Unauthorized use of COVID-19 vaccine is illegal, says FDA after inoculation of Duterte’s PSG



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MANILA – The Food and Drug Administration (FDA) said Monday that it has not yet approved any COVID-19 candidate vaccine for local use, despite admission by government officials that some members of the group President Rodrigo Duterte’s security officers were already inoculated with China’s Sinopharm vaccine.

“To date, the FDA has not issued an Emergency Use Authorization for any COVID-19 vaccine. Without proper authorization, there is no guarantee on the safety, quality and efficacy of this vaccine since it has not been subjected to the technical evaluation required by the FDA, “said FDA Director General Eric Domingo in a statement. .

The agency also maintained that “the manufacture, import, export, sale, offer for sale, distribution, transfer, non-consumer use, promotion, advertising or sponsorship of any unauthorized vaccine” remains prohibited.

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

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

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

President Rodrigo Duterte’s spokesman previously urged the public to “just accept” that some soldiers have been vaccinated against COVID-19, even if regulators have not yet approved a vaccine for this.

Some soldiers received the experimental coronavirus candidate developed by Chinese pharmaceutical company Sinopharm, said presidential spokesman Harry Roque.

“Do not deny our soldiers if they have protection,” he said in a virtual press conference.

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