MANILA, Philippines – President Rodrigo Duterte has allowed the Food and Drug Administration (FDA) to issue emergency use authorization (EUA) for COVID-19 vaccines and drugs that are expected to be made available in the Philippines next year.
Under Executive Order (EO) No. 121 signed on Dec. 1 and made public by Malacañang on Wednesday, Duterte granted authority to the FDA director general to issue EUA for COVID-19 drugs and vaccines, subject to provided conditions.
The EO stated that an EUA on a COVID-19 vaccine or drug shall be issued and remain valid only when all of the following circumstances 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; and
- There is no adequate, approved and available alternative to the drug or vaccine for diagnosing, preventing or treat9ing COVID-19
An application for the issuance of an EUA shall be submitted by the industry or government agency concerned, such as the national procurer or public health program implementer, the EO read.
The FDA shall then convene a panel of experts on drug and vaccine development to review available data on the safety and effectiveness of a COVID-19 drug or vaccine applied for an EUA. The panel will then submit its report and recommendations to the FDA director general.
“In evaluating applications for EUA, the FDA director general shall have the power to implement reliance and recognition processes for emergency use of drugs and vaccines,” the order stated.
“For this purpose, the FDA director general may accept the regulatory decision of the WHO (World Health Organization), US-CDC, or other internationally recognized and established regulatory authorities,” it added.
An EUA issued pursuant to the order shall be valid within the duration of the declared public health emergency due to COVID-19, and may be revoked or revisited by the FDA director general.
FDA director general Eric Domingo earlier assured they will not compromise public safety with the sped-up process.
The Philippine government is looking to administer the vaccines to at least 70 million Filipinos under an immunization program that may be carried out within three to five years. – RRD (with details from Correspondent Rosalie Coz)