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November 30, 2020

Moderna to seek early and conditional approval in the US and Europe for its Covid-19 vaccine

By Allie Nawrat

US biotech Moderna has announced its Covid-19 vaccine mRNA-1273 met its primary endpoint in a Phase III study. As a result, Moderna plans to file for emergency use authorisation (EUA) in the US and conditional approval in Europe.

Final data from the Phase III COVE trial showed Moderna’s mRNA-1273 achieved 94.1% efficacy. The vaccine’s efficacy was consistent across the different age, race, ethnicity and gender demographics enrolled in the study. These efficacy results are based on the 196 cases of Covid-19 that occurred in the COVE study; 185 of which were in the placebo group.

In addition, Moderna announced mRNA-1273 also achieved its secondary endpoint of preventing severe Covid-19. There were 30 severe cases in the COVE study, but all of these were in the placebo group. Also, the only Covid-19 related death in the trial was also from the placebo group.

Moderna also reported that the vaccine was well tolerated and that safety data would continue to be collected by the trial’s data safety monitoring board.

The company’s CEO Stéphane Bancel commented: “This positive primary analysis confirms the ability of our vaccine to prevent Covid-19 disease with 94.1% efficacy and importantly, the ability to prevent severe Covid-19 disease.

“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.

“We will file today for an EUA from the FDA and continue forging ahead with the rolling reviews that have already been initiated with several regulatory agencies around the globe.”

These final efficacy results are relatively consistent with the 94.5% interim efficacy data from the COVE study, which were announced by Moderna in mid-November.

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