EU regulator launches real-time review of AstraZeneca's COVID-19 vaccine - https://www.reuters.com/article/health-coronavirus-astrazeneca-oxford-eu/eu-regulator-launches-real-time-review-of-astrazenecas-covid-19-vaccine-idUSL4N2GS134

Oct 1(Reuters) - The European health regulator said on Thursday it started a rolling review of the experimental COVID-19 vaccine from AstraZeneca and Oxford University, aiming to speed up any future approval process.

The European Medicines Agency (EMA) said its human medicines committee has started evaluating the first batch of data on the vaccine, and will continue till sufficient data is available and a formal application is submitted. (bit.ly/36qyDZM)

The news comes just weeks after several global trials of the vaccine were halted due to an unexplained illness in a study participant. U.S. trials are still under review, with regulators widening their probe.

EMA starts first rolling review of a COVID-19 vaccine in the EU - https://www.ema.europa.eu/en/news/ema-starts-first-rolling-review-covid-19-vaccine-eu

The vaccine, called COVID-19 Vaccine AstraZeneca, is expected to work by preparing the body to defend itself against infection with the coronavirus SARS-CoV-2. This virus uses proteins on its outer surface, called spike proteins, to enter the body’s cells and cause disease. COVID-19 Vaccine AstraZeneca is made up of another virus (of the adenovirus family) that has been modified to contain the gene for making the SARS-CoV-2 spike protein. The adenovirus itself cannot reproduce and does not cause disease. Once it has been given, the vaccine delivers the SARS-CoV-2 gene into cells in the body. The cells will use the gene to produce the spike protein. The person’s immune system will treat this spike protein as foreign and produce natural defences − antibodies and T cells − against this protein. If, later on, the vaccinated person comes into contact with SARS-CoV-2, the immune system will recognise the virus and be prepared to attack it: antibodies and T cells can work together to kill the virus, prevent its entry into the body’s cells and destroy infected cells, thus helping to protect against COVID-19.

Lancet report: Safety and immunogenicity of the ChAdOx1 nCoV-19 vaccine against SARS-CoV-2: a preliminary report of a phase 1/2, single-blind, randomised controlled trial https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(20)31604-4/fulltext

Funding:

UK Research and Innovation, Coalition for Epidemic Preparedness Innovations, National Institute for Health Research (NIHR), NIHR Oxford Biomedical Research Centre, Thames Valley and South Midland's NIHR Clinical Research Network, and the German Center for Infection Research (DZIF), Partner site Gießen-Marburg-Langen.

A Study of a Candidate COVID-19 Vaccine (COV001) - https://clinicaltrials.gov/ct2/show/NCT04324606?term=NCT04324606&draw=2&rank=1

Principal Investigator: Andrew Pollard, Prof University of Oxford

https://en.wikipedia.org/wiki/Andrew_Pollard_(biologist)

Andrew Pollard MRCP, FHEA, FIDSA, FRCPCH is a vaccinologist who specialises in paediatrics and is the Director of the Oxford Vaccine Group (OVG).[1] He is a Professor of paediatric infection and immunity at the University of Oxford.

https://en.wikipedia.org/wiki/Oxford_Vaccine_Group

2003: a study looking at the mid- to long-term effectiveness of the Meningitis C vaccine.[13][14] This research showed that immunity waned over time, and formed part of the evidence leading to the changes in the UK MenC vaccine schedule in 2013.[15][16]

2005 onwards: collaborative projects with the paediatric department of Patan Hospital in Nepal, studying children admitted to the hospital with febrile illnesses and cases of typhoid, Haemophilus influenzae type b (Hib disease) and pneumonia, and evaluating carriage of Hib disease and Streptococcus pneumoniae.

2006: a study looking at the effectiveness of a new vaccine against the bird flu virus H5N1 in children and adults.[17][18]

2006: a phase II trial of a new vaccine against MenB disease.[19] This was the first time the vaccine had been used in babies. The trial results were successful and led to phase III trials and ultimately the licensing of the new vaccine, Bexsero, in 2013.[3]

2009: a study comparing the effectiveness of two new vaccines against the swine flu virus H1N1 in children and adults.[20][21][22]

2010: a study of a new quadrivalent meningococcal (MenACWY) vaccine.[23]

2011 onwards: Ongoing participation in an EU Childhood Life-threatening Infectious Disease Study (EUCLIDS) work package looking at genetic responses to MenC and MenB vaccines.[24]

2011 onwards: a series of challenge studies to test new vaccines against typhoid and paratyphoid fever.

2014-15: a phase 1 study into a new vaccine against Ebola.[25][26] In January 2015 this trial was commended in the House of Commons by Nicola Blackwood MP and Prime Minister David Cameron.[27]

2020 onwards: a COVID-19 vaccine candidate has been created and currently in third phase of trial.

Pollard at the WHO https://www.who.int/immunization/sage/members/bio_pollard/en/

He runs surveillance for invasive bacterial diseases and studies the impact of pneumococcal vaccines in children in Nepal and leads a project on burden and transmission of typhoid in Nepal, Bangladesh and Malawi.

https://www.ovg.ox.ac.uk/team/andrew-pollard

He chairs the UK Department of Health and Social Care’s Joint Committee on Vaccination and Immunisation and the European Medicines Agency scientific advisory group on vaccines and is a member of WHO’s SAGE

Typhoid:

https://twitter.com/EricTopol/status/1146479977535197185 [tweetsave not working again]

Would you volunteer to take typhoid toxin?

They did! And it challenges dogma.

https://imgur.com/a/reBcSPM

Surveillance of three large cohorts for Typhoid Fever: The Strategic Typhoid Alliance across Africa and Asia - https://www.coalitionagainsttyphoid.org/wp-content/uploads/2016/07/Shakya.Surveillance-of-three-large-cohorts-for-typhoid-fever-the-strategic-typhoid-alliance-across-Africa-and-Asia.pdf

Written by:

Authors: Mila Shakya,1 Deus Thindwa,2 Farhana Khanam,3 Merryn Voysey,4

Buddha Basnyat,1 Melita

Gordon,2 Firdausi Qadri,3 Andrew J. Pollard 4

on behalf of STRATAA Study Consortium.

Oxford University Clinical Research Unit-Patan Academy of Health Sciences, Nepal

2. Malawi Liverpool Wellcome Trust Clinical Research Programme (MLW), Malawi

3. International Centre for Diarrhoeal Diseases Research, Dhaka, Bangladesh

4. Oxford Vaccine Group, Centre for Clinical Vaccinology and Tropical Medicine, Department of

Paediatrics, University of Oxford and the National Institute for Health

TyVAC Bangladesh: Typhoid Vaccine Trial - http://www.isrctn.com/ISRCTN11643110

Funding the study: Bill and Melinda Gates Foundation (USA), grant number: OPP1151153

Main contact: Prof. Andrew Pollard

Alternative name(s)

बिल एंड मिलिंडा गेट्स फाउंडेशन, Bill & Melinda Gates Foundation, Gates Foundation, 比尔及梅琳达·盖茨基金会, BMGF, B&MGF

The Nepalese scientific community is not very happy about the testing of vaccines on their children..

More to come..