President Rodrigo Duterte has allowed the Food and Drug Administration (FDA) to issue an emergency use authorization (EUA) for drugs and vaccines against the coronavirus disease (COVID-19) — a move that is expected to speed up its regulatory approval.
With the newly-signed Executive Order No. 121, copies of which were given to reporters on Wednesday, a vaccine can be approved for use within 21 days instead of undergoing the usual six-month review period.
As stated in the order, an EUA shall be issued only when “adequate” data from “well-known controlled trials” showed that a COVID-19 drug or vaccine is effective to prevent, diagnose, or treat patients with the illness.
In addition, the EUA can only be issued if potential benefits of the drug or vaccine outweigh its potential risks, and if there are no other options available.
According to the EO, an application for the issuance of an EUA shall be submitted by the industry or government agency concerned, such as the national procurer or the public health program implementer.
The application should also demonstrate compliance with current good manufacturing processes, accompanied by an undertaking by the manufacturer to complete the development of the drug and vaccine, it added.
“An EUA issued pursuant to this order 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,” Duterte wrote in the EO.
The FDA shall convene a panel composed of experts on drug and vaccine development which will review available data on the safety and effectiveness of a COVID-19 drug or vaccine applied for an EUA, the EO stated. The agency shall also conduct a “post-authorization monitoring” to track product deployment.
The President also asked the FDA to formulate guidelines for the EO’s implementation and to submit a monthly report in line with the use of EUA.
Duterte said the EO shall take effect immediately upon its publication in the Official Gazette or in a newspaper of general circulation.
Prior to the issuance of the order, the Philippines, unlike other countries such as the United States, does not have a mechanism for EUA that will hasten availability and use of COVID-19 drugs and vaccines.
Health Secretary Francisco Duque III has earlier said that an EUA will cut the processing time for vaccine approval to just 21 days.
Despite the shortened time of review, Duque has assured that stringent protocols are in place to ensure the safety and efficacy of vaccines.
The EUA, however, is only as good as the availability of COVID-19 vaccines or drugs.
Even if the Philippines’ FDA will issue an EUA to any of potential vaccines, it may take up to the second quarter of 2021 to roll out mass vaccination against COVID-19 because of limited supply and high demand worldwide.
Vaccine czar Carlito Galvez Jr. also said earlier that the immunization program will be carried out for three to five years since the health department cannot inoculate 60 million Filipinos in just a year.
The Philippines, through the efforts of around 30 private companies, has so far secured 2.6 million doses of the AstraZeneca’s potential vaccine against COVID-19. The government is still in talks with Russia’s Gamaleya Institute, America’s Pfizer, and China’s Sinovac Inc.
