Moderna filing for emergency use of coronavirus vaccine in U.S.

Dec 01 , 2020. 8 hours ago – 02:11 KYODO NEWS

A view of U.S. biotechnology company Moderna Inc.’s headquarters in Cambridge, Massachusetts, on May 8, 2020. (Getty/Kyodo) 

WASHINGTON – U.S. biotechnology firm Moderna Inc. said it is filing on Monday for emergency use authorization for its experimental coronavirus vaccine from U.S. and European regulators, after finding the vaccine more than 94 percent effective against the COVID-19 disease.

The announcement came after pharmaceutical giant Pfizer Inc., along with its German partner BioNTech SE, became the first to apply for such authorization of a coronavirus vaccine from the U.S. Food and Drug Administration earlier in November.

Moderna said in a press release that its latest analysis of its final-stage clinical trial showed the efficacy of its two-dose vaccine was 94.1 percent, as compared with 94.5 percent in the initial analysis announced on Nov. 16.

Vaccine efficacy against severe COVID-19 was 100 percent, with all 30 severe cases occurring in participants who received dummy shots and none in the vaccinated group.

There was one COVID-19-related death in the study, which occurred in the placebo group, and no serious safety concerns have been identified to date, Moderna said.

The company said it is working with U.S. authorities as well as stakeholders around the world to be prepared for distribution of the vaccine called mRNA-1273, in the event that it receives an emergency use authorization and similar global authorizations and approvals.

By the end of 2020, the company expects to have approximately 20 million doses of mRNA-1273 available in the United States and remains on track to manufacture 500 million to 1 billion doses globally in 2021.

Moderna has an agreement with the Japanese government to supply the Asian country with enough vaccine doses for 25 million people starting in the first half of next year.

The United States remains the country with the highest number of coronavirus cases and deaths in the world. On Friday, the country recorded 205,557 new cases, according to a tally by Johns Hopkins University.

The FDA will decide whether to issue the emergency use authorization for experimental vaccines after hearing opinions from an advisory committee.

A committee meeting for Pfizer’s vaccine is scheduled on Dec. 10. For Moderna’s vaccine, a committee meeting will likely be scheduled on Dec. 17, the company said.

The latest developments raise the possibility of two vaccines becoming available to high-risk populations by the end of December in the United States.

Cr:KYODO NEWS