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 20, 2022 06:24:13 PM; about your request under Executive Order No. 2 (s. 2016) on Freedom of Information in the Executive Branch, for clinical trials:FDA-approved Covid-19 vaccines on prenatal development: germinal, embryonic, fetal. Our response to your request is due on Nov 10, 2022 06:24:13 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 08, 2022 06:24:13 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/aglzfmVmb2ktcGhyHQsSB0NvbnRlbnQiEERPSC0yMzQyMTUzMzExNDUM, for request with ticket number #DOH-234215331145. Thank you. Respectfully, FOI Decision Maker FOI Officer

December 13, 2022 Dear Ryan Cuartero, Greetings! Thank you for your request dated Oct 20, 2022 06:24:13 PM under Executive Order No. 2 (s. 2016) on Freedom of Information in the Executive Branch. Your Request You asked for clinical trials:FDA-approved Covid-19 vaccines on prenatal development: germinal, embryonic, fetal. Response to Request Your FOI request is approved. The link below will take you to full product information about COVID-19 vaccines that have been approved by the Philippine Food and Drug Administration (FDA) under Emergency Use Authorization: * The full product information of each Philippine FDA approved vaccine regarding Animal reproductive toxicity studies, Human Fertility, Pregnancy and Lactation: https://www.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 the 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 You may also refer to this link for further information 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 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