Moderna to seek U.S., EU emergency use after COVID-19 vaccine shows 94.1% protection
Updated 20:39, 30-Nov-2020
CGTN

Moderna Inc said it will apply for U.S. and European emergency authorization of its COVID-19 vaccine on Monday based on full results from a late-stage study that showed 94.1% efficacy with no serious safety concerns.

"Moderna plans today to request EUA (Emergency Use Authorization) from the US FDA (Food and Drug Administration)," Moderna said in a statement, adding it would also "apply for a conditional marketing authorization with the European Medicines Agency (EMA)." 

The company said primary efficacy analysis of the Phase 3 COVE study of mRNA-1273 involving 30,000 participants included 196 cases of COVID-19, of which 30 cases were severe. Vaccine efficacy against COVID-19 was 94.1 percent and vaccine efficacy against severe COVID-19 was 100 percent.

Moderna's announcement follows news from Pfizer Inc and German partner BioNTech SE that their vaccine, which also uses a new technology called synthetic messenger RNA (mRNA), was 95 percent effective. Pfizer has applied for emergency use authorization, putting it about a week ahead of Moderna.

The filing sets Moderna's product up to be the second vaccine likely to receive U.S. emergency use authorization this year.

The success rate was just slightly less than the interim analysis result of 94.5 percent revealed earlier this month, but Moderna said the difference was statistically insignificant. 

Read more:

Pfizer says final results show vaccine 95% effective

Pfizer is first to apply for U.S. emergency use for COVID-19 vaccine

Source(s): Reuters ,AFP