The Food and Drugs Administration (FDA) has confirmed that Sinovac, a potential Corona Virus Disease 2019 (COVID-19) vaccine developed by China, has submitted its application on conducting independent clinical trials in the Philippines.
According to FDA Director-General Eric Domingo, Sinovac is the only vaccine that has passed the pre-screening of the vaccine expert panel. The panel has seen “very mild” side effects in the results of the vaccine’s phase 1 and phase 2 clinical trials.
The FDA is also asking Sinovac for other documents such as labeling and study design before it undergoes technical and regulatory review.
According to Department of Health (DOH) Undersecretary Maria Rosario Vergeire, once Sinovac has completed its requirements, and has been granted approval, it may start its phase 3 clinical trials.
“’Yung kanilang documents now are with single joint research ethics board, yung SJ-REB. Kasama ‘yan sa proseso. Kapag nakatapos na sa ethics board at naaprubahan, tutuloy na ito ito doon sa FDA process natin for the clinical trial clearance (Their documents are now with single joint research ethics board (SJ-REB). It is part of the process. Once it is done with the ethics board and has been approved, it will proceed to our FDA process for the clinical trial clearance) .”
Meanwhile, Philippine Ambassador to China Chito Sta. Romana reminded that the Philippines must have enough cold chain storage facilities. He also assured that China prioritizes the country for the vaccine distribution.
“Hopefully, mass production and distribution will happen in the near future, as early as November and December in terms of production. And it will depend on our capability to receive the vaccines in terms of our facilities, in terms of distribution.”
DOH USec. Vergeire assured that “It is not going to be an issue when it comes to warehousing, distribution because hindi ‘yan ganyan karami (it’s not that plenty) as what we envision it to be.”
Report from Mark Fetalco
