Candidate vaccines will be fairly treated, FDA assures

Published September 24, 2020, 7:28 PM

by Analou de Vera

There will be no special treatment in approving candidate vaccines for coronavirus disease (COVID-19).

Food and Drug Administration (FDA) Director-General Rolando Enrique Domingo gave this assurance on Thursday despite President Duterte’s previous statement that the government will prioritize COVID-19 vaccines developed by China and Russia if proven safe and effective. 

“All of the vaccines will be checked expeditiously and will be evaluated expeditiously. There will be no special treatment for any of the vaccines,” said Domingo in an online forum. 

To note,

“For the FDA, the process will [be the same] for everybody, for all vaccines. It will not vary from vaccine to vaccine,” he added. 

Domingo said that the regulatory processes will be expedited for all applications for COVID-19 candidate vaccines.

“[The] safety and efficacy assurance checks will be the same but what we are going to do is do it faster by employing a team that is really dedicated to it; getting our experts involved to evaluate it quickly,” he said. 

“We will do it faster but all of the steps will still be there and the safeguards,” he added. 

Domingo said part of the evaluation team is vaccine experts panel of the Department of Science and Technology (DOST). 

“Bibilis kasi yung evaluation natin for COVID-19 because unlike with other vaccines before, ngayon meron tayong vaccine experts panel with DOST who will already be doing like a pre-screening. Titingnan na nila yung Phase 1 and Phase 2 clinical data [Our evaluation for COVID-19 will be faster because unlike with other vaccines before, we now have a vaccine experts panel from DOST who will already be doing pre-screening. They will look at Phase 1 and Phase 2 clinical data (of the candidate vaccines)],” he said.

“Yung technical review ng FDA instead of four weeks, kaya na namin gawin in two weeks yan kasi meron ng pre-evaluation [The technical review of the FDA will now be done in two weeks, instead of four weeks, because there is already pre-evaluation],” he added. 

 
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