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Monday, November 30, 2020

Moderna To Send Its COVID-19 Vaccine To FDA For Emergency Use Authorization - CBS Boston

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BOSTON (CBS) – Moderna announced Monday it will request 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.”

“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.

Moderna said a meeting to review the data package with the FDA will likely be scheduled for December 17th, a week after Pfizer.

The Link Lonk


December 01, 2020 at 12:02AM
https://boston.cbslocal.com/2020/11/30/moderna-covid-19-vaccine-emergency-use-authorization-fda-coronavirus-cambridge-massachusetts/

Moderna To Send Its COVID-19 Vaccine To FDA For Emergency Use Authorization - CBS Boston

https://news.google.com/search?q=Send&hl=en-US&gl=US&ceid=US:en

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