Department of Health(DOH)

Dear Ryan Cuartero Please be informed that we have endorsed your request to FDA for action. Kindly await for their response, thank you

November 2, 2022 Dear Ryan Cuartero, I refer to my letter of Oct 23, 2022 12:10:31 AM; about your request under Executive Order No. 2 (s. 2016) on Freedom of Information in the Executive Branch, for Suspected Severe Adverse Reactions of Covid-19 vaccines. Our response to your request is due on Nov 12, 2022 12:10:31 AM. Unfortunately, it is taking longer than expected to deal with your request because we are awaiting for the data from FDA being the data custodian of your request and requested an extension to work further on this request I apologize for this delay but have applied for an extension so we could work further on your request. We hope to be able to send you a response on or before Dec 09, 2022 12:10:31 AM. Should you have any questions regarding your request, kindly contact me using the reply function on the eFOI portal at https://www.foi.gov.ph/requests/aglzfmVmb2ktcGhyHQsSB0NvbnRlbnQiEERPSC0xODgyODkwMzI0NTkM, for request with ticket number #DOH-188289032459. Thank you. Respectfully, FOI Decision Maker FOI Officer

January 25, 2023 Dear Ryan Cuartero, Greetings! Thank you for your request dated Oct 23, 2022 12:10:31 AM under Executive Order No. 2 (s. 2016) on Freedom of Information in the Executive Branch. Your Request You asked for Suspected Severe Adverse Reactions of Covid-19 vaccines. Response to Request Your FOI request is approved. Since the start of the vaccination program last 01 March 2021, the FDA continuously monitor the benefit-risk of Covid-19 vaccines. 1. As of 30 September 2022, there were 10,012 (0.006% of total doses administered) serious suspected adverse reaction reports to COVID-19 vaccines. You may check our Reports of suspected adverse reactions to COVID-19 vaccines on the FDA website: https://www.fda.gov.ph/list-of-fda-issued-emergency-use-authorization/. 2. Reports of adverse events following immunization/ suspected adverse reaction are collected through a spontaneous reporting system where health professionals and vaccinees voluntarily submit case reports. Pharmaceutical companies are also mandated to report such to the FDA. The Philippine National COVID-19 Vaccination Deployment Plan provides details in the reporting system. 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 the 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 FOI Receiving Officer