Biological E (BE) is expecting its COVID-19 vaccine Corbevax to be rolled out by the end of November even as the Hyderabad-based firm is getting ready with 100 million doses for the launch, Mahima Datla, Managing Director, BE, said. Speaking on the sidelines after signing a financing agreement with the US International Development Finance Corporation, she said currently the doses were being sent to the Central Drugs Laboratory, Kasauli, for regulatory testing.
“Corbevax is in phase-III trials. We are likely to complete all the studies by the end of November which is when we are expecting licence [from the drug regulator]. The licence for children should follow one month later. The study in children is underway as well,” she said.
Biological E’s anti-coronavirus shot, Corbevax, is a RBD protein sub-unit vaccine and is currently undergoing phase-II/III clinical trials on adults.
The phase-III trials were going to be a study in comparison with the already licensed vaccines, though the study in children was not a comparative study, she said.
“We are submitting doses to Kasauli for release. So, it is my hope that at the day of launch … it has always been our vision to have close to 10 crore doses on the day. By the end of November, this may happen as soon as we get the licence,” she said.
On the vaccine manufacturing capacities, she said currently BE had the capacity to make one billion doses of Corbevax per annum, and 600 million doses of Johnson & Johnson’s jab.
Biological E had earlier said it entered into an agreement with Janssen Pharmaceutica NV, part of pharma major Johnson & Johnson, for creation and enhancement of production capabilities to manufacture the latter’s COVID-19 vaccine.
Meanwhile, David Marchick, Chief Operating Officer, DFC and Datla yesterday unveiled the expansion of Biological E’s vaccine manufacturing facility and finalised a US government financing arrangement formalising $50 million to expand the company’s capacity to produce COVID-19 vaccines.
“DFC’s partnership with Biological E will support capacity for production of more than one billion vaccine doses by the end of 2022 for India and for developing countries around the world,” Marchick said in a press release.
“We are pleased with the financial support from the US government, especially the DFC, which was announced at the Quad Summit in March 2021. This investment will not only help us augment our capacity to produce more COVID-19 vaccines, but also help the global community that has been relentlessly fighting against the spread of the COVID-19 pandemic,” Datla said.