FDA review clears path for second coronavirus vaccine, this one developed by Moderna

By the end of the week, the United States could have two coronavirus vaccines.

A vaccine candidate developed by biotechnology company Moderna appears poised for regulatory clearance after a detailed data review by Food and Drug Administration scientists confirmed the two-shot regimen was 94 percent effective in a clinical trial and carried no serious safety concerns.

The FDA is likely to authorize the vaccine as soon as Friday, according to a person with knowledge of the situation who spoke on the condition of anonymity because they were not authorized to speak on the issue. Anticipating that decision, Gen. Gustave Perna, who is overseeing the federal effort to develop and distribute vaccines, said Monday that the U.S. was preparing to ship almost 6 million doses of the Moderna vaccines to 3,285 locations in the first week.

“It will be a very similar cadence that was executed this week with Pfizer, where we’re hitting initial sites on Monday, follow on Tuesday and Wednesday,” Perna said.

The 54-page FDA document positions the Moderna vaccine to follow the same historic track as the Pfizer-BioNTech vaccine. After the agency gave a positive review of the Pfizer-BioNTech vaccine exactly a week ago, the shots were endorsed by a panel of outside experts on Thursday and granted a green light by regulators a day later. The first doses were administered to health care workers on Monday.

Moderna’s vaccine will be reviewed Thursday by the same panel of independent experts at an all-day public meeting. The data it will consider echoes the evidence that led to a 17 to 4 vote to authorize the Pfizer-BioNTech vaccine, which was 95 percent effective. In addition, the two-shot Moderna regimen was particularly effective against severe disease. There were 30 cases of severe covid-19, the disease caused by the virus, in the trial, none of them in the group that got the vaccine.