DOH to do away with phase 4 trials for COVID-19 drugs, vaccine to expedite procurement

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Health-care workers administer flu and pneumonia vaccines to 75-year-old Lolita Espiritu as part of their community vaccination drive in Barangay Pembo, Makati City on Aug. 12, 2020. George Calvelo, ABS-CBN News

MANILA — The Department of Health (DOH) announced Friday it was letting go of the final phase of clinical trials for COVID-19 drugs and vaccines to "accelerate our national response to the pandemic."

The decision was made after deliberations by the DOH, Health Technology Assessment Council, Food and Drug Administration, and Philippine Medical Association, the health department said in written responses to media.

According to the World Health Organization, phase 4 studies take place after country approval and there is a need for further testing in a wide population over a longer timeframe.

The DOH added that the move had "historical precedent" in other countries.

"Accelerated clinical trials and regulatory approvals in response to threats such as Ebola and Meningitis contributed to mitigating the spread of Ebola and decline in the incidence of Meningitis in the sub-Saharan belt," DOH said. 

The DOH bared this after being sought for comment regarding a provision in the Bayanihan to Recover as One bill (Bayanihan 2), which sets aside the phase 4 trial requirement for any drug under the Universal Health Care Act. 

Bayanihan 2, which this week got the nod of the bicameral conference committee, is designed to authorize President Rodrigo Duterte to swiftly extend assistance to sectors affected by the pandemic, acquire vaccine against COVID-19, and assist government financial institutions.

While it was doing away with the phase 4 trials, the DOH said that as safeguards, it would conduct safety and effectiveness surveillance and keep a database of recipients of the drugs and vaccines.

The Department of Science and Technology said clinical trials in the Philippines for various COVID-19 vaccines would most likely start in the 4th quarter of 2020, while the distribution of approved vaccines to the public won’t start until the 2nd quarter of next year.

Meanwhile, clinical trials for Japanese drug Avigan, which showed promising results for COVID-19 patients, started in the Philippines on Monday.

Besides Avigan, the Philippines also has ongoing clinical trials for anti-viral drug remdesivir through the WHO's Solidarity Trial. 

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