Moderna files for emergency vaccine approval with US, EU regulators

American Biotech company Moderna said it would on Monday submit its Covid-19 vaccine candidate for emergency regulatory approval in the United States and the European Union after preliminary analysis of late-stage testing showed an efficacy rate of 94%, reported EFE-EPA.

Moderna enlisted 30,000 participants in its Phase 3 clinical trial for the mRNA vaccine, including 196 cases of Covid-19, 30 of which were severe. The primary goal of the shot is to prevent Covid-19 symptoms.

Preliminary results from the clinical trial showed it has 100% efficacy against severe Covid-19.

Following the findings, Moderna confirmed in a statement that it would file for emergency approval with the US Food and Drug Administration and conditional approval from the European Medicines Agency.

“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,” said Stéphane Bancel, chief executive officer at Moderna.

“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.”

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

According to Moderna, the vaccine proved effective regardless of age, race and ethnicity, and gender demographics and no serious side-effects were reported.

Several other vaccine candidates are in the late stages of regulatory checks and could come into use by December, just as the globe wrestles with a second wave of Covid-19.

American pharmaceutical giant Pfizer and Germany company BioNTech are leading the race after announcing earlier this month that its candidate showed an efficacy rate of 95% percent in Phase 3 studies.

The AstraZeneca/Oxford University vaccine is also being reviewed by the United Kingdom’s regulatory body.

Travel restrictions and severe curbs to social freedoms remain in force in much of the world almost a year after the emergence of the new coronavirus was first reported in the Chinese city of Wuhan.

There have been more than 60 million recorded cases of Covid-19 worldwide and nearly 1.5 million related deaths.

The US is the worst-hit nation, registering well over 100,000 new cases each day. An estimated 267,000 Americans have died from Covid-19.