Palace: FDA to ensure COVID-19 vaccine is safe before Duterte gets it

The Philippine Food and Drug Administration (FDA) will make sure that the Russia-made COVID-19 vaccine is safe before it will be administered to President Rodrigo Duterte, Malacañang said Wednesday.

Russia on Tuesday became the first country to give regulatory approval to a vaccine despite concerns that it may be putting national prestige before sound science and safety.

Earlier, Duterte expressed his trust in the Russian vaccine, saying he was willing to have himself injected in public.

“The good news is the Russians have declared that they have the vaccine. Whether or not we could actually use it will depend on the compliance on our existing laws because we have a statute that penalizes the use of any drug without prior approval of the FDA,” presidential spokesperson Harry Roque told CNN Philippines in an interview.

“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. The words of the President constitute some 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.”

Roque also said the Presidential Security Group’s (PSG) assessment will be a factor.

“It was perfectly fine for him to offer it because that’s his way of telling the people that ‘I want us to have a vaccine and if I have to be the guinea pig for it, I don’t mind’ because that’s the attitude of the President,” he said.

“He can sacrifice his life for the Filipino people. But as to whether or not PSG will actually allow him is a different thing.”

Sought for comment, PSG commander Colonel Jesus Durante III said they will allow it provided that the vaccine is approved by the FDA and the Department of Health.

Roque also said they will check if the Russian vaccine will be given to the Philippines for free.

“There is still an issue of whether or not it is actually going to be free. The President understands it will be for free but we’re clarifying. Let’s also wait for that clarification,” Roque said.

On Tuesday, the World Health Organization (WHO) said it wants to review the safety and efficacy data of the Russian vaccine.

A total of 168 candidate vaccines are being worked on across the globe, the WHO said.

It said 28 have progressed to the various phases of being tested on humans, of which six are the furthest ahead, having reached Phase 3 of clinical trials.

Meanwhile, despite the recent development in Russia regarding a vaccine against COVID-19, Health Undersecretary Maria Rosario Vergeire on Wednesday said it is still not certain if such a vaccine will be available locally by December.

“Hindi pa po natin masabi kasi nasa Phase 3 pa lang ng clinical trials. Makikita po natin kung paano magpo-progress ito,” Vergeire told Unang Hirit when asked on the possibility of the vaccine's availability by December.

Vergeire said the Philippines is still waiting for the results of the trials of the Russian vaccine. “Itong bakuna galing Russia... ito ay nasa Phase 3 ng clinical trials. Kailangang tapusin muna Phase 3 clinical trials,” she said. —LBG/KG/BM, GMA News