January 19, 2023
Dear Ryan Cuartero,
Greetings!
Thank you for your request dated Oct 13, 2022 03:56:51 PM under Executive Order No. 2 (s. 2016) on Freedom of Information in the Executive Branch.
Your Request
You asked for Covid-19 vaccines and Sudden Adult Death Syndrome.
Response to Request
Your FOI request is approved.
The COVID-19 vaccines issued with 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 no registered drug or vaccine exists 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 that have 100% efficacy, and are without any adverse events after immunization.
Please refer to the full product information through this link: https://www.fda.gov.ph/list-offda-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. 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 reaction 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-adversereaction-to-COVID-19-vaccines-as-of-30-September-2022.pdf
Please refer also 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 provided information has addressed all your concerns regarding the safety and effectiveness of 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 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
FOI Receiving Officer
