MANILA – The Presidential Security Group (PSG) on Wednesday said they will allow President Rodrigo R. Duterte to be inoculated with a coronavirus disease 2019 (Covid-19) vaccine from Russia as long as it has received approval from the Food and Drug Administration (FDA).
“As long as the vaccine is approved by FDA and DOH (Department of Health),” said PSG commander, Col. Jesus Durante, in a text message to reporters.
The FDA is an attached agency of the DOH.
Durante’s statement comes after Presidential Spokesperson Harry Roque said that there is no certainty whether the PSG will allow the President to be injected by the vaccine despite being the first to volunteer.
“As to whether or not (the) PSG will actually allow him, it’s a different thing because already we know that even in the last (state of the nation address), after his address he wanted to shake hands with the members of Congress and PSG did not allow him. So it’s difficult to be President because, in a way, you have limited your free will. The PSG is there to guard you and they are very good at doing their job,” Roque said in an interview over CNN Philippines.
Roque also said Duterte’s willingness to be the first person to be injected could also be taken as a “signal” to the FDA to ensure the thorough review of the vaccine before it is administered to the public.
“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. So, the words of the President constitute 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 said.
Before vaccines are mass produced, Roque said they would first have to undergo clinical trials.
“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,” he said.
Vaccine could also be given for purpose of compassionate use or expanded access, he added.
According to the US FDA, compassionate use is a potential pathway for a patient with an immediately life-threatening or serious disease or condition to gain access to an investigational medical product for treatment outside of clinical trials when no comparable or satisfactory alternative therapy options are available.
In a separate CNN Philippines interview, FDA Director-General Eric Domingo said he would first like to know what “approval process” the vaccine went through.
Domingo raised concern about the Russian vaccine because it has yet to enter Phase 3 or the last phase of clinical trials.
He said the FDA approves vaccines only after the completion of tests on a large number of patients and once the “safety and efficacy” of the vaccines are assured.
Developed by the Moscow-based Gamaleya Institute, the Russian vaccine is named Sputnik-V, a reference to the surprise 1957 launch of the world’s first satellite by the Soviet Union.
On Monday, Duterte accepted Russia’s offer to provide the Philippines with a supply of vaccine and volunteered to be among the first to be injected by the vaccine. (PNA)