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VACCINES for COVID-19 (coronavirus disease 2019) could be available in the country starting in March after the formal approval of their emergency use by President Rodrigo R. Duterte.
The Director General of the Food and Drug Administration (FDA), Rolando Enrique D. Domingo, said Thursday that an emergency use authorization (US) for January can be granted to some vaccine manufacturers.
“It is possible that by the first weeks of January we will be able to grant an emergency use authorization,” he said in Filipino during the Palace’s daily briefing, “and perhaps there is a possibility that we can have the vaccine in the Philippines by March.”
President Rodrigo R. Duterte signed Executive Order No. 121 on Wednesday, authorizing the FDA to issue an EUA for coronavirus drugs and vaccines.
With the EO, the FDA approval process will be shortened from 21 days to 28 days from the usual six-month period.
The issuance of a USA is already practiced in other countries.
Domingo said there is a good chance that pharmaceutical companies that already have a USA from other countries will get local emergency approval when they apply for one.
In a separate briefing on Thursday, Domingo said the FDA is finalizing its guidelines on US applications.
“The EUA applicant must comply with our conditions. The first is that they must have an EUA from the countries they are from or have an approval from a foreign counterpart from the FDA with strict regulation or a prequalification from the World Health Organization, ”he said in Filipino.
He added that even with the speedy approval of drugs and vaccines through the EUA, the review of their available data will remain strict.
He also said that the FDA will conduct “post-authorization monitoring” of those who received the vaccine for adverse effects.
Meanwhile, the Department of Health (DoH) reported 1,061 coronavirus infections Thursday, bringing the total to 435,413.
The death toll increased by 10 to 8,446. Recoveries reached 399,325 with 328 more patients having recovered, 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% moderate.
Davao City and Quezon City reported the highest number of new cases with 92 each, followed by Rizal with 50, Pampanga with 44, and Quezón province with 43.
The DoH said five duplicates were removed from the total case count, while three recovered cases were reclassified as deaths.
About 5.5 million people have been tested for COVID-19, the Department of Health said on its tracking website. The coronavirus has sickened about 65 million and killed 1.5 million people worldwide, according to the Worldometers website, which cites various sources, including data from the World Health Organization (WHO). About 45 million people have recovered, he said. – Gillian M. Cortez Y Won Marlo M. Villegas
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