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3月4日のまにら新聞から

FDA yet to start evaluation for Sinophaarm COVID-19 vaccine EUA application by local distributor

[ 336 words|2021.3.4|英字 ]

The Food and Drug Administration (FDA) has yet to start evaluating the application for emergency use authorization for China's Sinopharm vaccine, an official said on Wednesday.

In the "Laging Handa" public briefing, FDA Director General Rolando Enrique Domingo said it was not the Sinopharm company that submitted the letter applying for EUA but SouthMed Pharma Corporation, a local company claiming to be the distributor of Sinopharm.

"On Monday afternoon, a local pharmaceutical company distributor submitted a letter online applying for the emergency use authorization for Sinopharm. Unfortunately, there were no documents included. So, we're still asking for the documents so that we can evaluate their application like proof that they are the distributor of Sinopharm in the Philippines; their clinical trial results; certificate of good manufacturing practice of the vaccine," he said.

"So, when they submit all the papers and that's the time we can start the evaluation," Domingo said.

Presidential Spokesperson Harry Roque earlier said President Rodrigo Duterte, who prefers Sinopharm vaccine, would wait for the approval of EUA for the Chinese vaccine by the FDA.

Some of Duterte's security personnel have been vaccinated with a Chinese vaccine last year.

The Presidential Security Group leadership had sought for a "compassionate special permit" from the FDA to use Sinopharm vaccine to other PSG members.

Domingo clarified that the compassionate special permit is not in anyway a guarantee of efficacy and safety of a vaccine.

"When we give compassionate special permit, it's clear for those asking such permit that they are the ones completely responsible for the product. The FDA is not evaluating (the product) because it is registered abroad and not available here, we're granting the permit if the conditions are right," he explained.

In the case of compassionate special permit for Sinopharm, Domingo said whoever is the doctor of the PSG Hospital who requested for the Chinese vaccine, "he's the one completely responsible and we have reminded that the FDA won't evaluate and we can't comment on the safety and efficacy (of the vaccine)." Celerina Monte/DMS