PH Grants Emergency Use of Authorization for Sinovac Vaccine
The Philippine Food and Drug Administration (FDA) has granted the Emergency Use of Authorization (EUA) for the China-based Sinovac COVID-19 Vaccine for the country’s national vaccination program set to roll out this month.
This was announced by FDA Director-General Dr. Eric Domingo today, February 22, 2021 (Monday), during the Laging Handa Public Briefing.
Furthermore, it was stated by Domingo that it was shown in the ongoing Phase 3 trial of Sinovac that it has an efficacy of 65.3 to 91.2 percent after the first dose when used on clinically healthy members of the community age 18 to 59.
“It is decided that all conditions for an EUA are present and that the benefit of using the vaccine outweighs the known potential risks. The interim data from the ongoing Phase 3 trial shows that when the vaccine is used on clinically healthy members of the community age 18 to 59, it has an efficacy of 65.3 to 91.2 percent after the first dose.”-FDA Director General Domingo | PNA
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3 Vaccines Granted EUA in PH
- United States-Germany based Pfizer vaccine
- UK-based AstraZeneca vaccine
- China-based Sinovac
Conditions for Issuance of EUA
Under Executive Order No. 121, EUA on coronavirus drug or vaccine shall be issued and remain valid only when the following are present:
- 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 or treat COVID-19 outweigh the known and potential risks of the drug or vaccine if any.
- There is no adequate, approved, and available alternative to the drug or vaccine for diagnosing, preventing, or treating COVID-19.
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