India secures deal for 30 crore Biological-E Covid-19 vaccine doses

The vaccine, which is currently undergoing phase-3 clinical trials, is likely to be available in the next few months, the health ministry said in a statement

The Union Health Ministry has struck an agreement with Hyderabad-based vaccine manufacturer Biological-E to reserve 30 crore of its vaccines for which the ministry would be making an advance payment of Rs 1,500 crore.

The company would manufacture and stockpile the vaccine, currently undergoing phase-III clinical trials after successful phase-I and II evaluations, between August and December.

“The Covid-19 vaccine of Biological-E is currently undergoing phase-III clinical trials after showing promising results in phase-I/II trials. It is likely to be available in the next few months. The proposal of Biological-E was examined and recommended for approval after due diligence by the National Expert Group on Vaccine Administration for Covid-19,” the ministry said in a statement.

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The third phase trial began around 40 days ago at 15 sites across India on 1,268 persons of 18-80 years of age. The trial, sources said, might take at least another two months to complete following which the results will be submitted to the Central Drugs Standard Control Organisation.

Developed jointly with Baylor College of Medicine, Houston, the RBD (receptor binding domain) protein sub-unit vaccine was found to be safe and triggered an immune response in the phase-I/II of clinical trials, involving 360 healthy subjects in the age bracket of 18-65 years. The vaccination schedule consists of two doses administered via intramuscular injection 28 days apart.

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The vaccine candidate has been supported by the Centre from pre-clinical stage with the Department of Biotechnology not only providing financial assistance of more than Rs 100 crore but also by partnering with Biological-E to conduct all animal challenge and assay studies at Translational Health Science Technology Institute, Faridabad.

This is one of the five under-development Covid-19 vaccines that the Centre has taken into account while estimating availability of 216 crore doses by 2021 end to inoculate a target population of 95 crore Indians.