Biological E's protein sub-unit vaccine roll out likely in November

Firm plans to make a billion annual doses of the vaccine apart from 600 million J&J doses a year

The much-awaited Biological E protein sub-unit Covid-19 vaccine Corbevax is likely to be rolled out by November end, the company’s senior official said on Monday.

Mahima Datla, managing director, Biological E, said the firm was getting ready with 100 million doses for the launch. “Cobevax is in phase-3 trials. We are likely to complete all the studies by end of November which is when we are expecting a licence (from the drug regulator). The license for children should follow one month later. The study in children is underway as well," she said.

She was speaking to reporters at the sidelines of the event of the US International Development Finance Corporation (DFC), where the firm also received $50 million in funding. The DFC funding will support one billion vaccine doses by the end of 2022 for India and other developing countries around the world.

Datla also added that the manufactured doses of the vaccine are currently being sent to the Central Drugs Laboratory (CDL), Kasauli in Himachal Pradesh for regulatory testing.

"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 (100 million) doses on the day. By end of November this may happen as soon as we get the license," she said.

Biological E has the capacity to make a billion doses of Corbevax annually. As for the Johnson & Johnson (J&J) vaccine it has a capacity to make 600 million doses per year.

The firm can further scale up this capacity to 2 billion doses depending on market demand.

"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.

Apart from a billion Corbevax doses  and 600 million J&J doses, the Hyderabad based company has plans to make 600 million doses of an mRNA vaccine for Covid by 2022.

It has tied up with Canadian firm Providence Therapeutics. The vaccine, named PTX-COVID19-B, is under development in Canada and the plan includes conducting clinical trials in India. Providence will transfer technology to make the vaccine in India, with a minimum production capacity of 600 million doses in 2022 and target capacity of one billion doses.

The Indian government has supported Biological E’s candidate since the pre-clinical stage. The Department of Biotechnology extended a grant-in-aid) of over Rs 100 crore, and also partnered with Biological-E to conduct all animal challenge and assay studies through its Research Institute Translational Health Science Technology Institute (THSTI), Faridabad.

In December last year, the Coalition for Epidemic Preparedness Innovations (CEPI), which is backed by 14 governments, the Bill and Melinda Gates Foundation and UK’s Wellcome Trust, chipped in with an initial amount of $5 million and an option to provide more to produce 100 million doses of the vaccine in 2021.

The global vaccine alliance’s interest in Biological E’s candidate is due to its scalability. In a press statement, CEPI had indicated that Biological E's vaccine candidate has “the potential to be produced at scale, and characteristics which could make it suitable for broad distribution in developing countries”. The Indian government is betting on Biological E for the same reason.

--With Inputs from PTI