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12月3日のまにら新聞から

Duterte grants FDA emergency use authorization for COVID-19 vaccines

[ 520 words|2020.12.3|英字 (English) ]

President Rodrigo Duterte has issued an executive order granting the director general of the Food and Drug Administration (FDA) to issue emergency use authorization (EUA) for coronavirus drugs and vaccines.

Duterte, under EO 121 signed on December 1, said it is a priority of the State to ensure that the lives of the Filipino people, especially the underprivileged, poor and marginalized, frontliners, healthcare providers, police officers and soldiers, and those in the essential services shall be protected from COVID-19 by ensuring accessibility and adequacy of supply of related drugs and vaccines.

Thus, Duterte issued an EUA to the FDA director general subject to conditions.

"Outside clinical trials and except cases where a Compassionate Special Permit is issued, no unregistered COVID-19 drug and vaccine may be manufactured, sold, imported, exported, distributed or transferred without an EUA," the EO read.

The EO said an EUA on a COVID-19 drug or vaccine 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 know 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 treating COVID-19.

"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. For this purpose, the FDA director general may accept the regulatory decision of the WHO (World Health Organization) US-CDC (Centers for Disease Control and Prevention), or other international recognized and established regulatory authorities," the EO said.

The FDA is tasked to convene a panel composed of experts on drug and vaccine development, which shall conduct a review of available data on the safety and effectiveness of a COVID-19 drug or vaccine applied for an EUA. After review, the panel shall submit to the FDA director general its report and recommendations on the application for EUA.

The EUA shall be valid only within the duration of the declared public health emergency due to COVID-19 without prejudice to the discretion of the FDA director general to revisit or revoke the same as may be appropriate, to protect the general public health and safety.

The FDA, together with other concerned offices of the Department of Health, is also directed to conduct post-authorization monitoring to track product deployment, additional relevant information, and the status from the manufacturer concerning full-product life-cycle.

"The holder of an EUA shall be required to complete specific pharmacovigilance obligations, with a view to providing comprehensive data confirming a positive benefit-risk balance," the EO said.

Duterte ordered the FDA to submit, through the DOH, a monthly report on the implementation of the EO.

The EO shall take effect immediately upon publication in the Official Gazette or in a newspaper of general circulation. Celerina Monte/DMS