Aurobindo will manufacture the finished doses at its facilities in Hyderabad.
Drugmaker Aurobindo Pharma on Thursday said it has entered into an agreement to develop, commercialise and manufacture U.S. firm COVAXX’s COVID-19 vaccine candidate for India and the United Nations Children’s Fund (UNICEF) agency.
It is the first multitope, synthetic peptide-based vaccine candidate in clinical trials, and does not require special cold storage facilities. Normal refrigeration facilities (no freezing required) would suffice, a release said. This is expected to make the distribution process easier.
The Phase 1 clinical trial for UB-612, the vaccine candidate, by COVAXX is underway. Phase 2/3 trials are expected to begin early in the first quarter of 2021 in Asia, Latin America and the U.S.
Aurobindo and COVAXX have signed an exclusive license agreement under which the Hyderabad-based firm will develop, commercialise and manufacture the vaccine for India and UNICEF. Besides the exclusive rights, Aurobindo, under the agreement, has also got non-exclusive rights for other select emerging and developing markets.
The release said Aurobindo will be produced the finished doses at its facilities in Hyderabad. The company has a capacity to manufacture 220 million doses in multi-dose presentation and building additional facilities that will more than double the capacity, to nearly 480 million doses, by June 2021.
Managing Director N. Govindarajan said: “We are proud to partner with COVAXX in developing the first-ever synthetic peptide-based vaccine to combat the COVID-19 pandemic. This vaccine has immense potential in eliminating shedding and hence containing, the spread of the pandemic.”
COVAXX co-founder and CEO Mei Mei Hu said his company is committed to equitable distribution of UB-612 by prioritising emerging markets where the unmet need is greatest. “During this global health crisis response, we must establish partners with the strongest capabilities, like Aurobindo, to prioritise the development and the delivery of our vaccine,” he said, while describing Aurobindo as the ideal partner to advance UB-612 in India and other emerging countries.