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Manila Bulletin devider Philippines devider National devider 'FDA approval needed for COVID-19 vaccine trials,' DOH reminds Cavite prov'l gov't

'FDA approval needed for COVID-19 vaccine trials,' DOH reminds Cavite prov'l gov't

Published Sep 2, 2020 04:27 pm

The Department of Health (DOH) reminded the provincial government of Cavite that they need to secure the approval of the Food and Drug Administration (FDA) before they could start their planned participation in COVID-19 vaccine clinical trials.

MANILA BULLETIN FILE

DOH Undersecretary Maria Rosario Vergeire emphasized the importance of the regulatory process when it comes to conducting clinical trials for vaccines and medicines. 

“Walang pwedeng mag-umpisa ng any clinical trial kung wala kayong approval ng FDA at wala kayong approval ng ethics review . If you do that, you are violating specific laws, so you will be sanctioned and you will be asked to stop,” said Vergeire. 

“Kailangan na re-regulate ng gobyerno para masiguro natin na magiging ligtas ito para sa ating mga kababayan. Kapag hindi po dadaan sa ganitong proseso, hindi natin masisiguro na ligtas iyan and that might cause harm to our citizens so that we can ensure that it will be safe for our countrymen. If we do not go through this process, we can not be sure that it is safe and it might cause harm to our citizens],” she added.  

Vergeire said that they already notified the research team, who will be leading the trial, on the processes that they need to undertake.  

“Nung Sabado, I read the article at may nagbigay na ng report sa atin, so we immediately contacted the proponent, ito yung leader na magre-research, and we have discuss with him kung ano dapat ang proseso and they should notify DOH ,” said Vergeire. 

“Sa ngayon , they are still trying to negotiate at ipina-final pa rin nila yung kanilang protocol ,” she added.

Recently, Cavite Governor Jonvic Remulla announced that Caviteños will participate in the conduct clinical trials for COVID-19 vaccines in partnership with the De La Salle Medical and Health Sciences Institute that is located in Dasmariñas City, Cavite.  

The candidate vaccines that will undergo the clinical trials are being developed by pharmaceutical companies in the United States and United Kingdom, said Remulla.

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