AstraZeneca’s application for COVID-19 vaccine trials in PH now with FDA — DOST official

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Metro Manila (CNN Philippines, December 2) — The proposal of United Kingdom-based firm AstraZeneca to hold COVID-19 vaccine clinical trials in the Philippines is now up for the final stage of assessment, according to an official from the Department of Science and Technology.

Dr. Jaime Montoya, executive director of the DOST-Philippine Council for Health Research and Development, told CNN Philippines’ News Night on Wednesday that AstraZeneca’s application has been forwarded to the Food and Drug Administration for regulatory approval.

This came after it passed separate evaluations by a panel of vaccine experts and by the ethics review board, which is also composed of vaccine experts, technical experts, and scientists tasked to recommend possible vaccine candidates for the Philippines.

The FDA, meanwhile, has the final say on which firms will be allowed to conduct clinical trials in the country.

Shortly after Montoya made the disclosure, FDA Director General Eric Domingo said he has yet to receive the endorsement from DOST.

AstraZeneca is currently applying to hold Phase 3 of the clinical trials in the country, wherein a vaccine is tested on larger populations in different countries to confirm its efficacy and safety.

The national government, along with the private sector, inked a deal with the UK company last Nov. 27 for 2.6 million doses of the vaccine. This is expected to be rolled out in the Philippines by June 2021 if it passed clinical trials.

READ: Private sector secures 2.6M doses of AstraZeneca COVID-19 vaccine for PH

According to vaccine czar Carlito Galvez Jr., AstraZeneca is offering its vaccine at $10 or almost ₱500 per dose, making it the easiest and cheapest purchase among vaccine candidates. Meanwhile, the downpayment for every dose is only $5 or nearly ₱250.

However, Galvez also previously admitted the risks in signing the agreement amid doubts on AstraZeneca's efficacy. The drugmaker itself had confirmed that its clinical trials were put on hold twice due to concerns about two study participants who became seriously ill.

The country's COVID-19 task force is looking to administer vaccines from different manufacturers to at least 70 million Filipinos. The vaccination program will be carried out for three to five years with 25-30 million Filipinos vaccinated each year.

President Rodrigo Duterte has, meanwhile, signed an order granting FDA the power to issue emergency use authorization for COVID-19 vaccines and treatments. This directive allows a vaccine to be approved for use within one month instead of undergoing the usual six-month review.