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Emergency use of any COVID-19 vaccine not yet authorized -- FDA

Published Dec 28, 2020 05:21 pm

The Food and Drug Administration (FDA) said Monday it has not issued any emergency use authorization of any vaccine for coronavirus disease (COVID-19), reiterating its call to the public to refrain from using unauthorized vaccines.

(PIXABAY / FILE PHOTO / MANILA BULLETIN)

Following reports that some soldiers have received vaccines against the viral disease, FDA called on the public anew on taking extreme caution on the purchase and use of vaccines claiming to be safe and effective in preventing COVID-19.

Director General Eric Domingo stressed that “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,” Domingo said.

The FDA warned that the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertisement, or sponsorship of any unauthorized vaccine is prohibited.

“Commission of such prohibited acts may lead to possible liabilities provided under the law,” Domingo said.

The director general also said they will coordinate with other agencies and take appropriate regulatory action involving any unauthorized vaccines.

The Department of Health, on the other hand, maintained that all vaccines should undergo the evaluation and regulatory process of regulatory and expert bodies.

“We also reiterate that the use of unregistered products poses harm to a person's health and safety. This is why only vaccines which have been approved and found to be safe should be administered,” the Health department said in a statement.

It added that the administration of approved vaccines is also accompanied by strict monitoring of all vaccine recipients in order to ensure proper management of possible effects.

“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 said.

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

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