FDA PR
Following reports that certain individuals have received vaccines against COVID-19, the Food and Drug Administration (FDA) reiterates its public advisory (FDA 2020-1395-00-A) 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 stated 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.”
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. The 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 said. “We will concentrate on making sure that only vaccines that pass standards will be made available to the public” he added.
