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Duterte signs COVID vaccine emergency use

PRESIDENT Rodrigo R. Duterte has signed the executive order granting the emergency approval on coronavirus disease 2019 (COVID-19) medicines and vaccines.

On Wednesday, the Palace released EO No. 121, which allows the Food and Drugs Administration (FDA) to issue emergency use authorization (EUA) to coronavirus drugs and vaccines.

“Outside clinical trials and except in cases where a Compassionate Special Permit is issued, no unregistered COVID-19 drug and vaccine may be manufactured, sold, imported, exported, distributed or transferred without an EUA,” the EO states.

Mr. Duterte last month approved in principle the recommendation of the Department of Health (DoH) for EUAs.

An EUA will be issued and remain valid if there is evidence that the drug or vaccine is effective in diagnosing, treating, or preventing the coronavirus; the potential benefits of the COVID-19 drug or vaccine outweigh the risks; and there is no available or not enough alternatives to the drug or vaccine.

Earlier on Wednesday, Secretary Carlito G. Galvez Jr., designated as the country’s vaccine czar, said vaccines could possibly be procured as early as the first quarter 2021.

He was referring in particular to vaccines from China’s Sinovac Biotech Ltd. and Russia’s Gamaleya Research Institute of Epidemiology and Microbiology.

“There is a possibility that our best-case scenario will be shifted to the first quarter. Our best-case scenario that we have presented is more or less May but for now, if we will succeed in negotiating with two to three vaccines from different countries, we might be able to get it during the first quarter,” he said in a briefing.

The government is prioritizing its COVID-19 vaccine purchase from four firms: Sinovac, Gamaleya, AstraZeneca plc, and Pfizer, Inc.

Mr. Galvez also said they are currently in negotiations with other foreign firms, including four US vaccine developers.

He assured that the government is doing its best to acquire vaccines amid the global demand and insufficient supply.

He said around 80% of vaccines have already been pre-purchased by developed countries while 2% were bought by the World Health Organization (WHO) for its Solidarity Trials.

Ang naiwan na lang po talaga sa atin (What is left for us) is 18% and there is really an acute source or supply of vaccine,” he said.

The Philippines has the second highest number of COVID-19 cases among southeast Asian countries, and experts have warned of a potential surge during the December holidays.   

The Health department reported 1,438 new coronavirus infections on Wednesday, bringing the total to 434,357.

The death toll rose by 18 to 8,436 while recoveries increased to 399,005 with 232 more patients who have gotten well, it said in a bulletin.

There were 26,916 active cases, 84.7% of which were mild, 7.1% did not show symptoms, 5.2% were critical, 2.7% were severe, and 0.29% were severe.

Davao City reported the highest number of new cases at 142, followed by Laguna at 89, Quezon City at 80, Manila at 63, and Pampanga at 63.

The department said six duplicates were removed from the total cases count and six recovered cases were reclassified as deaths.

Eleven laboratories failed to submit their data on Dec. 1.

About 5.5 million individuals have been tested for coronavirus, according to the agency’s COVID-19 tracker website. Around 64.2 million people have been infected and around 1.5 million people died of coronavirus globally, according to the Worldometers website, which cited various sources including data from the World Health Organization.

About 44.5 million people have recovered, it said. — Gillian M. Cortez and Vann Marlo M. Villegas

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