25ºF

Moderna COVID-19 vaccine hits another milestone, moves step closer to public use

Moderna submits application for emergency use authorization

Moderna’s COVID-19 vaccine hit another major milestone, as the company is submitting its application for an emergency use authorization, starting the formal review process and moving a step closer to public use.

Moderna submitted emergency use authorization to the Food and Drug Administration on Monday. The company’s president said everyone feels the pressure of this moment.

“This is clearly the most important point prior to making the vaccine broadly available,” Moderna President Dr. Stephen Hoge said. “We have to compile all the data from these large phase three studies that prove the vaccines are safe and effective and submit it to regulators, including the FDA, to make sure that we can have authorization to distribute it to people.”

Coronavirus in Michigan: Here’s what to know Nov. 30, 2020

Moderna says analysis of its vaccine found 196 confirmed cases of COVID-19 among the trial’s 30,000 participants. Of those, 185 were in the placebo group, and just 11 were in the group that received the vaccine -- an efficacy rate of 94.1%.

Another encouraging sign: Nobody who received the vaccine developed a severe case of COVID-19.

One person in the placebo group died from COVID-19.

“There have been no serious safety concerns,” Hoge said. “The side effects that have been reported have been mostly the local injection-associated reactions that people get with many vaccines. Those include aches and pains, occasionally headaches, pain at the injection site.”

Experts want people to be prepared for those side effects, which typically went away in a day or two.

Moderna’s vaccine has one advantage over Pfizer’s vaccine: It can be stored in regular freezers and refrigerators, which eases one challenge of a massive distribution effort.

“Ultimately, it is the FDA’s call whether to approve this authorization, but if they do, we’ll immediately start deploying the vaccine to the public,” Hoge said.

Pfizer was the first company to submit its data to the FDA. The agency will be meeting to discuss that vaccine Dec. 10.

Moderna expects its review to happen in mid- to late December.

If either vaccine is granted an emergency use authorization, the first doses of that vaccine would be shipped out to the states within 24 hours.


About the Authors: