“Vaxxinity product did not go as (per the) plan. They did not get the approval with TFDA,” said N Govindarajan, Managing Director of Aurobindo Pharma, at the company’s earnings call.
The Taiwan Food and Drug Administration (TFDA) denied EUA for UB-612 in August, citing that the vaccine failed to meet the two efficacy standards for granting EUA in its experts review. The Texas-based Vaxxinity has conducted clinical trials in Taiwan with a local partner United BioPharma Inc.
Govindarajan didn’t comment on status of the licensing agreement. As per the licensing agreement – Aurobindo can terminate the agreement if UB-612 fails to meet clinical end-points or fails in development.
Aurobindo which has entered into licensing agreement in December 2020 with Vaxxinity, was banking on the EUA in Taiwan to develop, manufacture and commercialise the COVID vaccine in India and other countries.
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.
Aurobindo earlier said that Vaxxinity has placed orders for 30 million doses (for contract manufacturing), linked to the approval of TFDA.
To grab a slice of COVID-19 vaccine opportunity, Aurobindo has set up a new facility to manufacture viral vector vaccines with an investment of Rs 250-Rs 275 crore. The company said its facility will have the capacity to manufacture 400 – 450 million doses of COVID-19 vaccines.
“We are open in terms of opportunity for contract manufacturing,” Govindarajan said.
Vaxxinity said in addition to appealing TFDA’s decision, the company is also planning to pursue regulatory approval for UB-612 from one or more regulators in other jurisdictions, along with a three-dose regimen and accelerating development of second COVID-19 product candidate, UB-612A.