Informal Request for ATI Records Previously Released

Organization: Health Canada

Year: 2025

Month: February

Request Number: A-2021-000974

Request Summary: Application for AstraZeneca's Covid-19 vaccine ( ChAdOxl-S ). Provide all documents, data, correspondence, or any other item made available to Health Canada by AstraZeneca as of August 20, 2021. Provide all documents received/exchanged/sent by Health Canada and AstraZeneca concerning : Monthly safety reports, control number: 252386, 251336, 250447; Amendment numbers: 252545, 253087, 251532, 250727, 250891, 250447, 250081; Risk management plan, control numbers: 251571, 251008, 250447. the "new safety review initiated by Health Canada" (between 2021-02-28 and 2021-03-30). The Summary Basis of Decision for AstraZeneca's Covid-19 vaccine succinctly discusses the clinical and non-clinical reasons for Health Canada's decision. Clinical Reasons : Provide Health Canada's complete expert reports on AstraZeneca's clinical trials for its Covid-19 vaccine, including: phase 1/2 study COV001 ( NCT04324606 ); phase 2/3 study COV002 ( NCT04400838 ); phase 2/3 study COV003 ( ISRCTN89951424 ); phase 1/2 study COV005 ( NCT04444674 ). Also provide all questions, remarks, criticisms, recommendations issued by Health Canada and transmitted to AstraZeneca concerning these clinical trials, as well as the laboratory's responses to Health Canada. Non-clinical reasons : Provide the complete expert reports, manufacturer's data, remarks, analyses, criticisms and any other documents in the possession of, issued and/or received by Health Canada concerning these reasons and in particular: pharmacology studies; biodistribution studies; repeated-dose toxicity studies; reproductive and developmental toxicity studies; Qualitative reasons : Provide complete expert reports, manufacturers' data, remarks, analyses, critiques and any other documents in the possession of, issued and/or received by Health Canada concerning these grounds and in particular : the characterization of the Drug Substance the current manufacturing and control process for the Drug Substance and the drug product control of the Drug Substance and Drug Product; stability of drug substance and drug product; evaluation of the safety of adventitious agents; all the images obtained during the examination of the product itself (the contents of the vaccine vial), the list of techniques and tools used for these examinations (Optical Microscopy...) and the comments and analyses resulting from these observations.

Disposition: Disclosed in part

Number of pages: 4

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