Hyderabad-based Biological E. Limited (BE) has launched its Covid-19 vaccine Corbevax for children aged 12-15 years, as India's first recombinant protein subunit vaccine and with claims of being the most affordable Covid-19 vaccine in India as well as globally.

The company has priced Corbevax at ₹990 inclusive of all taxes and vaccine administration charges for the private market and is supplying at ₹145 to the Indian government, Mahima Datla, managing director, Biological E. Limited, said at a press conference. "That pricing will help the exchequer save about ₹1,500 crore," she said.

The vaccine had a few months ago got the Emergency Use Authorisation (EUA) for vaccinating the Indian population between the age group of 12 to 80 years, but the government is currently using it for free administration to children in the 12-15 age group. The vaccine is administered through an intramuscular route with two doses scheduled 28 days apart and can be stored at 2 to 8 degrees Celsius.

The Union Health Ministry in June had capped charges (including GST and administration charges) of Covishield at ₹780, Covaxin at ₹1,410, and Sputnik V at ₹1,145 in private hospitals.

She said the company has set up manufacturing facilities with capability to make one billion doses a year and so far has achieved capacity to make 100 million doses a month. The company has been stockpiling the vaccine for the last few months and has already supplied 50 million doses to the government. The Union Government has placed an order of 300 million doses and the rest of the 20 million doses will be given in 'a short time', in accordance with the ability of states to use the given consignments at the earliest. To date, 300 million vaccines have been produced as part of the commitment made to the Government of India. The company has applied for WHO prequalification and is awaiting inspection from authorities, said officials. Biological E, which has produced 3 billion different vaccines in the last 5 years, is using multiple Biological E facilities in Hyderabad to produce the Covid-19 vaccine.

They said Corbevax was tested among 3,500 plus volunteers in 35 trial sites and induced immune response was indicative of over 90% effectiveness against the ancestral virus strain and 80% above in the case of the Delta strain based on the level of neutralising antibody titers. The vaccine induced immune response demonstrated consistent neutralisation of the ancestral SARS-CoV-2 strain as well as the variants of concern (VoC) such as Beta, Delta and Omicron. Antibody response is also highly persistent for more than six months post vaccination, which was found waning in some of the mRNA vaccines.

The subunit protein vaccine, made through traditional and time tested ways of making vaccines, was developed by Biological E in collaboration with the Texas Children’s Hospital and the Baylor College, US. Dynavax, Inc from USA supported development by providing the adjuvant and THSTI Delhi conducted key immunogenicity testing as part of a comprehensive clinical trial development plan. BIRAC, a division of the Department of Biotechnology, Bill & Melinda Gates Foundation and Coalition for Epidemic Prevention and Innovation (CEPI) provided partial funding during clinical development.

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