Dr John Campbell
@campbellteaching·3.3M subscribers·3.1K videos
Vaccine, looking very good
Posted
November 18, 2020
Views
66,873
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3,446
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November 18, 2020
66,873
3,446
1,538
7.45%
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15:39Now PlayingPfizer / BioN Tech vaccine, what we know
HTTPS://WWW.BUSINESSWIRE.COM/NEWS/HOME/20201118005595/EN/
PFIZER AND BIONTECH CONCLUDE PHASE 3 STUDY OF COVID-19 VACCINE CANDIDATE, MEETING ALL PRIMARY EFFICACY ENDPOINTS
Wednesday, November 18, 2020 - 06:59am
Phase 3, 27th July
Primary efficacy analysis, 95% effective
(p less than 0.0001), 9, 999 out of 10,000
high rate of protection against COVID-19 can be achieved very fast after the first 30 µg dose
beginning 28 days after the first dose
170 confirmed case
10 severe cases
N = 41,135
42% of global participants and 30% of U.S. participants have racially and ethnically diverse backgrounds
41% of global and 45% of U.S. participants are 56-85 years of age
Placebo group
162 infections
9 severe cases
Vaccine group
8 infections
1 severe case
Efficacy was consistent across age, gender, race and ethnicity demographics
Observed efficacy in adults over 65 years of age was over 94%
Two month safety test
Safety data milestone required by U.S. Food and Drug Administration (FDA) for Emergency Use
Authorization (EUA) has been achieved
Side effects
FDA adverse events rules
Well tolerated across all populations
No serious safety concerns observed
Mostly less than 2%
Grade 3 adverse event
Fatigue 3.8%
Headache 2.0%
Plan to submit within days to the FDA for EUA and share data with other regulatory agencies around the globe
expect to produce globally up to 50 million vaccine doses in 2020
1.3 billion doses by the end of 2021
Pfizer is confident in its vast experience, expertise and existing cold-chain infrastructure to distribute the vaccine around the world
Manufacturing
Germany
Belgium
3 US sites
Logistics
Specially designed, temperature-controlled thermal shippers
Utilizing dry ice
Maintain temperature conditions of -70°C±10°C
They can be used be as temporary storage units for 15 days by refilling with dry ice
UK
40 million doses, 10 million by end of the year
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