Aurobindo Pharma faces delay in getting its COVID-19 vaccine plan rolling

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26 Aug, 2025 12:21

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Aurobindo Pharma, which is in the race to develop and manufacture a COVID-19 vaccine, said there has been some delay in the vaccine development at its partner's end.

Aurobindo said its partner Vaccinity was in the process of seeking emergency use approval (EUA) from Taiwan in the second half of July. But now the approval may come only by September-October.

Aurobindo Pharma had entered into an exclusive agreement with US biotech company COVAXX in December 2020 to develop and manufacture COVID-19 vaccine UB-612 for India and UNICEF. COVAXX was renamed Vaxxinity in April 2021. UB-612 is based on virus-like particle (VLP) or peptide-based platform. Aurobindo Pharma has exclusive rights to develop and commercialise UB-612 in India and to UNICEF, and non-exclusive rights in other select emerging markets. Aurobindo Pharma can supply up to 480 million doses of UB-612 for India and other countries.

"They have already placed orders for 30 million doses (for contract manufacturing), they would pick up based on the approval of Taiwan (regulatory authorities), which is expected in two weeks to a month, based on that the contract manufacturing would begin," said N Govindarajan, Managing Director of Aurobindo Pharma, at the company's earnings call.

India timeline

Moneycontrol learnt from sources that the Indian trials of UB-612 have not yet taken off despite Aurobindo's partner Vaxxinity got a go-ahead from CDSCO to conduct Phase II and Phase III clinical trials in June this year.

"Trials in India to be conducted by the partner, so we wouldn’t be able to comment," Aurobindo spokesperson told Moneycontrol.

The company also said it will not be able to share any anticipated timelines on vaccine launch in India, as it would depend "on the outcome of trials."

Govindarajan earlier said Vaxxinity has appointed certain CROs (contract research organisations) to conduct a clinical trial, and they are expected to initiate it in the next few weeks.

Aurobindo is setting up a new facility to manufacture viral vector vaccines with an investment of Rs 250-Rs 275 crore. The company’s upcoming vaccine facility will have the capacity to manufacture 400 - 450 million doses of COVID-19 vaccines.

Analysts doubt whether the UB-612 vaccine will make it to the Indian market in 2021.

"Delays to get the clinical trials rolling and approvals on time mean that Aurobindo risks losing out on the COVID-19 vaccine opportunity," an analyst at a Mumbai-based brokerage firm, who didn't want to be named, said.

India has so far approved six COVID-19 vaccines -- Serum Institute of India's Covishield, Bharat Biotech's Covaxin, Sputnik V, Zydus Cadila's ZyCoV-D, Moderna and Johnson & Johnson vaccines. While Covishield remains the workhorse for India's COVID-19 vaccines, Covaxin is seeing a ramp-up of supplies. Sputnik V supply also is expected to go up from October.