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Pangilinan: Why did FDA allow unlicensed firm to deliver COVID-19 vaccines to Bicol?

By HANA BORDEY,GMA News

Senator Francis Pangilinan on Friday asked the Food and Drug Administration why it allowed an unlicensed logistics company to deliver 7,500 doses of COVID-19 vaccines to Bicol.

His statement came after reports that thousands of AstraZeneca vaccine vials were sent back to the Department of Health due to the defective thermometers used by the logistics firm.

The minority senator argued that the FDA is the one authorizing the logistics companies to transfer and distribute the vaccines.

He cited Section 11(k) of Republic Act 3720 —the law creating the FDA— as amended by RA 9711 which prohibits the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, or retail of any drug, device or in-vitro diagnostic reagent without the license to operate from the FDA required under the same law.

“Sabi ng DOH, ngayong araw, malamang na umabot na ng 700,000 COVID cases natin at 100,000 ang active cases. Tapos mababalitaan nating maaaring nasayang ang libo-libong doses ng bakuna dahil pinayagaan ang hindi lisensyadong logistics company ang mag deliver nito,” Pangilinan said.

(According to the DOH, today our COVID cases is most likely to breach 700,000 and the active cases, 100,000. Then we get reports that thousands of doses of vaccines may be lost because an unlicensed logistics company was allowed to deliver them.)

“Kailangang may managot (Somebody should be held accountable),” he added, suggesting to launch a probe and determine if the company should be blacklisted.

The opposition lawmaker likewise urged the FDA and the Inter-Agency Task Force on Emerging Infectious Diseases to study whether the involved logistics company violated Section 11 of the FDA Law.

FDA director general Eric Domingo said they have nothing to do with the logistics firm and the transport of the vaccines.

"The FDA does not license logistics firms. We only license importers, manufacturers, and distributors. It is the responsibility of the distributors to make sure that products are properly transported," he said in a text message to GMA News Online.

He said DOH is the licensed distributor of vaccines and contracted the logistics company.

The DOH earlier stated that it is looking into

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the reported 'wasted' AstraZeneca vaccine vials.

On Friday, the Health department said the vaccine vials are still potent and can still be used.

Meanwhile, Senator Joel Villanueva raised a similar issue in Central Visayas where it was reported that half of the 30,000 doses of AstraZeneca for medical frontliners which are left unused will be shipped to areas with high-COVID-19 cases following orders from the Department of Health.

The lawmaker suggested to allow local health officials to reallocate the unused vials supposedly for the health workers to the next priority groups.

Villanueva said there should no “round-trips” for the vaccines, noting the “archipelagic nature” of the Philippines.

“Marami tayong isla. Hindi naman tayo isang landmass na pwedeng isakay mo kaagad sa trak. Kung ikakarga ulit sa eroplano, ang laki ng gastos at abala,” he said.

If time is of the essence, then a “no return” policy should be imposed, he added.

Taking advantage of the vaccination set-up in place and inviting other priority recipients is the most practical solution to this dilemma, the senator said.

Earlier this week, the DOH said vaccines unused by March 24 would be transferred to areas suffering the brunt of a fresh surge in COVID-19 cases.

The plan to transport vaccines from one province to another was opposed by local governments and vaccine czar Secretary Carlito Galvez Jr., who pointed out possible logistical bottlenecks.

As of March 23, around half a million individuals have been inoculated with their first dose of COVID-19 vaccine.—AOL, GMA News