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FDA says COVID-19 vaccines could be available by March

VACCINES for COVID-19 (coronavirus disease 2019) could be available in the country as early as March after President Rodrigo R. Duterte’s formal approval of its emergency use.

Food and Drug Administration (FDA) Director General Rolando Enrique D. Domingo said on Thursday an emergency use authorization (EUA) can be granted by January to some vaccine manufacturers.

“It is possible by the first few weeks of January we can give an emergency use authorization,” he said in Filipino during the Palace daily briefing, “and maybe there is a chance that we can have the vaccine in the Philippines by March.”

President Rodrigo R. Duterte signed Executive Order No. 121 on Wednesday, which authorizes the FDA to issue an EUA to coronavirus drugs and vaccines.

With the EO, the approval process by the FDA will be shortened to 21 to 28 days from the usual period of six months.

The issuance of an EUA is already practiced in other countries.

Mr. Domingo said there is a good chance that pharmaceutical firms that already have an EUA from other countries will be granted a local emergency approval when they apply for one.

In a separate briefing on Thursday, Mr. Domingo said the FDA is finishing its guidelines on the EUA applications.

“The applicant for the EUA should comply with our conditions. The first is they should have an EUA from the countries they are from or have an approval from a foreign counterpart of the FDA with strict regulation or a World Health Organization pre-qualification,” he said in Filipino.

He added that even with the swift approval for the drugs and vaccines through the EUA, review on their available data will still be stringent.

He also said that the FDA will conduct a “post authorization monitoring” on those who received the vaccine to check for adverse effects.

Meanwhile, the Department of Health (DoH) reported 1,061 coronavirus infections on Thursday, bringing the total to 435,413.

The death toll rose by 10 to 8,446. Recoveries reached 399,325 with 328 more patients who have gotten well, it said in a statement.

There were 27,642 active cases, 85.2%  of which were mild, 6.9% asymptomatic, 5% critical, 2.6% severe, and 0.28% were moderate.

Davao City and Quezon City reported the highest number of new cases at 92 each, followed by Rizal at 50, Pampanga at 44, and Quezon province at 43.

The DoH said five duplicates were removed from the total case count while three recovered cases were reclassified as deaths.

Around 5.5 million people have been tested for COVID-19, the DoH said on its tracker website. The coronavirus has sickened about 65 million and killed 1.5 million people worldwide, according to the Worldometers website, citing various sources including data from the World Health Organization (WHO). About 45 million people have recovered, it said. — Gillian M. Cortez and Vann Marlo M. Villegas

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