Department of Health(DOH)

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

November 2, 2022 Dear Ryan Cuartero, I refer to my letter of Oct 13, 2022 03:51:17 PM; about your request under Executive Order No. 2 (s. 2016) on Freedom of Information in the Executive Branch, for Covid-19 vaccines will not cause Death. Our response to your request is due on Nov 03, 2022 03:51:17 PM. 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 01, 2022 03:51:17 PM. 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/aglzfmVmb2ktcGhyHQsSB0NvbnRlbnQiEERPSC01Mjk4NzYxNDc5NDIM, for request with ticket number #DOH-529876147942. Thank you. Respectfully, FOI Decision Maker FOI Officer

December 13, 2022 Dear Ryan Cuartero, Greetings! Thank you for your request dated Oct 13, 2022 03:51:17 PM under Executive Order No. 2 (s. 2016) on Freedom of Information in the Executive Branch. Your Request You asked for Covid-19 vaccines will not cause Death. Response to Request Your FOI request is approved. Please be informed that the COVID-19 vaccines issued with the Emergency Use Authorization (EUA) have been evaluated and approved based on the following: 1. The totality of the current evidence available, including data from adequate and well-known controlled trials, supports that the drug or vaccine is effective to prevent, diagnose or treat COVID-19; 2. The known and potential benefits of the drug or vaccine, when used to diagnose, prevent, treat COVID-19, outweigh the known and potential risks of the drug or vaccine, if any; and 3. There is no adequate, approved and available alternative to the product for diagnosing, preventing or treating COVID-19. This condition is deemed present when there exists no registered drug or vaccine in the country for diagnosing, preventing or treating COVID-19. Based on the clinical trial data submitted to the National Regulatory Authorities (NRAs) around the world, including the Philippine FDA, there are no COVID-19 vaccines which have 100% efficacy, and without any adverse events after immunization. Please refer to the full product information through this link fda.gov.ph/list-of-fda-issued-emergency-use-authorization/ There is a DOH-FDA Pharmacovigilance system, which is a shared commitment with all stakeholders utilizing the COVID-19 vaccines. The Philippine FDA publishes an overview of reports of suspected adverse reactions to COVID-19 vaccines that are currently in use in the vaccination program of the Philippines. The reports of suspected adverse drug reactions issued on a weekly basis have provided timely and relevant information to healthcare professionals and the public on the safety of COVID-19 vaccines used in the vaccination program of the government as implemented by the National COVID-19 Vaccination Operations Center (NVOC) In line with the high vaccination coverage and operational strategy, updates will be on a monthly basis. Monitoring the safety of COVID-19 vaccines shall remain on a regular interval. All suspected adverse reactions reports received by the Philippine FDA regarding COVID-19 Vaccines are posted on the FDA website for healthcare professionals and consumer awareness. Please refer to this link regarding reports on suspected adverse reactions to COVID-19 vaccines: https://www.fda.gov.ph/wp-content/uploads/2022/10/Reports-of-suspected-adverse-reaction-to-COVID-19-vaccines-as-of-30-September-2022.pdf Please also refer to the following websites for further information: US FDA CDC (2020) web article entitled: Overview, History and How the safety process works https://www.cdc.gov/vaccinesafety/ensuringsafety/history/index.html "Before vaccines are approved by the Food and Drug Administration (FDA), scientists test them extensively to ensure they are effective and safe. Vaccines are the best defense we have against infectious diseases, but no vaccine is actually 100% safe or effective for everyone because each person’s body reacts to vaccines differently." We hope that the information we have given you answers all of your queries regarding the safety and effectiveness of the Philippine FDA approved COVID-19 Vaccines under EUA. 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