Vaccine, game changer
November 9, 2020
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Dr John Campbell Episodes Around November 9, 2020
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21:45Now PlayingVaccine, game changer
YouTube Description
as posted by the channelVaccines
47 vaccines in human trials
PFIZER AND BIONTECH ANNOUNCE VACCINE CANDIDATE AGAINST COVID-19 ACHIEVED SUCCESS IN FIRST INTERIM ANALYSIS FROM PHASE 3 STUDY
mRNA-based, spike protein vaccine candidate, BNT162b2
First interim efficacy analysis
N = 43,538 participants
Half vaccine, half placebo
Six countries
42% from diverse backgrounds
94 people have caught coronavirus, mostly in the placebo group
No serious safety concerns have been observed
Safety and additional efficacy data continue to be collected
Stored at – 18’C
More than 90% effective…
Seven days after the second dose
in preventing COVID-19…
in participants without evidence of prior SARS-CoV-2 infection
US approval
Submission for Emergency Use Authorization (EUA) to the U.S. Food and Drug Administration (FDA), third week of November
UK approval
40 million pre-ordered
Apply for UK approval end on this month
Could be granted by early December
Clinical trial to continue through to final analysis at 164 confirmed cases
More information
Independent Data Monitoring Committee (DMC) from the Phase 3 clinical study
Protection is achieved 28 days after the initiation of the vaccination
Expect to produce globally up to 50 million vaccine doses in 2020
Up to 1.3 billion doses in 2021
Plan to submit data from the full Phase 3 trial for scientific peer-review publication
Unknowns
Prevention of asymptomatic viral shedding
Time span of immunity
Side effect profile
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