Hinihintay ng pamahalaan ang pagsusumite ng requirements ng Hyderabad-based Bharat Biotech para sa COVID-19 vaccine clinical trials.
Ayon kay Department of Science and Technology (DOST) Secretary Fortunato Dela Peña, hindi pa nagpapasa ang Indian biotechnology company ng kanilang clinical trial requirements para sa Confidentiality Disclosure Agreement (CDA) kasama ang 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,” sabi ni Dela Peña sa isang pahayagan.
Sinabi ng kalihim na tatlong vaccine developers pa lamang ang inaprubahn na magsagawa ng kanilang Phase 3 clinical trial sa Pilipinas.
Kabilang na rito ang Janssen Pharmaceuticals, Clover Biopharmaceuticals at Sinovac.
“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,” dagdag pa ni Dela Peña.
Sa kaniyang weekly report, sinabi ni Dela Peña na ang CDA ay nilagdaan ng Task Group on Vaccine Evaluation and Selection para sa sa German company na Curevac, kung saan aabot na sa 12 ang napirmahang CDA.
Nasa 19 mula sa 25 vaccine developers ang nakikipagtulungan sa Task Group na naghayag ng interes na magsagawa ng clinical trials sa bansa.
