Moderna to seek emergency clearance for COVID-19 vaccine from USFDA, European regulators

Moderna Inc on November 30 said that it will be seeking emergency use authorisation of its COVID-19 vaccine from the United States Food and Drug Administration (USFDA) and European regulators after results from a late-stage study showed its vaccine was 94.1 percent effective.

It also reported a 100 percent success rate in preventing severe cases, news agency Reuters reported.

"We believe that we have a vaccine that is very highly efficacious. We now have the data to prove it," Moderna Chief Medical Officer Dr. Tal Zaks said in a interview, adding that Moderna expects to play a "major part in turning around this pandemic".

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"It was the first time I allowed myself to cry. At this level of effectiveness, when you just do the math of what it means for the pandemic that's raging around us, it's just overwhelming," Zaks said, according to Reuters.

Earlier on November 16, reports had suggested that Moderna Inc's experimental COVID-19 vaccine is more stable than expected at temperatures than ordinary refrigerators can provide and can be distributed using existing cold-chain shipping and storage infrastructure.

What comes next?

According to the Associated Press, The FDA has pledged that before it decides to roll out any COVID-19 vaccines, its scientific advisers will publicly debate whether theres enough evidence behind each candidate.

It will first deliberate on the candidate being developed by Pfizer and BioNTech on November 10. The firms will present data suggesting their vaccine candidate is 95% effective.

Moderna said its turn at this science court is expected exactly a week later, on Dec. 17.

-- With inputs from Associated Press