LGUs required to get FDA approval before joining vaccine clinical trials

Bonz Magsambol

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LGUs required to get FDA approval before joining vaccine clinical trials

BALANCING ACT. In this file photo, FDA Director General Enrique Domingo answers media's questions in a press conference.

File photo by Angie de Silva/Rappler

'We have very, very strict protocols when it comes to human trials especially for a vaccine that is not yet existing,' says Food and Drug Administration Director General Eric Domingo

Before joining coronavirus vaccine clinical trials, local government units must first get the clearance of the Food and Drug Administration.

This was the stern warning of FDA Director General Eric Domingo to LGUs which have publicized their participation in forthcoming clinical trials.

“We have very, very strict protocols when it comes to human trials especially for a vaccine that is not yet existing. ‘Yung safety kasi talaga (Because of the safety),” Domingo said in a virtual press briefing on Friday, September 25.

Domingo added that it was illegal to use these clinical trial vaccines if these do not have FDA approval.

The vaccines (produced by overseas drug companies) will not be allowed to enter the country. And it won’t be legally administered to anyone because the vaccine is not a registered product and thus, should not be available, Domingo said in Filipino.

In August, Cavite Governor Jonvic Remulla said that some 10,000 Caviteños would participate in September in trials for the coronavirus vaccines developed by American and British pharmaceutical companies.

Health Undersecretary Maria Rosario Vergeire earlier told the Cavite provincial government to first comply with legal requirements before it joins clinical trials.

During Friday’s briefing, Domingo said that all clinical trials need to pass through FDA’s technical working group and vaccine expert panel.

“I-endorse ito ng vaccine panel sa FDA. At ang oversight panel ay babantayan ng FDA ang pagsusuri,” Domingo said. (The clinical trial should be endorsed by the vaccine panel to FDA. And the FDA would oversee the oversight panel for their evaluation.)

The Department of Science and Technology (DOST), along with a panel of experts, is crafting the first stages of a vaccine strategy that would allow the Philippines to participate in clinical trials for the most advanced vaccine candidates. 

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University of the Philippines College of Public Health Professor Nina Gloriani, who leads the country’s vaccine expert panel, said there were 3 phases in clinal trials that all vaccines need to complete these to test its effectiveness.

DOST Secretary Fortunato dela Peña told reporters on Friday that the Philippines has signed 6 Confidentiality Data Agreements (CDA) with foreign pharmaceutical companies.

In an unprecedented effort, over 100 vaccines are being developed across multiple countries to accelerate a process that would typically take years to find an effective vaccine. 

According to the New York Times, 11 potential vaccines are already in phase 3 trials as of September 24.

As of Thursday, the Philippines still has the most number of COVID-19 infections in the region at 296,755 confirmed cases, despite having one of the longest lockdowns in the world. –

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Bonz Magsambol

Bonz Magsambol covers the Philippine Senate for Rappler.