EMA leaked papers

There is an analysis from the BMJ after the EMA leaked papers, which consist of pictures, PDFs and docs. I’ll also post it here where you can view. INVESTIGATION – The EMA covid-19 data leak, and what it tells us about mRNA instability PDF

Rapporteur Rolling Review Report Overview LoQ – COVID-19 mRNA Vaccine BioNTech

Rapporteur’s Rolling Review Report New Active Substance Status – COVID-19 mRNA Vaccine BioNTec

Rapporteur’s Rolling Review Report Quality – COVID-19 mRNA Vaccine BioNTec

BNT CMC Peer Reviewer Comparability

COVID-19 mRNA Vaccine BioNTech – EMA peer review comments

INX100434736_AnalyticalMethodTransferBNT162b2-DPMethods

Peer Reviewers Comments_NO 23.11.2020

2020 11 30 – Priority OCs to company

Priority OCs in quality LoQ – COVID-19 mRNA Vaccine BioNTech

20201126_BNT162b2_EMAmeeting_final

Annex 1 – Draft 3.2.P.2.2 Drug Product

Annex 2 – VAL100130986 + attachment_All approved

Annex 3 – BNT162b2 Manufacturing Equipment and Scale

Annex 4 – BNT162b2 CMC Data Timelines_for Pre-sub Meeting_PPQ

M1 20 Nov 2020 FDA Query Responses

M3 20 Nov 2020 FDA Query Responses

COVID-19 mRNA Vaccine BioNTech – CHMP Opinion

COVID-19 mRNA Vaccine BioNTech – CHMP Overview and LoQ

Written procedure for COVID-19.mRNA.Vaccine.BioNTech-5735 for your comments by 3011 1700 CET

Agenda for ETF meeting on COVID-19 vaccines – 26 November 2020

BWP report BioNTech mRNA COVID19 vaccine- Adopted

COVID-19 vaccine (recombinant, adjuvanted) Draft joint report as agreed by Rapps

Summary of the ETF meeting on COVID-19 vaccine – 26 November 2020

British Medical Journal Analysis

INVESTIGATION – The EMA covid-19 data leak, and what it tells us about mRNA instability PDF

These were some other pictures to explain some of the above papers

 

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