MANILA – The “world’s first” coronavirus disease 2019 (COVID-19) vaccine from Russia still needs to be reviewed thoroughly by the Food and Drug Administration (FDA) before being administered to the public.
Presidential spokesperson Harry Roque said in an interview with CNN Philippines yesterday that just like other medicines, the COVID-19 vaccine being offered by Russia will not be issued a permit by FDA if it did not undergo clinical trial here.
“Before the FDA could approve it, the universities will have to conduct clinical studies to prove that it has no adverse effects. So it is good news but it still has to go through our local processes because we can’t do away with them,” Roque said.
Roque added that President Rodrigo Duterte’s desire to be injected with the COVID-19 vaccine, even if he is not qualified based on the guidelines since he is over 59 years old, could force the FDA to speed up the clinical studies on the vaccine.
“With the President saying he wants to be injected with it, I think the FDA would have to go out of its way to fast-track the clinical studies that are required and it can be done anyway,” Roque said.
“So, the words of the President constitutes actionable policy and it’s a signal also to our local FDA to do everything and anything it can to make sure that it can be administered to the President safely,” he added.
On Tuesday, Russian President Vladimir Putin announced the approval of Sputnik-V, a COVID-19 vaccine developed by the Moscow-based Gamaleya Institute, amid concern and unanswered questions over its safety and effectiveness.
Putin bragged that it was the first-ever approved COVID-19 vaccine in the world even if the treatment is yet to go through crucial Phase 3 trials where it would be administered to thousands of people./PN
