President Rodrigo Duterte has approved the Emergency Use Authorization (EUA) for drugs and vaccines against coronavirus disease 2019 (Covid-19).
Duterte signed Executive Order (EO) No. 121 on December 1, granting authority to the director general of the Food and Drug Administration (FDA) to issue a EUA for Covid-19 drugs and vaccines subject to several conditions.
“Outside clinical trials and except in 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 EAU,” the EO reads.
A EUA on a Covid-19 drug or vaccine may be issued 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.
It may also be issued if 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.
The EUA, according to EO 121, may also be issued if there is no adequate, approved, and available alternative to the drug or vaccine for diagnosing, preventing, or treating Covid-19.
To apply for a EUA, an industry or government agency concerned must submit an application that demonstrates compliance with current Good Manufacturing Practice, and accompanied by an undertaking by the manufacturer to complete the development of the drug and vaccine, among others.
In evaluating applications for EUA, the FDA director general must have the power to implement reliance and recognition processes for emergency use of drugs and vaccines.
The FDA director general may accept the regulatory decision of the World Health Organization, US-Center for Disease Control and Prevention, or other internationally recognized and established regulatory authorities.
The FDA must convene a panel composed of experts on drug and vaccine development, which must conduct a review of available data on the safety and effectiveness of a Covid-19 drug or vaccine applied for a EUA.
After review, the panel must submit to the FDA director general its report and recommendation on the application for EUA.
Under the EO, the EUA will 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 DOH, must 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 a EUA must be required to complete specific pharmacovigilance obligations, to provide comprehensive data confirming a positive benefit-risk balance.
The FDA must formulate and issue guidelines, as may be necessary, for the effectiveness of the order.
In signing the EO, Duterte recognized the need to strengthen interventions and responses against Covid-19 that other countries such as Australia, China, and the United States of America adopted and the World Health Organization recognized, the regulatory practice of issuing an Emergency Use Authorization to hasten the availability and use of Covid-19 drugs and vaccines, particularly those supported by strong evidence that patients have benefited from them in the absence of available approved and adequate alternatives.
“It is a priority of the state to ensure that the lives of the Filipino people, especially the underprivileged, poor, and marginalized, our front-liners, 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,” the EO read.
Vaccine czar Secretary Carlito Galvez Jr. earlier endorsed the proposal on the EUA for Covid-19 vaccines, saying it will guarantee 30 million to 50 million doses in the country by next year.
Last month, Duterte also approved the recommendation to make advance payments to suppliers of Covid-19 vaccines.*PNA