https://www.nbcnews.com/news/us-news/covid-19-moderna-submits-vaccine-fda-regulatory-approval-n1249323
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Moderna will submit its coronavirus vaccine for regulatory approval on Monday, the company said the second leading drug to pass the milestone this month.
The Massachusetts biotech firm said it will ask the Food and Drug Administration for emergency use authorization after completing its Phase 3 trial, finding the vaccine was 94.1 percent effective against Covid-19.
Moreover, Moderna said the vaccine was 100 percent effective at preventing severe cases of the disease.
These results were the same across all age, race and gender categories, the company said in a statement. There have been no serious safety concerns so far, it added, with the most common side effects being fatigue, headaches, and muscle and joint pain.
Moderna said it expects the FDA's Vaccines and Related Biological Products Advisory Committee to convene on Dec. 17 to discuss its submission. That is a week after the FDA is expected to discuss another candidate, developed by the U.S. pharma giant Pfizer and its German partner BioNTech, which has also applied for regulatory approval having observed a similar level of efficacy.
Both the Moderna and Pfizer-BioNTech drugs involve inserting special code called mRNA into the body, tricking it into developing an immune response. No mRNA-based drug has ever won approval before.
Hajo Zeeb, a professor at Germany's Leibniz Institute for Prevention Research and Epidemiology, said it's hugely encouraging that two separate studies both found similar high levels of success.
"I would be surprised if something different came out in the FDA process, and I think these are highly likely to be approved," he said.
Though optimistic, Zeeb cautioned that the exact percentages may change once hundreds of millions, rather than tens of thousands, of people start taking the vaccine.
"These are still small numbers overall," he said of the trial's sample size, "but the reduction in severe cases is exactly what we want to see. If it's just a mild virus, we can live with that."
Moderna received more than $1 billion in U.S. federal government funding to develop and produce its candidate, and another $1.5 billion to supply it to the American public.
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Its trial involved 30,000 people, half of whom were given the vaccine candidate and other half a placebo. Of this group, the scientists recorded 196 cases of Covid-19, only 11 of whom were from the group that had been given the vaccine. There were 30 cases of serious illness all of them in the placebo group.
So of the 15,000 people given the vaccine, not one became seriously ill with Covid-19 during the trial period, the company said.