MALACAÑANG expects the clinical trial in the country of several potential vaccines for the novel coronavirus disease (Covid-19) will start before the end of the year.
“We expect involvement in the vaccine clinical trials by the last quarter of 2020 with the Department of Science and Technology (DOST) taking a lead role,” Presidential spokesperson Harry Roque said in a statement on Sunday.
In its resolution No. 39, series of 2020, the Inter-Agency Task Force for the Management of Emerging Infectious Diseases’s (IATF) approved the recommendation of the DOST for the country to participate in clinical trials being conducted by four foreign firms and institutions.
The collaborating organizations include two Taiwan-based firms (Adimmune Corporation; Academia Sinica) as well as a national academy and state-owned firm from mainland China (Chinese Academy of Science-Guangzhou Institute of Biomedicine and Health; SinoPharma-Wuhan Institute of Biological Products and Beijing Institute).
Roque said President Duterte supports the clinical trials, which he hopes will save the life of Filipinos during the Covid-19 pandemic.
Stringent requirements
The said organizations will be required to comply with the World Health Organization’s (WHO) requirements for Covid-19 Vaccine Target Product profiles as well as the prequalification process for the approval of their vaccines.
They must also follow the Food and Drug Administration (FDA) updated guidelines on Clinical Trials.
“Pursuant to the foregoing, the FDA is directed to advise on the process to facilitate the issuance of permit for the conduct of the clinical trial in the Philippines,” the IATF said.
The foreign firms and institutions must identify the sites where the trials will take place as well as researchers who will be involved in the said activities.
“Once clinical trials are finished, these will form part of the requirements for the vaccine registration process by the FDA for issuance of the Certificate of Product Registration (CPR) for market release in the Philippines,” the IATF said.
Local vaccine development
The IATF recommended the creation of a sub-technical working group to be chaired by the DOST to coordinate with the Department of Health (DOH), Research Institute of Tropical Medicine (RITM) and WHO on matters related to the clinical trial.
DOST will also assist local participating institutions in their proposals and budgets; to obtain Ethics Board approvals; and to formalize the agreements related to the clinical trial.
To initiate the country’s “self-reliance and self-sufficiency” for vaccine development, the IATF also backed the proposal of the DOST to create the Virology S&T Institute in New Clark City and the reactivation of the Pharmaceutical Development Unit at DOST-Industrial Technology Development Institute.
Roque clarified the proposal is still waiting for the approval of Duterte.
“If and once approved by PRRD, both can start in 2020,” Roque said.
“We understand that the DOST has included the establishment of the aforesaid research centers in its 2021 Budget Proposal,” he added.
Aside from vaccines, the country is also involved in the clinical trials for potential Covid-19 treatment drugs led by WHO and the Japanese government for a Japanese anti-flu drug, Avigan.
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