Aurobindo Pharma and its partner Vaxxinity have sought the Drugs Controller General of India’s (DCGI) approval to carry out Phase II/III clinical trials of its Covid-19 vaccine, UB-612, in the country.
UB-612 is based on a virus-like particle or peptide-based platform.
In December last year, Aurobindo Pharma signed an exclusive agreement with US biotech firm COVAXX to develop and produce UB-612 for India, as well as the United Nations Children’s Emergency Fund (UNICEF). In April this year, COVAXX was renamed Vaxxinity.
Under the deal, Aurobindo Pharma holds exclusive rights to develop and market the vaccine in India and to UNICEF, in addition to non-exclusive rights in some other emerging markets.
Aurobindo Pharma is equipped to supply up to 480 million doses of the vaccine in India and various other countries.
At an earnings call, Aurobindo Pharma managing director N Govindarajan said that the company anticipates obtaining approval for UB-612 in December this year or January next year.
Initially, Vaxxinity planned to trial the vaccine in Brazil and awaited four to five months to commence the study. With the emergence of variant mutation, the company decided to carry out the trial in India.
In February this year, the Subject Expert Committee (SEC) of the Central Drugs Standard Control Organisation of India reviewed Aurobindo’s proposal and asked the company to submit the Phase II/III trial protocol approved by the Brazilian regulatory authority.
The panel also recommended some amendments to the trial protocol.
Govindarajan added: “We had a pre-submission discussion (with the SEC) to the extent we do not expect too many queries. Most of the queries are taken into consideration. We expect the SEC approval to happen…, we would be starting the trial in India.”
Currently, Vaxxinity is working on obtaining emergency use approval (EUA) for the vaccine from the Taiwanese regulatory authority next month.
Expecting Taiwan approval, Aurobindo Pharma noted that the company plans to commence manufacturing 25 million doses of the vaccine, which can be scaled up with increasing demand.