No automatic approval for Russia's COVID vaccine in PHL, says FDA exec

The Food and Drugs Administration said Wednesday that the Russia-developed COVID-19 vaccine will still be under the review of the regulatory agency.

Interviewed on Dobol B sa News TV, FDA director general Health Undersecretary Eric Domingo noted the review on the vaccine will take two to four weeks to come up with a decision.

“Ang FDA, sinusuri niya lahat ng data. Kailangna maipakita po sa amin 'yung data, findings, tsaka 'yung scientific na mga information about the vaccine to assure na safe siya at tsaka effective siya,” he said.

“Hindi naman po ibig sabihin porke na-approve na, e approve na po sa lahat. Porke approve na siya sa Russia, e automatic approval dito,” he added.

On Tuesday, Russian President Vladimir Putin announced that Russia became the first country in the world to approve a COVID-19 vaccine after less than two months of human testing, calling it Sputnik V, after the world's first satellite successfully launched into space by Russia in 1957.

Earlier, President Rodrigo Duterte said he had accepted Putin's offer to provide the country with a vaccine against COVID-19 and that he is willing to try it for himself  during clinical trials.

Citing information from a meeting with the World Health Organization (WHO), Domingo said that there were doubts on how Russia jumped to the approval of the COVID-19 vaccine.

“Ang huling update natin ay sa Russia mukhang nasa Phase 2 clinical trial pa lamang at patapos pa lamang. Kaya siguro nagulat din ang buong mundo na biglang kine-claim nila na approved na,” he said.

"Hindi natin alam kung ano 'yung approval process na nangyari sa Russia or baka talagang nag-approve na sila after Phase 2 o kung talagang na-complete nila 'yung Phase 3,’ he added.

Domingo said the FDA will get more information about the approval of the Sputnik V vaccine.

However, "Defeat COVID-19 Ad Hoc Committee" chairperson and former Health secretary Iloilo 1st District Rep. Janette Loreto-Garin said that Russia only released limited information about the vaccine.

“Mahirap po kasi dahil walang transparency sa kanilang scientific data 'yung Sputnik V,” she said in a separate interview on Dobol B sa News TV.

“Kung titingnan mo very limited kasi 'yung kanilang information na nire-release,” she added.

Garin, who is also a vaccinologist, said Russia claimed to start the Phase 3A of the clinical trial on Wednesday, August 12, and to mass manufacture in September. For Garin, this is impossible.

She noted that Phase 3A clinical trial usually encompasses 10,000 to 30,000 subjects. According to her, 80 to 90 percent of trials usually fail at this stage.

Garin said the mass manufacture of vaccines can start  six to eight months after the completion of Phase 3 clinical trial. In emergency cases like the pandemic, three to four months of process is possible.

Based on the plan of Russia, the entire process is reduced to a month, which, Garin said, never happened before.

“I would not agree to the Philippines being part of the Phase 3 simply because we don’t have a copy of their protocol,” she said.

“The world, and the vaccinologists, and WHO are not aware how Russia was able to finish Phase 2,” she added.

For Garin, these details are red flags on the safety of the vaccine. —LBG, GMA News