drug Administration after Pfizer and BioNTech filed their application 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, the company 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.

The news sent Moderna’s stock price surging 10 percent in premarket trading Monday to $139.80 as of 7:51 a.m.

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

Massachusetts-based Moderna said it expects to ship its vaccine to distribution points throughout the US “shortly after” the FDA grants the emergency use authorization. The first doses could be administered as soon as Dec. 21 if the process goes as planned, Bancel told The New York Times.

Moderna says it will have about 20 million doses available in the US by the end of the year, enough to inoculate about 10 million people with two doses apiece. Manhattan-based Pfizer, meanwhile, expects to have produced up to 50 million doses of its shot globally by year’s end and has said its shot could be distributed to high-risk populations by mid- to late December. The FDA’s vaccine panel is scheduled to discuss the company’s emergency use authorization at a Dec. 10 meeting.

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

Moderna deemed its vaccine highly effective after a new analysis of 196 people who contracted COVID-19 in its clinical trial of more than 30,000 people. Only 11 of those who got sick had received the vaccine while the other 185 had gotten a placebo, the company said.

Some 30 participants came down with severe cases of the coronavirus, none of whom had been vaccinated, Moderna said. One person in the study died of COVID-19-related causes but the patient had received a placebo, according to the company.

Moderna’s latest analysis found no serious safety problems with the shot, though the company noted that patients have reported fatigue, muscle aches, joint pain, headaches, and pain and redness at the injection site.

Moderna also announced that it will seek conditional approval for the vaccine on Monday from the European Medicines Agency, the European Union’s drug regulator. The company said it has already started the approval processes in the UK, Israel and Singapore.

Both Moderna’s and Pfizer’s vaccines use messenger RNA, manufactured genetic material that’s injected into cells to provoke an immune response in the body. That makes them different from another leading candidate from AstraZeneca, which uses a deactivated cold virus to deliver a gene for the coronavirus’ spike proteins into the body. The British drugmaker said last week that its shot was up to 90 percent effective.