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FDA ordered to decide on vaccines in 20 days

THE PHILIPPINES’ Food and Drug Administration (FDA) risks being penalized if it fails to decide on product registration applications for coronavirus vaccines within 20 days, according to the agency against bureaucratic red tape.

This would ensure that vaccines and other medical supplies could be quickly rolled out, the Anti-Red Tape Authority (ARTA) said in a statement on Tuesday.

“The processing time for the certificate of product registration should not go beyond 20 days since this is a highly technical transaction,” ARTA Director-General Jeremiah B. Belgica said.

The agency said it had received reports that the initial process before a product could be registered at the FDA had been causing delays.

“Except for justifiable reasons provided in writing, any applications pending beyond the prescribed processing time is already punishable,” Mr. Belgica said.

A law that mandates the efficient delivery of government services and ease of doing business for companies requires agencies to process “highly technical” transactions in 20 days. Failure to do so could result in suspension, dismissal, imprisonment, or fines.

The FDA should approve vaccines and medical products that have been cleared by its counterparts in “other reputable countries,” ARTA said.

The FDA last week said that it would issue emergency use authorization for Pfizer, Inc.’s COVID-19 vaccine within a month.

Emergency authorization will shorten vaccine approval to 21 days from six months. The Pfizer vaccine has been approved by regulators in the United States, United Kingdom, Bahrain, Canada and Saudi Arabia.

VIRUS TALLY

The Department of Health (DoH) reported 937 coronavirus infections on Tuesday, bringing the total to 479,693.

The death toll rose by 58 to 9,321, while recoveries increased by 114 to 448,375, it said in a bulletin.

There were 21,997 active cases, 81.4% of which were mild, 8.5% did not show symptoms, 6.2% were critical, 3.3% were severe and 0.55% were moderate.

Davao City reported the highest number of new cases at 85, followed by Isabela at 54, Agusan del Sur at 49, Pampanga at 48, and Misamis Occidental at 43. DoH said five duplicates had been removed from the tally, while 14 recovered cases were reclassified as deaths. Nine laboratories failed to submit their data on Jan. 4.

More than 6.4 million people have been tested for coronavirus disease 2019 (COVID-19) in the Philippines as of Jan. 3, according to DoH’s tracker website.

The coronavirus has sickened about 86.1 million and killed 1.9 million people worldwide, according to the Worldometers website, citing various sources including data from the World Health Organization (WHO).

About 61.1 million people have recovered, it said.

Health authorities this week said they expect more coronavirus infections by mid-January as testing laboratories become fully operational after the holidays.

Some labs failed to submit data because these were closed during the holidays. Fewer people also got tested last month.

Average laboratory submissions during the holidays fell to about 22,000 from 36,000 daily.

Positive cases nationwide during the holidays dropped by 5%, while cases in Metro Manila declined by 4%.

DoH suspended the license of one laboratory for failing to submit coronavirus test results. Four other laboratories could face similar suspensions, DoH said.

Health authorities earlier urged local governments to work with the National Government in procuring and deploying coronavirus vaccines.

They said only the National Government could order vaccines that were given emergency use authority by the FDA.

But the National and local governments can pool their funds for vaccines, Health Undersecretary Maria Rosario S. Vergeire said on Monday.

The city of Manila has started a pre-registration for free vaccines, allotting P200 million, while Makati City has allocated P1 billion, according to news reports. San Juan City has set aside P50 million, while Pasig City Mayor Victor Ma. Regis N. Sotto said the city had allotted P300 million.

Only Pfizer, Inc. has applied for emergency use of its coronavirus vaccine in the country.

Vaccine czar Carlito G. Galvez, Jr. said at a Cabinet meeting last month the government was in talks with vaccine makers for 80 million doses. — Jenina P. Ibañez and Vann Marlo M. Villegas

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