Moderna and other vaccines
December 5, 2020
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Dr John Campbell Episodes Around December 5, 2020
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25:13Now PlayingModerna and other vaccines
YouTube Description
as posted by the channelModerna / NIH
Application for approval, November 30
First injections could start on December 21
Genetic instructions for building a coronavirus spike protein
United States government, nearly $1 billion in support
Moderna Announces Primary Efficacy Analysis in Phase 3 COVE Study for Its COVID-19 Vaccine Candidate and Filing Today with U.S. FDA for Emergency Use Authorization
(November 30)
Confirms the high efficacy observed at the first interim analysis
Study includes
7,000 over the age of 65
5,000 under the age of 65 but have high-risk chronic diseases
Diabetes, severe obesity and cardiac disease
11,000 from communities of color
6,000, Hispanic or Latin
Phase 3
COVE study
mRNA-1273, 100 µg
n = 30,000
196 infections occurred
Vaccine group
11 cases
Non severe
Placebo group
185 cases
30 severe
1 death
Efficacy
94.1%
100%
Side effects
mRNA-1273 continues to be generally well tolerated
Temporary
Injection site pain, fatigue, myalgia, arthralgia, headache, and erythema/redness at the injection site.
Increased in frequency after the second dose
No serious safety concerns identified to date
Exceeded 2 months follow-up (required by the U.S. FDA for Emergency Use Authorization)
Safety data continue to accrue
Emergency Use Authorization
U.S. FDA
European Medicines Agency
UK, Medicines and Healthcare Products Regulatory Agency
Rolling reviews
FDA meeting, December 17, 2020
First served
August 11, United States government paid $1.5 billion for 100 million doses
November 25, European Commission 80 million then 80 million
UK, 7 million doses
Canada, Japan, Qatar, Switzerland, Singapore, Israel
UK up to 7 million does, March
US government, 456 million for development
Adeno virus 26
Same virus as used for Ebloa vaccine
Phase 3, 1 dose, started September, 60,000
Phase 3, 2 dose, started November 16th
Bookings
US, $1 billion for 100 million doses
EU, 200 million doses
Production, 1 billion does in 2021
Guests & Subjects Covered
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