Hyderabad-based vaccine maker, Biological E expects the rollout of its Covid-19 vaccine 'Corbevax' by the end of November and is looking to supply nearly 10 crore doses on the day of its launch.
The company's Managing Director, Mahima Datla on Monday said Corbevax is currently in Phase-3 trials.
"We are likely to complete all these trials by the end of November which is when we expect the license. The license for children should follow one month later but children studies are underway as well," she added.
She said the Phase-3 trials for Corbevax vaccine for adults are a comparative study in comparison with an already licensed vaccine.
She clarified that the study was not for Corbevax as a booster. "The study is for primary immunization. It's head-to-head study. We have a controlled group with a comparative and our group with our vaccine," she added.
Mahima was talking to the media after signing a $50 million financing agreement with the United States International Development Finance Corporation (DFC) Chief Operating Officer, David Marchick.
DFC is providing the finance to the company to support capacity for production of more than one billion doses of Covid-19 vaccines by the end of 2022 for India and developing countries around the world.
She said the company has already begun manufacturing Corbevax and submitting doses to Central Drugs Laboratory (CDL), Kasauli, for release. "It's our vision that on the day of the launch we supply close to 10 crore doses," she added.
Corbevax is manufactured by Biological E jointly with Baylor College of Medicine, Houston, and Dynavax, California.
The Union Health Ministry had announced in June that Biological E will supply 30 crore doses of Corbevax to the Central government by December.
Replying to a query, Mahima said Biological E currently has a capacity to manufacture nearly a billion doses of Corbevax and about 600 million doses of Johnson & Johnson's vaccine.
"We can look to scale this but we have to see dynamics next year. We will be happy to scale this to more than two billion doses, if necessary," she added.
She said Covid vaccines manufactured with the $50 million funding by U.S DFC will be both to meet the needs of India and also for exports. The idea is to act as support for the countries that need the vaccines more both in the Indo-Pacific region and in the rest of the world, she added.
Mahima revealed Biological E was in the process of developing mRNA vaccine which will serve as a strategic technology platform not just for Covid vaccine but also other infectious diseases and immunotherapy. "It's at an early stage. I can't disclose too many details about it," she said.
Founded in 1953, Biological E claims to be the first private sector biological products company in India. It develops, manufactures and supplies vaccines and therapeutics.
The company supplies its vaccines to more than 100 countries and its therapeutic products are sold in India and the US. It currently has eight World Health Organization-prequalified vaccines in its portfolio.