Informal Request for ATI Records Previously Released

Organization: Health Canada

Year: 2025

Month: January

Request Number: A-2023-000440

Request Summary: In response to OPQ #1448, Health Canada responded as follows: "The referred report [5.3.6 CUMULATIVE ANALYSIS OF POST-AUTHORIZATION ADVERSE EVENT REPORTS OF PF-07302048 (BNT162B2) RECEIVED THROUGH 28-FEB-2021. During the time period referenced, Health Canada reviewed three safety reports from the manufacturer. These reviews were started on January 15, 2021 and completed on April 4, 2021". Provide the 3 safety reports provided to Health Canada (HC) by the manufacturer and HC’s review/reports related to all three. Any internal or external communications such as reports, emails, briefs, text messages, records of telephone conversations, memorandums, drafts, documents, press releases and presentations in relation to same. LINK: <https://phmpt.org/wp-content/uploads/2021/11/5.3.6-postmarketing-experience.pdf&gt;

Disposition: Disclosed in part

Number of pages: 6210

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