FDA Reviews Moderna’s COVID Vaccine for Emergency Clearance

In a report on Tuesday, the Food and Drug Administration had confirmed that in Moderna’s clinical trial, the company’s two-shot regimen of its coronavirus vaccine was 94 percent effective at preventing illness and was particularly effective against severe disease.

There were 30 cases of severe covid-19 in the trial, none of them in the group that got the vaccine. The vaccine has not caused major safety problems, the report also confirmed.

Now on Thursday, an FDA panel is discussing the vaccine’s safety and efficacy and, if all goes as expected, the shots could get emergency clearance as soon as Friday.

Moderna’s vaccine would become the second vaccine authorized after Pfizer and BioNtech’s vaccine which was cleared last Friday.

Gen. Gustave Perna, who is overseeing the federal effort to distribute vaccines, said on
Monday that the United States 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 FDA anel is expected to discuss on Thursday the potential for severe allergic reactions. Recently a health-care worker in Alaska had a serious allergic reaction after getting the Pfizer-BioNTech vaccine on Tuesday and had no history of allergic reactions.

A second worker had a less serious reaction on Wednesday, was treated and quickly recovered, according to Alaska media reports.

According to Paul Duprex, director of the Center for Vaccine Research at the University of Pittsburgh, Moderna’s vaccine looked effective and safe, with tolerable side effects and predicted it would be authorized soon.

Duprex believes an advantage of the Moderna vaccine its simpler logistics, because it does not require specialized ultracold storage conditions like the Pfizer-BioNTech vaccine.

“I like the fact that now we have something can be stored in a minus-20 [degrees Celsius] fridge — the same kind of fridge you keep your ice cream in,” Duprex said.

Moderna has developed its vaccine in partnership with the National Institute of Allergy and Infectious Diseases.

Disclaimer: We have no position in any of the companies mentioned and have not been compensated for this article.