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Moderna To Seek FDA Emergency Authorization After COVID-19 Vaccine Shows 94% Efficacy In Final Analysis

30 November 2020. ABC News: Moderna has promised to publish full details from the trial through a formal scientific review process. Additional details about the trial will become available through the FDA’s review process, which the agency has pledged will be transparent to the public.

“While 94.1% efficacy is phenomenal, we are still dealing with small sample sizes and likely we will see differences in vaccine effectiveness when deployed in the population,” Brownstein said.

But Monday’s press release included some new details about Moderna’s vaccine, including the fact that it appears to be equally effective among people of different races, ethnicities, ages and genders.

Among the 196 people who developed COVID-19 in the trial, 33 were older adults (ages 65 and up), 29 were Hispanic or Latino, six were Black or African American, four were Asian American and three were multiracial.

Moderna is also claiming that the Phase 3 data shows the vaccine was highly effective at preventing more severe cases of COVID-19. According to the press release, 30 out of the 196 volunteers developed severe illness, but all 30 were among the group of volunteers who got the placebo shot. This shows the vaccine demonstrated 100% efficacy at preventing severe COVID-19, according to the company.

According to Benkeser, this isn’t enough data to prove Moderna’s vaccine will prevent severe illness in every single person who receives it, “however, it is common for vaccines to be more effective against severe disease than mild disease,” he said.

“The idea is that though a vaccine might not fully protect you against infection, it can make the subsequent illness less severe,” he added. “Therefore, it really is quite plausible that the short-term efficacy against severe disease is indeed close to 100%.”

Monday’s announcement means Moderna is on track to see a possible FDA-authorized vaccine by the end of the year. The company is also on track to produce 20 million doses available for distribution around the U.S. by the end of December: enough doses to vaccinate 10 million people.

Moderna said it will also ask European regulators for a conditional approval, and the company is on track to manufacture 500 million to 1 billion doses globally in 2021.

Experts said that even the “final” analyses of both vaccine trials — Pfizer’s and Moderna’s — will not provide the final answer about just how well the vaccines will work, especially in the long term, but their results, both boasting greater than 90% efficacy, bode well for the future.

“There’s a light at the end of the — as of yet — very dark tunnel,” he said, “but for the first time since March, I feel hopeful about turning a corner.”

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1 Manchester United 19 12 4 3 36 25 +11 40
2 Manchester City 18 11 5 2 31 13 +18 38
3 Leicester City 19 12 2 5 35 21 +14 38
4 Liverpool 19 9 7 3 37 22 +15 34
5 Tottenham Hotspur 18 9 6 3 33 17 +16 33
6 Everton 17 10 2 5 28 21 +7 32
7 West Ham United 19 9 5 5 27 22 +5 32