FDA studying Aussie pharma firm’s bid for COVID-19 vaccine clinical trials

Published October 30, 2020, 2:59 PM

by Analou de Vera

The country’s vaccine experts panel is currently evaluating the application of an Australian pharmaceutical firm to conduct clinical trial Phase 3 for its COVID-19 candidate vaccine in the Philippines.

Food and Drug Administration (FDA) Director-General Rolando Enrique Domingo

Food and Drug Administration (FDA) Director-General Rolando Enrique Domingo said that the vaccine experts panel informed him Friday, October 30 that Australia’s Clover Biopharmaceuticals has submitted its applications to hold clinical trials here.

“We have been officially informed by the vaccine experts panel that there is a company that has shown interest (in) doing clinical trials here in the Philippines and they are now undergoing pre-screening,” said Domingo in an online forum.

“Clover Biopharmaceuticals from Australia is now also being evaluated by the vaccine experts panel;” he added.

Currently, there are now four vaccine developers that are undergoing evaluation. The other three are: China’s Sinovac Biotech, Russia’s Gamaleya Research Institute, and United States of America’s Janssen Pharmaceuticals of Johnson & Johnson.

Sinovac Biotech, which was “endorsed positively” by the vaccine expert panel, is still undergoing evaluation from the Single Joint Research Ethics Board and the FDA. The vaccine panel cleared Sinovac for clinical trials last October 15.

Janssen Pharmaceuticals is still in the pre-screening stage of the vaccine expert panel, Domingo said.

Meanwhile, the vaccine expert panel is still awaiting additional documents from the Gamaleya Research Institute before they could formally begin the evaluation of its candidate vaccine called “Sputnik V.”

“I asked for some updates on that…meron pang mga tanong at hinihingi ang vaccine experts panel. And when they submit that, formal evaluation by the vaccine expert panel will start,” said Domingo.

Aside from these four vaccine developers, Domingo said that there are other pharmaceutical companies that are showing interest in conducting clinical trials in the Philippines.

“I think there are at least…maybe right now… seven or eight companies that have been asking for the process, requirements. But of course, until they submit an actual protocol for the vaccine experts panel for pre-screening, we do not count them as applicants for clinical trials,” said Domingo.

“But yes, there have been several companies from all over asking for the requirements and processes for clinical trials,” he added.

One of those who expressed interest is United Kingdom’s Astrazeneca Pharmaceuticals.

“I think they’ve already asked the vaccine experts panel about conducting clinical trials here and they were already given the information on what is required and what the process is,” said Domingo.

“Of course if they would decide to make an application then the government is ready to evaluate. But so far they have not yet submitted (an application),” he added.

With these developments, Domingo reminded the public that there are still no approved clinical trials for COVID-19 vaccines in the Philippines.

“Wala pang approve na clinical trial [No clinical trial has been approved yet]. Yung [The] most advanced is still undergoing evaluation and we hope to have a decision within one to two weeks…either give an approval or a denial,” he said.