FDA Vaccine Advisory Committee Recommends Moderna COVID-19 Vaccine For Emergency Use Authorization
PITTSBURGH (KDKA) - The FDA's vaccine advisory committee met in a daylong session to discuss Moderna's mRNA COVID-19 vaccine, just one week after Pfizer's vaccine received emergency use authorization.
The committee voted overwhelmingly yes that the benefits of the Moderna vaccine outweighed the risks for people 18 and up. The FDA will now decide on emergency use authorization for the vaccine. m
"We're on a roll here. Another remarkable vaccine with awesome efficacy," says Kelly Stefano, Director of Microbiology at the Allegheny Health Network. "This doesn't guarantee FDA approval, obviously, but to end a pandemic like this, we are really going to need the best of anything we can get right now."
Because no vaccine is FDA approved and because supplies are limited, EUA for another vaccine is appropriate.
Moderna's vaccine does not need mixing, and it stays stable in the refrigerator. It's 94% effective and might prevent asymptomatic infections as well.
"They did a little bit more analysis," says Dr. Stefano. "Since asymptomatics can transmit, it's something we really want to prevent."
Side effects included pain, redness and swelling, especially after the second dose that comes four weeks after the first.
Questions came up about a facial droop called Bell's Palsy and severe allergies. Two cases of anaphylaxis occurred in health care workers in Alaska with the Pfizer vaccine.
"It is not something we anticipate to widely happen in the population of people unless they have some history," she says.
The public expressed concerns about the need for more attention to specific communities and more time.
"There are concerns obviously from multiple constituents, and those are not to be taken lightly," Dr. Stefano says.
Another recurring concern -- how to analyze the data when people who received a placebo leave the study to get an EUA vaccine.
"If you unblind a trial, are you compromising the ultimate outcome of the data that is being analyzed?" Dr. Stefano echoes the concern. "There is more than one way to continue the vaccination process without the risk of losing people in the trial when they know other vaccines are available."
