Illustration: Gabby K./Pexels
Hyderabad: Biological E, Ltd. (BE) is expecting its COVID-19 vaccine Corbevax to be rolled out by the end of November even as the city-based firm is getting ready with 100 million doses for the launch, managing director Mahima Datla said on October 25.
Speaking to reporters on the sidelines of signing a financing agreement with the US International Development Finance Corporation (DFC), she said currently the manufactured doses are being sent to Central Drugs Laboratory (CDL), in Kasauli, Himachal Pradesh, for regulatory testing.
“Corbevax is in phase 3 trials. We are likely to complete all the studies by 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.
BE’s anti-coronavirus shot, Corbevax, is a RBD protein sub-unit vaccine and is currently undergoing phase 2/3 clinical trials on adults. ‘RBD’ stands for the virus’s receptor binding domain.
The Phase 3 trials are going to be a study in comparison with the already licensed vaccines, though the study in children is not a comparative study, she further said.
“We are submitting doses to Kasauli for release. So it is my hope that at the day of launch it is always been our vision to have close to ten crore doses on the day. By end of November this may happen as soon as we get the license,” she said.
On the COVID-19 vaccine manufacturing capacities, she said currently BE has the capacity to make one billion doses of Corbevax per annum, and 600 million doses of Johnson & Johnson’s jab.
BE 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, DFC’s chief operating officer David Marchick and Mahima Datla today unveiled the expansion of BE’s vaccine manufacturing facility here and finalised a US government arrangement formalising $50 million to expand its 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 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,” Mahima Datla said.