- The Washington Times - Monday, November 30, 2020

Drugmaker Moderna said Monday it will request emergency approval of its coronavirus vaccine after a final analysis showed it to be 94% effective and able to stave off serious disease.

The results are consistent with an earlier analysis of the two-dose, messenger RNA shots and prodded the Cambridge, Massachusetts, company to file with the Food and Drug Administration and European regulators, as the world awaits an immunization campaign that can bring the virus to manageable levels in 2021.

Moderna said it counted 196 cases among its tens of thousands of participants and that 185 of them were in the placebo arm of the trial versus 11 among those who received the vaccine, resulting in an efficacy of 94.1%.

Scientists counted 30 instances of severe COVID-19 in the trial. All of those cases occurred in the placebo arm.

There was also one COVID-19 death in the placebo group.



The efficacy of the shots was consistent across ethnic groups, according to Moderna.

“We believe that our vaccine will provide a new and powerful tool that may change the course of this pandemic and help prevent severe disease, hospitalizations and death,” Moderna CEO Stéphane Bancel said.

Pfizer previously requested emergency approval of its mRNA shots, which showed similar efficacy, from the FDA.

The agency is set to meet with an advisory panel on Dec. 10 to discuss the Pfizer candidate. A similar meeting for the Moderna shots is tentatively scheduled for Dec. 17.

Emergency-use authorization and delivery of the first doses could follow shortly after the sessions, as the Trump administration seeks to immunize at least 20 million people before the end of the year.

“Pfizer and Moderna’s incredibly promising and impressive efficacy data further demonstrate that President Trump’s Operation Warp Speed is rapidly advancing on a trajectory of success to save millions of American lives — five times faster than any other vaccine in history,” White House spokesman Michael Bars said.

Federal and state officials are pleading with Americans to buckle down and observe basic precautions while they wait for the vaccines, as the virus surges across the country.

As envisioned, the vaccine rollout will take multiple months, starting with health workers, essential employees and the sick and elderly before the general population begins to roll up its sleeves by March or April.

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