Duterte allows FDA to grant emergency use authorization for COVID-19 drugs, vaccines

President Rodrigo Duterte has allowed the Food and Drug Administration (FDA) to issue an emergency use authorization (EUA) for COVID-19 drugs and vaccines.

Duterte gave his consent through Executive Order 121 he signed on Tuesday.

An EUA will reduce the processing time for the approval of the vaccines for local use from six months to 21 days, officials earlier said. The issuance of an EO on EUA was both proposed by Health Secretary Francisco Duque III and vaccine czar Carlito Galvez Jr.

The EO said an EUA may be issued if the following conditions are met:

• 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 treating COVID-19

An EUA shall be valid only within the duration of the declared public health emergency due to the COVID-19 pandemic but the FDA Director General could revisit or revoke the same “to protect the general public health and safety,” the EO stated.

An application filed by the industry or government agency concerned must show compliance with current good manufacturing practices, including an undertaking by the manufacturer to complete the development of the drug and vaccine.

Panel of experts

Duterte instructed the FDA to convene a panel composed of experts on drug and vaccine development, which will conduct a review of available data on the safety and effectiveness of a COVID-19 drug or vaccine that applied for an EUA.

After review, the panel must submit its findings and recommendations to the FDA Director General, who may also accept the regulatory decision of the World Health Organization, US Centers for Disease Control and Prevention, or other internationally recognized and established regulatory authorities.

The FDA and the Department of Health were tasked 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 must also fulfill pharmacovigilance obligations to determine and assess the effects of the drug or vaccine.

Duterte tasked the FDA to submit a monthly report to his office on the EO’s implementation.

The Philippines is eyeing to acquire vaccines developed by the United States, China, Russia, and the United Kingdom with the government assuring that the vaccination program is still on track to be implemented by next year.

“Our best case scenario that we have presented is more or less May but for now, if we will succeed in negotiating [for] two to three vaccines from different countries, we might be able to get it during the first quarter,” Galvez said at the Laging Handa briefing.

Tripartite agreement

Last Friday, the Philippine government, the private sector and AstraZeneca signed a tripartite agreement for the country to secure a supply of 2.6 million doses of the pharmaceutical firm’s potential COVID-19 vaccine.

This supply, to be paid for by the private sector, will inoculate over one million Filipinos as the British drugmaker's vaccine requires two doses.

American pharmaceutical giant Pfizer and its German partner BioNTech, meanwhile, said last month that their potential vaccine was found to be 95% effective based on the results of final-stage testing.

The UK approved on Wednesday the Pfizer-BioNTech COVID-19 vaccine for use beginning next week.

Their rival Moderna reported that its vaccine candidate was 94.5% effective at preventing people from catching the virus while Russia’s Sputnik V vaccine is said to be 92% effective based on interim results. — RSJ, GMA News