Food and Drug Administration (FDA) Director General Dr. Eric Domingo on Monday said India’s Bharat Biotech is interested in supplying the country with Covaxin, the company’s vaccine for the coronavirus disease 2019 (Covid-19), but has yet to submit documents from its clinical trials.
“We’re still waiting for the interim results of their Phase 3 trials and they haven’t submitted that, that is our basis for efficacy evaluation,” Domingo said in an online public briefing partly in Filipino.
Last week, Bharat Biotech said it is seeking approval for its Covid-19 vaccine from 40 countries and is already in the process of filing necessary regulatory documents.
Domingo said to date, there are no other applications for emergency use authorization (EUA) from vaccine manufacturers and clinical trials.
Meantime, the regulatory agency is still studying the documents submitted by Gamaleya Institute for Russia’s Covid-19 vaccine, Sputnik V.
Domingo said the agency would not delay Sputnik V’s granting of EUA “once all the requirements are satisfied.”
He was responding to Foreign Affairs Secretary Teddy Locsin’s statement that Sputnik V “should be good to go in a country like ours if advanced countries okay a vaccine”.“It’s true that approval would be quick if the vaccine has been approved by a stringent regulatory authority or advance counterpart of our FDA. Unfortunately, Gamaleya received approval from other countries but none of them from a stringent regulatory authority,” Domingo said. SOVEREIGNPH