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COVID Vaccines Need FDA Approval, Here's Why It's Important

Soldiers got vaccinated before FDA clearance.
by Arianne Merez
Dec 29, 2020
Photo/s: shutterstock

The Food and Drug Administration (FDA) cautioned Filipinos on Monday against using COVID-19 vaccines that have yet to undergo approval by the agency after some soldiers were inoculated with China's Sinopharm vaccines.

The Philippines has yet to authorize the distribution and sale of any COVID-19 vaccine, FDA Director-General Eric Domingo said as he reiterated that the distribution and sale of unauthorized drugs are against the law.

"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,” he said.

Both Malacañang and the Armed Forces of the Philippines admitted that some soldiers, including members of the Presidential Security Group, were given China's Sinopharm vaccines even though the drugs have yet to be reviewed by the local FDA.

The inoculation of soldiers has drawn criticism since it goes against the government's COVID-19 immunization plan, where health workers are first in line to get vaccinated against the virus once the FDA authorizes the use of a certain drug.

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The FDA said it would 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.

President Rodrigo Duterte earlier allowed the FDA to grant emergency use authorization of COVID-19 vaccines as nations worldwide rush to secure supplies of the highly sought drugs.

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