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FDA says Chinese firm Sinovac has passed pre-vaccination screening

fda says chinese firm sinovac has passed pre vaccination screening - FDA says Chinese firm Sinovac has passed pre-vaccination screening

THE FOOD and Drug Administration (FDA) on Thursday said Chinese pharmaceutical firm Sinovac Biotech Ltd. is the only company so far to pass the pre-vaccination screening phase locally among three applicants and is expected to begin clinical trials soon.

FDA Director General Rolando Enrique D. Domingo, in a briefing, said out of the three applicants that approached the Department of Science and Technology’s vaccine expert panel, only Sinovac has completed the pre-screening process.

“They applied today with the FDA for clinical trial permission to conduct a clinical trial here,” he said in mixed Filipino and English..

The FDA official said the Sinovac vaccine for the coronavirus disease 2019 (COVID-19) will still go through the local regulatory process despite being already administered in China.

Mr. Domingo said the other two applicants in the pre-screening process, the Gamaleya Research Institute in Russia and Janssen Pharmaceutica of Johnson & Johnson from the United States, are still being studied by the panel.

Meanwhile, Philippine Ambassador to China Jose Santiago Santa Romana said November is the “optimistic” projection as to when China will mass produce vaccines for the COVID-19.

“Hopefully, mass production and distribution will happen in the near future, as early as November and December in terms of production. And it will depend on our capability to receive the vaccines in terms of our facilities, in terms of distribution. So, the prospects are bright in terms of a breakthrough in vaccine,” he said.

He added that even if the Philippines is one of the priority recipients, Chinese pharmaceutical firms will first be assessing the country’s capability to store the vaccines, especially given the tropical climate. — Gillian M. Cortez 

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