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Moderna to apply today for FDA authorization for its Covid-19 vaccine
By Elizabeth Cohen, CNN Senior Medical Correspondent
(CNN) Pharmaceutical company Moderna intends to apply Monday to the US Food and Drug Administration for authorization of its Covid-19 vaccine.
The company will ask the FDA to review an expanded data set showing the vaccine is 94.1% effective at preventing Covid-19 and 100% effective at preventing severe cases of the disease.
“This is striking,” said Dr. Paul Offit, a member of the FDA’s vaccine advisory committee. “These are amazing data.”
Categories: Vaccine
Among the approximately 15,000 people who received the vaccine, 11 developed Covid-19.
Among the approximately 15,000 people who received the placebo, 185 developed Covid-19.
That amounts to a 94.1% efficacy for Moderna’s vaccine.
None of the 11 people who received the vaccine became severely ill, but 30 of the 185 who received the placebo became severely ill, and one of them died.
https://www.cnn.com/2020/11/30/health/moderna-vaccine-fda-eua-application/index.html
Vice President Mike Pence told governors on Monday that distribution of a coronavirus vaccine could begin by the third week of December, signaling that U.S. regulators will swiftly approve an emergency authorization for the first shots.
“We strongly believe the vaccine distribution process could begin the week of December 14,” Pence told governors, according to a summary of the call provided by the office of Washington Governor Jay Inslee. “The American people deserve to know the cavalry is on the way.”
Pence told governors they will have the final say on vaccine distribution as the “ultimate arbiters” in their states, according to the summary.
Moderna Inc. joined Pfizer Inc. on Monday in requesting the FDA issue an emergency use authorization for its shot. Both vaccines are better than 90% effective, according to preliminary results of clinical trials, though their distribution challenges include requiring two shots.
https://www.bloomberg.com/news/articles/2020-12-01/pence-says-covid-vaccine-distribution-could-begin-mid-december?srnd=premium&sref=eGA8az79