Dr John Campbell
@campbellteaching·3.3M subscribers·3.1K videos
First peer-reviewed vaccine evidence
Posted
December 9, 2020
Views
119,149
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December 9, 2020
119,149
4,611
2,300
5.80%
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32:31Now PlayingV Day, good start
Three-and-a-half, 975 doses
Over-80s and NHS and care home staff
70 hospital hubs
800,000 doses
One million from Belgium by next week
2020, 5 million doses
Two adverse reactions
Anaphylactoid
Both shortly after
Both fine
Both history of serious allergies and carry adrenalin pens
Severe allergic patents not in trials
Professor Stephen Powis
As is common with new vaccines, the MHRA have advised on a precautionary basis that people with a significant history of allergic reactions do not receive this vaccination after two people with a history of significant allergic reactions responded adversely
Dr June Raine, (MHRA)
Only right to take this step now that we've had this experience
First peer-reviewed vaccine evidence
Safety and efficacy of the ChAdOx1 nCoV-19 vaccine
(AZD1222) against SARS-CoV-2: an interim analysis of
four randomised controlled trials in Brazil, South Africa,
and the UK
)326611/fulltext
Oxford University
Replication-deficient chimpanzee adenoviral vector
Containing the SARS-CoV-2 structural surface
glycoprotein antigen (spike protein; nCoV-19) gene.
Evaluated the safety and efficacy
Methods
Four ongoing blinded, randomised, controlled trials
UK, Brazil, and South Africa
Participants aged 18 +
Randomly assigned, 1:1
Vaccine or control (meningococcal group conjugate vaccine or saline)
Vaccine group
Two doses containing 5 × 1010 viral particles (standard dose)
A subset in the UK trial, half dose first (low dose) and a standard dose second
Infections recorded more than 14 days after a second dose
Data cutoff Nov 4, 2020
April 23 to Nov 4, 2020
23,848 participants were enrolled
11,636 participants (7548 in the UK, 4088 in Brazil), interim primary efficacy analysis
There were 131 cases of symptomatic COVID-19 in
LD/SD or SD/SD recipients combined
Vaccine group
N = 5,807
30 cases
Control group
N = 5,829
101 cases
Resulting in overall vaccine efficacy of 70.4%
SD/SD group
Vaccine group, 27 cases
Control group, 71 cases
Vaccine efficacy was 62·1%
UK, 60·3% efficacy
Brazil, 64·2% efficacy
LD/SD goup
Vaccine group, 3 cases from 1,367
Control group 30 cases from 1,374
Vaccine efficacy was 90%
LD/HD group had less asymptomatic infections
Six week gap may also help
Implications for ongoing contagion
From 21 days after the first dose
Ten cases hospitalised for COVID-19, two classified as severe, one death
Vaccine efficacy 100%
Safety
74,341 person-months of safety follow-up
175 severe adverse events occurred in 168 participants
84 events in vaccine group
91 in the control group
Three events were classified as possibly related to a vaccine
One in the vaccine group, one in the control group
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