DOST disclosed that the Philippine government was awaiting the submission of requirements by Bharat Biotech for a vaccine trial.
The Department of Science and Technology (DOST) on Thursday disclosed that the Philippine government was awaiting the submission of requirements by Bharat Biotech for the COVID-19 vaccine clinical trial.
According to DOST Secretary Fortunato dela Peña, Bharat Biotech has yet to submit the requirements for clinical trial amidst its recent signing of a “Confidentiality Disclosure Agreement” with the Task Group on Vaccine Evaluation and Selection.
DOST Secretary Fortunato dela Peña told the Manila Bulletin that a non-disclosure agreement with Bharat Biotech for their clinical trial in the country was recently signed, adding that the submission of their requirements for clinical trial was being awaited which would be evaluated by the Ethics Board and the Vaccine Expert Panel before it was given to the Food and Drug Administration (FDA) for approval.
He also noted that three COVID-19 vaccine developers had been approved to conduct their Phase 3 clinical trial in the country so far — Sinovac, Janssen Pharmaceuticals, and Clover Biopharmaceuticals.
“You should know that there were other CDAs signed in relation to vaccine clinical trial but so far there are only three approved. Others, even if they have signed CDAs, have not yet applied to FDA for clinical trials. Others may have applied but have not gotten endorsements yet from the Vaccine Expert Panel and the Health Research Ethics Board,” dela Peña said.
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Dela Peña announced in his weekly report on January 22 that a non-disclosure agreement had been signed by the Task Group on Vaccine Evaluation and Selection with Curevac, bringing the total signed non-disclosure agreements to 12.
The Task Group signed non-disclosure agreements with the following vaccine developers: Sinovac Biotech, AstraZeneca, Janssen, Gamaleya Research Institute, Anhui Zhifei, Sinopharm Group, University of Queensland, Adimmune Corporation, Tianyuan Biopharma, Academia Sinica, Bharat Biotech, and CureVac.
According to Dela Peña, 19 of the 25 vaccine developers that were working with the Task Group had signified their interest to conduct clinical trials in the Philippines.
He also noted that the 25 vaccine developers hailed from 10 countries: six each from the United States and China, three from Chinese Taipei, two each from Australia, Russia, and Germany; and one each from Japan, India, Canada, and United Kingdom.
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