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Manila Bulletin devider Philippines devider National devider Confidentiality data agreements for virus vaccine candidates being finalized

Confidentiality data agreements for virus vaccine candidates being finalized

Published Aug 16, 2020 03:44 pm

Confidentiality data agreements between the Department of Science and Technology (DoST) and partners in China are being finalized to provide the preliminary data of their vaccine candidates for the review of the Vaccine Expert Panel for possible COVID-19 clinical trials in the country.

(PIXABAY / MANILA BULLETIN)

DoST Secretary Fortunato dela Pena announced this during his weekly report. 

Last May, participation in the clinical trials for COVID-19 vaccines were approved by the Inter-Agency Task Force for the Management of Emerging Infectious Diseases (IATF-EID) which includes partners from China. 

Under Resolution No. 39, the country will  collaborate with Adimmune Corp.; Academia Sinica;Chinese Academy of Science - Guangzhou Institute of Biomedicine and Health; and SinoPharma - Wuhan Institute of Biological Products and Beijing Institute.

The resolution stated that collaborating organizations will be provided with the World Health Organization (WHO) requirements for COVID-19 vaccine target product profiles; pre-qualification process for WHO approvals; and the FDA's 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 resolution said.

The agency requires that the study sites will be identified together with the researchers who will be involved in the clinical trials.

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.

"These vaccine candidates are those that the IATF has previously approved to be pursued by the Sub-Technical Working Group (TWG)," Dela Pena said.
Discussions are ongoing with various vaccine manufacturers in India, Japan, Canada, Russia, and the United States.

Dela Pena added that local vaccine manufacturing as well as the country's vaccine development plans were recently discussed by the Technical Advisory Group (TAG) for Vaccine Industry led by the DoST.

On WHO Solidarity vaccine trials, the WHO has yet to release the detailed protocol and the list of candidate vaccines to be evaluated. Meanwhile, preparatory activities are already being undertaken locally. 

The main trial sites will be at the Philippine General Hospital, RITM,  and Manila Doctors Hospital. 

The PGH and RITM have  formed a 16- and 17-person team, respectively, to implement the Solidarity trials. Several other hospitals which will affiliate with the three main sites are being evaluated by the DoST Vaccine Expert Panel.

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