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Date: May 27, 2022, 12:38 p.m.

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Date: 2022-05-27 13:46:40.000000

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Date: 2022-06-29 08:52:53.000000

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FOI: Moderna's Emergency Use Authorization Application to Food and Drug Administration - Philippines

Published by Department of Health(DOH) on May 27, 2022.
Requested from DOH by M. Ayag at 12:38 PM on May 27, 2022.
Purpose: Transparency to the public.
Date of Coverage: 01/01/2020 - 01/30/2022
Tracking no: #DOH-954911892142

D.BESA May 27, 2022, 12:38 p.m.

Hi, Good day! I am sending this request to your respective office with regard to Moderna's EUA application to FDA for transparency purposes. Here are the scopes of my request: *Moderna - application documents submitted for EUA of covid19 vaccine, including supporting data; post-authorization adverse event reports; *Minutes of meetings where Moderna EUA application was discussed, deliberated and decided on, including dates of said meetings, attendees of such meetings and vote distribution on decision to grant EUA Thank you, Dominic Alfred Besa

F.RECEIVING OFFICER May 27, 2022, 1:46 p.m.

May 27, 2022 Dear Dominic Alfred, Thank you for your request dated May 27, 2022 under Executive Order No. 2 (s. 2016) on Freedom of Information in the Executive Branch, for FOI: Moderna's Emergency Use Authorization Application to Food and Drug Administration - Philippines. We received your request on May 27, 2022 and will respond on or before Jun 17, 2022 12:38:32 PM, in accordance with the Executive Order's implementing rules and regulations. Should you have any questions regarding your request, kindly contact me using the reply function on the eFOI portal at http://efoi-ph.appspot.com/requests/aglzfmVmb2ktcGhyHQsSB0NvbnRlbnQiEERPSC05NTQ5MTE4OTIxNDIM, for request with ticket number #DOH-954911892142. Thank you. Respectfully, FOI Receiving Officer FOI Officer

F.MAKER May 27, 2022, 4:18 p.m.

Dear Dominic Alfred Besa Please be informed that we have endorsed your request to the FDA for action. Kindly await for their response, thank you

F.MAKER June 29, 2022, 8:52 a.m.

June 29, 2022 Dear Dominic Alfred Besa, Greetings! Thank you for your request dated May 27, 2022 12:38:32 PM under Executive Order No. 2 (s. 2016) on Freedom of Information in the Executive Branch. Your Request You asked for FOI: Moderna's Emergency Use Authorization Application to Food and Drug Administration - Philippines. Response to Request Your FOI request is approved. Below are the responses from FDA in response to your request * For queries related to EUA, you can visit the FDA website with the link: https://www.fda.gov.ph/list-of-fda-issued-emergency-use-authorization/ * For all relevant information and updates such as the list of approved EUA including the weekly reports of suspected adverse reaction to COVID-19 vaccines. Please note that we are only able to provide some of the information you have requested for as other requests for minutes of the meeting in this particular FOI fall under the exemption to FOI or Inventory of Exceptions to Executive Order No. 2 (s.2016), 24 November 2016, specifically no.4 (a) and 5 (a). Please see attached file for reference. Thank you Your right to request a review If you are unhappy with this response to your FOI request, you may ask us to carry out an internal review of the response by writing to Undersecretary Lilibeth C. David, Chair of Data Governance Oversight Committee/ DOH Central Appeals and Review Committee, at [email protected]. Your review request should explain why you are dissatisfied with this response, and should be made within 15 calendar days from the date when you received this letter. We will complete the review and tell you the result within 30 calendar days from the date when we receive your review request. If you are not satisfied with the result of the review, you then have the right to appeal to the Office of the President under Administrative Order No. 22 (s. 2011). Thank you. Respectfully, FOI Decision Maker

Attachments:

inventory-of-exceptions-to-eo-2 (2).pdf - FOI Decision Maker - [email protected]

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