Unauthorized use of COVID-19 vaccine illegal, FDA says after Duterte's PSG inoculated


Posted at Dec 28 2020 04:16 PM | Updated as of Dec 28 2020 04:47 PM

Unauthorized use of COVID-19 vaccine illegal, FDA says after Duterte's PSG inoculated 1

MANILA - The Food and Drug Administration on Monday said it has yet to approve any COVID-19 vaccine candidate for local use, despite admission of government officials that some members of President Rodrigo Duterte's security group were already inoculated with China's Sinopharm vaccine. 

“As of date the FDA has not issued any Emergency Use Authorization to any vaccine for COVID-19. Without the proper authorization, there is no guarantee on the safety, quality and efficacy of said vaccine as the same has not undergone the required technical evaluation by the FDA," said FDA Director General Eric Domingo in a statement. 

The agency also maintained that "manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertisement, or sponsorship of any unauthorized vaccine" remain prohibited.

The FDA said illegal distribution is punishable under the law, and that FDA "will coordinate with other agencies and take appropriate regulatory action involving any unauthorized vaccines."

“Rest assured that the FDA is observing utmost diligence in the regulation of vaccines. Vaccines will only be approved if there is reasonable scientific evidence to show that benefit outweighs risk.” Domingo added. 

“We will concentrate on making sure that only vaccines that pass standards will be made available to the public,” he said.

President Rodrigo Duterte's spokesman earlier urged the public to "just accept" that some soldiers have been inoculated against COVID-19, even if regulators have not yet approved a vaccine for this. 

Some soldiers received the experimental coronavirus candidate developed by Chinese drug maker Sinopharm, said Presidential Spokesperson Harry Roque. 

"Huwag 'yo naman pong ipagkait sa ating mga sundalo kung nagkaroon sila ng proteksyon," he said in a virtual press briefing. 

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