Moderna Applying Today For FDA Approval Of 94%-Effective Vaccine
Moderna released final testing data that shows its vaccine to be 94.1% effective. Of the few trial participants who contracted COVID-19, a "remarkable" zero developed a severe form of the disease.
CNBC:
Moderna Covid Vaccine Is 94.1% Effective, Plans To Apply For Emergency OK Monday
Moderna said Monday it will request emergency clearance from the Food and Drug Administration for its coronavirus vaccine after new data confirms the vaccine is more than 94% effective in preventing Covid-19 and was safe. Moderna is the second drugmaker to seek emergency use from the FDA after Pfizer, another front-runner in the Covid-19 vaccine race, applied for the same authorization on Nov. 20. The announcement means some Americans could get the first doses of Moderna’s two-dose vaccine within a few weeks. (Lovelace Jr., 11/30)
AP:
Moderna Asking US, European Regulators To OK Its Virus Shots
Moderna is just behind Pfizer and its German partner BioNTech in seeking to begin vaccinations in the U.S. in December. Across the Atlantic, British regulators also are assessing the Pfizer shot and another from AstraZeneca. Moderna created its shots with the U.S. National Institutes of Health and already had a hint they were working, but said it got the final needed results over the weekend that suggest the vaccine is more than 94% effective. (Neergaard, 11/30)
Science Magazine:
‘Absolutely Remarkable’: No One Who Got Moderna's Vaccine In Trial Developed Severe COVID-19
Continuing the spate of stunning news about COVID-19 vaccines, the biotech company Moderna announced the final results of the 30,000-person efficacy trial for its candidate in a press release today: Only 11 people who received two doses of the vaccine developed COVID-19 symptoms after being infected with the pandemic coronavirus, versus 185 symptomatic cases in a placebo group. That is an efficacy of 94.1%, the company says, far above what many vaccine scientists were expecting just a few weeks ago. More impressive still, Moderna’s candidate had 100% efficacy against severe disease. There were zero such COVID-19 cases among those vaccinated, but 30 in the placebo group. (Cohen, 11/30)
The Guardian:
Moderna Covid Vaccine Has 94% Efficacy, Final Results Confirm
Although the firm has done deals around the world, the US will get access first. Moderna said it expected to have 20m doses of its vaccine ready for use in the US by the end of this year. In August, the US bought 100m doses with an option on 400m more. Moderna says it is on track to manufacture 500m to 1bn doses globally in 2021. (Boseley, 11/30)
Also —
KHN:
How Pharma Money Colors Operation Warp Speed’s Quest To Defeat COVID
April 16 was a big day for Moderna, a Massachusetts biotech company on the verge of becoming a front-runner in the U.S. government’s race for a coronavirus vaccine. It had received roughly half a billion dollars in federal funding to develop a COVID shot that might be used on millions of Americans. Thirteen days after the massive infusion of federal cash — which triggered a jump in the company’s stock price — Moncef Slaoui, a Moderna board member and longtime drug industry executive, was awarded options to buy 18,270 shares in the company, according to Securities and Exchange Commission filings. The award added to 137,168 options he’d accumulated since 2018, the filings show. (Pradhan, 11/30)
