Moderna Sends Its COVID-19 Vaccine To FDA For Emergency Use Authorization
BOSTON (CBS) – Moderna announced Monday it has requested emergency use authorization from the Food and Drug Administration for its COVID-19 vaccine.
The latest test results indicate it's 94.1% effective against COVID-19 and 100% effective against "severe cases."
Dr. Lindsey Baden, the co-principal investigator of the vaccine trial, called the data released Monday morning "terrifically encouraging."
Update: Moderna's data for the Emergency Use Authorization request for mRNA-1273 has been submitted to the U.S. FDA.
— Moderna (@moderna_tx) November 30, 2020
"There are still many more questions but the key findings are incredibly encouraging that the vaccine works, works in a broad range of members of our broad community," he told WBZ-TV.
"Those patients or participants who became sick with COVID, requiring hospitalization, supplemental oxygen, additional care, there were 30 such events. They all were in the placebo group, suggesting the vaccine can elicit an immune-response that can protect against acquiring COVID that leads to clinical illness and more importantly to development of severe illness."
Related: Moderna's Vaccine – What's Next And Why Masks Will Still Be Needed
According to Moderna, efficacy was consistent across various demographics, including age, race and ethnicity.
"We also need to realize the data are small, even though they're very impressive, they're small and so we have to move forward with care," Dr. Baden said.
While the data strongly suggests the safety and efficacy are favorable, Dr. Baden said additional review from external bodies, like the FDA and CDC, is needed to increase confidence in the findings.
"I'm hopeful over the next couple of weeks multiple bodies will independently review the data, provide their insights as to what it means and give us guidance as to how to roll this out to the community," Dr. Baden told WBZ.
Dr. Baden said it appears the pros of the vaccine outweigh potential cons.
"There are side effects to every medicine, that can be rare and so we need to be vigilant and monitor for that," Dr. Baden said. "But, that needs to be balanced against the known benefit."
Tufts Medical Center is geared up with the freezers needed to store the vaccines. "The mRNA vaccines both require freezers," said Dr. Helen Boucher. "One, the Pfizer vaccine a special kind of freezer that's minus 80."
Dr. Boucher said it will most likely be frontline healthcare workers first in line once the FDA gives a green light.
The Brockton Neighborhood Health Center hopes staff donning PPE will soon distribute vaccines in what's currently their COVID-19 testing site to the most vulnerable of their community.
"We are definitely trying to be equipped to conduct vaccination on our premises as well as off site," said Dr. Maria Celli of the community health center.
Moderna said a meeting to review the data package with the FDA will likely be scheduled for December 17th, a week after Pfizer.