First peer-reviewed vaccine evidence

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V 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

https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(20)32661-1/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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