Manila to wait for FDA consent before using free China shots

HYTTALO SOUZA/UNSPLASH

By Kyle Aristophere T. Atienza
and Vann Marlo M. Villegas, Reporter

THE PHILIPPINES will wait for an emergency use authorization (EUA) from its Food and Drug Administration (FDA) before accepting and using 500,000 doses of coronavirus vaccines donated by China, according to the Health department.

“All vaccines whether donated or procured should have an emergency use approval,” Health Undersecretary Maria Rosario S. Vergeire said in a Viber message on Tuesday.

This was after officials from the Executive branch issued contradictory statements on the matter.

FDA Director General Rolando Enrique D. Domingo on Tuesday said the government could accept and use the Chinese vaccines even without an emergency use authorization from the agency. This is as long as Chinese regulators have approved the vaccines,  he added.

“The Department of Health (DoH) is allowed to accept medications that are not yet registered in the country,” he told an online news briefing. Philippine Health authorities should use the Chinese vaccines under DoH’s strict supervision, he added.

“They have to be very careful and they have to study it very closely whether to accept and use the vaccines because it will become their responsibility,” he said.

He was contradicted hours later by presidential spokesman Harry L. Roque, who said the donated Chinese vaccines must first be approved by the FDA before these could be injected on people.

“That definitely requires an emergency use authorization,” he told a televised news briefing on Tuesday, citing the sheer number of doses. “The law is clear.”

Mr. Domingo later corrected himself. “If DOH accepts the donation, it will have to apply for authorization from the FDA to use the donated vaccines,” he said in a mobile phone message.

China has pledged to donate 500,000 doses of its COVID-19 vaccine to the Philippines, State Councilor and Foreign Minister Wang Yi told President Rodrigo R. Duterte during a meeting at the presidential palace at the weekend.

China’s Sinovac Biotech Ltd. is one of several drug makers who had applied for emergency use authorization from the Philippines for its coronavirus vaccine. The FDA is also evaluating its application for local clinical trials.

The Philippines approved the emergency use of Pfizer, Inc. and BioNTech’s coronavirus vaccine, the first in the country last week. The vaccine has a 95% efficacy rate.

Meanwhile, Mr. Domingo said Beijing’s vaccine donation would not pressure the FDA into approving applications for emergency use from any Chinese drug makers.

Opposition Senator Francis N. Pangilinan on Sunday said China’s gesture should not pressure the FDA and Health Technology Assessment Council (HTAC) to approve the use of Sinovac’s vaccine.

Science, data and the results of clinical trials should be the sole basis and not “political goodwill,” he tweeted.

The DoH reported 1,357 coronavirus infections on Tuesday, bringing the total to 504,084. The death toll rose by 69 to 9,978, while recoveries increased by 324 to 466,249, it said in a bulletin.

There were 27,857 active cases, 86.1% of which were mild, 6.1% did not show symptoms, 4.7% were critical, 2.7% were severe and 0.42% were moderate.

Davao City reported the highest number of new cases at 130, followed by Rizal at 71, Quezon City at 66, Pampanga at 54 and Benguet at 52.

DoH said seven duplicates had been removed from the tally, while 56 recovered cases were reclassified as deaths. Four laboratories failed to submit their data on Jan. 18.

About 6.9 million Filipinos have been tested for the coronavirus as of Jan. 17, according to DoH’s tracker website.

The coronavirus has sickened about 96.1 million and killed about 2.1 million people worldwide, according to the Worldometers website, citing various sources including data from the World Health Organization (WHO).

About 68.7 million people have recovered, it said.

Leave a Reply

Your email address will not be published. Required fields are marked *