The Philippine government is awaiting the submission of requirements by Hyderabad-based Bharat Biotech for COVID-19 vaccine clinical trials, the Department of Science and Technology (DOST) disclosed Thursday.
DOST Secretary Fortunato dela Peña said the Indian biotechnology company has yet to submit the requirements for clinical trials amid its recent signing of a Confidentiality Disclosure Agreement (CDA) with the Task Group on Vaccine Evaluation and Selection.
"A CDA with Bharat Biotech for their clinical trial in the Philippines was recently signed. Submission of their requirements for clinical trial is being awaited which will be evaluated by the Vaccine Expert Panel and Ethics Board before it is given to FDA for approval,” he told the Manila Bulletin.
He noted that so far, three vaccine developers have been approved to conduct their Phase 3 clinical trial in the Philippines.
These are Janssen Pharmaceuticals, Clover Biopharmaceuticals, and Sinovac, dela Peña said.
“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,” he said.
"Others may have applied but have not gotten endorsements yet from the Vaccine Expert Panel and the Health Research Ethics Board,” the DOST chief added.
In his weekly report on January 22, Dela Peña announced that a CDA has been signed by the Task Group on Vaccine Evaluation and Selection with German company Curevac, bringing the total signed CDAs to 12.
The Task Group inked CDAs with the following vaccine developers: Janssen, Sinovac Biotech, AstraZeneca, Gamaleya Research Institute, Sinopharm Group, Anhui Zhifei, University of Queensland, Adimmune Corporation, Academia Sinica, Tianyuan Biopharma, Bharat Biotech and CureVac.
Dela Peña said 19 of the 25 vaccine developers that are working with the Task Group have signified their interest to conduct clinical trials in the country.
He noted that the 25 vaccine developers hail from 10 countries: six each from China and the United States, three from Chinese Taipei, two each from Russia, Australia, and Germany; and one each from India, Japan, United Kingdom, and Canada.