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17 manufacturers want to hold Phl clinical trials

Gabbie Parlade



As countries grapple for a solution to the coronavirus disease, the Department of Science and Technology (DoST) on Friday revealed that 17 vaccine manufacturers have been interested to be the Philippines’ bilateral partner on the COVID-19 vaccine development.

DoST Secretary Fortunato De la Peña said it includes international manufacturers coming from China, Russia, the United States, India, Canada, Taiwan and Australia.

Out of these developers, six have already signed a confidentiality data agreement (CDA) which signified their interest in pushing for a local trial.

“Because of their interest to conduct clinical trial in the Philippines, they’re willing to show us their data and information on the results of their trials in their country, particularly in the phases that have already been completed,” he told reporters.

It includes Russia’s Gamaleya Research Insititute, Austrialia’s University of Queensland, Taiwan’s Adimmune and three from China — Sinovac, Sinopharm and the ZSFW Biologics Company.

Aside from these manufacturers, the Philippines is also part of the World Health Organization Solidarity trial for vaccines which will involves a wider range of qualified candidates.

In estimate, De la Peña said that once a finalized list has already been provided the trial is eyed to start by the last quarter of this year.

He said that ultimately it is expected to last for three to six months as the earliest seen forecast for the release of vaccines may probably be by April of next year.

Based on the zoning guidelines, the volunteers for the trial will be selected among five to 10 barangays with the highest reported number of COVID-19 cases.

Although the WHO solidarity trial will be prioritized due to the country’s existing commitment, De la Peña assured that independent trials will not be deprived of proper sites.

He said that as mandated only one vaccine trial is allowed per area.

Health Undersecretary Maria Rosario Vergeire said that in discussion with the Food and Drug Administration (FDA), they vowed that a prioritized lane has been allotted for the approval of local trials in order to fast track the process.

FDA Director-General Eric Domingo said based on their projection, a WHO pre-qualified vaccine will take up to a maximum of 60 days for it to be evaluated before distribution.

But he said that if the vaccine has a FDA counterpart in its respective countries, the review of the vaccine may be shortened to only up to 45 days.

Meanwhile on other treatment ventures, the Department of Health (DoH) said that it is still awaiting for finalized documents on the clinical trial agreement for the Avigan trials.

Reports have shown that the Japan-made antiviral drug has so far shown a positive feedback in its third phase of the clinical trial where it was said that patients with mild symptoms acquired a reduced amount of recovery time.

Vergeire said that at present, the documents are with the chancellor of the University of the Philippines — Philippine General Hospital — which is considered as one of the possible sites — for its reviewal and final signatories.

The other eyed trial centers also include Dr. Jose N. Rodriguez Memorial Medical Center, Sta. Ana Hospital, and the Quirino Memorial and Medical Center.

Since it has already undergone the approval of the FDA, she said that the trials may start once all documents have already been submitted.

To date, the Philippines has tallied over 296,000 cases of COVID-19 with more than 231,000 recoveries and a death toll reaching 5,000.