DOH seeks Duterte’s OK to grant FDA authority to fast-track approval of COVID-19 vaccines

November 18, 2020

The Department of Health (DOH) has urged President Rodrigo Duterte to issue an executive order granting the Food and Drug Administration an authority to accelerate the approval of vaccines against coronavirus disease and other imported medicines in this time of pandemic.

Health Secretary Francisco Duque III made the proposal amid the Philippines' impending importation of COVID-19 vaccines.

"To facilitate the approval of the vaccines and other medicines against COVID-19, the DOH through FDA, we are respectfully proposing the adoption of the emergency use authorization or EUA, and with EUA, we can use medicine, vaccine, and other health technologies through the process of reliance and recognition," Duque said in a taped televised meeting with Duterte on Tuesday night.

He said the EUA is a facilitated approval in the context of public health emergencies, such as the coronavirus pandemic.

Duque explained that reliance and recognition pertains to trust and acceptance of FDA on the evaluations conducted and regulatory decisions made by the national regulatory authorities by other countries on their medicines or vaccines.

He said the issuance of EUA is only being made whenever there is a medical health emergency; serious or life-threatening disease; proof that the product may be effective to prevent, diagnose, or treat a disease; positive risk/benefit balance; and no adequate or approved and available alternative.

The FDA will conduct a thorough post-marketing surveillance activities and the EAU could be revised or revoked by the FDA if necessary to protect the health of the Filipinos, he said.

"We are respectfully requesting that you consider the issuance of an executive order for FDA to grant and emergency use authorization for the various vaccines that will enter the country for which applications are to be filed," Duque said.

With this, he said the processing time will be cut from six months to about 21 days, thus, cutting the red tape.

National Task Force Against COVID-19 Chief Implementer Carlito Galvez Jr, also the vaccine czar, said government vaccine experts have ranked 17 possible sources of vaccines from various countries.

"And out of the 17, nine are already on the Phase 3 trial. And of those at Phase 3 trial, three of them will have a trial here this coming December and January," he said in the same meeting.

He thanked various private companies and groups for their promise to donate vaccines.

"They have already raised more than one million. And hopefully, that can still increase by one or to two million doses. They will donate 80 to 50 percent of the vaccine and the rest will be used for their poor essential workers at no cost to us (government)," he said.

Galvez said if there will be an advance procurement of COVID-19 vaccines by the end of the year, the signing of loan agreements with lending agencies can already take place.

The government is planning to borrow money to fund the purchase of COVID-19 vaccines.

"That's why our recommendation, Mr. President, is we enter on the advance market commitment through the multilateral arrangement with World Bank and ADB (Asian Development Bank) as our finance manager. At the same time, we have also to have various modes of financing include private-public tripartite agreement without the cost with the government," he said.

"So the private sector will finance it by buying directly to the vaccine company but with the regulation that the DOH will be the one who will know, who will decide where the vaccine will be given," Galvez said.

He also expressed support on the recommendation of the DOH for Duterte to come up with an EO about the EUA to be issued by the FDA. Celerina Monte/DMS