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Duterte approves emergency use of coronavirus vaccines

By Vann Marlo M. Villegas and Gillian M. Cortez, Reporters

PRESIDENT Rodrigo R. Duterte would allow the emergency use of coronavirus vaccines, which would cut the approval process for drugs approved in countries where these were developed, his spokesman said on Thursday.

The President would issue an executive order for the emergency vaccine use, which allows local use after 21 days, shorter than the usual six months required for verification, presidential spokesman Harry L. Roque told an online news briefing.

Mr. Duterte had also approved advanced orders for COVID-19 vaccines to ensure there is supply for the Philippines, vaccine czar  Carlito G. Galvez, Jr.  said at the same briefing.

He said the FDA was fast-tracking the approval process for at least three drug makers that seek to hold clinical trials here.

“The exploratory negotiations are ongoing so the 14 centers and testing requirements are prepared this coming December or January,” he said in Filipino.

Mr. Duterte last month said the government had funds to buy coronavirus vaccines, but it needs more so the entire population of more than 100 million could be inoculated.

He said he would look for more funds so all Filipinos could be vaccinated. The President said he was okay with vaccines developed by Russia or China. About five drug makers intend to conduct coronavirus clinical trials in the Philippines, according to the local Food and Drug Administration (FDA).

They include China’s Sinovac Biotech Ltd., Russia’s Gamaleya Research Institute of Epidemiology and Microbiology and Janssen Pharmaceutical Companies of Johnson & Johnson.

The FDA was now evaluating Sinovac’s application, FDA Director-General Rolando Enrique D. Domingo told an online news briefing in Filipino on Thursday. “It won’t take long before the clinical trials are approved,” he said, adding that the drug maker just had to submit some other requirements.

An expert panel from the Science and Technology department has approved Sinovac’s application. A separate ethics board must also approve the application.

“Only Sinovac has applied officially with the FDA,” Mr. Domingo said in a mobile phone message. “The others are still with the vaccine expert panel,” he said, adding that the FDA and ethics board were evaluating the application simultaneously to speed up the process.

He said drug makers don’t have to conduct clinical trials here. They just have to register for product approval by the FDA, he added.

In the Philippines have an advantage because their results would show that their drugs were effective among Filipino patients, he said.

8,000 DEATHS
The Department of Health (DoH) reported 1,337 coronavirus infections on Thursday, bringing the total to 413,430.

The death toll rose by 41 to 7,998, while recoveries increased by 286 to 374,939, it said in a bulletin.

There were 30,493 active cases, 84.5% of which were mild, 8% did not show symptoms, 4.7% were critical, 2.5% were severe and 0.21% were moderate.

Davao City reported the highest number of new cases at 110, followed by Laguna at 74, Quezon City at 66, Batangas at 54 and Manila at 53.

The agency said four duplicates had been removed from the tally, while 10 recoveries previously tagged as recovered were reclassified as deaths. Eleven laboratories failed to submit their data on Nov. 18, it added.

The coronavirus has sickened about 56.6 million and killed 1.4 million people worldwide, according to the Worldometers website, citing various sources including data from the World Health Organization.

About 39.4 million people have recovered, it said.

Health Secretary Francisco T. Duque III on Tuesday asked Mr. Duterte to issue an order on the emergency vaccine use to fast-track the approval process for coronavirus vaccines.

Moderna, Inc. had informed Science and Technology officials that it does not plan to hold clinical trials here for a coronavirus vaccine it was developing, Health Undersecretary Maria Rosario S. Vergeire said this week. The company claims the drug is 94.5% effective.

Pfizer, which claims its vaccine is 95% effective, also does not plan to conduct clinical trials in the Philippines, she said.

Mr. Duterte said he had spoken with outgoing Russian Ambassador Igor A. Khovaev and was told that Russia intends to set up a pharmaceutical company in the Philippines that will make the vaccines available here.

He said soldiers and the police will be among the first ones to be vaccinated, along with poor Filipinos.

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