Moderna requests authorization to use the vaccine in the US, will seek approval in Europe

FILE PHOTO.  Moderna's logo is reflected in a drop on a syringe needle in this illustration taken on November 9, 2020. REUTERS / Dado Ruvic FILE PHOTO. Moderna’s logo is reflected in a drop on a syringe needle in this illustration taken on November 9, 2020. REUTERS / Dado Ruvic

By Julie Steenhuysen and Michael Erman

Nov 30 (.) – Moderna Inc applied for emergency U.S. clearance for its COVID-19 vaccine on Monday, after full results from a late-stage study showed it was 94.1% effective without serious security problems, the company said.

Moderna, which also plans to seek European approval, reported that its vaccine’s efficacy rate was consistent across all aspects – age, race, ethnicity and gender – as well as having a 100% success rate in preventing severe cases. from a disease that has killed nearly 1.5 million people.

The procedure leaves Moderna second in line to receive emergency use authorization for its vaccine this year in the United States, after the formula developed by Pfizer and BioNTech will be 95% effective in clinical trials.

“We thought we had a highly effective vaccine. Now we have the data to prove it,” Ral Zaks, the firm’s chief medical officer, said in a telephone interview. “We hope to play an important role in defeating this pandemic.”

Zaks said he was excited to see the 94.1% result over the weekend: “It’s the first time I’ve allowed myself to cry. With this level of effectiveness, when you do the math on what this means for the pandemic that It surrounds us, it’s just overwhelming. “

Of the 196 volunteers who became infected with COVID-19 in the trial with more than 300,000 people, 185 had received a placebo and only 11 the vaccine. Moderna reported 30 severe cases of the coronavirus – all in the placebo group – which means that the formula is 100% effective in preventing severe symptoms of COVID-19.

“As the numbers of coronavirus in the world increase, so is confidence in the incredible level of protection that a product can offer to the population,” said Alexander Edwards, associate professor of biomedical technology at the University of Reading in the United Kingdom. .

Pfizer has already requested approval for emergency use of its vaccine in the United States and Europe, which is one week ahead of Moderna.

Moderna said it was on track to have about 20 million doses of its vaccine ready for distribution in the United States by the end of 2020, enough to inoculate 10 million people.

(Additional reporting by Ankur Banerjee in Bengaluru. Edited in Spanish by Carlos Serrano and Marion Giraldo)