FDA awaits Bharat Biotech’s phase 3 trial interim results

FDA awaits Bharat Biotech’s phase 3 trial interim results

MANILA – Food and Drug Administration (FDA) Director General Dr. Eric Domingo on Monday said India’s Bharat Biotech has yet to submit documents from the clinical trials of its Covid-19 vaccine, Covaxin.

“Hinihintay pa rin namin po ‘yung interim results ng kanilang (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.

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”.

“Totoo po ‘yun kapag na-approve siya sa isang stringent regulatory authority or ‘yung FDA natin na counterpart na advance, mabilis po talaga ang approval. Unfortunately, ito pong Gamaleya mayroon po siyang approval sa ibang bansa (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. (PNA)

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