THE Philippines’ Food and Drug Administration (FDA) has been granted the authority to allow emergency use of COVID-19 vaccines and treatments.
President Rodrigo Duterte on Tuesday, December 1, signed Executive Order No. 121 allowing FDA Director General Eric Domingo to issue Emergency Use Authorization (EUA) for vaccines or treatments deemed safe and effective against the novel coronavirus.
The order shortens the process of approving vaccines from the regular six months to 21 days.
“It is a priority of the State to ensure that the lives of the Filipino people, especially the underprivileged, poor, and marginalized, our frontliners, healthcare providers, police officers and soldiers, and those in the essential services shall be protected from COVID-19 by ensuing accessibility and adequacy of supply of related drugs and vaccines,” said Duterte in the order.
EUA can be issued provided these 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.
The order allows the FDA to convene a panel of experts to conduct a review of data on the safety and efficacy of a COVID-19 drug or vaccine applying for an EUA. Afterwards, the panel needs to submit to the FDA Director General its report and recommendations on the application for EUA.
The issued EUA will only be valid “within the duration of the declared public emergency due to COVID-19.” The FDA director general may revisit or revoke the EUA to protect the general public health and safety.
Domingo, for his part, welcomed the order.
“We at the FDA will do our best to help make safe and efficacious COVID-19 vaccines available in the Philippines,” he told Philstar.com.
Last Friday, November 27, the Philippines signed a tripartite agreement for two million doses of AstraZeneca’s vaccine against COVID-19.
According to the country’s vaccine czar Carlito Galvez Jr., the two million doses will be funded by the private sector as the national government negotiates with the British vaccine maker for 20 million doses using public money.
