April 26, 2023
Dear Ryan Cuartero,
Greetings!
Thank you for your request dated Oct 19, 2022 12:16:24 AM under Executive Order No. 2 (s. 2016) on Freedom of Information in the Executive Branch.
Your Request
You asked for DOH approves Sinovac COVID-19 vaccine for 6 to 17-year-olds.
Response to Request
Your FOI request is approved.
Respectfully sending herewith the eFOI responses from the FDA, for your reference.
The COVID-19 vaccines issued with Emergency Use Authorization (EUA) have been reviewed, evaluated, and approved based on the following:
Based on the totality of evidence available, including data from adequate and well- known controlled trials, it is reasonable to believe that the drug or vaccine may be effective to prevent, diagnose, or treat COVID-19;
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
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.
We are currently gathering specific updates on male fertility from the drug developers. In this connection, we will be sending these updates as soon as they are provided.
You may also refer to this web article from US FDA CDC (2022) entitled: COVID-19 vaccine for people who would like to have a baby for your reference (https://www.cdc.gov/coronavirus/2019-ncov/vaccines/planning-for-pregnancy.html):
According to the article “Currently, no evidence shows that any vaccines, including COVID-19 vaccines, cause male fertility problems. A recent small study of 45 healthy men who received an mRNA COVID-19 vaccine looked at sperm characteristics, like quantity and movement, before and after vaccination. Researchers found no significant changes in these sperm characteristics after vaccination.
However, one study found that COVID-19 infection may be associated with a decline in fertility for men for up to 60 days after COVID-19 infection.
Fever from any illness has been associated with a short-term decrease in sperm production in healthy men. Although fever can be a side effect of COVID-19 vaccination, there is no current evidence that fever after COVID-vaccination affects sperm production. Fever is also a common symptom of COVID-19 infection”.
There is a DOH-FDA pharmacovigilance system which is a shared commitment with all stakeholders utilizing the COVID-19 vaccines. The Ph 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 reactions reports received by the Ph 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
We hope that this answers all of your queries regarding the safety and effectiveness of Ph 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.
Kindly accomplish the FOI Request Feedback form at the link: https://bit.ly/DOHFOIFeedbackForm
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
