Jetzt trage ich als langer stiller Teilnehmer auch mal was bei:
CNN.com
6:05 p.m. ET, October 20, 2020
Moderna and Pfizer will meet with FDA vaccine committee meeting this week
From CNNs Elizabeth Cohen and Wes Bruer
Moderna and Pfizer, the two frontrunners in the US race for a Covid-19 vaccine, will be making presentations to an all-day meeting Thursday of a US Food and Drug Administration advisory committee, but both companies said they will not be presenting data from their Phase 3 clinical trials.
"This is not a moment where we will be sharing data. This is a discussion from the FDA to discuss the requirements for efficacy, safety and manufacturing, a spokesperson for Pfizer said in an email to CNN.
Both companies have said they could possibly apply to the FDA for authorization to market their vaccines in the coming weeks if their Phase 3 clinical trial data turns out to be positive.
Pfizer has said it could apply for emergency use authorization after the third week in November. Moderna has said the federal government could give an EUA to the companys experimental Covid-19 vaccine in December if the company gets positive interim results in November.
Once the companies apply for emergency use authorization from the FDA, the Vaccines and Related Biological Products Advisory Committee will advise the agency on whether it thinks authorization should be given.
The Thursday meeting is scheduled from 10 a.m. to 5 p.m., but Dr. Paul Offit, a member of the FDAs Vaccines and Related Biological Products Advisory Committee, said members have been asked to keep their schedules clear until 7 p.m. because it might run long.
Offit, director of the Vaccine Education Center at Childrens Hospital of Philadelphia, said general parameters will be discussed for how to measure vaccine safety and efficacy. |
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