Requested from DOH by K. Doering at 05:55 PM on
Aug 14, 2023.
Purpose: Transparency
Date of Coverage: 01/01/2018 - 08/14/2023
Tracking no: #DOH-888422373762
Doering 05:56 PM, Aug 14, 2023
Good day!
Does DOH have figures from Placebo-controlled, randomized and blinded scientific studies that provide statistically significant evidence that subjects treated with the substance BNT162b2 (so-called "Comirnaty-COVID-19 vaccine" from "BioNTech/Pfizer"), or any other substance from Moderna, Sinovac, Johnson & Johnsons as well as AstraZenica have overall suffered from fewer medically undesirable events as subjects who received placebo (saline solution), and if so, what are they and what is the date of the most recent analysis of the numbers,
Doering 05:57 PM, Aug 14, 2023
.... at which time the criteria of placebo-controlled, randomized and blinded were still met?
Receiving Officer 07:48 AM, Aug 15, 2023
August 15, 2023
Dear Kai,
Thank you for your request dated Aug 14, 2023 under Executive Order No. 2 (s. 2016) on Freedom of Information in the Executive Branch, for Placebo-controlled, randomized and blinded scientific studies.
We received your request on Aug 14, 2023 and will respond on or before Sep 04, 2023 05:55:59 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 https://www.foi.gov.ph/requests/aglzfmVmb2ktcGhyHQsSB0NvbnRlbnQiEERPSC04ODg0MjIzNzM3NjIM, for request with ticket number #DOH-888422373762.
Thank you.
Respectfully,
FOI Receiving Officer
FOI Officer
Maker 09:41 AM, Aug 15, 2023
Good day!
Please be informed that we have endorsed your request to the FOOD AND DRUG ADMINISTRATION & RESEARCH INSTITUTE FOR TROPICAL MEDICINE for action.
Kindly await for their response.
Thank you.
Doering 12:18 PM, Sep 05, 2023
Update please.
Doering 10:41 PM, Oct 03, 2023
What takes so long to answer this inquiry?
Maker 02:21 PM, Jan 27, 2024
January 27, 2024
Dear Kai Doering,
Greetings!
Thank you for your request dated Aug 14, 2023 05:55:59 PM under Executive Order No. 2 (s. 2016) on Freedom of Information in the Executive Branch.
Your Request
You asked for Placebo-controlled, randomized and blinded scientific studies.
Response to Request
Your FOI request is approved.
The link will direct you to comprehensive product information (for Healthcare Providers) regarding COVID-19 vaccines approved by the Philippine Food and Drug Administration, including details about the clinical study results for these vaccines.
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 monthly 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.
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.
The link provides access to posted reports of a suspected adverse reaction:
https://www.fda.gov.ph/wp-content/uploads/2023/08/Reports-of-suspected-adverse-reaction-to-COVID-19-vaccines-as-of-31-July-2023.pdf
We hope that this answers all your queries.
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 foi@doh.gov.ph. 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 about 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
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