The Food and Drug Administration (FDA) said that it is still reviewing the data of the coronavirus disease (COVID-19) vaccine developed by China's Sinovac Biotech before these vaccines can be authorized for emergency use in the Philippines.
“Sa ngayon meron pa silang mga huling datos at papeles na sinubmit ng Friday afternoon kaya tuloy-tuloy ang aking mga meeting to evaluate itong mga datos (They submitted another data and documents last Friday afternoon and I’ll have continuous meetings (with local health experts) to evaluate these new data),” FDA-Director General Rolando Enrique Domingo told the DZBB in an interview on Sunday, Feb. 21.
Asked when will the FDA finish its evaluation, Domingo said it “depends.”
“Depende kasi kakadating palang at binabasa pa lahat. Ayaw natin mag allow ng produkto hanggang meron tayong kulang na impormasyon especially kung tungkol sa safety and efficacy ng mga products (It depends because the additional data has just arrived and we need to review it. We don’t want to allow a product (to be used here) when it is still lacking some information, especially when it comes to safety and efficacy),” he said.
“We just want to do extra care and due diligence. Ayaw natin na pag sa huli na eh pag pinayagan at nandito na saka tayo magkakaroon ng problema (We don’t want to encounter problems later on when it is already approved for use here),” he added.
On Feb. 11, Presidential Spokesperson Harry Roque said that the Chinese government will donate 600,000 doses of Sinovac COVID-19 vaccines which are expected to arrive on Tuesday, Feb. 23.
However, Roque said last Feb. 18 that Sinovac has decided to wait for the emergency use authorization (EUA) from the FDA before they will send the vaccines to the Philippines. The Sinovac filed its EUA application last Jan. 13.
Moderna
American pharmaceutical company Moderna has already expressed its interest in applying for an EUA, said Domingo.
“Nung nag meeting kami last week, tinanong ko kailan ba kayo mag-aapply? Sabi nila they are just completing the applications and that they will file soon (When we met last week, I asked when will you apply? They say they are just completing the applications and that they will file soon),” he said.
Domingo said that it would be easy for them to review the data of the Moderna vaccine since it already passed stringent regulatory authorities abroad.
“Ito meron ng EUA from very stringent regulatory authorities katulad ng Amerika. Pag ganyan, napaka dali ng i-review nyan kasi kumpleto papeles and pati yung evaluation report from the US isa-submit iyan sa amin, so hindi na uulitin ng ating experts yung ibang question and answer portions (It has EUA from very stringent regulatory authorities like America. In that case, it is very easy to review because the paperwork is complete and even the evaluation report from the US will be submitted to us, so our experts will not repeat the other clarificatory questions),” he added.