Aurobindo eyes EUA nod for its vax by end of year

Hyderabad: Pharma major Aurobindo Pharma, which has recently applied to the Drugs Controller General of India (DCGI) for conducting Phase II/III human clinical trials of Covid-19 vaccine candidate UB-612 in India, is eyeing emergency use authorisation (EUA) for the vaccine in India by 2021 end or early 2022.

UB-612 is a multi-tope, synthetic peptide-based Covid-19 vaccine candidate that Aurobindo is developing in collaboration with US-based Vaxxinity, which was formerly known as COVAXX. The vaccine candidate needs just normal refrigeration for distribution. “If everything goes well, we can even look at launch approval in India towards the end of the year or the beginning of next year,” Aurobindo Pharma’s managing director N Govindarajan said in a recent earnings call.

Aurobindo has exclusive rights for developing, commercialising and manufacturing the vaccine in India and UNICEF (United Nations Children's Fund).

Pointing out that the company had just applied for Phase II/III trials approval for UB-612 and also held pre-submission discussions with the regulatory authorities, he said the company does not expect too many queries from the regulatory authorities and hopes to kick off the Phase II/III trials as soon as they get approval.

Govindarajan also indicated the company expects to begin commercial manufacturing at its viral vaccines facility in Hyderabad, which is coming up at an investment of around Rs 250-275 crore and will have a capacity to manufacture around 480 million doses per annum.

“Our viral vaccines facility, all the equipment will be installed and all the qualification for the equipment will be completed by June and from July onwards, our process validation would start. We can start with our commercial batches after the process validation is completed,” Govindarajan said.