Bharat Biotech’s covaxin inches closer to the WHO’s emergency use listing

INDIA – Following an acceptance of its expression of interest by World Health Organization (WHO), Bharat’s covaxin could make it to the emergency use listing (EUL) after providing WHO with additional data.

Bharat Biotech is a pioneering biotechnology company known for its world-class R&D and manufacturing capabilities and is the brainchild behind covaxin among numerous drugs.

The pre-submission meeting of the vaccine maker with WHO has been planned in reference to the WHO EUL guidance document that was uploaded on the WHO website.

A WHO EUL would open doors of several countries for the desi vaccine and put to rest concerns about travel curbs being imposed on those who have taken jabs.

Several countries have been mulling a vaccine passport, with Israel and seven European Union (EU) nations — Bulgaria, Croatia, Czech Republic, Denmark, Germany, Greece and Poland — already putting in place such systems, even as EU is gearing up to implement it from July1.

A review of the covaxin dossier would be fully taken up for review by WHO only if Bharat submits phase 3 clinical trials data.

Bharat has already conducted phase 3 clinical trials on 25800 volunteers across India which has shown the virus to be 78% efficient, it is also conducting another phase 3 clinical trial on 4500 volunteers in Brazil and will expand the trial program in the US.

India has so far given more than 260 million doses of three approved vaccines Covishield, Covaxin and Sputnik V.

With a total case tally of more than 29 million, India is now just behind the United States which has reported over 33 million cases hence the need for more vaccines is now more crucial than ever.

The government aims to vaccinate all Indians by the end of this year, but the drive has been hobbled by slow pace, shortage of doses and vaccine hesitancy.

Though the covaxin was earlier on mired in controversies after an approval by the Drugs Controller General of India (DCGI) during its phase 3 trial, an approval by the WHO would be a major boost against the fight against the corona virus.

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