(Eagle News) – The vaccine expert panel of the Department of Science and Technology (DOST) has recommended China’s Sinovac vaccine for COVID-19 to have its clinical trials here in the country, according to the Food and Drug Administration (FDA).
FDA Director General Rolando Enrique Domingo said that of the five COVID-19 vaccine manufacturers or developers from various countries, it was Sinovac so far which has passed the evaluation by the panel and recommended to the FDA for approval.
“Well, sa pag-uulat po sa atin ng meeting namin kanina with DOST, medyo mga lima na po yata iyong nag-signify ng intention na maggawa ng clinical trial dito sa atin. At may isa po na actually na-endorse na ng vaccine expert panel ng DOST sa FDA, ito po iyong sa Sinovac,” Domingo said in a press briefing.
He said that the final steps for its approval could be finished soon as the FDA is already evaluating this vaccine.
Domingo said that they are only awaiting a few more requirements for the Sinovac’s clinical trial in the country for this to be approved.
He said that other vaccines which have applied for clinical trial in the country are still being studied by the expert panel.
Vaccines which will be used for clinical trial in the country will have an advantage as to the FDA’s approval for its distribution later, he said.
“Siyempre po iyong magki-clinical trial dito, parang may konti po silang bentahe dahil makikita talaga natin kung ano ang magiging epekto ng bakunang ito dito sa ating sitwasyon, sa atin pong kinalalagyan at saka sa mga Pilipino mismo. So mayroon po siyang dagdag na advantage,” he said.
(Of course, those [vaccines] which conducted clinical trials here would have the slight advantage because we can see the vaccine’s effects in our situation here in the Philippines itself. They have this additional advantage)
But Domingo stressed that even if the COVID-19 vaccines have not done clinical trials in the country, it could still get FDA approval for its distribution or use here if their safety and efficacy is proven.
“Pero ang hindi po paggawa ng clinical trial ay hindi naman po ibig sabihin ay hindi na maaaring pumunta at magparehistro or magpa-approve dito sa Pilipinas ang isang bakuna (But if clinical trials were not conducted in the country, this doesn’t mean that a vaccine cannot be registered or get approval here),” he said.
The FDA chief explained that these vaccines could be registered in the country and approved for use if their manufacturers would be able to prove that their vaccines are safe and effective. A history of use and efficacy for Asians would also be a disadvantage
“Kaya lang siyempre po kapag magpaparehistro sila sa atin, pagkatapos hindi dito ginawa ang clinical trial, kailangan maipakita nila na iyong kanilang produkto, halimbawa iyong kanilang bakuna, ay magiging mabisa rin sa mga katulad natin ‘no, kalahi natin – Pilipino o kaya Asyano. At ang produkto nila kapag dinala dito sa Pilipinas, doon po sa environment dito halimbawa, sa init dito, ay magiging stable din at hindi po siya magiging problema,” he explained.
(But if they asked to be registered here, but the clinical trial was done done here, they have to show that their product, for example their vaccine, would also be effective for us — Filipinos or Asians. And their product if brought here in the Philippines, in our kind of enviroment, for example [with the ] the heat here, it would still be stable and would not be a problem)
(Eagle News Service)