Moderna (MRNA) announced Monday it would file for emergency use authorization (EUA) for its COVID-19 vaccine, making it the second company to potentially provide a vaccine in the U.S. by the end of the year.
The company announced details of its Phase 3 results, noting the vaccine is 94.1% efficacious, a slight drop from 94.5% in the first-read on November 16.
But the company also measured the efficacy of the vaccine against severe cases of COVID-19, and that came in at 100%. Health experts are excited about that number because it means the strain on hospitals could be reduced.
CEO Stéphane Bancel told Yahoo Finance when he got the news Sunday, “I was almost tap dancing in the house yesterday when I heard.”
The data showed that among the 196 cases reported, 185 were in the placebo group, in which one person died from COVID-19. The distribution of cases reflected the real world, with the elderly and minorities disproportionately affected.
The efficacy against severe disease, which has resulted in all of the ICU and deaths in the country, is particularly of interest as it helps avoid the progression from symptom onset to critical care.
“If you can stop that whole cascade, that is, I believe, a game-changer,” Bancel said.
The U.S. Food and Drug Administration (FDA) is set to hold a vaccine advisory committee meeting on December 17, with an EUA anticipated soon after if all goes well.
Bancel said the company will be ready to ship the vaccines within 24 hours after an authorization.
‘The most important year in the company’s history’
The company’s market cap soared past $58 billion Monday, marking a new chapter in Moderna’s history. But the implications of an approval go beyond 2020..
If authorized, and eventually fully licensed, the vaccine would become the first product on the market for the decade-old company. It also validates the company’s platform, messenger RNA, and would make it among the first — alongside Pfizer (PFE) and BioNTech’s (BNTX) vaccine — products using the technology on the market.
Bancel said that since Moderna is also now pursuing a flu vaccine, the COVID-19 vaccine sets up the company to utilize a manufacturing and delivery infrastructure that can be used for other products.
It’s why Bancel said, “2021, I think is going to be the most important year in the company’s history.”
Th company is on its way to be a 40-plus pipeline company and could end 2021 with a strong balance sheet, he said, which would put the company on par with some traditional pharmaceutical companies.
Moderna is also filing for conditional market authorization with the Europeans Medicines Agency, where it had previously initiated a rolling review process. Moderna is also targeting a number of other global regulatory bodies in Canada, Switzerland, the U.K., Israel, and Singapore as well as with the World Health Organization.
Bancel said the current capacity of the vaccine production is mostly sold out, and the company has been running round the clock to meet a 1 billion dose goal by next year.
“I think we are seeing the light at the end of the tunnel,” Bancel said.
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