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Panel of experts preparing for clinical trials of Russian vaccine
Panel of experts preparing for clinical trials of Russian vaccine
The country's panel of vaccine experts is still gathering necessary documents from Russia's Gamaleya Research Institute to complete its evaluation for the conduct of Phase III clinical trials of the latter's COVID-19 candidate vaccine in the Philippines.
"The vaccine experts panel is still asking for some more documents and for some information before they can make a full assessment of the proposal," said Food and Drug Administration (FDA) Director-General Rolando Enrique Domingo.
Domingo noted that the experts are looking at the results of the Phase I and Phase II clinical trial of a candidate vaccine.
“My assumption is that they are waiting for more details of the clinical trial results. Hindi ko eksaktong alam anong documents yun, but I'm sure it has to do with the Phase I and Phase II trials," he added.
“The vaccine experts panel works quite quickly. Once all documents are complete, they can do an assessment in one week because I've seen it with the other applicants. They are just waiting for more information for a complete assessment,” he added.
To note, three vaccine developers are seeking approval to conduct Phase III clinical trials in the Philippines: China’s Sinovac Biotech, Russia’s Gamaleya Research Institute, and Janssen Pharmaceutical Companies of Johnson & Johnson from the United States.
The candidate vaccine of Sinovac has already been cleared by the vaccine experts panel. However, it still needs to secure approval from the Single Joint Research Ethics Board and the FDA.
Unregistered vaccine
In a related development, the FDA is monitoring a facility in Makati City for allegedly selling unregistered COVID-19 vaccines.
Domingo said that they received a report that the facility is selling unregistered COVID-19 vaccines with an advertisement written in Chinese characters.
"Pumunta yung ating mga ahente doon last week. At nangako naman yung administrator ng kanilang facility na hindi raw po totoo. In fact, naglabas din sila ng disclaimer ," said Domingo.
"But of course, we are continuously monitoring at mukhang mapapadalas po ang ating inspection doon sa facility na iyon to make sure na hindi po nagbebenta or nag-a-administer ng unregistered na bakuna ," he added.