FDA: COVID-19 vaccines may arrive in PH before mid-2021 with emergency use authorization order

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FILE PHOTO

Metro Manila (CNN Philippines, November 20) — COVID-19 vaccines may be available in the Philippines earlier than the "best-case scenario" pegged by officials, if President Rodrigo Duterte allows the Food and Drug Administration to grant emergency use.

FDA Director General Eric Domingo on Friday said it is possible the vaccines may arrive in the country before the end of the second quarter of 2021, the ideal timeline set by government officials. He said once vaccine manufacturers receive an emergency use authorization from the FDA of other countries, it will speed up the country's own regulatory review since there has already been a thorough study of the drug's safety and efficacy.

"Yes, I would think so. Once we have the EUA mechanism in place then once nakakuha na sila ng EUA for example sa US FDA, mas mapapabilis talaga ang proseso... That will hasten the process of having them available here," he said in a media forum.

[Translation: Once we have the EUA (emergency use authorization) mechanism in place and once they receive an EUA, from US for example, that will really speed up the process.]

He set Pfizer, Moderna, and AstraZeneca as examples, saying they are planning to apply for emergency use in the US soon. He said it won't take long before they start applying in other countries, including the Philippines.

President Rodrigo Duterte has approved "in principle" the order authorizing FDA to issue EUA to vaccine firms after a rigorous evaluation, Domingo said, but an executive order should be issued. ​Once this order is out, the FDA can cut its six-month review process down to under one month.

Domingo assured the public, their safety will not be compromised with the sped-up process. He said the FDA and Department of Health are already working on strengthening the government's vaccine monitoring efforts to easily spot possible adverse effects after inoculation.

"Kapag ginamit natin siya under emergency use, kailangan very strong naman ang ating surveillance para makita kung mayroon tayong adverse events na darating or kung may nakikitang signals that might make us reevaluate the program or the use of the vaccine," the official said.

[Translation: When we use it under EUA, we need to establish a strong surveillance system so we can see the adverse effects or any sign that we need to reevaluate the use of the vaccine.]