FDA cautions public vs. use of unauthorized Covid-19 vaccines

By Ma. Teresa Montemayor

December 28, 2020, 7:07 pm

MANILA – The Food and Drug Administration (FDA) on Monday reminded the public to take extreme caution on the purchase and use of vaccines claiming to be safe and effective against the coronavirus disease 2019 (Covid-19).

In a statement, FDA Director General Eric Domingo reiterated the reminder following reports that certain individuals have received Covid-19 vaccine shots.

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

In coordination with other agencies, the FDA will take appropriate regulatory action involving any unauthorized vaccines and concentrate on ensuring that only vaccines which passed the standards will be made available to the public.

"Rest assured 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. (PNA)